5008S Fresenuis Service Manual

5008S
Service Manual
Edition: 9/01.11
Part no.: M46 081 1
0123
Fresenius Medical Care

Page
Table of contents
1 Index
2 Important information
2.1 Important information on the Service Manual ........................................................................ 2-1
2.2 Important information on the device ....................................................................................... 2-2
2.3 Addresses .................................................................................................................................. 2-3
3 Installation
3.1 Important information on the installation / initial start-up..................................................... 3-1
3.2 Initial start-up report ................................................................................................................. 3-1
3.3 Explanations on the initial start-up report .............................................................................. 3-7
4 Specifications
4.1 Dimensions and weight ............................................................................................................ 4-1
4.2 Type label (device identification) ............................................................................................. 4-1
4.3 Electrical safety (classification according to EN 60601-1, IEC 601-1) .................................. 4-2
4.4 Electrical supply ........................................................................................................................ 4-2
4.5 Fuses .......................................................................................................................................... 4-2
4.6 Guidance and manufacturer's declaration on EMC (IEC 60601-1-2:2001) ........................... 4-3
4.7 Operating conditions ................................................................................................................ 4-5
4.8 External connection options .................................................................................................... 4-6
4.9 Override conditions................................................................................................................... 4-6
4.10 Operating programs .................................................................................................................. 4-7
4.11 Dialysate circuit and safety systems....................................................................................... 4-8
4.12 Extracorporeal blood circuit and safety systems ................................................................ 4-11
4.13 DIASAFE®plus ......................................................................................................................... 4-13
4.14 OCM .......................................................................................................................................... 4-13
4.15 ONLINEplus™ .......................................................................................................................... 4-13
4.16 Single-Needle (option) ............................................................................................................ 4-14
4.17 BPM (option) ............................................................................................................................ 4-14
4.18 BTM (option) ............................................................................................................................ 4-15
Fresenius Medical Care 5008S SM-EN 9/01.11 iii

Chapter :
4.19 Network..................................................................................................................................... 4-16
5 Setup
5.1 SYSTEM SCREEN settings ....................................................................................................... 5-1
5.2 Operator setup ........................................................................................................................... 5-2
5.3 Technician's setup .................................................................................................................. 5-29
6 TSC / maintenance
6.1 Important information regarding the procedure..................................................................... 6-1
6.2 Accessories and supplies......................................................................................................... 6-2
6.3 TSC / MA test report ................................................................................................................. 6-2
6.4 Explanations on the TSC / MA test report ............................................................................... 6-7
6.5 TSC report ................................................................................................................................ 6-31
7 Error messages
8 Tools (service equipment)
9 Calibration / adjustment
9.1 Selecting the Service menu ...................................................................................................... 9-1
9.2 Service menu, contents ............................................................................................................ 9-1
9.3 Flow diagram.............................................................................................................................. 9-1
9.4 Calibrate ..................................................................................................................................... 9-2
9.5 Diagnostics ................................................................................................................................ 9-9
9.6 Setup......................................................................................................................................... 9-12
9.7 Module ...................................................................................................................................... 9-12
9.8 Various...................................................................................................................................... 9-12
9.9 Update....................................................................................................................................... 9-12
10 Repair
10.1 Precautions for working on the hemodialysis system......................................................... 10-1
10.2 Component overview .............................................................................................................. 10-2
iv Fresenius Medical Care 5008S SM-EN 9/01.11

Page
10.3 Assembly of components..................................................................................................... 10-10

10.4 Equipment .............................................................................................................................. 10-12
10.5 Placing the system on its side / carrying the system ........................................................ 10-13
10.6 IV pole..................................................................................................................................... 10-14
10.7 Housing .................................................................................................................................. 10-15
10.8 Monitor ................................................................................................................................... 10-19
10.9 Updating the monitor operating system M1 ....................................................................... 10-26
10.10 Power supply unit and power cable .................................................................................... 10-27
10.11 Extracorporeal Blood Circuit Module EBM ......................................................................... 10-28
10.12 Hydraulics .............................................................................................................................. 10-48
10.13 Cart, braking mechanism and concentrate container holder............................................ 10-66
10.14 Removing and installing the battery.................................................................................... 10-69
10.15 Checking the network interface ........................................................................................... 10-70
10.16 Printed circuit boards ........................................................................................................... 10-72
11 Functional description
11.1 Complete system..................................................................................................................... 11-1
11.2 P.C.B.s, overview..................................................................................................................... 11-3
11.3 Monitor ..................................................................................................................................... 11-4
11.4 EBM (Extracorporeal Blood Circuit Module)......................................................................... 11-6
11.5 Hydraulics (block diagram / description) .............................................................................. 11-8
11.6 Power supply unit.................................................................................................................. 11-10
11.7 Pneumatics ............................................................................................................................ 11-12
11.8 Hydraulics (flow diagram / legend / description)................................................................ 11-14
11.9 Endless rinse program.......................................................................................................... 11-18
12 Service program (option)
Fresenius Medical Care 5008S SM-EN 9/01.11 v

Chapter :
vi Fresenius Medical Care 5008S SM-EN 9/01.11

Chapter 1: Index
1 Index
How to use the index: Index entry 1-3, for example, refers to chapter 1, page 3.
A BVM 5-27 EMC 4-3

Emergency 5-21
Accessories and supplies 6-2
Addresses 2-3 C Emergency (button) 5-21
Air bubble detector 4-12 Calibrate 9-2 Equipment 10-12
Air bubble detector ABD 10-42 Calibration / adjustment 9-1 Error messages 7-1
Air bubble detector ABD, removing Carrying the 5008S dialysis Explanations on the TSC / MA test
and installing 10-42 system 10-14 report 6-7
Air bubble detector settings 5-33 Cart 10-66 External connection options 4-6
Alarm override 4-7 Cleaning programs 4-8 Extracorporeal Blood Circuit

Module EBM 10-28
Alarm processing 5-15 Component overview 10-2
Anticoagulation 5-3 Concentrate container holder
AquaUNO 4-6 10-66 F
Arterial pressure measurement Concentrate rinse chamber, Flap lid 10-63
unit, removing and installing 10-33 removing and installing 10-51 Float switch S01 of the water inlet
Audible alarm 4-13 Concentrates 4-10 chamber, removing and installing
10-48
Audible alarm suppression 4-7
D Flow alarm 4-11
Auto On 5-20
Flow diagram 9-1, 11-14
AutoFlow 4-10 Define options 5-17
Flow diagram, description 11-17
Auto-Single-Needle 4-14 Degassing orifice, removing and
installing 10-65 Flush 4-8
Auto-sub 5-23
Diagnostics 9-9 Functional description 11-1
Dialysate flow 4-10 Fuses 4-2
B
Dialysate temperature 4-10
Balancing chamber, removing and
installing 10-57 Dialyzer coupling, removing and G
installing 10-18 Gear pump drive, removing and
Battery, removing and installing
10-69 Dialyzer holder, removing and installing 10-57
installing 10-18 Graphic time scale 5-1
bibag® connector 10-62
DIASAFE®plus 4-13 Grip handle of the occlusion
Bicarbonate rinse chamber,
removing and installing 10-53 Dimensions 4-1 clamps, removing and installing
Disinfectant valve V20 10-64 10-41
Blood leak detector 4-8
Blood leak detector, removing and
installing 10-55 E H
Blood pressure 4-14 EBM doors 10-28 Heat exchanger, removing and
Blood pump 5-2 installing 10-59
EBM, block diagram 11-6
Body temperature control 4-15 Heater rod, removing and
EBM, description 11-7
installing 10-61
BPM 5-27 EcoFlow 4-10
Heparin pump 4-12
Braking mechanism 10-66 Electrical safety 4-2
Heparin pump drive, removing and
Braking mechanism, removing and Electrical supply 4-2 installing 10-45
installing 10-66
Electromagnetic compatibility Heparin pump grip handle,
BTM 5-28 (EMC) 4-3 removing and installing 10-42
Fresenius Medical Care 5008S SM-EN 9/01.11 1-1

Chapter 1: Index
Heparin pump length sensor, Media supply rail, opening 10-15 Power supply unit, description
removing and installing 10-44 Miscellaneous 5-26 11-11
Hydraulics 10-4, 10-5 Monitor 10-19 Power supply unit, removing and
Hydraulics legend 10-8 installing 10-27
Monitor M1 operating system,
Hydraulics, block diagram 11-8 updating 10-26 Preparation 4-7
Hydraulics, description 11-9 Monitor transport protection 10-25 Pressure holding test 4-9
Monitor, block diagram 11-4 Pulse 4-15
I Monitor, description 11-5
Identification 2-1 Moving the hemodialysis system Q
to a horizontal position 10-13 Quick guide 12-1
Important information on the
installation / initial start-up 3-1
Important information regarding N R
the procedure 6-1 Network (LAN) 4-16 Recirculation measurement 4-15
Ingress of fluid via the pressure Network interface 10-70 Reinfusion 5-3
line 10-34
Removing and installing the air
Initial start-up report 3-1
O bubble detector ABD 10-41
Initial start-up report, explanations
Occlusion clamp, removing and Repair 10-1
3-7
installing 10-33 Rinse/reinfusion volume 5-3
Installation 3-1
OCM 4-13, 5-26 Room temperature 5-28
International service 2-3
ONLINE (bolus) 5-23
ISO-UF (Sequential therapy) 4-7
IV pole, removing and installing
ONLINEplus™ 5-23 S
10-14 Operating conditions 4-5 Self-cutting screws 10-11
Operating programs 4-7 Service menu, contents 9-1
K Operator setup 5-2 Service menu, selecting 9-1
Optical detector 4-12 Service program (option) 12-1
Kinking (BLK) 5-28
Override conditions 4-6 Settings EBM 5-31
Kinking / clotting 5-28
Kt/V warning 5-26 Settings Hydraulics 5-30
P Settings, SYSTEM SCREEN 5-1
L P.C.B. LP 1131 10-86 Setup 5-1, 5-2
P.C.B. LP 1142 10-92 Shunt interlock, removing and
LAN (network) 4-16
P.C.B.s, overview 11-3 installing 10-16
Level detector 4-12
PatientCard 5-22 Side panel, opening 10-15
Level detector, removing and
PC board 10-99 Single programs 5-20
installing 10-47
PC service software 12-1 Single-Needle 4-14, 5-26
Loudness (audible alarm) 5-1
Placing the system on its side / Single-Needle Click-Clack 4-13,
LP 1105 10-78
carrying the system 10-13 5-26
LP 1106 10-80
Pneumatics of the arterial Single-Needle pressure
LP 1107 10-82 transducer with internal
pressure measurement unit, check
LP 1140 10-88 10-36 compliance chamber, check for
LP 1141 10-90 leakage 10-38
Pneumatics, block diagram 11-12
LP 1145 10-96 SN chamber 4-14
Pneumatics, description 11-13
LP1134-1 10-87 SN hydrophobic filter (WET) 5-15
Power cable, removing and
installing 10-27 SNAPLOC attachment 10-10
M Power supply unit, block diagram Specifications 4-1
11-10 Stroke volume 4-14
Manufacturer 2-3
Substitution 5-23
1-2 Fresenius Medical Care 5008S SM-EN 9/01.11

Chapter 1: Index
T
T1 test 4-7
Technician's setup 5-29
Time 5-1
Tools (service equipment) 8-1
Transmembrane pressure 4-8
TSC / MA test report 6-2
TSC / maintenance 6-1
TSC report 6-31
Type label 4-1
U
UF pump 10-56
UFC measurement 4-9
Ultrafiltration 4-9, 5-14
User interface 5-16
V
Ven. hydrophobic filter (WET) 5-15
Venous pressure measurement
4-12
Venous pressure transducer,
check for leakage 10-36
W
Water inlet flow regulator,
removing and installing 10-54
Weekly programs 5-20
Weight 4-1
Wrench torques 10-11

Chapter 1: Index

Chapter 2: Important information
2 Important information
2.1 Important information on the Service Manual
2.1.1 How to use the Service Manual
Identification The document can be identified by the following information on the title
page and on the labels, if any:
– 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 1/01.05, for example, refers to: 1st edition,
January 2005.
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.
Changes Document changes will be released as new editions or supplements. In

general, this manual is subject to change without notice.
Reproduction Reproduction, even of extracts, may only be performed with written

authorization.
2.1.2 Significance of the safety precautions
Explanation of the Caution and Note symbols used:
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.

2.2 Important information on the device
2.2.1 Technician's qualification
Purpose This technical document is intended for service technicians and is to be

used for first studies (to acquire a basic knowledge) and for reference
purposes (for TSC, maintenance and repair). The study of this
document, however, does not replace the training courses offered by
the manufacturer.
Requirements Knowledge of the current Operating Instructions of the respective

device.
The technician must be proficient in mechanics, electrical and medical
engineering.
2.2.2 Precautions for working on the device
Authorized persons Assembly, extensions, adjustments, modifications or repairs may only

be carried out by the manufacturer or persons authorized by him.
Test equipment and The activities described in this technical document require the
accessories availability of the necessary technical measuring equipment and
accessories.
Specifications Any information on the specifications must be observed.
Precautions Before turning power on, repair any visible damage.

Prior to opening the device and when working on the open device, the
following precautions have to be observed:
– Protect the components against ingress of fluids.
– Do not touch live parts.
– All plugs, connections and components may only be disconnected or
connected if de-energized.
ESD precautions When repairing the device and when replacing spare parts, observe the
applicable ESD precautions.
Monitor support arm If the hemodialysis system is to be placed in a horizontal position for
servicing, the monitor support arm must be protected with the transport
protection to prevent it from flipping over.
To be observed after Disinfection, a T1 test and a check of the electrical safety (see Service
working on the device Manual chapter 6) must be performed after working on the device.
To be observed after After a disinfection program has been stopped or if the system is to be
stopping a disinfection preserved, the hemodialysis system must be disconnected from the
program water supply after a maximum of 3 days. When the system is returned
to use, check that the pressure of the water supply meets the prescribed
minimum pressure.

2.3 Addresses
Please address any inquiries to:
Manufacturer Fresenius Medical Care AG & Co. KGaA

D-61346 Bad Homburg
Germany
Phone: +49 (0)6172 609-0
www.fmc-ag.com
International Fresenius Medical Care

service Deutschland GmbH
Service Support International
Hafenstrasse 9
D-97424 Schweinfurt
Germany
Phone: +49 (0)9721 678-333 (hotline)
Fax: +49 (0)9721 678-130
Local service


Chapter 3: Installation
3 Installation
3.1 Important information on the installation / initial start-up
For initial start-up only This technical document is only intended for the initial start-up. This
technical document is not intended for recommissioning devices that
have been removed from service or have temporarily been taken out of
service.
Environmental conditions Variations in temperature during transport may lead to condensation

water developing on conducting parts. In the event of major variations
in temperature, allow sufficient time for the system to adjust to the
ambient temperature before start-up.
Tester's qualification The tests must be performed by the Technical Service of Fresenius
Medical Care or a person authorized by them.
The tests may only be performed by persons who are qualified to
properly perform the specified checks owing to their educational
background and training, their knowledge and experience gained in
practice. Furthermore, the persons performing the tests must not be
bound by any directives when performing this activity.
accessories.

TSC / MA intervals The TSC / MA procedures on this device are to be performed after 24
months.
3.2 Initial start-up report
See following pages.


5008S Initial start-up report Fresenius Medical Care
Technician's name: Customer / customer no.:
Type including option(s) / Device no.: Inventory no.:

Software version:
Service report number: Operating hours: Equipment code:
No. Description Oper. cond. Correct. Meas. 

value
1 Unpacking
1.1 Unpack the device. Off – – 
1.2 It has been verified that all parts of the device are included in the Off – – 
delivery.
1.3 Device without visible shipping damage. Off – – 
2 Visual inspections
2.1 Labels and inscriptions are present and legible. Off – – 
2.2 The mechanical condition permits further safe use. Off – – 
2.3 There are no signs of damage or dirt. Off – – 
2.4 The power cable shows no signs of damage. Off – – 
3 Preparation
3.1 Arterial and venous occlusion clamps checked. Off – 
3.2 Transport protection for the monitor support arm removed and Off – 
stored.
3.3 Insert IV pole into the monitor support arm and secured with a Off – 
threaded pin. (Torque: 90 Ncm)
3.4 Dialyzer holder mounted. (Torque: 130 Ncm) Off – 
3.5 Shipping plug removed from the overflow. Off – 
3.6 Connect the water supply tubing. Drain tubing connected. Flush Off – 
tubing (option) connected.
Tubings protected from slipping out. Off – 
Standard: Length 3 m, internal diameter 6 mm
Tubing dimensions adjusted: SERVICE, – 
Length ____ m, internal diameter ____ mm SETUP
3.7 Antifreeze rinsed out. Mandatory – 
Ensure that no disinfectant container is connected. rinse
3.8 CDS tubing connected and protected from slipping out. Off – 
Shrink tube marking for the CDS tubing applied.
Off – 


value
3.9 Filter change program selected. CLEANING – 
Connect the filter. DIASAFE®plus / ONLINEplus™ SCREEN,
In the SERVICE menu, delete mandatory disinfection. Filter change
Then completely run the rinse program.
4 Setup
4.1 Setup checked on the hemodialysis system. SERVICE, – 
(Technician's setup / Operator setup) SETUP
5 Water inlet flow
5.1 MaxWaterFlow checked. SERVICE,  Yes 
Desired value: 1300 ml/min to 1550 ml/min. FLOW  No ______
DIAGRAM
6 Dialysate pressure
6.1 Zero point S03 / S07 checked. SERVICE,  Yes 
Check S03. 0 mbar ±30 mbar CALIBRATE  No ______
Check S07. 0 mbar ±30 mbar ______
Check the difference S03 / S07. Difference |(S03 - S07)| ≤ 20 mbar ______
7 Blood leak detector
7.1 Blood leak checked. SERVICE,  Yes 
Desired value: 4.8 V to 5.2 V CALIBRATE  No ______
7.2 Dimness checked. SERVICE,  Yes 
8 Temperature / conductivity (39 °C)
8.1 Temperature: Specified value 39.0 °C, flow 800 ml/min SERVICE,  Yes 
Comparison of sensors PT7, PT8 and PT9 CALIBRATE  No
(Bypass, open the shunt interlock):
Difference |(PT7 - PT8)| ≤ 0.1 °C ______
Difference |(specified value - PT7)| ≤ 0.2 °C ______
Mean value = (PT7 + PT9) / 2
(No bypass, close the shunt interlock):
Difference (mean value - specified value) +0.2 °C to -0.5 °C ______
8.2 Conductivity SERVICE,  Yes 
Display of the hemodialysis system: 14.5 mS/cm to 15.7 mS/cm CALIBRATE  No
Comparison of sensors CD7 and CD9
Difference |(CD7 - CD9)| ≤ 0.2 mS/cm ______
Difference |(Expected value - CD7)| ≤ 0.7 mS/cm ______
9 Degassing
9.1 Degassing calibrated. SERVICE, – 
CALIBRATE
10 Check of the electrical safety
according to EN 62353:2008, IEC 62353:2007
10.1 Visual inspections performed according to item 2. Off 
10.2 Protective earth resistance measured. Off 
Max. 0.3 Ω (with power cable) ____ Ω


value
10.3 Measurement of the device leakage current performed. Preparation – 
 Device leakage current - differential current measurement
according to fig. 5
or
 Device leakage current - direct measurement according to fig. 4
Nominal voltage of power supply: _______ V
Device leakage current mains polarity 1: _____ μA
with line voltage: _______ V
scaled to nominal voltage
(maximum 500 μA, see Additional requirements) ___ μA
11 Final checks
11.1 Error memory erased. SERVICE, – 
CALIBRATE
11.2 Calibration data and setup settings saved. SERVICE, – 
CALIBRATE
11.3 T1 test performed. T1 test – 
(Perform additional checks only after completion of the T1 test.)
11.4 Arterial pressure display
11.4.1 Zero point of arterial pressure display checked Preparation 
Desired value: 0 mmHg ±5 mmHg ______
11.4.2 Slope of the arterial pressure display checked for a built-up Preparation 
pressure of approx. 280 mmHg. Desired value: built-up pressure ______
±5 mmHg
11.5 Venous pressure display
11.5.1 Zero point of venous pressure display checked Preparation 
11.5.2 Slope of the venous pressure display checked for a built-up Preparation 
pressure of approx. 280 mmHg. Desired value: built-up pressure ______
±5 mmHg
11.6 Temperature / conductivity (37 °C)
11.6.1 Temperature: Specified value 37.0 °C, flow 800 ml/min Preparation  Yes 
Comparison of sensors PT7, PT8 and PT9  No
(Bypass, open the shunt interlock):
Difference |(specified value - PT7)| ≤ 0.2 °C ______
11.6.2 Conductivity Preparation  Yes 
Display of the hemodialysis system: 12.8 mS/cm to 14.0 mS/cm  No
Difference |(CD7 - CD9)| ≤ 0.2 mS/cm ______
Difference |(Expected value - CD7)| ≤ 0.7 mS/cm ______
11.7 Disinfection program performed. Cleaning – 
(with Puristeril® 340 or Puristeril® plus or Diasteril® or Citrosteril®)


value
11.8 Alarm function during the disinfection program checked. Cleaning – 
Open the shunt interlock.
Audible alarm and status indicator
11.9 Absence of residual disinfectant checked by means of test strips. After cleaning – 
(not with Citrosteril®)
11.10 Entries recorded in the medical device register and on the machine Off – 
card.
11.11 Operating Instructions and accessories package complete and Off – 
match the device.
Test equipment used:

Temperature, conductivity, pressure (type, serial number):
__________________________________________________________________________________________________
Protective earth resistance, leakage current (type, serial number):
__________________________________________________________________________________________________
Comments:
Date: Signature: Stamp:
The device has been released for its intended use.  Yes
(Attach inspection label)  No
Date of next inspection:
Comments:

3.3 Explanations on the initial start-up report
Identification Technician's name:

Technician's first name and surname.
Device type including option(s) / software version:
Device name with possible options or extras. Software version, if
available.
Service report number:
Number of the service call.
Customer / customer no.:
Number of the final customer.
Device no.:
Serial number indicated on the type label.
Inventory no.:
The device's inventory number.
Operating hours:
Operating hours, if a time meter is installed.
Equipment code:
The equipment code attached to the device.
(e.g. EC xxx, E-code xxx)
Re 1 Unpacking
Re 1.1 Unpack the device.

Remove the device from its transport packaging and save the
packaging for possible future return shipments.
Re 1.2 It has been verified that all parts of the device are included in the
delivery.
Check that all parts of the device have been accounted for. Inform your
contact at Fresenius immediately of any missing parts.
Re 1.3 Device without visible shipping damage.

Check that all components of the device have been accounted for,
check for any visually detectable damage and contamination affecting
safety.
Re 2 Visual inspections
Re 2.1 Labels and inscriptions are present and legible.

Operating condition: Off

Front view:
bibag®flap and flap for suction tubes: Warning - risk of scalding and
caustic burning
Below bibag® flap: reference to bibag®
Rear view:
IV pole: maximum load warning.

Upper area: warning - risk of tilting, type label.
Between Filter 1 and Filter 2: Warning - risk of scalding and caustic
burning.
On the filter holders, Filter 1 and Filter 2: Warning - risk of scalding and
caustic burning.
Disinfectant connector: warning - risk of caustic burning
Hydraulics connectors: potential equalization, ZKV/CDS, warning - risk
of scalding and caustic burning, accumulator.

Right side:
Below shunt door: Warning - risk of scalding and caustic burning,

arrows on dialyzer connectors.
Re 2.2 The mechanical condition permits further use.

There must not be any damage or dirt affecting the electrical and
mechanical properties.
The following and other checks must be performed:
– The monitor can be swiveled and stays in the position desired.
– If its brakes are not locked, the carriage can be moved as desired.
Check the brake.
Re 2.3 There are no signs of damage or dirt.

– Check EBM, concentrate connectors, filter holder, and complete
hydraulics (e.g. leaks, corrosion, broken parts, loose parts).
Re 2.4 The power cable shows no signs of damage.

Re 3 Preparation
Re 3.1 Check arterial and venous occlusion clamps.


Integrity of:
1 Grip handle
2 Valve tappet
3 Clamping and tappet surfaces
When pushing the grip handle back, a significant counterpressure can
be felt. When the tappet is released, it will move back to its initial
position.
Re 3.2 Transport protection for the monitor support arm removed and stored.
Unscrew and remove the screw.

(Keep the screw for subsequent transportation.)
Re 3.3 IV pole inserted into the monitor support arm and secured with a
threaded pin. (Torque: 90 Ncm)
Place the protective cover for the monitor support arm.
Screw the IV pole hanger onto the IV pole.
Re 3.4 Dialyzer holder mounted. (Torque: 130 Ncm)


Attach dialyzer holder at the displayed points with 2 screws.

Replace protective caps.
Re 3.5 Shipping plug removed from the overflow.

Vent (water inlet chamber)
Re 3.6 Water supply tubing, drain tubing, flush-tubing (option)
Caution
Observe the following rules of hygiene when connecting to the water
supply:
– Only use tubings 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.
Connect the water supply tubing. Connect the drain tubing. Connect the
flush tubing (option).
Protect the tubings from slipping out.
Standard: Length 3 m, internal diameter 6 mm
When using other tubing dimensions,
Adapt the tubing parameters in the SERVICE menu, under "SETUP".
Tubing dimensions adjusted: Length ___ m, internal diameter___ mm

Re 3.7 Antifreeze rinsed out.

Ensure that no disinfectant container is connected.
Operating condition: Mandatory rinse
Turn the device on.
Insert the ServiceCard.
Message: Mandatory rinse required – Start
Touch the Start button.
Re 3.8 CDS tubing connected and protected from slipping out.

Apply shrink tube marking for the CDS tubing.
Re 3.9 Filter change program selected.
Caution
Observe the following rules of hygiene when inserting the
DIASAFE®plus:
– Only use filters with undamaged packaging.
– Remove the packaging and the protective straps only immediately
before installing the filter
– Only touch the connectors if required.
Select filter change program.

Operating condition: CLEANING SCREEN, filter change
Connect the filter. DIASAFE®plus / ONLINEplus™
In the SERVICE menu, under "SETUP", "Novram", delete mandatory
disinfection.
Then completely run the rinse program.
Re 4 Setup
Re 4.1 Setup checked on the hemodialysis system.

(Technician's setup / Operator setup)
Operating condition: SERVICE, SETUP
Make the appropriate settings for the respective hospital, if necessary.
During the initial start-up, the "Installation altitude" must be set under
"Settings Hydraulics", "Heater rod".
Re 5 Water inlet flow
Re 5.1 MaxWaterFlow checked.

Operating condition: SERVICE, (CALIBRATE), FLOW DIAGRAM
Basic requirements:
The hemodialysis system must be closed.
Flow on.

Check MaxWaterFlow.
Desired value: 1300 ml/min to 1550 ml/min.
Use A04 for making corrections, if necessary.
(If it is not possible to set a water inlet flow ≥ 1300 ml/min, it will not
always be possible to achieve the dialysate flow of 1000 ml/min.)
Re 6 Dialysate pressure
Re 6.1 Zero point S03 / S07 checked.

Operating condition: SERVICE, CALIBRATE
(Plausibility check must have been successfully completed,
e.g. selection of degassing after hemodialysis system On/Off.)
Basic requirements:
Flow on until dialysate lines are free from air. Then flow off.
Remove both dialysate lines from the shunt interlock and bring them to
the same level as the shunt interlock. Close the shunt interlock.
Check zero point S03 / S07.
Check S03. 0 mbar ±30 mbar
Check S07. 0 mbar ±30 mbar
Check the difference S03 / S07.
Difference |(S03 - S07)| ≤ 20 mbar
Example:
S03: -10 mbar
S07: -5 mbar
Difference S03 / S07: Difference |(-10 mbar - (-5 mbar)| = 5 mbar
Re 7 Blood leak detector

Basic requirements:
The hemodialysis system must be closed (avoid incidence of ambient
light).
Temperature in the range between 34 °C and 39 °C, conductivity
stable, flow on, flow 500 ml/min
Re 7.1 Blood leak checked.


Desired value: 4.8 V to 5.2 V
Re 7.2 Dimness checked.

Re 8 Temperature / conductivity (39 °C)
Re 8.1 Temperature checked at 39 °C.

Basic requirements:
Temperature: specified value: 39.0 °C, flow on, flow 800 ml/min
Bypass, open the shunt interlock.
Wait until the values have stabilized.
Comparison of sensors PT7, PT8 and PT9:
Difference |(PT7 - PT8)| ≤ 0.1 °C
Difference |(specified value - PT7)| ≤ 0.2 °C
No bypass, close the shunt interlock.
Mean value = (PT7 + PT9) / 2
Difference (mean value - specified value) +0.2 °C to -0.5 °C
Re 8.2 Conductivity checked at 39 °C.

The display of the hemodialysis system shall range between
14.5 mS/cm and 15.7 mS/cm.
Difference |(CD7 - CD9)| ≤ 0.2 mS/cm
Difference |(Expected value - CD7)| ≤ 0.7 mS/cm
Re 9 Degassing
Re 9.1 Degassing calibrated.

Basic requirements:
Flow on.
Perform the degassing adjustment.
Touch the Degassing (A01 / P01) button.
Re 10 Check of the electrical safety
According to (DIN) EN 62353:2008, IEC 62353:2007
Re 10.1 Visual inspections performed.


– Fuses accessible from the outside comply with the indicated values.
– Labels and inscriptions are present and legible.
– The mechanical condition permits further safe use.
– There are no signs of damage or dirt.
– The power cable shows no signs of damage.
Re 10.2 Protective earth resistance measured.

Max. 0.3 Ω (with power cable)
The protective earth resistance must be checked on the following
measurement points.
Measurement point: power supply unit (power supply unit housing)
Measurement point: shunt door

Measurement point: potential equalization
Measurement point: heater rod chamber
Measurement point: EBM pumps

blood pump, substituate pump, Single-Needle pump (option)
(e.g. measurement point substituate pump)

Measurement points: BTM (option)

Left: arterial measuring head - right: venous measuring head
Re 10.3 Measurement of the device leakage current performed.

Operating condition: Preparation
Device leakage current - differential current measurement according to
fig. 5
or
Device leakage current - direct measurement according to fig. 4

Basic requirements:
– Measurement of the protective earth resistance performed.
– Perform the measurement with the hemodialysis system being at
operating temperature.
– Dialysate:
Dialysis temperature: ≥ 37 °C
Dialysate flow: ≥ 300 ml/min
Conductivity: ≥ 13 mS/cm
– When performing a direct measurement, the following precautions
also must be observed:
The device must be insulated when installed.
All external connections must have been removed from the device.
The line voltage during the measurement will be recorded, as well as
the maximum device leakage current of both mains polarities, scaled to
the nominal voltage of the power supply. Maximum device leakage
current: 500 µA
Example:
Line voltage during measurement: 225 V
Device leakage current
with mains polarity 1: 180 µA
Maximum value of both mains polarities: 180 µA
Nominal voltage of the power supply: 230 V
Scaled to nominal voltage 184 µA
(180 µA: 225 V x 230 V = 184 µA
Device leakage current < 500 µA: OK
Additional conditions:
If the device leakage current, scaled to the nominal voltage is higher
than 90 % of the admissible alarm limit (= 450 µA), the last measured
value or the first measured value must additionally be considered for the
rating.
If the device leakage current has considerably increased since the last
measurement or has continuously increased since the first
measurement (slow deterioration of the insulation), or if the sum
composed of the current value plus the difference since the last
measurement is > 500 µA, the measurement has not been passed.
Example 1:
Device leakage current: 470 µA
Last measured value: 450 µA
470 + (470 – 450) = 470 + 20 = 490; is OK
Example 2:
470 + (470 – 390) = 470 + 80 = 550; not passed
Re 11 Final checks
Re 11.1 Error memory erased.


With service program:

Erase the error memory.
Re 11.2 Calibration data and setup settings saved.

With service program:
Save the calibration data and setup settings.
Re 11.3 T1 test performed.

Operating condition: T1 test
(Perform additional checks only after completion of the T1 test.)
Re 11.4 Arterial pressure display
Re 11.4.1 Zero point of arterial pressure display checked

Basic requirements:
Insert the tubing set. Arterial pressure dome connected. Tubing set
must be open against the atmosphere.
Check the arterial pressure display.
Desired value: 0 mmHg ±5 mmHg
Re 11.4.2 Slope of arterial pressure display tested.

Basic requirements:
Insert the tubing set. Arterial pressure dome connected. Connect the
reference meter. Using a syringe, build up a pressure of approx.
280 mmHg.
Desired value: built-up pressure ±5 mmHg
Example:
Built-up pressure: 283 mmHg
Desired value: 278 mmHg to 288 mmHg
Re 11.5 Venous pressure display
Re 11.5.1 Zero point of venous pressure display checked

Basic requirements:
Insert the tubing set. Tubing set must be open against the atmosphere.
Check the venous pressure display.
Re 11.5.2 Slope of venous pressure display tested.


Basic requirements:
Insert the tubing set. Venous pressure line connected. Connect the
280 mmHg.
Example:
Re 11.6 Temperature / conductivity (37 °C)
Re 11.6.1 Temperature and the conductivity checked at 37 °C.

Basic requirements:
Temperature: specified value: 37.0 °C, flow on, flow 800 ml/min
Bypass (open the shunt interlock)
Wait until the values have stabilized.
Comparison of sensors PT7, PT8 and PT9:
Difference |(specified value - PT7)| ≤ 0.2 °C
Re 11.6.2 Conductivity checked at 37 °C.

Conductivity:
The display of the hemodialysis system shall range between
12.8 mS/cm and 14.0 mS/cm.
Difference |(CD7 - CD9)| ≤ 0.2 mS/cm
Difference |(Expected value - CD7)| ≤ 0.7 mS/cm
Re 11.7 Disinfection program performed.

Operating condition: Cleaning
(with Puristeril® 340 or Puristeril® plus or Diasteril® or Citrosteril®)
Re 11.8 Alarm function checked during the disinfection program.

Open the shunt interlock.
Audible alarm and status indicator
Alarm message
Reclose the shunt door.
The disinfection program will be continued.
Re 11.9 Absence of residual disinfectant checked by means of test strips. (not

with Citrosteril®)
Operating condition: After cleaning

Re 11.10 Entries recorded in the medical device register and on the machine
card.
Re 11.11 Operating Instructions and accessories package complete and match

the device.
Confirmation of the test Test equipment used:

Type and serial number of the test equipment used.
Comments:
Irregularities encountered during the test will be recorded in this section.
Date, signature, stamp
Performance of the test has to be confirmed by indicating date, tester's
signature and stamp.
Assessment of the test The device has been released for its intended use.
Attach inspection sticker.
It must be ensured that the intended use of the device will not present
a hazard to patients, operators or other third parties.
Within the scope of the overall assessment, the tester must make a
definite decision whether the device may be used or not. The
responsible organization has to be informed immediately about any
signs of damage detected.
The date for the next inspection must be entered in the report.
The intervals specified by the manufacturer have to be observed.
Comments:
Irregularities encountered during the assessment will be recorded in
this section.
Date, signature, stamp:
Assessment of the initial start-up has to be confirmed with date, tester's


Chapter 4: Specifications
4 Specifications
4.1 Dimensions and weight
Dimensions Height: approx. 168 cm (approx. 210 cm incl. IV pole)

Width: approx. 52 cm (on base incl. brake)
Depth: approx. 78 cm (approx. 90 cm incl. container holder)
Weight Approx. 100 kg (without options)
4.2 Type label (device identification)
The type label shown is only an example. The decisive criterion is the
data specified on the type label of the device.
1 Type identification
2 Serial number
3 Power requirements
4 Protection against ingress of liquids: drip-proof
5 CE mark
6 Manufacturer (year of manufacture, address)
7 Degree of protection against electric shock: type B
8 Identification of electric and electronic devices
9 Equipment code (EC: Equipment Code)

4.3 Electrical safety (classification according to EN 60601-1,

IEC 601-1)
Type of protection against Safety class I

electric shock
Degree of protection Type B, symbol:

against electric shock
Applicable only to the BPM Defibrillator-protected applied part of the type CF,
blood pressure cuff: Symbol:
Degree of protection
against electric shock
Degree of protection Drip-proof, symbol: IPX1

against ingress of liquids
Leakage currents According to EN 60601-1
4.4 Electrical supply
Line voltage 100 to 240 V AC, ±10 %, 47 to 63 Hz

(The decisive criterion is the line voltage and the operating current
specified on the type label of the device.)
Connection to power 16 A, regulation according to VDE 0100 part 710

supply
Operating current Approx. 6 A, (at 230 V)

Dialysis at a water inlet temperature of 17 °C
Dialysate temperature: 37 °C
Dialysate flow: 500 ml/min
Power supply +24 V ± 3 %, 20 A short-circuit proof

(internal) +18 V ± 3 %, 14 A short-circuit proof
480 W total power output
Battery Lead-acid battery (maintenance-free)

24 V, 7 Ah
4.5 Fuses
Main power switch 2 x G 16 A (miniature circuit-breaker) rear of power supply unit

4.6 Guidance and manufacturer's declaration on EMC

(IEC 60601-1-2:2001)
 Electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions

The hemodialysis system is intended for use in the electromagnetic environment specified below. The customer
or the user of the hemodialysis system should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions CISPR 11 Group 1 The hemodialysis system uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B The hemodialysis system is suitable for use in all
Harmonic emissions Class B establishments, including domestic establishments and those
IEC 61000-3-2 directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker Complies
emissions IEC 61000-3-3
 Electromagnetic immunity
Guidance and manufacturer's declaration – Electromagnetic immunity

The hemodialysis system is intended for use in the electromagnetic environment specified below. The customer
or the user of the hemodialysis system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered with
according to synthetic material, the relative humidity
IEC 61000-4-2 should be at least 30 %.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial and / or hospital
IEC 61000-4-4 ±1 kV for input/output Not applicable environment.
lines
Surge IEC 61000-4-5 ±1 kV differential ±1 kV differential Mains power quality should be that of a
mode mode typical commercial and / or hospital
±2 kV common mode ±2 kV common mode environment.
Voltage dips, short <5 % UT (>95 % dip <5 % UT (>95 % dip After power supply interruptions, the
interruptions and in UT) for 0.5 cycle in UT) for 0.5 cycle hemodialysis system battery takes over
voltage variations on 40 % UT (60 % dip in 40 % UT (60 % dip in the supply without delay.
power supply input UT) for 5 cycles UT) for 5 cycles
lines IEC 61000-4-11
70 % UT (30 % dip in 70 % UT (30 % dip in
UT) for 25 cycles UT) for 25 cycles
<5 % UT (>95 % dip <5 % UT (>95 % dip
in UT) for 5 sec in UT) for 5 sec

Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be

(50/60 Hz) magnetic at levels characteristic of a typical location
field IEC 61000-4-8 in a typical commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level
Portable and mobile RF communications
equipment should be used no closer to any
part of the hemodialysis system, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3V d = 1.17 √P
IEC 61000-4-6 150 kHz to 80 MHz for 150 kHz to <80 MHz
Radiated RF 3 V/m 10 V/m d = 0.35 √P
IEC 61000-4-3 80 MHz to 2.5 GHz for 80 MHz to <800 MHz
d = 0.7 √P
for 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
compliance level in each frequency range
b
.
Interference may occur in the
vicinity of equipment marked with
the following symbol.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
hemodialysis system is used exceeds the applicable RF compliance level above, the hemodialysis system
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the hemodialysis system.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
 Recommended separation distances between portable and mobile RF communications

equipment and the hemodialysis system
Recommended separation distances between portable and mobile RF communications equipment and
the hemodialysis system

The hemodialysis system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the hemodialysis system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the hemodialysis system 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 = 1.17 √P d = 0.35 √P d = 0.7 √P
0.01 0.11 0.035 0.07
0.1 0.37 0.11 0.22
1 1.17 0.35 0.7
10 3.7 1.10 2.21
100 11.7 3.5 7.0
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.
4.7 Operating conditions
Water inlet pressure 1.5 to 6.0 bar
Water inlet temperature 5 °C to 30 °C

for "Integrated hot rinse": 85 °C to 95 °C
In case of line voltages between 100 V and 120 V and low water inlet
temperatures, a restriction of the dialysate flow is possible due to the
available mains voltage.
Example:
Line voltage 110 V, heater output 1200 W, water inlet temperature 10 °C, dialysate
temperature (desired value) 37 °C,
= flow ≤ 800 ml/min
Water inlet rate 1.5 l/min; with an inlet pressure of 1.5 bar
Water drain 0 up to 100 cm above the ground, no less than 5 cm free fall. The water
drain must be located at a lower level than the dialyzer position.
Concentrate supply 0 to –100 mbar; maximum suction height 1 m

With Central Delivery System (option): 0.05 to 2.0 bar
Heat dissipation Dialysis:

approx. 400 watts (at an ambient temperature of 20 °C)
Operating temperature 15 °C to 35 °C
range
Atmospheric pressure 700 hPa to 1060 hPa

Relative humidity 30 % to 75 %, temporarily 95 %
Stability 5°
Admissible inclination during operation: ≤ 3°
IV pole load capacity Maximum: 5 kg

Maximum load capacity of one hook: 5 kg
4.8 External connection options
Caution
Additional equipment connected to medical electrical equipment must
comply with the respective IEC or ISO standards (e.g. IEC 60950 for
data processing equipment). Furthermore all configurations shall
comply with the requirements for medical electrical systems (see IEC
60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively).
Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical
systems. Attention is drawn to the fact that local laws take priority over
the above mentioned requirements. If in doubt, consult your local
representative or the technical service department.
Caution
The external alarm indicators do not relieve the operator of the
obligation to observe the local alarms of the device.
LAN Interface for the exchange of data.

Electrically isolated by transformer.
Port: RJ 45
Service / diagnostics (Protected by cover!)

For inhouse computer diagnostics.
Interface for the exchange of data (RS232).
24 V (1 A fuse)
Port: DSUB 15-pin
Connector for AquaUNO (single station reverse osmosis unit)
Alarm output For the connection of an external alarm indicator (staff call). (Potential-
free alarm output. Alternating contact maximum 24 V/24 W).
Port: 5-pin diode plug via a shielded line; shield grounded on either side.
4.9 Override conditions
When overriding a safety system the responsibility for the patient’s

safety rests with the operator of the system.

Audible alarm suppression Mute alarm time: maximum 2 minutes

(adjustable in the Operator setup)
Alarm override After confirmation of the error message and start of the blood systems:
The arterial and venous pressure alarms will be overridden for approx.
10 seconds. (window inactive)
Blood leak override Override time: maximum 2 minutes
Override air-bubble Override time:

detector – After starting active removal of air: approx. 4 seconds
– Micro bubbles alarm: 120 seconds
4.10 Operating programs
T1 test Automatic test for verification of the operating and safety systems.
The T1 test is mandatory
– after power on (not following a power failure)
– after a cleaning program
Preparation Defined by the optical detector located below the venous bubble
catcher.
Preparation is terminated as soon as the optical detector senses dark
in the blood lines.
Priming and rinsing the Minimum rinse volume 500 ml; automatic switching to Rinse mode, if
blood lines fluid level detected in the level detector. Automatic raising of the fluid
level during the rinse phase.
Reinfusion Reinfusion volume adjustable in the Operator setup.

Return to dialysis still possible.
Dialysis Bicarbonate dialysis
ISO-UF (Sequential Ultrafiltration without dialysate flow (Bergström method)

therapy)
Single-Needle Click-Clack With blood pump, arterial and venous occlusion clamp.
Pressure-pressure-controlled with adjustable pressure reverse values.
Exceptional procedure in case of problems with the vascular access
during Double-Needle treatment.
Circulation (during the The Circulation function allows to disconnect the patient from the
treatment) hemodialysis system for a short time during the treatment.

During circulation the hemodialysis system shows the following

behavior:
– the blood flow is set to 100 ml/min
– the heparin pump rate is set to 1 ml/h
– the alarm limits for the arterial and the venous pressure are
monitored for not exceeding the respective end of scale
– Ultrafiltration, ONLINEplus™ and OCM are inactive
– the BTM option is inactive
– the interval mode of the BPM option is turned off
Cleaning programs Free rinse / Rinse / Mandatory rinse:

Time adjustable in the Technician's setup,
Temperature: approx. 37 °C,
Flow: 600, 700 ml/min (adjustable in the Technician's setup)
Degreasing/cold disinfection, cold disinfection:
Heat disinfection:
In all programs:
Progress of the program (time-counting) is interrupted in the event of a
flow alarm.
The cleaning programs can be stopped.
A mandatory rinse is performed after the following programs:
– Chemical disinfection
– Heat disinfection
Endless rinse: (possible only with ServiceCard)

Time not adjustable,
Flush (option) Rinsing of the water supply area
4.11 Dialysate circuit and safety systems
Blood leak detector Response threshold ≤ 0.5 ml blood loss per minute into the dialysate at
a hematocrit of 0.25.
(Flow rate 100 ml/min up to 1000 ml/min)
Transmembrane pressure Display range: -100 to 400 mmHg

Resolution: 5 mmHg

Definition:
TMP = Pbo – (Pdi + Pdo) / 2 + Offset
TMP = Transmembrane pressure

Pbo = blood pressure on the outlet side of the dialyzer
Pdi = dialysate pressure on the inlet side of the dialyzer
Pdo = dialysate pressure on the outlet side of the dialyzer
Offset = Correction of flow-dependent pressure drops
A default value is used for the TMP offset as a standard.

In case of Double-Needle dialysis, the TMP offset for the High-Flux
dialyzers by Fresenius Medical Care is calculated depending on the
dialyzer if, in the Technician’s setup, “TMP offset“ is set to “Depending
on dialyzer”. The different flow resistance values are taken into account.
Ultrafiltration Selectable UF rate: 0 ml/h to 4000 ml/h (in increments of 10 ml)

Maximum rate internally adjustable to 1, 2, 3, or 4 l/h
Pump volume accuracy: ±1 % (for Pdi > –500 mbar)
The UF rate/effective blood flow ratio is being monitored during the
treatment. If a discrepancy occurs a warning will be displayed after
approx. 10 seconds.
Pressure holding test Event-controlled
UFC measurement At the beginning of the treatment, a measurement of the ultrafiltration

coefficient (UFC) of the dialyzer connected is performed. This value is
taken as initial value for different parameters (e.g. TMP monitoring)
If this measurement cannot be performed successfully 3 times because
of malfunctions, a message will be displayed: 3rd invalid UFC
measurement
together with the corresponding information about possible causes. As
long as no current value is measured, a default value is used for the
calculation instead of the measured value.
Balancing Accuracy: 0.1 % related to the total dialysate volume
Maximum balancing error

F = FUF + FBil
F = Maximum balancing error

FUF = Ultrafiltration error
FBil = Balancing error
Example:
Ultrafiltration error: with 1000 ml in 1 hour: ±1 % = ±10 ml/h
Balancing error: at 30 l fluid flow in 1 hour at 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 Method: Negative pressure

Dialysate concentration Display range: 12.8 to 15.7 mS/cm

(conductivity) Resolution: 0.1 mS/cm
Accuracy: 0.1 mS/cm
Method:
Temperature-compensated electronic conductivity meter with
adjustable alarm limits.
Concentrates Entering concentration types

Adjustment range: 125 to 151 mmol/l, depending on the concentrate
used ±10 % of the base value.
Bicarbonate readjustment range: corresponds to ±8 mmol/l
bibag® Bicarbonate concentrate preparation from the bibag®

Temperature range: 15 to 35 °C
Dialysate temperature Adjustment range: (prescribed temperature) 34.0 °C to 39.0 °C

Resolution: 0.5 °C
Measuring accuracy: + 0.2 °C / – 0.5 °C
(measuring accuracy under calibration conditions for a dialysate flow of 500 ml/min.)
The measuring accuracy may differ in case of lower dialysate flows.)
Dialysate flow Display range: 100 to 1000 ml/min

Resolution: 100 ml/min
Desired values: 100 to 1000 ml/min
Measurement by means of time pulse monitoring and balancing
chamber volume
AutoFlow: The AutoFlow function automatically regulates the dialysate
flow, depending on the dialyzer type and blood flow.
Entering the factor (AutoFlow) will modify the ratio of selected blood flow
to dialysate flow. The default value of the factor (AutoFlow) in the
Operator setup is 1.5.
Example:
Blood flow: 300 ml/min, factor: 1.5
Dialysate flow = 450 ml/min
The factor (AutoFlow) may be modified in the Operator setup and in the
DIALYSATE SCREEN.
Values above 1.5 may result in a minor increase of the dialysis dose. At
the same time, the water, concentrate and energy consumption
increases.
The contrary applies to values below 1.5, i.e., the dialysis dose may
decrease, while the water, concentrate and energy consumption may
be reduced.
EcoFlow: dialysate flow automatically reduced to 100 ml/min in
Preparation
The following has to be observed regarding the dialysate flow:
If the water inlet rate is not sufficient for achieving the maximum
dialysate flow of 1000 ml/min, the admissible adjustment range will be
delimited accordingly.
Rinse temperature Rinsing:

Desired temperature: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C

Hot rinse:
Resolution: 0.5 °C
Disinfection temperature Cold disinfection:

Resolution: 0.5 °C
Degreasing / cold disinfection:
Resolution: 0.5 °C
Heat disinfection:
Resolution: 0.5 °C
Rinse and disinfection flow Desired value: 600 ml/min or 700 ml/min (depending on the settings in
the Technician's setup) (During the recirculation phase of the
disinfection, the flow is always 600 ml/min)
Concentration of Dilution:
disinfectant The disinfectants (Citrosteril®, Diasteril®, Puristeril® 340,
Puristeril® plus) are diluted with purified water in the hemodialysis
system at a ratio of 1+24.
The disinfectant (Sporotal® 100) is diluted with purified water in the
hemodialysis system at a ratio of 1+34.
Flow alarm Dependent on the programmed flow
4.12 Extracorporeal blood circuit and safety systems
Arterial pressure Display range: -300 to +300 mmHg

measurement Resolution: 5 mmHg
Accuracy: 7 mmHg (typical)
OD senses light:
Alarm window width: -300 to +300 mmHg
OD senses dark:
Alarm window width: +40 to +200 mmHg
Default value adjustable in the Operator setup, factory setting
120 mmHg
Blood pump Delivery rate: 30 to 600 ml/min

Resolution: 10 ml/min (at a line diameter of 8 mm)
Accuracy: ±10 % (Single-Needle operation: –10 to +15 %)
Line diameter: 4.4 mm, 6.4 mm, 8.0 mm
Blood pump stop alarm: 60 seconds
(During Single-Needle operation - option - 180 seconds.)
Spring-loaded rollers, fully occluding, pressure-limited to 2 bar with 8 x
2.1 pump segment line (when using the prescribed blood lines).

Venous pressure Display range: -100 to +500 mmHg

measurement Resolution: 5 mmHg
Accuracy: 7 mmHg (typical)
OD senses light:
Alarm window width: -100 to +500 mmHg
OD senses dark:
Alarm window width: 40 to 200 mmHg
Default value adjustable in the Operator setup,
factory setting 120 mmHg
adjustable over a range of 20 to 500 mmHg
(adjustable in the Operator setup from –100 to 500 mmHg.)
Level detector Method:

Capacitive measurement
Switching point 13 mm, ±4 mm from upper edge
Optical detector Method: Infrared transmission

Distinguishes between
OD light (rinse solution or air in the blood lines)
OD dark (blood in the blood lines).
Air bubble detector Method:

Ultrasonic transmission measurement on the line
Sensitivity:
– Air bubbles: Bubble volume ≥ 20 µl
– Blood foam (air-blood mixture)
– Micro bubbles
Air alarm:
– BP rate < 100 ml/min:
Air bubble: Volume ≥ 20 µl
Blood foam
Micro bubbles
– BP rate ≥ 100 ml/min:
10 air bubbles with an air bubble volume of < 50 µl each
or 1 air bubble with an air bubble volume of ≥ 50 µl,
Blood foam
Micro bubbles
The specified data refer to the most unfavorable case with a BP rate of
0 to 600 ml/min when using the blood lines approved for the
hemodialysis system.
Heparin pump Delivery rate: 0.5 to 10 ml/h

Resolution: 0.1 ml/h
Accuracy: ±5 % for delivery rates of 0.5 to 10 ml/h and a measuring time
of 2 hours for a pressure range from –0.4 to +0.4 bar
(calibrated for 30 ml Fresenius heparin syringes)
With delivery rates of <1.0 ml/h the tolerance may exceed the specified
±5 %
.
Stop time: 0 minutes up to 2 hours
Resolution: 1 min
Bolus administration: 1.0 to 20.0 ml
Resolution: 0.1 ml

30 ml Fresenius heparin syringe
Single-Needle Click-Clack Stroke volume: depending on the blood lines used

Cycle monitoring:
Arterial phase: 50 ml
Venous phase: 15 s
Width of SN pressure window, venous pressure: 80 to 480 mmHg
Maximum SN pressure: 480 mmHg
Minimum SN pressure: 20 mmHg
Audible alarm Adjustment range of the loudness of the audible alarm:

Factory setting ≥ 65 db (adjustable)
Minimum setting: ≥ 65 db
4.13 DIASAFE®plus
Filter life: maximum 12 weeks.

Monitored by the hemodialysis system and a warning (Filter change) is
displayed.
When using ONLINEplus™:
Filter life: maximum 100 treatments.
Monitored by the hemodialysis system and a warning (Filter change) is
displayed. If the warning is ignored, ONLINEplus™ will be disabled after
the respective number has been exceeded.
The number of the remaining treatments will be displayed in the
cleaning programs and under "Status", "Device info".
4.14 OCM
Measuring accuracy of the clearance: ± 6 % standard deviation

Shortest measuring interval: 25 min
Time scale of the display: 10 s
4.15 ONLINEplus™
Sub rate: 25 to 600 ml/min (inside line diameter: 8.0 mm)

Resolution: 1 ml/min
Sub goal: depending on the treatment parameters
Accuracy: ±10 %
(This specification only applies to the range from 30 to 350 ml/min. With
delivery rates of < 30 ml/min the deviation may be greater.)
Sub volume:
Resolution: 0.1 liters

Spring-loaded rollers, fully occluding, pressure-limited to < 1.3 bar.

Auto-sub: Automatic control of the substitution rate, considering the
following factors:
– Procedure (pre- / postdilution)
– Dialyzer class (filter capacity)
– Effective blood flow
– Hematocrit (Hct)
– Total protein (TP)
– UF rate
If one of the above-mentioned factors is altered, the substitution rate will
be adapted automatically.
4.16 Single-Needle (option)
Stop alarm During Single-Needle operation 180 seconds.

Blood pump
Single-Needle pump
Stroke volume 10 to 50 ml in increments of 5 ml (SN conventional)

10 to 60 ml in increments of 5 ml (SN extended)
SN chamber 50 ml stroke volume (SN conventional)

60 ml stroke volume (SN extended)
Auto-Single-Needle +20 % (Adjustable in the Operator setup.)

Delivery rate of the
Single-Needle pump
4.17 BPM (option)
Blood pressure Display range

– Systole: 30 mmHg to 280 mmHg
– Diastole: 10 mmHg to 240 mmHg
– MAP: 20 mmHg to 255 mmHg
Resolution: 1 mmHg
Accuracy of blood Maximum systematic deviation in measurement:

pressure measurement Systolic blood pressure: -0.9 mmHg
Diastolic blood pressure: -3.2 mmHg
Standard deviation according to clinical tests:
Systolic blood pressure: 6.4 mmHg
Diastolic blood pressure: 7.1 mmHg
BHS grading:
Systolic: A
Diastolic: B
Maximum deviation in measurement of the cuff pressure: ±3 mmHg

Pulse Display range: 20 to 245 1/min

Resolution: 1/min
4.18 BTM (option)
Required blood flow for ≥ 120 ml/min

accurate BTM function (The measuring and control functions of the BTM are deactivated if the
blood flow is < 100 ml/min.)
Temperature Accuracy of the fistula temperatures (if correct ambient temperature is

measurement indicated): ± 0.5 °C
Error in fistula temperatures per °C error of the set ambient temperature
0.08 °C (at a blood flow of 100 ml/min)
0.03 °C (at a blood flow of 300 ml/min)
Body temperature change accuracy: ± 0.2 °C
Recirculation Accuracy of recirculation measurement

measurement (for 2.5 °C venous bolus amplitude): ± 2 %
Maximum bolus amplitude: – 3 °C or + 3 °C
Maximum duration of the bolus: up to 10 min
Body temperature control Allowed range of desired values for body temperature change rate:
– 0.5 °C/h to + 0.5 °C/h
Dialysate temperature range used by the BTM:
– Minimum dialysate temperature: 35.5 °C
– Maximum dialysate temperature: 37.0 °C to 38.0 °C
(Adjustable in the Operator setup)

4.19 Network
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 (staff call).

Chapter 5: Setup
5 Setup
5.1 SYSTEM SCREEN settings
 Selecting the SYSTEM SCREEN settings
The device is turned on.

Touch the SYSTEM menu button.
Select the settings in the SYSTEM menu.
 Adjusting the SYSTEM SCREEN settings
Select the desired function.

Make changes, if required. Save with OK.
Select default values with FMC Logo.
 SYSTEM SCREEN settings – overview
Submenu Default value Value range Resolution Selectable

options
Date Day, month, year – – –

(Adjustable only
with ServiceCard)
Time – 00:00 to 0:01 h:min –

23:59 h:min
Loudness 6 1 to 9 1 –
Graphic time scale Auto – – Auto

(The last time 10 min
segments of the 20 min
respective 30 min
treatment will be 1h
displayed.) 2h
4h
6h
10 h

Chapter 5: Setup
5.2 Operator setup
 Selecting the Operator setup

Insert the UserCard.
In the SYSTEM menu touch the OPERATOR SETUP button.
 Adjusting the settings in the Operator setup
In the OPERATOR SETUP menu

 Blood line

options
Blood line AV Set 5008 – – –
 Blood pump

options
Pump segment 8.0 mm – – –
Delivery rates
Prime 100 ml/min 30 to 600 ml/min 10 ml/min –
Precirculation 100 ml/min 30 to 600 ml/min 10 ml/min –
Reinfuse 100 ml/min 30 to 300 ml/min 10 ml/min –

Chapter 5: Setup
 Rinse / reinfusion volume (Only in case of preparation with NaCl bags.)

options
Preparation (NaCl)
Rinse vol. 500 ml 500 to 5000 ml 100 ml –
UF rinse vol. 0 ml – – –
Reinfusion (NaCl)
Reinfusion volume 250 ml 100 to 480 ml 10 ml –
 Anticoagulation

options
Heparin
Heparinization Yes – – Yes

No
Heparin unit ml – – –
Heparin start Automatic – – Automatic

Manual
Hep. rate 1.2 ml/h 0.5 to 10.0 ml/h 0.1 ml/h –
Stop time 0:30 h:min 0:00 to 2:00 h:min 0:01 h:min –
Syringe Fresenius 30 ml – – Depending on

Operator setup
(Define syringe
types)
Bolus 5.0 ml 1.0 to 20.0 ml 0.1 ml –
Auto bolus No – – –

Chapter 5: Setup
Define syringe types

options
Remove syringe types from the operator list by touching the Remove syringe button. Remove own syringe types
by touching the Delete syringe button.
Operator list Fresenius 30 ml – – –
Syringe types – – – Fresenius 30 ml

B. Braun 20 ml
B. Braun 30 ml
B&D 20 ml
B&D 30 ml
JMS 20 ml
Nipro 20 ml
Safti 20 ml
Terumo 20 ml
Terumo 30 ml
Parameter – – – –
Displays the
parameters of the
selected syringe.
Currently not active:

By means of the following list, define own syringe types in the Syringe types list by touching the New syringe
button (see the following heparin pump illustration).
Syringe name – – – –
Diameter (1) – 10.00 to 5 mm –

(Internal diameter) 30.00 mm
Volume (2) – 10.00 to 30.00 ml 5 ml –
Syringe total length (3) – 30.00 to 5 mm –

95.00 mm
Total length (i.e. rem. – 5.00 to 30.00 mm 5 mm –

length) (4)

Chapter 5: Setup
 Dialysate

options
Default values Dialysate
Concentrate Depending on – – Depending on

Operator setup Operator setup
"Define "Define
concentrates". concentrates".
SK-F 203
Prescr. Na 138 mmol/l 125 to 160 mmol/l 1 mmol/l –
Prescr. Bic 32.0 mmol/l 0 to 40.0 mmol/l 1 mmol/l –
Flow 500 ml/min 100 to 100 ml/min –

1000 ml/min
AutoFlow Yes – – Yes

No
Factor 1.5 1.0 to 2.0 0.1 –
Temperature 36.5 °C 34 °C to 39 °C 0.5 °C –
Bags
Empty bibag Automatic – – Automatic (if

optical detector
does not sense
blood),
Manual

Chapter 5: Setup
Define concentrates
Submenu Default value Selectable options
Remove concentrates from the operator list by touching the Remove concentrate button. Remove own
concentrates by touching the Delete concentrate button.
Add own concentrates to the Concentrates list by touching the New concentrate button (adjustable only with
ServiceCard).
The composition of the concentrate selected under "Dialysate", "Default values, dialysate" cannot be changed
and the concentrate cannot be deleted.
Operator list AC-F 113 (10 l) – – –

AC-F 219/3 (6 l)
AC-F 311 (6 l)
AC-F 411 (6 l)
AC-F 419 (6 l)
SK-F 203 (6 l)
SK-F 311 (10 l)
AC-F 213 (6 l)
Concentrates list – Folder: SK-F...
Folder: AF...
Folder: AC-F...
Folder: smartbag...
Folder: Others...

Chapter 5: Setup
Explanation of the terms used in the Settings menu
Name Explanation
Concentrate name Abbreviation used by the manufacturer, usually name of the A concentrate.
Proportions of the components
A concentrate, Parts Proportion of the acidic concentrate of the composition, is the reference quantity of the
mixing ratio, constant = 1.
B concentrate, Parts Proportion of the bicarbonate concentrate of the composition. In case of acetate
dialysis the value is 0.
Water, Parts Proportion of the RO water of the composition.
Electrolytes
Na+ (sodium) Is the concentration of the respective ions in the ready-to-use dialysate.
K+ (potassium)
Ca++ (calcium)
Mg++ (magnesium)
Cl- (chloride)
HCO3- (bicarbonate)
CH3COO- (acetate) Acetate is the concentrate of the acetate in the ready-to-use dialysate.
In case of bicarbonate dialysis:
If the value set here is zero, it is assumed that the prescription contains hydrochloric
acid (HCl).
Other ingredients
Glucose Is the concentration of the glucose in the ready-to-use dialysate. Caution: The unit of
measure is g/l.
Component ingredients
Acid (A) CH3COOH (acetic acid) or HCl (hydrochloric acid), is the concentration of the acid
which originates from the acidic or A concentrate (prior to the reaction with the
bicarbonate component), in case of bicarbonate dialysis it is in most cases identical
with the acetate. If the value set here is zero, it is assumed that it is identical with
acetate, i.e. that the acetate of the ready-to-use dialysate is produced by the reaction
of the acetic acid of the acid concentrate with the bicarbonate and that the
concentrates did not contain any acetate prior to this reaction. This is the normal case.
Acetic acid and hydrochloric acid are considered as acid.
Na(B) Is the concentration of the sodium in the ready-to-use dialysate which originates from
the B concentrate (bicarbonate concentrate). If the bicarbonate concentrate does not
contain any additional saline, this value equals the total of the values for bicarbonate
and acid (acid is in most cases identical with the acetate).
If the B concentrate contains additional saline, the value for Na(B) equals the total of
the final concentration of this saline in the ready-to-use dialysate, the HCO3-
(bicarbonate) and the acid (A).
If a zero figures under Na(B), it is assumed to be pure bicarbonate concentrate.

Chapter 5: Setup
Explanation of the tables of the Settings menu
The input limits cannot prevent that the prescriptions entered

– will affect several setting limits and will generate a conductivity
alarm,
– are not physiologic.
The concentrate setting limits for acetate dialysis and bicarbonate

dialysis specified hereafter also affect the limits which can be set by the
operator. Some of the expected operator adjustments may then no
longer be possible:
Operator setting limits:
(Whichever condition is the most stringent applies.)
Prescr. Na:
Concentration of the prescription ±10 % (rounded off)
and:
12.8 mS/cm ≤ expected conductivity ≤ 15.7 mS/cm
and:
125 mmol/l ≤ prescribed Na ≤ 155 mmol/l
Prescr. Bic:
Concentration of the prescription ± 8 mmol/l
and:
20 mmol/l ≤ prescribed bicarbonate ≤ 40 mmol/l
and:
12.8 mS/cm ≤ expected conductivity ≤ 15.7 mS/cm

Chapter 5: Setup
Setting limits for acetate dialysis
Name Unit Min. value Max. value Requirement
Concentrate
name
A concentrate non- 1 ( = constant)

dimensional
B concentrate non- 0
dimensional
Water non- 19 40
dimensional
Electrolytes
Na+ 1 mmol/l 125 150
K+ 1/100 mmol/l 0.00 5.00
Ca++ 1/1000 mmol/l 0.00 2.500
Mg++ 1/100 mmol/l 0.20 1.00
Cl- 1/100 mmol/l 80.00 126
HCO3- 1/10 mmol/l 0 0
CH3COO- 1/100 mmol/l 30.00 40.00
Other ingredients
Glucose g/l 0 3
Acid (A) 0
Na(B) 0

Chapter 5: Setup
Setting limits for bicarbonate dialysis
Name Unit Min. value Max. value Requirement
Concentrate
name
A concentrate non- 1 ( = constant)

dimensional
B concentrate non- H2O component H2O component

dimensional s x 0.017 s x 0.055
Water non- 17.800, and 50.000 The following mixing ratio

dimensional additionally facilitates the calculation
19.000 B Mix = 1 + B concentrate parts +
concentrate H2O parts ≥ 20
parts
Electrolytes
Na+ 1 mmol/l 125 150 Requirement: the NaCl (saline)

concentration in the acidic
concentrate must be ≥ 1800
mmol/l.
K+ 1/100 mmol/l 0.00 5.00
Ca++ 1/1000 mmol/l 0.00 2.500
Mg++ 1/100 mmol/l 0.20 1.00
Cl- 1/100 mmol/l 80.00 126
HCO3- 1/10 mmol/l 24.0 40.0 Requirement: the concentration of

bicarbonate in the bicarbonate
concentrate must be ≥ 6 %.
CH3COO- 1/100 mmol/l 0.00 10.00 Acetate and acid input ≤ 10.00
Other ingredients
Glucose g/l 0 3
Acid (A) 1/100 mmol/l 1.50 4 in most cases = acetate
Na(B) 1/10 mmol/l = bicarbonate = bicarbonate +

HCO3- + acid 30.0
(A)

Chapter 5: Setup
Example for parameter entry in case of bicarbonate dialysis
1 Example of a concentrate
2 Electrolyte proportions in the bicarbonate
The canister label of the concentrate used as an example shows
the electrolyte proportions in the bicarbonate.
(On products from other manufacturers, this information may be
listed separately.)
3 A concentrate
4 Water
5 B concentrate

Chapter 5: Setup
Name Value Unit INFO
Concentrate name Example of a concentrate, (1+34)
A concentrate, Parts 1.000 l
B concentrate, Parts 1.225 l
Water 32.775 l
Electrolytes
Na+ (sodium) 138.00 mmol/l
K+ (potassium) 2.00 mmol/l
Ca++ (calcium) 1.75 mmol/l
Mg++ (magnesium) 0.50 mmol/l
Cl- (chloride) 109.50 mmol/l
HCO3- (bicarbonate) 32.00 mmol/l
CH3COO- (acetate) 3.00 mmol/l
Other ingredients
Glucose 2.00 g/l
Acid (A) 3 mmol/l CH3COO- (acetate)
Na(B) 35 mmol/l HCO3- (bicarbonate) Na+ in the bicarbonate

Chapter 5: Setup
It is possible to check data entry as follows:

The balance resulting from the sum of all electrolytes with a positive
charge and of all electrolytes with a negative charge must be equal to
0. The maximum deviation resulting from rounding errors is 0.04.
(When adding the electrolytes, it must be observed that some of them
may have a double charge. These electrolytes must be counted twice.)
Electrolytes with a positive charge (+) Electrolytes with a negative charge (–)
Positive electrolytes Value Total Negative electrolytes Value Total
Na+ (sodium) 138.00 138.00 Cl- (chloride) 109.50 109.50
K+ (potassium) 2.00 2.00 HCO3- (bicarbonate) 32.00 32.00
Ca++ (calcium) 1.75 3.50 CH3COO- (acetate) 3.00 3.00
Mg++ (magnesium) 0.50 1.00
TOTAL 144.50 TOTAL 144.50
Calculation example for concentrates indicated in g/l

Some manufacturers indicate the amount of the individual concentrate
components in g/l. For these concentrates, the unit mmol/l of the ready-
to-use dialysate must be calculated based on the atomic weights.
Canister labeling 1:35, NaCl 210.68 g/l
Atomic weight NaCl:
Atomic weight Na 22.990 + atomic weight Cl 35.453 = atomic
weight NaCl 58.443
Conversion NaCl from g/l to mmol/l:
NaCl 210.68 g/l / 35 (mixing ratio) = 6.019 g/l
6.019 g/l / 58.443 (atomic weight NaCl) = 0.103 mol/l = 103 mmol/l
Entry Na+:
Na+ = 103 mmol/l (Na+ of NaCl) + 35 mmol/l (Na+ of bicarbonate) =
138 mmol/l (entry Na+)

Chapter 5: Setup
 Ultrafiltration

options
UF start Automatic – – Automatic

(If optical detector
senses blood.)
Manual
UF with time/rate only Blocked – – Blocked

(rate preset, no time) Released
Free UF profile Blocked – – –
Max. UF rate 3000 ml/h 500 to 4000 ml/h 10 ml/h –
Max. profile rate 3500 ml/h 3010 to 4000 ml/h 10 ml/h –
Current treatment data

(Displays the current treatment data during the treatment.)
Max. UF rate – – – –
Max. profile rate – – – –

Chapter 5: Setup
 Alarm processing

options
Tone Mute time 120 sec 60 to 120 seconds 10 sec –
Warning times
Flow Off 10 min – – 10 min

20 min
30 min
UF Off 5 min 5 to 15 min 1 min –
Heparin Off 1 min 1 to 5 min 1 min –
Arterial / venous pressure settings
Art. alarm limit Centred – – Centred

Asymmetric
Art. alarm limit window 100 mmHg 40 to 200 mmHg 10 mmHg –

size
SN hydrophobic filter Yes – – Yes

(WET) No
Ven. alarm limit Asymmetric – – Asymmetric

Centred
Ven. alarm limit 100 mmHg 40 to 200 mmHg 10 mmHg –

window size
Ven. window position Unlimited – – Unlimited

≥ 20 mmHg
(Lower value of
the alarm limit
window not
adjustable below
20 mmHg.)
Reaction ven. Dynamic – – Static

window alarm Dynamic
Immediately
Ven. hydrophobic filter Yes – – Yes

(WET) No

Chapter 5: Setup
 User interface

options
Screen saver (= SCREEN SAVER)
Screen saver Yes – – Yes

No
Delay 0:05 h:min 0:01 to 1:00 h:min 0:01 h:min –
DataXchange Panel
Close DXP No – – No
Yes
Delay 0:05 h:min – – –

Chapter 5: Setup
Graphics

options
The diagram types listed under selectable options can be assigned to a group. Each group can contain a
maximum of 4 graphics. Each diagram type can be contained in any group, but only once. Graphics can only be
selected if the particular option is available.
Group 1 UF Na diagram – – UF Na diagram

OCM diagram Pressure graphs
Pressure graphs OCM diagram
BPM history BTM T control
BTM rec.
BTM events
BPM
BPM (MAP)
BPM history
BVM
Group 2 BPM – – See group 1

BPM (MAP)
Group 3 – – See group 1
Group 4 – – See group 1
Define options

options
A maximum of 4 option buttons may be added. The option buttons which have been added will appear on the
lower right above the SYSTEM button.
(If the BPM option is available, a maximum of 3 options may be created.)
Options can be added only if the particular option is available.
Option HEPARIN – – HEPARIN

ONLINE CIRCULATE
SINGLE NEEDLE
ONLINE
OCM
BPM
BTM
BVM

Chapter 5: Setup
Define controls

options
On the TREATMENT SCREEN 6 fields are displayed in one row by default. In addition, 2 further rows with a
maximum of 12 fields, depending on the field size, may be created.
Option fields can be added only if the particular option is available.
From the DIALYSATE – – – Concentrate

MENU Na profile
Temperature
Flow
Auto flow
Dialyzer
From the UF MENU – – – UF profile
From the HEPARIN – – – Hep. rate

menu Stop time
Bolus
Cum. vol.
Bolus I/O
From the ONLINE – – – Treatment mode

menu Auto-sub
Sub goal
Sub rate
Sub pump I/O
HCT
TP
From the – – – Effective blood

SINGLE-NEEDLE flow
menu Stroke vol.
Lower SN
pressure
Upper SN
pressure
Ratio (approx.)
From the BTM menu – – – Recirculation I/O

Chapter 5: Setup
 Cleaning

options
Autom. cleaning pgm. No – – No

after treatment Yes
Audible info No – – No
Yes
Auto Off 10 min – – 10 min

30 min
60 min
No
Immediately
Disinfection note Yes – – Yes

(Message: The last No
disinfection was
performed XX
hours/days ago. –
Ignore – Cleaning
menu)

Chapter 5: Setup
 Auto On
Following completion of the last disinfection of the

hemodialysis system 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.

options
Weekly programs The program and the power-up time may be preselected.
Then turn programming on or off via Status.
If several programming actions have been performed, it is possible to turn them all
on or off via the Auto On Programs I/O button.
Programs No program – – Rinse

Heat disinfection
+
Standby
T1 test
No program
power-up time 00:00 00:00 to 24:00 1 min –
Single programs The program and the power-up time may be preselected.
Then turn programming on or off via Status.
If several programming actions have been performed, it is possible to turn them all
on or off via the Auto On Programs I/O button.
Programs No program – – Rinse

Heat disinfection
+
Standby
T1 test
No program
power-up time 00:00 00:00 to 24:00 1 min –

Chapter 5: Setup
 Emergency (response after touching the Emergency button)

options
UF Off Yes – – Yes

No
Blood flow rate Yes – – Yes

reduction No
(to 100 ml/min)
Blood pressure No – – No
measurement Yes
Standard bolus Yes – – Yes

(activation of the bolus No
and bolus rate values
set hereafter)
Bolus 90 ml 90 to 240 ml 30 ml –
Bolus rate 200 ml/min 50 to 250 ml/min 10 ml/min –
Emergency bolus No – – No
(Preset: Yes
bolus = 240 ml,
bolus rate = blood flow
before emergency –
50 ml/min)

Chapter 5: Setup
 PatientCard

options
PatientCard Writing to the PatientCard:

– In the Operator setup, touch the PatientCard button.
(PatientCard part number:
– Remove the UserCard.
M35 765 1)
– Insert the PatientCard.
– Enter the desired data for the patient.
(After pressing the desired field enter the data using the keypad.)
– To confirm each entry of the patient data touch the OK button.
Visually check the confirmed patient data.
– Touch the Create PatientCard button.
– Message: Saving data to PatientCard. Leave PatientCard inserted!
– Remove the PatientCard following the message.
First name – – – –
Surname – – – –
Database ID – – – –
Date of birth – – – –

Chapter 5: Setup
 ONLINE (Can only be selected if the ONLINE option exists and if Filter 2 is set in the Device
standards submenu in the Technician's setup.)

options
Treatment mode
Treatment mode HDF postdilution – – HDF postdilution

HF predilution
HF postdilution
HD
HDF predilution
Bolus
Bolus 150 ml 90 to 240 ml 30 ml –
Bolus rate 200 ml/min 100 to 250 ml/min 10 ml/min –
Preparation (ONLINE)
Onl. rinse vol. 800 ml 500 to 5000 ml 100 ml –
ONLINE UF rinse vol. 500 ml 0 to 5000 ml 100 ml –

(If ONLINE UF rinse
vol. = 0, UF rinse will
not be displayed during
Preparation.)
Reinfusion (ONLINE)
Reinfusion volume 360 ml 60 to 480 ml 60 ml –
Substitution
Auto-sub Yes – – Yes

No
Hemoconcentration
Monitoring Yes – – Yes

(Intended to avoid No
excessive
hemoconcentration in
the dialyzer due to a
too high ultrafiltration.)
Dialyzer FX60 – – e.g.:

(Depends on the FX60
dialyzers available at FX80
present.) ...

Chapter 5: Setup
Define dialyzers (part 1)
Dialyzer identification
– High-Flux dialyzers by Fresenius Medical Care with a TMP offset depending on the dialyzer do not have any
identification marks. These dialyzers are already preset.
– All other dialyzers use a default value for the TMP offset as a standard. These dialyzers are identified by an
asterisk (*) before the dialyzer name.

options
Operator list (Dialyzers FX60 – – e.g.:

taken from the Dialyzer FX60
list) FX80
...
Dialyzer list (Depends – – – e.g.:

on the dialyzers FX60
available at present.) FX80
...
Parameter – – – –
Displays the
parameters (AutoSub
factor / Predilution and
Postdilution) of the
selected dialyzers.

Chapter 5: Setup
Define dialyzers (part 2)

options
Remove dialyzers from the operator list by touching the Remove dialyzer button.
Define new dialyzers for the Dialyzer list by touching the New dialyzer button. The newly created dialyzers are
assigned a default value for the TMP offset and are identified by an asterisk (*) before the dialyzer name.
Dialyzer name – – – –
AutoSub factor
Predilution 1.00 0.50 to 1.50 0.05 –
Postdilution 1.00 0.60 to 1.40 0.05 –
Define new High-Flux dialyzers by Fresenius Medical Care for the Dialyzer list by touching the Copy dialyzer
button. The copied dialyzers are assigned a TMP offset depending on the dialyzer and do not have any
identification marks. The original dialyzer name will be adopted, with an additional name having to be added.
Dialyzer
Dialyzer name – – – –
Additional name
AutoSub factor
Predilution 1.00 0.50 to 1.50 0.05 –
Postdilution 1.00 0.60 to 1.40 0.05 –
Delete dialyzers from the Dialyzer list by touching the Delete dialyzer button.

Chapter 5: Setup
 OCM (Can only be selected if OCM exists.)

options
OCM start Automatic – – Automatic

Manual
Kt/V warning Yes – – Yes

(see Description OCM) No
Use BCM data Yes – – Yes

No
 Single-Needle (Can only be selected if the device option exists.)

options
Blood line SN conventional – – SN conventional

SN extended
Stroke vol. 35 ml 10 to 50 ml 5 ml –
(SN conventional)
10 to 60 ml
(SN extended)
Rate ratio +20 % –60 % to +60 % 5% –

(ratio blood pump
speed to SN pump
speed)
Single-Needle Click-Clack
SN pressure window, venous pressure:
Width: 80 to 480 mmHg; maximum SN pressure: 480 mmHg, minimum SN pressure: 20 mmHg;
Lower SN pressure 50 mmHg – 10 mmHg –
Upper SN pressure 400 mmHg – 10 mmHg –
 Miscellaneous

options
Installation place Installation place of the hemodialysis system may be entered here (e.g. name of
(Displayed in submenu the hospital).
"Status", "Device info")

Chapter 5: Setup
 BPM (Can only be selected if the device option exists.)

options
SYS max 165 mmHg 100 to 280 mmHg 1 mmHg –
DIA max 100 mmHg 100 to 240 mmHg 1 mmHg –
MAP max 120 mmHg 80 to 255 mmHg 1 mmHg –
PULSE max 150 1/min 50 to 245 1/min 1 1/min –
SYS min 90 mmHg 30 to 140 mmHg 1 mmHg –
DIA min 50 mmHg 10 to 90 mmHg 1 mmHg –
MAP min 70 mmHg 20 to 120 mmHg 1 mmHg –
PULSE min 40 1/min 20 to 140 1/min 1 1/min –
Preselected pressure 160 mmHg 100 to 290 mmHg 1 mmHg –
 BVM (Can only be selected if the device option exists.)

options
BVM Passive – – Passive

(Cuvette detection Active
after turning power on)
Max. BVM rate 2800 ml/h 0 to 2800 ml/h 50 ml/h –
Hemoglobin unit g/dl – – g/dl

mmol/l
Use OCM / ONLINE Yes – – Yes

measurement data No
(Presetting of the
button in the BVM
menu)
Initial target volume deviation
Positive deviation 0 ml 0 to xxxx ml 50 ml –

(Limitation to the value
set in the Technician's
setup)
Negative deviation 0 ml 0 to xxxx ml 50 ml –

(Limitation to the value
set in the Technician's
setup)

Chapter 5: Setup
 BTM (Can only be selected if the device option exists.)

options
BTM
BTM Active – – Active

(Tubing detection after Passive
turning power on)
Recirculation
Recirculation Automatic – – Automatic

measurement Manual
Body temperature
Temp. control Automatic – – Automatic

Manual
Change rate 0.0 °C/h –0.5 to +0.5 °C/h 0.1 °C/h –
Max. dialysate 38.0 °C 37.0 to 38.0 °C 0.5 °C –

temperature
Room temperature
Room temperature 20.0 °C 15.0 to 35.0 °C 1.0 °C –

(Is not measured, but
has to be set.)
 Extended safety

options
Pressure holding test, Yes – – Yes

dialyzer couplings No
Kinking (BLK) Yes – – Yes

(kinking/clotting) No

Chapter 5: Setup
5.3 Technician's setup
 Selecting the Technician's setup

In the SYSTEM menu touch the SERVICE button.
Message: Remove ServiceCard!
Remove the ServiceCard.
In the SERVICE menu touch the SETUP button.
 Adjusting the settings in the Technician's setup
In the SETUP menu

 Changing to the Operator setup
You can change over from the Technician's setup to the Operator setup,
as well as from the Operator setup back to the Technician's setup.
Touch the appropriate buttons:
In the Technician's setup touch the Operator setup button.
In the Operator setup touch the SETUP button (for Technician's setup).

Chapter 5: Setup
 Settings Hydraulics

options
Device standards
Device standards DIASAFE Plus or – – –

ONLINE Plus
(not adjustable)
Filter 1 Available – – Available

with DIASAFE Equilibration
Plus and ONLINE chamber
Plus
Filter 2 Available – – Available

with ONLINE Plus Filter not present
Water inlet tube
Flush Yes – – –
or
No
(not adjustable)
Length 3.0 m 1.0 to 5.0 m 0.1 m –

(Only displayed if
Flush is set to "Yes".)
Internal diameter 6 mm 3 to 20 mm 1 mm –
(Only displayed if
Flush is set to "Yes".)
T1 test flow 800 ml/min – – 1000 ml/min

900 ml/min
800 ml/min
700 ml/min
600 ml/min
500 ml/min
Water supply
Reverse osmosis unit ---- – – ----

(Single station unit) AquaUNO

Chapter 5: Setup

options
Heater rod
Line voltage 230/240 V – – 230/240 V

120 V
110 V
100 V
(Selection not
possible)
Installation altitude above 2000 m – – below 800 m

(The setting influences 800 to 1400 m
the heating power in 1401 to 2000 m
the cleaning programs above 2000 m
as well as the
calibration of the
pressure transducers
and the degassing.)
Calcification
Drop in bicarbonate Yes – – Yes

(Reduction of the No
prescribed Bic during
Preparation.)
 Settings EBM

options
Motor type
Blood pump Premotec – – Papst

Premotec
Others
Single-Needle Premotec – – Premotec

Papst
Others
ONLINE Plus Papst – – Premotec

Papst
Others
Heparin pump
Heparin pump Available – – Available

Not available

Chapter 5: Setup
Correcting the level in the venous bubble catcher, if necessary
Note
The values set in the following table under Drip chamber should only be
changed if required.
Problems If alarms occur due to an increased foam formation in the venous

bubble catcher, or if the level permanently is too high, the following
setting can be selected.
Correct level in the venous The level must be within the following limits.
bubble catcher Lower limit:
during Double-Needle or The filler neck is submersed.
Single-Needle treatment Upper limit:
Up to a maximum of 3 mm below the cover of the venous bubble
catcher.
1 Adjustment range
2 Upper limit
3 Lower limit
Correct level in the venous The level must be within the following limits.
bubble catcher Lower limit:
during Singe-Needle Click- The filler neck is submersed.
Clack treatment Upper limit:
Up to a maximum of 2 mm above the lower limit.
1 Adjustment range
2 Upper limit
3 Lower limit

Chapter 5: Setup
Altering the level in the The level can be changed from values 0 ml to 30 ml under "Last fill
venous bubble catcher level". 1 ml corresponds to a level alteration of approx. 2 mm.
(Example: For raising the level by 6 mm, the value under "Last fill level"
must be increased by 3 ml.)

options
Bubble catcher
Last fill level 16 ml – – –
Last fill level (SNCC) 11 ml – – –

(Single-Needle Click-
Clack)
Extended safety
Disconnection (VAM) No No
Yes
 Air bubble detector settings
Caution
Only the values listed under standard blood lines in the following table
may be set on the hemodialysis system. When performing software
updates, these values must be checked and reset, if required.
The values given under standard blood lines in the table below may only
be modified following written instructions by Fresenius Medical Care.

options
Standard blood lines
Override time 120 sec – – –
Events 1000 – – –
Measurement time 30 sec – – –
Rate 2000.0 1/min – – –
Events (absolute) 2250 – – –
Meas. time (abs.) 900 sec – – –
Rate 150.0 1/min – – –

Chapter 5: Setup
 Define cleaning parameters

options
Page 1
Cleaning pgm Heat disinfection – – Heat disinfection

combination
Degreasing/cold
disinfection
Integrated hot
rinse + cool down
rinse
Integrated hot
rinse
Rinse
Disinfection port 1 Diasteril® – – Diasteril®

= suction via (6000 ml) (6000 ml)
disinfection port on
Citrosteril®
rear
(5000 ml)
Puristeril® 340
(4400 ml)
Puristeril® plus
Disinfection port 2 Sporotal® 100 – – Sporotal® 100

= suction from the (4300 ml) (4300 ml)
front, via the
bicarbonate suction
tube, blue
Disinfection port 2 Sporotal® 100 – – Sporotal® 100

(1000 ml) (1000 ml)

Chapter 5: Setup
Submenu Minimum time (minutes : seconds) Maximum time Resolution

(minutes) (minutes)
Flow 600 ml/min Flow 700 ml/min
Page 2
Free Rinse Not programmable
Hot rinse
with / without Not programmable

DIASAFE®plus
ONLINEplus™ Not programmable
Integr. hot rinse
with / without 19:38 19:03 60 1

DIASAFE®plus
ONLINEplus™ 22:51 22:08 60 1
Cool down rinse
with / without 5:19 5:19 60 1

DIASAFE®plus
ONLINEplus™ 5:19 5:19 60 1
Rinse
with / without 8:04 7:31 600 1

DIASAFE®plus
ONLINEplus™ 9:01 8:19 600 1
Free Rinse
with / without 7:11 6:40 60 1

DIASAFE®plus
ONLINEplus™ 8:39 8:01 60 1
Disinfection
with / without 10:00 10:00 60 1

DIASAFE®plus
ONLINEplus™ 10:00 10:00 60 1
Degreasing
with / without 16:32 16:32 30 1

DIASAFE®plus
ONLINEplus™ 16:32 16:32 30 1

Chapter 5: Setup
Submenu Minimum time (minutes : seconds) Maximum time Resolution

(minutes) (minutes)
Flow 600 ml/min Flow 700 ml/min
Page 2
Mandatory rinse
(after Disinfection/Degreasing)
with / without 21:20 (24:40)* 18:58 (24:40)* 60 1

DIASAFE®plus
ONLINEplus™ 22:09 (25:38)* 19:40 (25:38)* 60 1
Heat disinfection
with / without 13:17 (19:52)* 13:17 (19:52)* 60 1

DIASAFE®plus
ONLINEplus™ 14:00 (22:00)* 14:00 (22:00)* 60 1
Mandatory rinse
(after Heat disinfection)
with / without 19:22 17:14 60 1

DIASAFE®plus
ONLINEplus™ 20:10 17:56 60 1
* The time values indicated apply to a heater rod power rating < 2000 W (for heater rods: 100 V, 110 V, 120 V)

options
Page 2
Cleaning flow rate 600 ml/min – – 600 ml/min

700 ml/min
 Novram

options
Delete mandatory – – – –
disinfection
Delete mandatory – – – –
rinse

Chapter 5: Setup
 Miscellaneous
Caution
The submenu item "Skip T1 test?" may only be set to "Yes" for
servicing. If "Skip T1 test?" is set to "Yes", all required automatic checks
of the safety systems are deactivated.
After servicing "Skip T1 test?" must be set to "No" again.
The manufacturer does not assume any responsibility or liability for
personal injury or other damage resulting from the "Skip T1 test?" option
being set to "Yes" during the treatment.

options
Date – – – –
(current date)
Time – 00:00 to 23:59 0:01 –

(current time)
Loudness 6 1 to 9 1 –
Sound 1 0 to 3 1 –
Sound check OFF – – OFF

(Check of the selected Audible alarm
sounds. Sound check Audible warning
OFF = key click on) Info sound
Start-up sound
Can T1 test be No – – No
skipped? Yes
Loudspeaker test Yes – – Yes

No
Screen monitoring No – – No
Yes

Chapter 5: Setup

options
Recording Yes – – Yes

(Service data recorder) No
Recording rate Low – – Low

(Service data recorder) High
TMP offset Depending on – – Depending on

(For High-Flux dialyzer dialyzer
dialyzers by Fresenius Default value
Medical Care: either
depending on the
dialyzer or use of a
default value for
calculating the TMP
offset.)
Language – – – e.g.:
(depends on the German,
languages available at English,
present.) French,
...
Device name – – – –

Chapter 5: Setup
 Network

options
Network settings
Direct PC connect. Passive – – Passive

Active
Network Passive – – Passive

Active
TCP/IP settings
DHCP Passive – – Passive

Active
Device IP 192.168.120.0 – – –
Standard gateway 0.0.0.0 – – –
Subnet mask 255.255.255.0 – – –
Database
Database Passive – – Passive

Active
Server address 0.0.0.0 – – –
Port 0 0 to 65535 1 –
Test the connection – – – –
DataXchange Panel
If the DataXchange Panel is to be used, the network, the database and the DataXchange Panel must be
activated. Observe the following information regarding the DataXchange Panel "Address".
DataXchange Panel Passive – – Passive

Active
Address – – – –
Test the connection – – – –
The address for the start-up screen can be set under “DataXchange Panel", sub-item "Address”:
(1) If no address is selected, http://10.144.47.22/dXp/default.aspx will be used as the start-up screen.
(2) If only a path is entered in the address field, this path will be preceded by the database server address and the
protocol.
(3) If the address starts with http:/, the entire address is taken from the field.
Database DataXchange Panel Start-up screen

Server address Address
10.144.47.22 (1) http://10.144.47.22/dXp/default.aspx
10.144.47.22 (2) /malwasanderes/default.htm http://10.144.47.22/malwasanderes/default.htm
10.144.47.22 (3) http://192.168.0.1/test.htm http://192.168.0.1/test.htm

Chapter 5: Setup
 BTM (Can only be selected if the device option exists.)

options
Blood line correction

factor
Correction factor 5.644 3.000 to 15.000 0.001 –

Chapter 6: TSC / maintenance
6 TSC / maintenance
6.1 Important information regarding the procedure
Checks This chapter includes the Technical Safety Checks (TSC) and the
maintenance procedures (MA) to be performed.
The Technical Safety Checks (TSC) must be carried out every 2 years
(24 months).
Performance of the Technical Safety Checks must be entered in the
Medical Device Register.
The maintenance procedures (MA) are a recommendation of the
manufacturer. The maintenance procedures have to be carried out after
2 years (24 months) at the latest and serve to prevent malfunctions.
Tester's qualification The tests must be performed by the Technical Service of Fresenius
Medical Care or a person authorized by them.
The tests may only be performed by persons who are qualified to
properly perform the specified checks owing to their educational
background and training, their knowledge and experience gained in
practice. Furthermore, the persons performing the tests must not be
bound by any directives when performing this activity.
accessories.


6.2 Accessories and supplies
The following articles are required for performing TSC / MA.
Product Part number Description
TSC and maintenance set M42 100 1 For TSC and maintenance of a device.
Tubing set M37 591 1 For testing the venous occlusion clamp.
Unisilikon grease, L 250 L, (10 g tube) M30 267 1 Use only in places described in the
explanations.
Battery CR 2032, Lithium (3 V/230 mAh) M37 682 1 Replace every 4 years.
Battery CR 1225, Lithium (3 V/42 mAh) 644 456 1 Replace every 4 years.
Battery pack, lead (24 V/7.2 Ah) M40 737 1 Replace every 4 years.
Label set M37 589 1 Replace labels only if required.
Solenoid valve adapter fitting, one port M38 862 1 ---Only applicable when using
Puristeril® 340, Puristeril® plus:
replace V20
Solenoid valve adapter fitting, one port M38 862 1 ---Only applicable when using
Sporotal® 100:
replace V34
Filter F16 676 168 1 For second disinfectant connector on

systems with EC < 125
6.3 TSC / MA test report
See following pages.

5008S Test report – TSC / MA


Software version:
Type No. Description Oper. cond. Correct. Meas. 

value
TSC 1.1 Fuses accessible from the outside comply with the indicated Off – – 
values.
TSC 1.2 Labels and inscriptions are present and legible. Off – – 
TSC 1.3 The mechanical condition permits further safe use. Off – – 
TSC 1.4 There are no signs of damage or dirt. Off – – 
TSC 1.5 The power cable shows no signs of damage. Off – – 
2 Check, clean, change components
MA 2.1 Fan filter on the rear of the device replaced. Off – – 
MA 2.2 Filters (F01, F07), O-rings replaced. Off – – 
MA 2.3 O-rings in dialyzer couplings greased and replaced. Off – – 
MA 2.4 O-rings at bibag® connector greased and replaced. Off – – 
TSC 2.5 O-rings at substituate port and rinse port replaced. Off – – 
MA 2.6 Arterial and venous occlusion clamps checked. Off – – 
TSC 2.7 Color coding of rotor(s) checked. Rotor(s) cleaned. Off
Blood pump: red – – 
Substituate pump: blue – – 
---Only with Single-Needle: red – – 
TSC 2.8 ---Every 6 years only: Off – – 
Tubing in substituate valve (V31) replaced.
TSC 2.9 Filter (F06) replaced. Off – – 
TSC 2.10 Leakage sensors (EBM, S35) inspected visually. Leakage Off – – 
sensors cleaned.
MA 2.11 O-rings in suction tubes replaced. Off – – 
TSC 2.12 Check valve for water inlet (A05) checked for proper function. Off – – 
MA 2.13 Filters (F08, F10, F11, F12, F14, F16) and filter disinfectant Off – – 
container changed.
MA 2.14 Dirty or shabby tubes replaced. Off – – 
MA 2.15 Disinfectant valve(s) replaced. Off
---Only applicable when using Puristeril® 340, Puristeril® plus: – – 
Disinfectant valve (V20) replaced.
---Only applicable when using Sporotal® 100: – – 
MA 2.16 ---Every 4 years only: Batteries and accumulator changed. Off – – 


value
3 Hydraulics
3.1 Degassing pump checked.
MA 31.1 Negative pressure test SERVICE, – 
CALIBRATE ______
3.2 Loading pump checked.
MA 32.1 Loading pressure test (balancing chamber) SERVICE, – 
CALIBRATE ______
3.3 Flow pump checked.
MA 33.1 Flow pump calibrated. SERVICE, – 
CALIBRATE ______
MA 3.4 Water inlet flow: MaxWaterFlow checked. SERVICE,  Yes 
Desired value: 1300 ml/min to 1550 ml/min. FLOW DIAGRAM  No ______
MA 3.5 ---Only during exclusive use of concentrate canisters: – – 
Level sensor (S17) checked. SERVICE,
FLOW DIAGRAM
MA 3.6 ---Only during exclusive use of bicarbonate canisters: – – 
Level sensor (S19) checked. SERVICE,
FLOW DIAGRAM
MA 3.7 ---Only during exclusive use of CDS: SERVICE, – –
Function of suction tube flap checked. FLOW DIAGRAM 
4 Dialysate pressure
MA 4.1 Zero point S03 / S07 checked. SERVICE, – 
Reference measuring instrument: 0 mbar CALIBRATE ______
Check S03. Desired value: +11 mbar to +71 mbar ______
Check S07. Desired value: +11 mbar to +71 mbar ______
MA 4.2 Slope S03/S07 (+) checked. SERVICE, – 
Reference measuring instrument: +533 mbar (± 26 mbar) CALIBRATE ______
Check S03. Desired value: S03 = Display of reference measuring
instrument + (+11 mbar to +71 mbar) ______
MA 4.3 Slope S03/S07 (+) checked. SERVICE, – 
Reference measuring instrument: –533 mbar (± 26 mbar) CALIBRATE ______
TSC 5.1 Blood leak checked. SERVICE,  Yes 
TSC 5.2 Dimness checked. SERVICE,  Yes 
6 Temperature / conductivity
TSC 6.1 Temperature tested with reference instrument. SERVICE, – Device / 
Desired temperature on temperature display CALIBRATE ref.
Difference between device temp. / ref. temp.:
-0.5 °C to +0.2 °C ___/___
TSC 6.2 Conductivity tested with reference instrument. SERVICE, – Device / 
(If the bibag® option is used, the test must be performed with a CALIBRATE ref.
bibag®.)
Difference between device CD / ref. CD: ≤±0.2 mS/cm ___/___
7 OCM
TSC 7.1 OCM calibration performed. SERVICE, – – 
CALIBRATE
8 Error memory
MA 8.1 Save and delete error memory Save data. SERVICE, – – 
CALIBRATE


value
9 Options
9.1 BPM
MA 91.1 Tubing connector properly fixed to hemodialysis system. SERVICE – – 
MA 91.2 Tubings and cuffs checked for damage. SERVICE – – 
(damaged parts replaced)
TSC 91.3 Leakage test performed. SERVICE, – 
Pressure leakage rate: <6 mmHg/min. DIAGNO-STICS ______
TSC 91.4 Calibration performed. SERVICE, – Device / 
Pressure values / tolerance DIAGNO-STICS ref.
250 mmHg / ±3 mmHg ___/___
200 mmHg / ±3 mmHg ___/___
150 mmHg / ±3 mmHg ___/___
100 mmHg / ±3 mmHg ___/___
50 mmHg / ±3 mmHg ___/___
TSC 91.5 Safety valve tested. Standby – – 
System emptied by opening the safety valve.
TSC 91.6 Blood pressure measurement performed. Standby – – 
Measured values are plausible.
9.2 BTM: There are no additional Technical Safety Checks and Maintenance Procedures to be performed. (Exception:
measurement of the protective earth resistance)
9.3 BVM: There are no additional Technical Safety Checks and Maintenance Procedures to be performed.
10 T1 test
TSC / 10.1 T1 test performed with all options. T1 test – – 
MA
11 Extracorporeal components
TSC 111.1 Zero point of arterial pressure display checked Preparation – 
TSC 111.2 Check the slope of the arterial pressure display for a built-up Preparation – 
pressure of approx. 280 mmHg.
Desired value: built-up pressure ±5 mmHg ______
TSC 112.1 Zero point of venous pressure display checked Preparation – 
TSC 112.2 Check the slope of the venous pressure display for a built-up Preparation – 
pressure of approx. 280 mmHg.
TSC 11.3 Venous occlusion clamp checked. Preparation – – 
A pressure change within 3 minutes must not exceed the
following values:
Arterial pressure display, maximum change in pressure:
±5 mmHg
Pressure display of reference measuring instrument, maximum
pressure drop: –0.1 bar
TSC 12.1 Visual inspections performed. Off – – 
TSC 12.2 Protective earth resistance measured. Off 
Max. 0.3 Ω (with power cable) – ____ Ω


value
TSC 12.3 Measurement of the device leakage current performed. Preparation – 
 Device leakage current - differential current measurement
according to fig. 5
or
 Device leakage current - direct measurement according to fig.
4
13 Final inspection and testing
TSC / 13.1 Disinfection performed. Cleaning – – 
MA
---During disinfection: Cleaning
TSC 13.2 Power failure alarm checked. – – 
Audible alarm, alarm message: Power failure – Device is battery-
operated.

_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
Comments:
Comments:

6.4 Explanations on the TSC / MA test report
Identification Technician's name:

Technician's first name and surname.
Device type including option(s) / software version:
Device name with possible options or extras. Software version, if
available.
Service report number:
Number of the service call.
Customer / customer no.:
Number of the final customer.
Device no.:
Serial number indicated on the type label.
Inventory no.:
The device's inventory number.
Operating hours:
Operating hours, if a time meter is installed.
Equipment code:
The equipment code attached to the device.
(e.g. EC xxx, E-code xxx)
Re 1 Visual inspections
Re 1.1 The fuse accessible from the outside corresponds to the indicated
value.
Re 1.2 Labels and inscriptions are present and legible.


Front view:
bibag®flap and flap for suction tubes: Warning - risk of scalding and
caustic burning
Below bibag® flap: reference to bibag®
Rear view:
IV pole: maximum load warning.

Upper area: warning - risk of tilting, type label.
Between Filter 1 and Filter 2: Warning - risk of scalding and caustic
burning.
On the filter holders, Filter 1 and Filter 2: Warning - risk of scalding and
caustic burning.
Disinfectant connector: warning - risk of caustic burning
Hydraulics connectors: potential equalization, ZKV/CDS, warning - risk
of scalding and caustic burning, accumulator.

Right side:
Below shunt door: Warning - risk of scalding and caustic burning,

arrows on dialyzer connectors.
Re 1.3 The mechanical condition permits further safe use.

– The monitor can be swiveled and stays in the position desired.
– If its brakes are not locked, the carriage can be moved as desired.
Check the brake.
Re 1.4 There are no signs of damage or dirt.

– Check EBM, concentrate connectors, filter holder, and complete
hydraulics (e.g. leaks, corrosion, broken parts, loose parts).
Re 1.5 The power cable shows no signs of damage.

Re 2 Check, clean, change components
Re 2.1 Fan filter on the rear of the device cleaned or replaced.

Re 2.2 Filters (F01, F07), O-rings replaced.

Left side, filter F01, water inlet filter

Right side, filter F07, dialysate filter
Change filter including O-ring. Lubricate the O-ring with Unisilikon
grease before installation. After installation, the mark must be at the top.
Re 2.3 O-rings in dialyzer couplings greased and replaced.

Grease O rings with Unisilikon grease before installing them.
Re 2.4 O-rings at bibag® connector greased and replaced.

Grease O rings with Unisilikon grease before installing them.
Re 2.5 O-rings at substituate port and rinse port replaced.

Re 2.6 Arterial and venous occlusion clamps checked.


Integrity of:
1 Grip handle
2 Valve tappet
3 Clamping and tappet surfaces
When pushing the grip handle back, a significant counterpressure can
be felt. When the tappet is released, it will move back to its initial
position.
Re 2.7 Color coding of rotor(s) checked. Rotor(s) cleaned.

Visually check the rotor color coding (blood pump: red); rotor in proper
stator.
Rotor cleaned. Line rollers and guide pulleys are running smoothly.
Visually check the rotor color coding (substituate pump: blue); rotor in
proper stator.
---Only with Single-Needle:
Visually check the rotor color coding (Single-Needle pump: red); rotor in
proper stator.
Re 2.8 ---Every 6 years only:

Tubing in substituate valve (V31) replaced.
Replace tubing in substituate valve (V31).

Re 2.9 Filter (F06) replaced.

F06
F06 hydrophobic filter, compressor.
Re 2.10 Leakage sensors (EBM, S35) inspected visually. Leakage sensors

cleaned.
Visually check leakage sensors for cleanliness and mechanical
damage. The lacquer coat of the sensors must not be damaged.
EBM (leakage sensor)
S 35 (leakage sensor, hydraulics)

Re 2.11 O-rings in suction tubes replaced.

Replace O rings in the concentrate suction tube (red) and the

bicarbonate suction tube (blue).
Re 2.12 Check valve for water inlet (A05) checked for proper function.
Basic requirements:
Device turned off.
Disconnect tubing connections from A05 (1).
Connect the external pressure gauge, connected with a syringe (3), to
the outlet side of A05 (2).
Using a syringe, build up a pressure of >2.5 bar.
Maximum pressure drop within 1 minute on the display of the pressure
gauge 60 mbar.
Re 2.13 Filters (F08, F10, F11, F12, F14, F16) and filter disinfectant container
changed.
Filter F08, UF pump

Devices with EC < 125:

F10 filter, disinfectant 1 (disinfectant connector yellow)
Devices with EC < 125:

Change F16 filter disinfectant 2.
Devices with EC >= 125:

F10 filter, disinfectant 1 (disinfectant connector yellow)
F16 filter, disinfectant 2 (disinfectant connector black)

F11 suction tube with filter, concentrate

F12 suction tube with filter, bicarbonate
F14 filter, CDS acid

Change filter disinfectant container.

Re 2.14 Dirty or shabby tubes replaced.

The following and other checks must be performed: Dialyzer supply and
drain line
Re 2.15 Disinfectant valve replaced.

Rinse valve V20 or V34 before repairing them.
In the Flow diagram: Individual control menu, open valve V20 or V34
and V40, V36, VS1, VS2 for this purpose.
Using a syringe, slowly inject 60 ml of permeate, and then 30 ml of air
into H20 or H35. (Fluid can possibly leak from the overflow.)
Continue to observe all safety measures applicable to the handling of
disinfectants.
---Only applicable when using Puristeril® 340, Puristeril® plus:
---Only applicable when using Sporotal® 100:

---Every 4 years only:

Re 2.16 Batteries and accumulator changed.

Monitor battery (CR 2032)
Replace battery swiftly to prevent loss of data.

Set the date and time, if necessary.
– Power supply unit battery (CR 1225)
After replacing the battery, turn the hemodialysis system on.

The current time is applied after the next power-on.
Erase the error memory.
No entry in error memory of power supply unit after turning the device
on / off (e.g. RTC3).
– Battery pack
Place the battery connection cable in the appropriate guides.
Re 3 Hydraulics
Re 3.1 Degassing pump checked.
Re 3.1.1 Negative pressure test

Re 3.2 Loading pump checked.
Re 3.2.1 Loading pressure test (balancing chamber)


Re 3.3 Flow pump checked.
Re 3.3.1 Flow pump calibrated

Re 3.4 Water inlet flow: MaxWaterFlow checked.

Operating condition: SERVICE, (CALIBRATE), FLOW DIAGRAM
Basic requirements:
Flow on.
Check MaxWaterFlow.
Desired value: 1300 ml/min to 1550 ml/min.
Use A04 for making corrections, if necessary.
(If it is not possible to set a water inlet flow ≥ 1300 ml/min, it will not
always be possible to achieve the dialysate flow of 1000 ml/min.)
---Only during exclusive use of concentrate canister

:
Re 3.5 Level sensor (S17) checked.
Operating condition: SERVICE, FLOW DIAGRAM
Bridge pins.
---Only during exclusive use of bicarbonate canister

:
Re 3.6 Level sensor (S19) checked.
Bridge pins.
---Only during exclusive use of CDS:

Re 3.7 Function of suction tube flap checked.
Check engagement and microswitches.
Re 4 Dialysate pressure
Re 4.1 Zero point S03 / S07 checked.


Basic requirements:
The reference measuring instrument must be placed at the bottommost
position of the IV pole.
Dialyzer couplings must be connected to the reference instrument.
Flow on until dialysate lines and reference measuring instrument are
free from air. Then flow off.
Reference measuring instrument: 0 bar
Open the vent valve (UMED).
Using a syringe (filled with fluid) set a value of 0 bar, via the vent valve.
Check S03. Desired value: +11 mbar to +71 mbar
Check S07. Desired value: +11 mbar to +71 mbar
Re 4.2 Slope S03 / S07 (+) checked.

Basic requirements:
Reference measuring instrument: +533 mbar (±26 mbar)
Using a syringe (filled with fluid) set a value of +533 mbar, via the vent
valve.
instrument + (+11 mbar to +71 mbar)
Re 4.3 Slope S03 / S07 (–) checked.

Basic requirements:
Reference measuring instrument: -533 mbar (± 26 mbar)
Using a syringe (filled with fluid) set a value of -533 mbar, via the vent
valve.

Re 5 Blood leak detector

Basic requirements:
The hemodialysis system must be closed (avoid incidence of ambient
light).
Temperature in the range between 34 °C and 39 °C, conductivity
stable, flow on, flow 500 ml/min
Re 5.1 Blood leak checked.

Re 5.2 Dimness checked.

Re 6 Temperature / conductivity
Re 6.1 Temperature tested with reference instrument.

PT7 (temperature) checked at 37 °C. (flow 500 ml/min)
Desired value: 36.8 °C to 37.2 °C (display on hemodialysis system)
Measure the reference temperature with an external measuring
instrument.
Difference = Reference temperature minus PT7
Desired value – difference: -0.5 °C to +0.2 °C
Re 6.2 Conductivity tested with reference instrument.

(If the bibag® option is used, the test must be performed with a bibag®.)
CD7 (conductivity) checked.
Desired value: approx. 13.5 mS/cm to approx. 14.5 mS/cm
Measure the reference conductivity with an external measuring
instrument.
Difference = Reference conductivity minus CD7
Desired value – difference: ±0.2 mS/cm
Re 7 OCM
Re 7.1 OCM calibration performed.

Before calibrating the OCM, the temperature and the conductivity must
have been calibrated. Select OCM calibration under "Calibration" in the
"Service menu". Automatic OCM calibration.

Re 8 Error memory
Re 8.1 Save and delete error memory Save data.

Re 9 Options
Re 9.1 BPM
Re 9.1.1 Tubing connector properly fixed to hemodialysis system.

Operating condition: SERVICE
Re 9.1.2 Tubings and cuffs checked for damage.

(damaged parts replaced)
Operating condition: SERVICE
Re 9.1.3 Leakage test performed.

Pressure leakage rate <6 mmHg/min
Operating condition: SERVICE, DIAGNO-STICS
In the service mode, select DIAGNOSTICS. Select BPM from the
DIAGNOSTICS menu.
Basic requirements:
Tube and blood pressure cuff connected.
The blood pressure cuff must be wrapped around a rigid metal vessel.
Pressure preselection 250 mmHg
Touch the Leakage test I/O button. (Test time approx. 4 minutes)
Read off the leakage rate from Info BPM. The maximum pressure
leakage rate must be <6 mmHg/min.
Re 9.1.4 Calibration performed.

Operating condition: SERVICE, DIAGNO-STICS
1 Rigid metal vessel

2 Pressure gauge
3 Drain valve

4 Pressure port
In the service mode, select DIAGNOSTICS. Select BPM from the
DIAGNOSTICS menu.
Remove tube and blood pressure cuff from the pressure connector.
Connect a rigid metal vessel (1), a pressure gauge (2), and an aspirator
bulb with drain valve (3) to the pressure connector.
Touch the Calibration test I/O button.
Set the appropriate test pressure using the drain valve. Wait until the
pressure has stabilized. Check the test pressure.
250 mmHg/ ±3 mmHg
200 mmHg/ ±3 mmHg
150 mmHg/ ±3 mmHg
100 mmHg/ ±3 mmHg
50 mmHg/ ±3 mmHg
Re 9.1.5 Safety valve tested.

Operating condition: Standby
Basic requirements:
Tube and blood pressure cuff connected.
The blood pressure cuff must be wrapped around a rigid metal vessel.
Touch the SYSTEM button.
Touch the OPTION button.
Touch the BPM button.
Touch the Bld. press. button.
Once the pressure has reached approx. 290 mmHg, increase the
pressure by slowly pressing the blood pressure cuff, until the safety
valve opens and the pressure is relieved.
The message "Maximum cuff pressure exceeded." will be displayed.
Re 9.1.6 Blood pressure measurement performed.

Operating condition: Standby
Place the blood pressure cuff around the arm.
Touch the Bld. press. button. The blood pressure measurement starts.
After the measurement, check whether the values are plausible.
Re 9.2 BTM
There are no additional Technical Safety Checks and Maintenance
Procedures to be performed. (Exception: measurement of the
protective earth resistance)
Re 9.3 BVM

There are no additional Technical Safety Checks and Maintenance

Procedures to be performed.
Re 10 T1 test
Re 10.1 T1 test performed with all options.

Operating condition: T1 test
Re 11 Extracorporeal components
Re 11.1 Arterial pressure display
Re 11.1.1 Zero point of arterial pressure display checked

Basic requirements:
Insert the tubing set. Arterial pressure dome connected. Tubing set
must be open against the atmosphere.
Re 11.1.2 Slope of arterial pressure display tested.

Basic requirements:
Insert the tubing set. Arterial pressure dome connected. Connect the
280 mmHg.
Example:
Re 11.2 Venous pressure display
Re 11.2.1 Check zero point of venous pressure display.

Basic requirements:
Insert the tubing set. Tubing set must be open against the atmosphere.
Re 11.2.2 Test slope of venous pressure display.


Basic requirements:
Insert the tubing set. Venous pressure line connected. Connect the
280 mmHg.
Example:
Re 11.3 Venous occlusion clamp checked.

Basic requirements:
– Insert the tubing set.
Open the doors. Insert the line guide into the blood pump until a
signal is sounded (1). Insert pressure dome into pressure
measurement unit (2).
Insert the line into the venous occlusion clamp (3). Close the doors.
– Open the doors.
– Connect pressure gauge (reference measurement instrument) with
the tubing set (4).
– Connect syringe (5a) and non-return valve (5b) with the tubing set.
– Close clamps (6a) and (6b) at the tubing set
– Prior to pressure build-up, the tubing set must have been in the
closed venous occlusion clamp for at least 1 minute at a temperature
of approx. 20 °C. (Pressure can be built up immediately if the tubing
set has a temperature of ≥ 33 °C.)

Pressure build-up – arterial side:

– Manually open the venous occlusion clamp (7).
– Using a syringe, build up an arterial pressure of 50 mmHg to
100 mmHg. Observe the arterial display on the device.
– Close the venous occlusion clamp (7).
Pressure build-up – venous side:
– Using a syringe, build up a pressure of 2.5 bar to 2.7 bar.
Observe the display on the external device (reference measuring
instrument).
After 3 minutes:
– Maximum pressure change on the arterial pressure display of the
device ±5 mmHg.
– Maximum pressure drop on the external pressure measurement
device (reference measuring instrument) –0.1 bar.
Re 12 Check of the electrical safety
Re 12.1 Visual inspections performed according to item 1.

– Fuses accessible from the outside comply with the indicated values.
– Labels and inscriptions are present and legible.
– The mechanical condition permits further safe use.
– There are no signs of damage or dirt.
– The power cable shows no signs of damage.
Re 12.2 Protective earth resistance measured.

Max. 0.3 Ω (with power cable)
The protective earth resistance must be checked on the following
measurement points.
Measurement point: power supply unit (power supply unit housing)

Measurement point: shunt door
Measurement point: potential equalization
Measurement point: heater rod chamber

Measurement point: EBM pumps

blood pump, substituate pump, Single-Needle pump (option)
(e.g. measurement point substituate pump)
Measurement points: BTM (option)

Left: arterial measuring head - right: venous measuring head
Re 12.3 Measurement of the device leakage current performed.

fig. 5
or


fig. 4
Basic requirements:
– Measurement of the protective earth resistance performed.
– Perform the measurement with the hemodialysis system being at
operating temperature.
– Dialysate:
Dialysis temperature: ≥ 37 °C
Dialysate flow: ≥ 300 ml/min
Conductivity: ≥ 13 mS/cm
– When performing a direct measurement, the following precautions
also must be observed:
The device must be insulated when installed.
All external connections must have been removed from the device.
The line voltage during the measurement will be recorded, as well as
the maximum device leakage current of both mains polarities, scaled to
the nominal voltage of the power supply. Maximum device leakage
current: 500 µA
Example:
Line voltage during measurement: 225 V
Device leakage current
Maximum value of both mains polarities: 180 µA
Nominal voltage of the power supply: 230 V
Scaled to nominal voltage 184 µA
(180 µA: 225 V x 230 V = 184 µA
Device leakage current < 500 µA: OK
Additional conditions:
If the device leakage current, scaled to the nominal voltage is higher
than 90 % of the admissible alarm limit (= 450 µA), the last measured
value or the first measured value must additionally be considered for the
rating.
If the device leakage current has considerably increased since the last
measurement or has continuously increased since the first
measurement (slow deterioration of the insulation), or if the sum
composed of the current value plus the difference since the last
measurement is > 500 µA, the measurement has not been passed.

Example 1:
470 + (470 – 450) = 470 + 20 = 490; is OK
Example 2:
470 + (470 – 390) = 470 + 80 = 550; not passed
Re 13 Final checks
Re 13.1 Disinfection performed.

Re 13.2 ---During disinfection:

Power failure alarm checked.
Permanent tone; alarm message: Power failure – Device is battery-
operated.
Alarm-free condition
Pull off power plug to check the power failure alarm.
Confirmation of the test Test equipment used:

Type and serial number of the test equipment used.
Comments:
Irregularities encountered during the test will be recorded in this section.
Date, signature, stamp
Performance of the test has to be confirmed by indicating date, tester's
Assessment of the test The device has been released for its intended use.
Attach inspection sticker.
It must be ensured that the intended use of the device will not present
a hazard to patients, operators or other third parties.
Within the scope of the overall assessment, the tester must make a
definite decision whether the device may be used or not. The
responsible organization has to be informed immediately about any
signs of damage detected.
The date for the next inspection must be entered in the report.
The intervals specified by the manufacturer have to be observed.
Comments:
Irregularities encountered during the assessment will be recorded in
this section.

Date, signature, stamp:

Assessment of the Technical Safety Checks (TSC) and Maintenance
Procedures (MA) has to be confirmed by indicating date, tester's

6.5 TSC report
5008S Test report – TSC


Software version:

value
1.1 Fuses accessible from the outside comply with the indicated values. Off – – 
1.2 Labels and inscriptions are present and legible. Off – – 
1.3 The mechanical condition permits further safe use. Off – – 
1.4 There are no signs of damage or dirt. Off – – 
1.5 The power cable shows no signs of damage. Off – – 
2 Check, clean, change components
2.5 O-rings at substituate port and rinse port replaced. Off – – 
2.7 Color coding of rotor(s) checked. Rotor(s) cleaned. Off
Blood pump: red – – 
Substituate pump: blue – – 
---Only with Single-Needle: red – – 
2.8 ---Every 6 years only:
Tubing in substituate valve (V31) replaced. Off – – 
2.9 Filter (F06) replaced. Off – – 
2.10 Leakage sensors (EBM, S35) inspected visually. Leakage sensors Off – – 
cleaned.
2.12 Check valve for water inlet (A05) checked for proper function. Off – – 
5.1 Blood leak checked. SERVICE,  Yes 
5.2 Dimness checked. SERVICE,  Yes 
6 Temperature / conductivity
6.1 Temperature tested with reference instrument. SERVICE, – Device / 
Desired temperature on temperature display CALIBRATE ref.
Difference between device temp. / ref. temp.:
-0.5 °C to +0.2 °C ___/___
6.2 Conductivity tested with reference instrument. SERVICE, – Device / 
(If the bibag® option is used, the test must be performed with a bibag®.) CALIBRATE ref.
Difference between device CD / ref. CD: ≤±0.2 mS/cm
___/___
7 OCM


value
7.1 OCM calibration performed. SERVICE, – – 
CALIBRATE
9 Options
9.1 BPM
91.3 Leakage test performed. SERVICE, – 
Pressure leakage rate: <6 mmHg/min. DIAGNO-STICS ______
9.1.4 Calibration performed. SERVICE, – Device / 
Pressure values / tolerance DIAGNO-STICS ref.
250 mmHg / ±3 mmHg ___/___
200 mmHg / ±3 mmHg ___/___
150 mmHg / ±3 mmHg ___/___
100 mmHg / ±3 mmHg ___/___
50 mmHg / ±3 mmHg ___/___
9.1.5 Safety valve tested. Standby – – 
9.1.6 Blood pressure measurement performed. Standby – – 
9.2 BTM
There are no additional Technical Safety Checks and Maintenance Procedures to be performed. (Exception: measurement
of the protective earth resistance)
9.3 BVM
There are no additional Technical Safety Checks and Maintenance Procedures to be performed.
10 T1 test
10.1 T1 test performed with all options. T1 test – – 
11 Extracorporeal components
11.1.1 Zero point of arterial pressure display checked Preparation – 
11.1.2 Check the slope of the arterial pressure display for a built-up pressure Preparation – 
of approx. 280 mmHg.
11.2.1 Zero point of venous pressure display checked Preparation – 
11.2.2 Check the slope of the venous pressure display for a built-up pressure Preparation – 
of approx. 280 mmHg.
11.3 Venous occlusion clamp checked. Preparation – – 
A pressure change within 3 minutes must not exceed the following
values:
Arterial pressure display, maximum change in pressure: ±5 mmHg
Pressure display of reference measuring instrument, maximum
pressure drop: –0.1 bar
according to (DIN) EN 62353:2008, IEC 62353:2007
12.1 Visual inspections performed. Off – – 
12.2 Protective earth resistance measured. Off 
Max. 0.3 Ω (with power cable) – ____ Ω


value
12.3 Measurement of the device leakage current performed. Preparation – 
 Device leakage current - differential current measurement according
to fig. 5
or
 Device leakage current - direct measurement according to fig. 4
13 Final inspection and testing
13.1 Disinfection performed. Cleaning – – 
---During disinfection: Cleaning
13.2 Power failure alarm checked. – – 
Audible alarm, alarm message: Power failure – Device is battery-
operated.

_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
Comments:
Comments:


Chapter 7: Error messages
7 Error messages
Up to 3 messages can be filed in the Message button.
Touch the X button to file the messages.
To retrieve the messages, touch the Current messages field.
If several messages are displayed, select the desired message.
The windows contain a brief description of the condition for the operator
and the required instructions to correct the problem.
Help can be displayed directly by touching the ? button in the window.
The associated Info window will be opened automatically.

Chapter 7: Error messages

Chapter 8: Tools (service equipment)
8 Tools (service equipment)
Caution
Only for OCM:
The precision of the measuring equipment used during calibration plays
an important role for the accuracy of the OCM measurement.
The measuring equipment used for the calibration of the conductivity
must have an accuracy of 0.05 mS/cm in the temperature range of
35 °C to 39 °C.
We recommend using the measuring device UMED (part no. M32 403
1) available from Fresenius Medical Care.
Pressure measuring device HMED with case

(set)
Part number: M30 770 1
Universal measuring device UMED with case

(set)
(conductivity, pressure, temperature)

Power supply cable UMED

Secutest VDE test device

(without printer module)
Part number: 631 064 1
Printer module
Carrying case (not illustrated)

PC Service Software

Graduated cylinder 100 ml

ESD Service Kit

ESD Workshop Kit


Tool kit

Chapter 9: Calibration / adjustment
9 Calibration / adjustment
9.1 Selecting the Service menu

In the SYSTEM menu touch the SERVICE button.
Message: Remove ServiceCard!
Remove the ServiceCard.
In the SERVICE menu touch the desired button.
9.2 Service menu, contents
FLOW DIAGRAM
CALIBRATE
DIAGNOSTICS
SETUP
MODULE
VARIOUS
UPDATE
9.3 Flow diagram
Flow diagram display with current device standards.

Display of the parameters of specific hydraulics assemblies (e.g.
temperature).

9.4 Calibrate
Display of certain basic information (e.g. target temperature).

Display of temperature sensor and pressure sensor values.
Calibration contents Calibrate touch screen

Pressure transducer (S03 / S07 / S15 / S16)
Degassing (A02 / P01)
Flow pump (A03)
Temperature (PT7 / PT8 / PT9)
Conductivity (CD7 / CD9)
Volumes
Blood leak
OCM
ECMP configuration (eccentric membrane pumps)
If a red "?" is shown in one of the fields, this indicates that no valid
calibration value is available.
 Calibrate touch screen
Select the Calibrate touch screen field. Touch the Start calibration
button.
The following message will be displayed on the upper left: Touch the
target center spot! Touch the "target center spot".
The following message will be displayed on the lower right: Touch the
target center spot! Touch the "target center spot".
After successful calibration, the CALIBRATE SCREEN will be
displayed.
If the menu cannot be selected (touch screen decalibrated), use the
following combination of buttons on the monitor. Consecutively press and
hold the following keys until the target points appear to the upper left of
the screen: Mute, Blood system Start, and Blood system Stop.
Thereafter, follow the steps above to continue calibration.
 Pressure transducer (S03 / S07 / S15 / S16)
Select the Pressure transducer (S03/S07/S15/S16) field. Touch the

Start calibration button.
Automatic adjustment of the zero of the pressure transducers S03, S07,
S15 and S16.
After successful calibration the following message will be displayed:
Please check or recalibrate degassing (P01) and loading pressure
(A02). Touch the Confirm button.
The CALIBRATE SCREEN will be displayed.

 Degassing (A02 / P01)
Basic requirements:
The pressure transducers (S03 / S07 / S15 / S16) have been calibrated.
Select the Degassing (A02 / P01) field.
Loading pressure test Touch the Loading pressure test button. The loading pressure (A02)
is being tested.
The following message will be displayed: Loading pressure (A02):
XXXX mbar.
Negative pressure test Touch the Negative pressure test button. The negative degassing
pressure of the degassing pump is being tested.
The following message will be displayed: Please wait. Filling phase in
progress!
Followed by the message: Degassing pressure -XXXX mbar.
Starting calibration Touch the Start calibration button.

The following message will be displayed: Please wait. Filling phase in
progress!
Followed by the message: Please wait. Plausibility check
S03/S07/S15/S16 in progress.
Message: Adjustment of relief valve A02 between 1800 and 1900 mbar
- Pressure: XXXX mbar.
If the pressure value is not within the defined range, it must be adjusted
using A02. Then touch the Confirm button.
Message: Initial degassing pump test in progress!
Automatic calibration starts with the “initial degassing pump test”.
(which checks the condition of the degassing pump.)
Message: Please wait. Filling phase in progress!
Message: Please wait. Automatic degassing calibration in progress!
Speed P01: XXXX rpm Pressure S16: -XXXX mbar
Message: Adjustment of relief valve A02 between 1800 and 1900 mbar
- Pressure: XXXX mbar.

After automatic calibration has been completed, the following message

will be displayed: Adjustment of relief valve A02 between 1800 and
1900 mbar - Pressure: XXXX mbar. If the pressure value is within the
range, touch the Confirm button.
If the pressure now is within the defined range, touch the Confirm
button.
 Flow pump (A03)
Basic requirements:
The pressure transducers (S03 / S07 / S15 / S16) have been calibrated.
Select the Flow pump (A03) field. Touch the Start calibration button.
The following message will be displayed: Adjustment of relief valve A03.
between 2450 and 2650 mbar – Pressure S15: XXXX mbar. If the
pressure is within the range, touch the Confirm button.
The CALIBRATE SCREEN will be displayed. The flow pump (A03) is
now calibrated.
If the pressure limitation is not within the desired range, it must be
adjusted using A03.
Note
In the Service menu, the dialysate flow can be set from 100 ml/min to
1000 ml/min in increments of 100 ml/min and be checked.
Touch the CALIBRATE button in the Service menu.
Select the desired flow.
Touch the Dialysate flow button (waves) to display the flow diagram.
If the flow deviates from the selected flow by more than ±30 ml/min the
flow pump (P03) will adjust the flow automatically.
If the flow pump (P03) adjusts the flow it is yellow in the flow diagram.
If the adjustment is completed, the flow pump (P03) will be shown in red
with yellow circles which means that the adjustment value has been
stored.
All selectable flows have to be checked by performing this procedure.

 Temperature (PT7 / PT8 / PT9)
Basic requirements:
Flow on, response time approx. 10 minutes
Select the Temperature (PT7 / PT8 / PT9) field. Touch the Start
calibration button.
Measure the reference temperature with an external measuring
instrument.
Select the Ref. temp. field. Enter the reference temperature. Touch the
OK button to confirm the value entered. Touch the Accept value
button.
Note
If the temperature has been recalibrated, the OCM must also be
recalibrated.
 Conductivity (CD7 / CD9)
Basic requirements:
The temperature (PT7 / PT8 / PT9) has been calibrated.
The connected concentrate is identical to the set concentrate.
Flow on, response time approx. 10 minutes
Measure the reference conductivity with an external measuring
instrument.
Select the Conductivity (CD7 / CD9) field. Touch the Start calibration
button.
Automatic setting of the Prescr. Na depending on the connected
concentrate.
Select the Ref. CD 13.00 mS/cm field. Enter the reference conductivity.
Touch the OK button to confirm the value entered. Touch the Accept
value button.
(If entering of the reference CD is not possible, the CD can be adapted
by changing the Prescr. Na.)
Automatic setting of the Prescr. Na depending on the connected
concentrate.
Select the Ref. CD 15.00 mS/cm field. Enter the reference conductivity.
Touch the OK button to confirm the value entered. Touch the Accept
value button.
(If entering of the reference CD is not possible, the CD can be adapted
by changing the Prescr. Na.)
Note
If the conductivity has been recalibrated, the OCM must also be
recalibrated.

 Volumes
Select the Volumes field. Touch the Start calibration button.

The following volumes will be displayed:
Balancing chamber (volume evaluated for the flow)
UF pump
The values displayed must match the values on the labels of the above
components.
 Blood leak
Basic requirements:
The hemodialysis system must be closed. (Avoid incidence of ambient
light.)
Temperature in the range between 34 °C and 39 °C, flow on, flow
500 ml/min
Select the Blood leak field. Touch the Start calibration button.
The following message will be displayed: Please confirm that the
cuvette is clear and is inserted correctly into the blood leak detector!
Calibration will then be performed automatically! – Confirm – Stop.
Touch the Confirm button.
displayed.
 OCM
Basic requirements:
The temperature (PT7 / PT8 / PT9) has been calibrated.
The conductivity (CD7 / CD9) has been calibrated.
Select the OCM field. Touch the Start calibration button.
Automatic OCM adjustment. (Duration approx. 18 minutes.)
After successful calibration the following message will be displayed:
Correction factor: Up = X,XXXX Down = X,XXXX Cdi-Cdo-deviation =
X µS/cm – Confirm
displayed.

 ECMP configuration (eccentric membrane pumps)
An eccentric membrane pump must be configured, if it was replaced.

The ultrafiltration pump (P04) can be replaced by an ultrafiltration pump
or by an universal eccentric membrane pump. The pump's contact
sheets / valve electrodes are required.
A concentrate pump (P06) or a bicarbonate pump (P05) can be

replaced by an ultrafiltration pump or by an universal eccentric
membrane pump. The pump's contact sheets / valve electrodes are not
required.
Select the ECMP configuration field. Touch the Start button.
Message: Please connect the ECMP to be programmed to the ECMP
service plug and confirm.
Connect the eccentric membrane pump to be configured to the X-Spare
plug on P.C.B. LP1141. Connect jumper J3 on P.C.B. LP1141 from
position 2/3 to position 1/2.
Select the desired pump.
Touch the Program button.

The following message will only be displayed if an ultrafiltration pump

(P04) has been configured: Pump equipped with contact sheets / valve
electrodes?
Touch the Yes button.
Message: Programming successfully completed. Please disconnect the
ECMP from the ECMP service plug and confirm.
Remove eccentric membrane pump from the X-Spare plug on P.C.B.
LP1141. Connect jumper J3 on P.C.B. LP1141 from position 1/2 to
position 2/3. Connect the eccentric membrane pump to the appropriate
plugs X_SOD, X_BIC or X_UF on P.C.B. LP1141.

9.5 Diagnostics
 Diagnostics contents
Monitor
Monitor - Info
EBM
EBM - Info
EBM - Sensors
Hydraulics
Hydraulics - Info
Flow diagram: Individual control
Hydraulics - Test
Power supply unit
Power supply unit - Info
BPM (option)
BPM - Info
BTM (option)
BTM - Info
 Monitor
Monitor - Info Displays the operating hours of the OS (operating system) and the SS
(safety system).
 EBM
EBM - Info Displays the operating hours of the OS (operating system) and the SS
(safety system).
EBM - Sensors This indicator shows the particular status of the assembly with regard to
operating system and safety system.
Applies only to sensor position 1, art. pressure measurement unit.
Touch position 1 in the EBM display to open or close the arterial
pressure measurement unit.
 Hydraulics
Hydraulics - Info Displays the operating hours of the OS (operating system) and the SS
(safety system).
Flow diagram: Individual Open the flow diagram of the hydraulics on the screen.
control It is then possible to open and close the individual valves by touching
the associated valve icon on the screen.

Caution
Before opening the CDS valves, ensure that the device has been
disconnected from the CDS and confirm this disconnection when
selecting a CDS valve.
After having been opened, some of the valves require a mandatory

rinse or a mandatory disinfection. Before such a valve is opened, the
device emits a message to prompt the operator accordingly.
The heater rod and the pumps are turned off and cannot be activated.
As soon as the "Flow diagram: Individual control" item is exited, all
valves are closed.
Hydraulics - Test Contains the following buttons for performing certain tests.
T1 test
Basic requirements:
Concentrate (acid) and bicarbonate must be connected.
The connected concentrated corresponds to the selected concentrate,
check / select the concentrate in the CALIBRATE menu.
S35, CD circuit, S10, S16, Loading time, Temp 07 / 08, S50 / S51, Blood
leak, Neg. pressure, Pos. pressure, DIASAFE, S09, CD circuit / CD
Others
ePHT
Cleaning pgm sequences
Prior to performing the tests (Test 1 and Test 2), touch the Test
preparation button to prepare the hydraulics for the test. Concentrate
and bicarbonate suction tube are in the rinse chamber.
Test preparation ( T ), Heat, V38 Test, Level sensors, Empty rinse
chamber, ( T ) - V03 Rinse, ( T ) - Test 1 (Heat exchanger / V03), ( T ) -
Test 2 (cleaning program rinse section test < 3 minutes), ( T ) - Suction
(rear), ( T ) - Suction (front).
 Power supply unit
Power supply unit - Info Displays the operating hours and the actual values of the 24 V, 18 V
and 5 V voltages, as well as the battery voltage.
 BPM
BPM - Info Displays the serial number, the BPU serial number, the operating hours
and the number of measurement cycles.
Contains buttons and displays for performing the MA test.
 BTM
BTM- info Displays the serial number and the operating hours.

Contains the sensor status indicator with information on the head

temperature (operating system), the line temperature (operating
system), the NTC temperature (safety system), and the door status.

9.6 Setup
Further information (see chapter, 5.3 page 5-29).
9.7 Module
(no contents yet)
9.8 Various
Possibility to select the preservation program from the Hydraulics

section.
9.9 Update
Possibility to update the respective components (OS to the left –

operating system; SS to the right – safety system).
Select the required components, then touch the Start button.
In the event of a software update via a CF card, the software version of
the CF card (on the left) and the software version of the modules (on the
right) will be displayed in the UPDATE menu.
If the software version of the CF card does not match the software
version of the module, all modules which must be updated will
automatically be highlighted.
Touch the Start button. The update will be performed.

Chapter 10: Repair
10 Repair
10.1 Precautions for working on the hemodialysis system
Authorized persons Assembly, extensions, adjustments, modifications or repairs may only

be carried out by the manufacturer or persons authorized by him.
accessories.

Prior to opening the hemodialysis system and when working on the
open hemodialysis system, the following precautions have to be taken:
Monitor support arm If the hemodialysis system is to be placed in a horizontal position for
servicing, the monitor support arm must be protected with the transport
protection to prevent it from flipping over.
To be observed after A disinfection, a T1 test and an electrical safety check must be

working on the performed after working on the hemodialysis system.
hemodialysis system
To be observed after After a disinfection program has been stopped or if the system is to be
stopping a disinfection preserved, the hemodialysis system must be disconnected from the
program water supply after a maximum of 3 days. When the system is returned
to use, check that the pressure of the water supply meets the prescribed
minimum pressure.

Chapter 10: Repair
10.2 Component overview
10.2.1 Monitor
2
9
8
3
4 5 6 7
1. Monitor rear
2. Loudspeaker and microphone
3. Monitor front with touch / display unit with screen failure sensor
4. PCB LP 1102-1 / LP1202 controller board (C167) monitor
5. P.C.B. LP 1104 monitor power supply board
6. PC board
7. P.C.B. LP 1145 Monitor interface
8. P.C.B. LP 1131 Monitor operating mode indicator
9. P.C.B. LP 1134 Chipcard reader

Chapter 10: Repair
10.2.2 Extracorporeal Blood Circuit Module (EBM)
11
7 12
13
9
8 18
21
20
5 17
6 14
15
22 10 19 3 4 2 1
Legend
1 Single-Needle pump (option) 11 P.C.B. LP 1202

2 Single-Needle ejector 12 P.C.B. LP 1107 EBM I/O
3 Blood pump board
4 Blood pump ejector 13 Venous pressure transducer
5 Substituate pump 14 Single-Needle pressure
6 Substituate pump ejector transducer (option)
7 Level detector 15 Heparin pump
(not visible) 16 Internal compliance chamber
8 Optical detector / air bubble for Single-Needle (option)
detector (ABD) 17 P.C.B LP 1126 Heparin pump
9 Venous occlusion clamp control board
10 Arterial occlusion clamp 18 Compressor
19 Arterial pressure
measurement unit
20 Leakage sensor
21 Sensor EBM door
22 ONLINE port (option)

Chapter 10: Repair
10.2.3 Hydraulics connectors, front view
1 2 3 4 5
1 Suction tube flap

2 Concentrate suction tube (red)
3 Bicarbonate suction tube (blue)
4 bibag® flap
5 bibag® connector

Chapter 10: Repair
10.2.4 Rear view, with hydraulics connectors
1 Monitor
2 External connection options
3 Push handle
4 Power supply
1 5 Fan filter
6 Filter 2 – ONLINEplus™, left
7 Filter 1 – DIASAFE®plus, right
2 8 Particle filter
9 Disinfectant connector H20
3
10 Disinfectant connector H35
11 Connector for CDS, red H29 (Central
4 Delivery System) acid (option)
12 Leakage sensor flap
5
13 Flush drain, H02 (option)
6
14 Drain, H19
7
15 Potential equalization
8 16 Battery compartment
9 17 Water supply (permeate) or connector

for water inlet filter, H01
10
18 Fuse for battery
19 Vent (water inlet chamber)
19
11
18
12
13 14 15 16 17

Chapter 10: Repair
10.2.5 Hydraulics, left side
V34

Chapter 10: Repair
10.2.6 Hydraulics, right side

Chapter 10: Repair
10.2.7 Hydraulics legend
Explanation of symbols
Axx Elements for adjustment PTx Temperature sensors

CDx Conductivity cells Sxx Other sensors
Fxx Filters Vxx Valves
Hxx Hydraulic components Vxxs Small valves (s)
Pxx Pumps
Legend
A02 Loading pressure valve, balancing chamber P01 Degassing pump

A03 Relief valve P03 Flow pump
A04 Pressure reducing valve, water inlet P04 UF pump
A05 Check valve, water inlet P05 Bicarbonate pump
P06 Concentrate pump
CD4 Conductivity cell, bicarbonate
CD5 Conductivity cell, bicarbonate PT2 Sensor, temperature control
CD7 Conductivity cell, overall conductivity PT4 Temperature sensor, CD bicarbonate
CD9 Conductivity cell, OCM PT5 Temperature sensor, CD bicarbonate
PT7 Temperature sensor, overall CD and temperature display
F01 Filter, water inlet PT8 Sensor, temperature re-adjustment
F04 Filter stage 1 PT9 Temperature sensor, CD OCM
F05 Filter stage 2
F06 Hydrophobic filter, compressor EBM S01 Float switch, water inlet chamber
F07 Particle filter, dialysate S03 Pressure transducer, dialyzer inlet
F08 Filter, UF pump S04 Sensor, shunt interlock inlet
F10 Filter, disinfectant S05 Sensor, shunt interlock open
F11 Suction tube, concentrate with filter S06 Sensor, shunt interlock outlet
F12 Suction tube, bicarbonate with filter S07 Pressure transducer, dialyzer outlet
F14 Filter, CDS S08 Blood leak detector
S09 Level sensor, secondary air separator
H01 Male connector, water inlet S10 Sensor, air separation valve
H02 Male connector, Flush S11 UF pump, CD inlet
H03 Water inlet chamber S15 Pressure transducer, balancing chamber switching
H04 Heat exchanger S16 Pressure transducer, fill dry concentrate bag
H05 Degassing orifice S17 Level sensor, concentrate rinse chamber
H06 Degassing chamber S18 Sensor, concentrate rinse chamber lock
H07 Heater rod chamber S19 Level sensor, rinse chamber, bicarbonate
H08 Heater rod S20 Sensor, bicarbonate rinse chamber lock
H09 Primary air separator S21 bibag® flap, bag operation position
H14 Balancing chamber S22 bibag® connected
H15 Sampling valve S27 Sensor 1, substituate port
H16 Dialyzer coupling, inlet S28 Sensor 2, substituate port
H17 Dialyzer coupling, outlet S29 Sensor 1, rinse port
H18 Secondary air separator S30 Sensor 2, rinse port
H19 Male connector, drain S35 Leakage sensor, hydraulics
H20 Male connector, disinfectant 1 S36 UF pump, CD outlet
H21 Rinse chamber, concentrate S38 UF pump, monitoring
H22 Rinse chamber, bicarbonate S47 bibag® flap, cleaning position
H23 Connector bibag® S50 Sensor, bicarbonate air separator
H29 Male connector, CDS S51 Sensor, concentrate air separator
H32 Substituate port S53 Sensor, suction tube flap
H33 Rinse port
H34 Male connector, compressor EBM
H35 Male connector, disinfectant 2
H36 Male connector, dialyzer coupling, to dialyzer
H37 Male connector, dialyzer coupling, from dialyzer
H42 Connector, potential equalization
H43 Male connector, vent water inlet chamber
H50 Air separation chamber, bicarbonate
H51 Air separation chamber, concentrate (continued next page)

Chapter 10: Repair
V02 Water inlet valve

V03 Recirculation valve, cleaning
V04 Degassing orifice bypass valve
V09 Fill valve, dry concentrate bag
V11 Balancing chamber valve
V19 Drain valve
V20 Disinfection valve
V21 Vent valve, filter stage 1
V22 Retentate valve
V23 Test valve
V24 Dialyzer inlet valve
V25 Dialyzer outlet valve
V26 Bypass valve
V28 Fill valve, secondary air separator
V29s Air separation valve
V30 Outlet valve
V31 Substituate valve
V32 Rinse valve 1, H(D)F
V35s Negative pressure valve 2
V36 Rinse valve
V38 Bypass valve, heat exchanger
V40 Shutoff valve, disinfection
V41 Rinse valve, disinfection
V50 Sensor, bicarbonate air separation valve
S51 Sensor, concentrate air separation valve
V53 Sensor, suction tube flap
VB1 Fill valve, bibag®

VB2 Deaeration valve, bicarbonate rinse chamber
VF1 Flush valve

VF2 Flush valve, drain
VS1 Rinse valve, concentrate rinse chamber

VS2 Deaeration valve, concentrate rinse chamber
VS3s CDS, shutoff valve OS
VS4s CDS, shutoff valve SS
VS5s CDS valve, test
VS6s CDS valve, inlet

Chapter 10: Repair
10.3 Assembly of components
10.3.1 SNAPLOC attachment
1 1. Chassis sheet
2 2. Buffer
3
3. Hook geometry
4. Coupling
5. Bolt
4 Insert the hook of the component slightly
5 tilted into the buffer.
With the hook inserted, move the bolt of the

component towards the coupling.
Slightly press the bolt into the coupling until it

clicks into place.

Chapter 10: Repair
10.3.2 Self-cutting screws
Many components are screwed into the

plastic housing by means of self-cutting
screws.
To be observed when screwing in the screws:
1. the wrench torque specified
2. do not tap a new thread
In order to do so, turn the attached screw anti-
clockwise with slight pressure until a slight
locking into the thread can be felt. While
applying only little force, turn the screw
clockwise until it screws into the thread.
Then, tighten the screw to the specified
wrench torque.
10.3.3 Wrench torques
 IV pole
1 threaded pin, IV pole , wrench torque 90 Ncm.
 Heparin pump
1 threaded pin, bearing sleeve, heparin pump 90 Ncm.
 Dialyzer holder
Fixation: 2 screws, dialyzer holder, wrench torque 130 Ncm.

Chapter 10: Repair
10.4 Equipment
10.4.1 Closing plugs
Closing plugs for hydraulics ports M35 958 1
10.4.2 Consumables
Molykote lubricant for the braking mechanism

on the cart
Screwlock Loctite 243 M33 993 1
Unisilicone grease M30 267 1

Chapter 10: Repair
10.5 Placing the system on its side / carrying the system
Caution
If the hemodialysis system is to be laid horizontal for servicing, the
monitor support arm must be protected with the transport protection to
prevent it from flipping over (see chapter, 10.8.3 page 10-25).
Use at least 2 people when moving the hemodialysis system to a
horizontal position.
10.5.1 Moving the hemodialysis system to a horizontal position
For stability reasons, the hemodialysis system may only be tilted if the
side panels are closed.
– Secure the monitor support arm with transport protection (see
chapter, 10.8.3 page 10-25).
– Apply the brake
– Put foamed material or something similar on the floor at the rear of
the cart.
– Put foamed material or something similar on the floor to cushion the
handle.
– Remove the left and the right door of the EBM (see chapter, 10.11.1
page 10-28).
– Hold the hemodialysis system by the EBM at the top and use two
people to tilt it backwards.

Chapter 10: Repair
10.5.2 Carrying the hemodialysis system
To be observed when carrying the system:

– Do not hold the 5008S dialysis system by
1
the concentrate container holder when
carrying.
– Remove the concentrate container holder
and the IV pole before carrying the system
(see chapter, 10.13.2 page 10-68).
– The push handle must not take the whole
weight of the 5008S dialysis system.
– Using at least 2 people, hold the push
handle 5008S(1) and the housing (2)
near the front rollers to carry the
dialysis system.
10.6 IV pole
10.6.1 Removing and installing the IV pole
Move the cover (1) on the monitor support

arm upwards.
Remove the 2.5 mm threaded pin (2).
Lift the IV pole to remove it.
1
To install, insert IV pole.
Observe the wrench torque when tightening
the threaded pin (2).
(see chapter, 10.3.3 page 10-11)

Chapter 10: Repair
10.7 Housing
10.7.1 Opening the side panel
Unscrew the 2 Allen screws (1) on the edge

of the rear panel.
Unscrew the 3 Allen screws (2).
Remove the side panel.
Disconnect the grounding cable.
1 This description applies to both the left and
2
the right side panel.
10.7.2 Opening the media supply rail
Remove the 4 screws and pull out the media

supply rail by approx. 2 cm.
Remove the fixation from the overflow tubing
(1).
Continue pulling out the media supply rail.
1
Observe that after closing it, it must be
possible to open the flap (2) to the inside.

Chapter 10: Repair
10.7.3 Removing and installing the shunt interlock
Remove the connector (1) for the

microswitches of the shunt interlock
X_S04_S05_S06 from P.C.B. LP 1140 /
electronics chassis.
Remove the (1) heat shrink tubing.

Open the tubing connection.
1 Connect a new shrink tubing after replacing
the shunt interlock.
Remove the 6 screws (1-6).

Remove the EMC sheet.
6 Remove the shunt interlock.
1 Follow the procedure in reverse order for
5 installation.
2
4

Chapter 10: Repair
10.7.4 Removing and installing the microswitch in the installed shunt interlock
Disconnect the connector for the microswitch

of the shunt interlock (1) X_S04_S05_S06 of
P.C.B. LP 1140 / electronics chassis.
The microswitches are replaced from the
inside of the hemodialysis system.
1
Remove the EMC sheet.
Unscrew the Phillips screw (1) to remove the
microswitch for the flap.
Unscrew the 2 Phillips screws (2) to remove
the two microswitches for the dialyzer
couplings.
2 Washers are placed between the

microswitches and the covers.
Open the strain relief to remove the cable.
Arrange the cable after replacing the
microswitch.
Plug the connector of the microswitch (1,
figure above) into P.C.B. LP 1140 /
electronics chassis, slot X_S04_S05_S06.
Check the microswitch in the flow diagram
– S4 = microswitch coupling, dialysate
supply
– S5 = microswitch flap
– S6 = microswitch coupling, dialysate
return
10.7.5 Removing and installing the shunt interlock mark
In order to do so, open the protective cap (1)

with a small screw driver and unscrew the
Phillips screw.
1 Remove and replace the color plate.
Once color coding has been replaced, the
color plate must be inverted.

Chapter 10: Repair
10.7.6 Removing and installing the dialyzer coupling
Using wring wrench (part no.: M33 624 1)

loosen the screws on the dialyzer coupling.
The ring wrench is in the accessories
package or in the service suitcase.
Remove the tubing from the dialyzer
coupling.
Prior to fitting, cut approx. 1 cm from the end
of the tubing.
Please observe that the tubing and the
clamping ring must be pushed onto the
dialyzer coupling completely.
1
Observe the arrow (1) marking the flow
direction.
10.7.7 Removing and installing the dialyzer holder
Remove the protective cap.

Unscrew the 2 mounting screws (1) of the
dialyzer holder.
Remove the dialyzer holder.
Follow the procedure in reverse order for
1
installation.
Observe the wrench torque when tightening
the 2 screws.
The dialyzer holder is attached with break

point screws. These shear if the dialyzer is
subjected to an excessive force in the pivot
direction.
The sheared-off thread pieces remaining in
the front of the module can be removed with
a screwdriver.
The thread of the break point screws has two
diagonal drill holes and will tear, if the screw
is tightened more than the given torque.

Chapter 10: Repair
10.8 Monitor
10.8.1 Removing and installing the monitor and the monitor support arm
Caution
High voltage, unplug power plug before working on the monitor.
Remove the IV pole.

Remove the 5 protective caps on the rear of
the monitor.
Unscrew the 5 screws.
Tilt the monitor touch / display unit to the
front.
Disconnect the connector from card reader.

Disconnect all connectors from the monitor
touch / display unit.
Detach the traction rope.
Tilt the monitor touch / display slightly

backwards and lift it to remove it from the 4
locking screws (1) .
Remove the monitor touch / display monitor
unit.

Chapter 10: Repair
Open both side panels.

Pay attention to the grounding cables when
removing the side panels.
Remove the P.C.B. cover (1).
To remove the cover, use pliers to squeeze
the holder.
1
Disconnect the 2 connectors on P.C.B.

LP 1142.
Remove the cable ties.
Disconnect the grounding cable to the
1
monitor from the grounding terminal.
Unscrew the 2 screws (1).

Chapter 10: Repair
Open the EBM.

Remove 1 CAN bus connector (1) from
P.C.B. LP 1106.
Remove the power supply unit.

(see chapter, 10.10 page 10-27)
1
2 Unscrew 1 screw (1).
3 Unscrew 1 screw (2) from the grounding
cable.
Unscrew the 2 screws (3) from the monitor
support arm.
88
Carefully lift the rear part of the monitor with

support arm and cables to remove it.

Chapter 10: Repair
 Installation

installation.
When installing the monitor, ensure that the
O-ring (1) fits properly.
1
Apply a little unisilicone to the O-ring.
Adjust the pivot shafts of the monitor as
described below:
After closing the monitor, it must be possible
to pivot the monitor while it remains securely
held in all positions.
Various display types are delivered. When
installing another display type, observe the
allocation of soldering straps BR1-3 on
P.C.B. LP 1104.

Chapter 10: Repair
10.8.2 Adjusting the monitor movement
The following describes the adjustment of the

3 shafts (a), (b) and (c) of the monitor.
c b
 Adjusting shaft (a)
Open the monitor touch / display unit.
1 Loosen the threaded pin on the locking

washer (1) with a 2.5 mm Allen wrench.
Turn the cross-drilled nut (1) with a 5 mm
Allen wrench to the right.
This increases the brake force.
Adjust the brake in such a way that the
monitor may be pivoted but is securely held in
all positions.
Once the brake has been set, the cross-

2 drilled nut must be secured with the threaded
pin.
1 Apply screwlock Loctite 243 to the thread of
the threaded pin.
Should the threaded pin no longer be
accessible once the cross-drilled nut has
been turned, the threaded pin has to be
screwed into another thread of the cross-
drilled nut.
Ensure that the the brass bolt (2) positioned
under the threaded pin (1) also must be re-
located.
Apply screwlock Loctite 243 to the thread of
the threaded pin.
Finally, close the monitor touch / display unit.

Chapter 10: Repair
 Adjusting axis (b)
Remove the Phillips screw at the bottom of

the cover.
Apply pressure to the positions marked by 2
arrows to remove the cover easily.
Unscrew the threaded pin using a 2.5 mm

Allen wrench.
Adjust the carrier screw (1) using a 5 mm

1 Allen wrench until the operator can move the
swivel arm easily.
the threaded pin.
Screw in the threaded pin.
Close the cover and screw in the Phillips
screws.

Chapter 10: Repair
 Adjusting axis (c)
Remove the protective cap (1).

Unscrew the threaded pin (2), using a 2.5 mm
Allen wrench.
Turn the bearing screw using a 5 mm Allen

wrench in order to adjust the brake until the
operator may move the swivel arm
comfortably.
Apply screwlock Loctite243 to the thread
of the threaded pin (2) (see previous figure).
Screw in the threaded pin.
Fit the protective cap.
Push the support arm cover downwards.
10.8.3 Monitor transport protection
Remove the IV pole.

Align the monitor support arm in parallel with
the front edge of the device.
Screw in the oval head screw M5x50 (1)
1 using a Phillips screwdriver.
Tilt the monitor to the back.

Chapter 10: Repair
10.9 Updating the monitor operating system M1
Please observe that, following an update of M1, the actual update

procedure will be performed only after turning the system off and on
again (i.e., when rebooting the system).
After turning the system on, the screen remains dark during the update,
for approx. 3 min.
Caution
Do not turn off the hemodialysis system during this phase.
Otherwise, program components will be erased from the Compact
Flash which cannot be recovered.
As a result, the hemodialysis system will not boot, but will stop showing
a black screen.
If this error has occurred, the Compact Flash must be replaced.

Chapter 10: Repair
10.10 Power supply unit and power cable
10.10.1 Removing and installing the power cable
Unscrew the screw (1) and disconnect the

cable.
1 To install:
After the installation, secure the power cable
using a screw (1).
10.10.2 Removing and installing the power supply unit
Remove the power cable.

Unscrew the 2 Phillips screws on the
3
retaining plate (1).
Move the retaining plate to the front of the
system.
1
Remove the heater rod connector (2).
Open the EBM.
2
Remove the 3 mounting screws M4x8 (4) of
3
P.C.B. LP 1106.
Insert P.C.B. LP 1106 into the hemodialysis
system.
Remove the grounding cable connector of the
power supply unit from the grounding
terminal on the left side of the hydraulics.
Unscrew the 3 mounting screws (3) of the
power supply unit.
Push the power supply unit towards the front
(front of EBM) and then remove it.
installation.
4 Connect the grounding cable.

Chapter 10: Repair
10.11 Extracorporeal Blood Circuit Module EBM
10.11.1 Removing and installing the EBM doors
In order to remove the EBM door, open it and

push it over the end stop of the hinge until the
hinge disengages from the holder.
To install, secure the hinge in the holder,
ensuring it clicks into place.

Chapter 10: Repair
10.11.2 Removing and installing the EBM
Open the EBM lock (1) on the left side of the

system.
Remove both EBM doors.
Flip the EBM outwards.
1 Remove both side panels.(see
chapter, 10.7.1 page 10-15)

Chapter 10: Repair
Caution
Risk of injury!
There is a risk of crushing body parts with the EBM hinge.
The following note must be observed:
There is a risk of crushing body parts with the

EBM hinge when opening the EBM.
Accordingly, access the hinge (1) only when
the EBM is open.
88
Note
Before closing the EBM, the lock (1) must be turned fully back to the end
stop.

Chapter 10: Repair
Remove the blue tubing (1) from the

compressor.
Remove the ONLINE port (option).

Remove the 3 mounting screws.
Place the ONLINE port in the interior of the
system.
Disconnect all plug connectors between the

EBM and the hemodialysis system.
Remove the (1) cable ties.
Remove the screw securing the strap (2).
2 Hold the EBM securely while doing so. The
hinge mounting mechanism may break if the
full weight of the EBM rests on the hinges.

Chapter 10: Repair
Lift the EBM to take it off its hinges.

installation.
When installing, ensure that the tubing and
the cables are not too slack. When closing the
EBM, there will be a risk of jamming the
tubing or the cables.

Chapter 10: Repair
10.11.3 Removing and installing the arterial pressure measurement unit
In order to open the lock, press the spring

outwards using a screw driver.
Turn the pressure measurement unit anti-
clockwise in order to remove it.
10.11.4 Removing and installing the venous and arterial occlusion clamp
The procedure for removing and installing the

venous and arterial occlusion clamp
corresponds to the procedure for removing
and installing the arterial pressure
measurement unit.

Chapter 10: Repair
10.11.5 Verification / repair procedure in case of ingress of blood or fluid via the pressure
line
Caution
Risk of infection
Contamination of the 5008S dialysis system with blood results in a risk
of infection.
The following must be observed to avoid an infection:
– Wear disposable gloves.
– Disinfect your hands after removing the gloves.
– Wear surgical mask and goggles if there is a risk of splashes and
aerosoles.
– Clean and disinfect the 5008S dialysis system before coming into
contact.
Checking the EBM front Check the housing front in the vicinity of the Luer-lock connectors for
residual blood, fluid and precipitation, especially at the following
positions:
– Venous pressure transducer
– Single-Needle pressure transducer
– Arterial pressure measurement unit
Checking the EBM inside Open the EBM

Imperatively check the following components of the pneumatic unit and
replace them in case of contamination:
– Venous pressure transducer
– Single-Needle pressure transducer
– Arterial pressure measurement unit
– Compressor unit
– Internal compliance chamber for Single-Needle
– Hydrophobic filter F06
If a component is replaced, the pneumatic tubing has to be replaced as
well.
The complete pneumatic unit (see components mentioned above) must
be replaced if it cannot definitely be detected which components have
been contaminated with blood or fluid.
Checking the housing If blood or fluid enters into the main housing section or into other
main part components (e.g. P.C.B. LP 1202, P.C.B. LP 1107, BVM, BTM, BPM,
online module, etc.) via the compressor unit, these must be cleaned or
replaced.

Chapter 10: Repair
Device-internal The internal hydrophobic filters (see following figures) must be checked
hydrophobic filters for wetting by fluid.
If internal hydrophobic filters have not been installed, retrofitting is
recommended.
(retrofit kit hydrophobic filter part. no.: M39 722 1)
Abb.: Device with Single-Needle option
Hydrophobic
filter before
compressor unit
Hydrophobic filter after
venous
Pressure transducer
Hydrophobic
filter before
SN compliance
chamber
Abb.: Standard device without Single-Needle option
Hydrophobic filter after

venous
Pressure transducer
Final check After the replacement of components:

Leakage test of the pneumatic unit (see following chapters)
Perform the T1 test and a disinfection.

Chapter 10: Repair
10.11.6 Checking the pneumatics of the arterial pressure measurement unit
– In the Diagnostics service menu, select EBM (see EBM - Sensors,

page 9-9).
– Touch position 1 in the EBM display to open the arterial pressure
measurement unit.
– The arterial pressure measurement unit must remain open for 2
minutes without the compressor starting to run.
– Close the arterial pressure measurement unit.
– Check the emergency unlocking mechanism:
To do so, unscrew the check valve (part no. 850 280 1) on the rear
of the system from the Luer-Lock parking position and screw it onto
the deaeration Luer-Lock.
Draw air into a 50 ml Luer-Lock syringe, screw it onto the check
valve, and empty the syringe.
The pressure measurement unit will be opened.
Then unscrew the check valve from the deaeration Luer-Lock and
screw it back onto the parking position Luer-Lock.
10.11.7 Checking the venous pressure transducer for leakage
– Use a 50 ml syringe to apply a pressure of approx. 500 mmHg from

the outside onto the venous Luer-Lock connector.
– Read the value displayed in the Diagnostics service menu, EBM
sub-item.
– Wait until the display has stabilized.
– After that, a pressure drop of 5 mmHg maximum is allowed within
1 minute.

Chapter 10: Repair
to hydraulics Orifice
Pven Venous Luer-

V1 V3 Lock
Check PVC tubing 4.3 x 6.8 mm

valve Length 690 +/- 10 mm
Part no. M307771
Compressor PSN Check valve

V4
SN Luer-Lock
V5
Compliance
chamber Deaeration and
emergency unlocking
mechanism
V2
Arterial press.
meas. unit

Chapter 10: Repair
10.11.8 Checking the Single-Needle pressure transducer with internal compliance

chamber for leakage
– Read the value displayed in the Diagnostics service menu, EBM

sub-item.
– Use a 50 ml syringe to apply a pressure of approx. 500 mmHg from
the outside onto the SN Luer-Lock connector.
– Wait until the display has stabilized.
– After that, a pressure drop of 5 mmHg maximum is allowed within
10 minutes.
to hydraulics
Orifice
Pven Venous
V1 V3 Luer-Lock
Check
valve
Compressor PSN
SN Luer-Lock
V4
PVC tubing 4.3 x 6.8 mm

V5 Length 690 +/- 10 mm
Part no. M307771 Check valve
Compliance
emergency unlocking
mechanism
V2
Arterial press.
meas. unit

Chapter 10: Repair
 Control states of the pneumatic valves
Operating mode V1 V2 V3 V4 V5 Compresso

r
Standby 0 0 0 0 0 0
Closing pressure dome 0 0 0 0 0 0
Blood line 0 0 0 0 0 0
inserted
Opening pressure 0 1 0 0 0 1
dome
Blood lines inserted 0 0 0 0 1 0

SN treatment
Priming blood lines 0 0 1 Bypass 0 0 0
Lowering ven. level 1 0 1 0 0 1
Raising ven. level 0 0 1 Bypass 0 0 0
Setting SN level 0 0 0 1 Bypass 1 0
Raising SN Click-Clack 0 0 1 Bypass 0 0 0

level
Lowering SN Click- 1 0 1 0 0 1
Clack
level
Reset ven. pressure 0 0 1 Bypass 0 0 0

transducer
Reset SN pressure 0 0 0 1 Bypass 0 0

transducer
SN inserted, Double- 1 0 0 1 0 1
Needle active, lowering
level
Diagnostics, EBM 0 0 0 0 1 0
0 Not controlled
1 Controlled

Chapter 10: Repair
to hydraulics
V1 Pven Venous
V3 Luer-Lock
PSN
Compressor V4 SN Luer-Lock
V5
Compliance
emergency unlocking
mechanism
V2
Arterial press.
meas. unit
V1 E1_PNEUMATIC_ValveFunctSelect
V2 E1_PNEUMATIC_ValveDockingUnitArt
V3 E1_PNEUMATIC_ValveLevelUpDownDC
V4 E1_PNEUMATIC_ValveSNLevelUpDown
V5 E1_PNEUMATIC_ValveSNCompliance

Chapter 10: Repair
10.11.9 Removing and installing the grip handle of the occlusion clamps
Place the mounting tool M37 557 1 under the

lateral tabs of the grip handle.
The lateral tabs will be bent upwards, and the
grip handle may be removed.
To install the grip handle, place the mounting

tool next to the clamp.
Push the grip handle from the side over the
mounting tool onto the clamp.
When removing the mounting tool, the lateral

tabs will click into place on the latches at the
clamp.
Check the grip handles for tight fit and correct
function.

Chapter 10: Repair
10.11.10Removing and installing the air bubble detector ABD
To remove the air bubble detector ABD, push

back the cover (1) and remove the connector.
Remove the P.C.B. cover.
2
To install, first tighten the two screws evenly
and slightly and then securely tighten them.
1 When the air bubble detector has been
removed, no tubing may be inserted since
this could cause the position of the ultrasonic
sensor to change.
installation.
Check and diagnostics: EBM, ABD, OD
10.11.11Removing and installing the heparin pump grip handle
Remove the protective cap (1).

Unscrew the Allen screw behind the
protective cap using an 1.5 mm Allen wrench.
Remove the cover (2).
Remove the self-locking nut (size 10 mm)
behind the cover.
1 2

Chapter 10: Repair
Prior to installation, the grip handle (1), a

sheath pushed over the slide carriage, must
lie flush with the upper rim,
whereby the grip handle is flatly knocked on
the table without activating the grip handle
unlocking lever/clamps.
Push the grip handle completely over the
slide carriage. The grip handle may not be
turnable prior to screwing in the Allen screw.
Tighten Allen screw.
Tighten self-locking nut.
Replace protective caps.
1 No scraping sounds may be heard when
adjusting the grip handle.
When releasing the unlocking lever, the
clamping nut inside the slide carriage must
snap securely into the drive screw. After this,
the grip handle is no longer movable.

Chapter 10: Repair
10.11.12Removing and installing the heparin pump length sensor
Open the EBM.

Remove the holder with the door sensors (1).
Remove P.C.B. LP 1126.
Remove the 6 locking screws from the length
sensor bracket (2) .
2
1
Remove the length sensor with the bracket.

3 Carefully lift and open the 2 plastic closures
(1) using a small screw driver.
1 Remove the length sensor.
1
installation.
To be observed after the installation:
– The length sensor spring (2) must be
2 locked into place.
– The length sensor cable outlet must be on
the right (3).
– Check for proper function.

Chapter 10: Repair
10.11.13Removing and installing the heparin pump drive
Open the EBM.

Remove the length sensor.
Disconnect the monitor grounding cable
connector.
Pull the syringe holder out of the front of the
EBM.
1
Remove the drive with the bearing tube and
the grip handle. While doing so, pay attention
to the adapter.
Remove the (1) female thread screw.
Press the grip handle and remove the drive

from the bearing tube.
To install:
Press the grip handle and insert the drive into
the bearing tube.
Screw in the female thread screw.
Install the drive with the bearing tube. While
doing so, ensure the adapter (1) is seated
properly.
Insert the syringe holder.
1
Connect the monitor grounding cable
For further installation see installation of the
length sensor,
Close the EBM.
Check for proper function.

Chapter 10: Repair
Slide carriages with 2 through-hole threads

1 are now mounted to reduce the number of
variants.
For an installation in the 5008S hemodialysis
system, use the left through-hole thread (1).
Observe wrench torque when tightening the
threaded pin.
Note
Always use a new threaded pin, as it is coated with self-locking lacquer.
Note
As different heparin pump types have been installed, installation details
may differ from the installation procedure described.

Chapter 10: Repair
10.11.14Removing and installing the level detector
Unplug the connector.

Remove the 4 mounting screws.
Remove the level sensor.
installation.
To be observed during installation:

1
– the correct fit of the seal (1).
– the correct installation position of the level
detector (see next figure).
First, tighten the 4 fixing screws evenly and
slightly, then securely tighten them.
The level detector is in the right installation

position when the axes (1) can be seen from
below.

Chapter 10: Repair
10.12 Hydraulics
10.12.1 Removing and installing the float switch S01 of the water inlet chamber
Disconnect connector S01 from P.C.B.

LP 1140.
Clamp the tubing (1) from the bottom of the
water inlet chamber.
Remove the tubing from the adapter fitting of
the degassing orifice.
Open the clamp and allow approx. 150 ml of
fluid to flow into a collection beaker.
1
Clamp the tubing (1) and remove it.

Chapter 10: Repair
Remove the water inlet chamber from the

SNAPLOC attachment.
Remove the 4 screws from the bottom of the
chamber.
Remove the bottom of the chamber with the
float switch from the housing.
Remove the fixing clamp (1).

Pull out the float switch with the cable.
Thinly grease a new O-ring with unisilicone

and insert it into the groove on the float
switch.

Chapter 10: Repair
Assemble the water inlet chamber in reverse

order.
Thinly grease a new O-ring with unisilicone
grease and insert it.
Screw the 4 self-cutting screws into the
housing cover
Insert the water inlet chamber into the
SNAPLOC attachment and connect the
tubings.
Connect connector S01 to P.C.B. LP 1140.

Chapter 10: Repair
10.12.2 Removing and installing the concentrate rinse chamber
Open the side panel (see chapter, 10.7.1

page 10-15).
Remove the suction tube from the rinse
chamber.
Remove the Online valve block (1) (option)
1 from the SNAPLOC attachment.
Remove the tubing (1) from the lower port of

the rinse chamber and close it with a closing
plug.
Use a screwdriver to push down the spring

under the rinse chamber and remove the
rinse chamber from the holder.

Chapter 10: Repair
Caution
Risk of injury!
There is a risk of crushing body parts with the EBM hinge.
Open the EBM before removing the tubing.
Open the EBM.

Remove the tubing (1) from the upper port of
the rinse chamber and close it with a closing
plug.
Remove the rinse chamber.

Unplug the level sensor connector.
Unplug the connector for valve VS 2.
Grease the seating of the O-ring with

unisilicone before installation.
installation.

Chapter 10: Repair
10.12.3 Removing and installing the bicarbonate rinse chamber
Open the side panel.

Open the electronics chassis.
Remove the 3 nuts to remove the strain relief.
Disconnect the temperature sensor
connector PT5 from P.C.B. LP 1140.
Disconnect the CD cell connector CD5 from
P.C.B. LP 1140.
Remove the suction tube from the rinse
chamber.
Remove the tubings (1- 4) and close them

1 with closing plugs.
Use a screwdriver to remove the bicarbonate
rinse chamber from the holder as described
2 in the removal procedure of the concentrate
rinse chamber.
3
Before installation, the O-ring or the seating

of the O-ring has to be greased thinly with
unisilicone.
installation.

Chapter 10: Repair
10.12.4 Removing and installing the water inlet flow regulator
Unscrew 2 screws to remove the water inlet

flow regulator.
To adjust, pull out the knob and turn it.
Perform adjustment.
Push in the knob after adjustment.

Chapter 10: Repair
10.12.5 Removing and installing the blood leak detector
Slide the cap (1) on the tubing upwards.

1
Open the blood leak detector
Remove the glass cuvette (1).

Unscrew the 2 screws (2) and replace the
blood leak detector.
After installation, the glass cuvette must not
show any signs of finger prints or other
2 contamination, otherwise measurement
results may be compromised.
Perform adjustment.

Chapter 10: Repair
10.12.6 Removing and installing the UF pump
Disconnect the connector (5) from the UF

pump on PCB 1140, slot X_S11_36.
1 3
Remove the tubings from the valve plate.
2
Disconnect connectors S11 / plate and S36 /
4 plate.
Remove the UF pump.
Connections of the UF pump:
– (1) S11 / male connector
– (2) S36 / male connector
– (3) S11 / plate
– (4) S36 / plate
– X_S11_36 / electronics chassis
– (see chapter, 10.16.1 page 10-72)
Install the UF pump.

Read the UF value (in this example 1199) and
enter it on the Service Menu in the field
Calibrate / Volumes(see Volumes,
page 9-6).

Chapter 10: Repair
10.12.7 Removing and installing the gear pump drive
A calibration must be performed after

replacing the gear pump or the gear pump
drive.
Degassing must be calibrated after replacing
P01.
Loading pressure must be calibrated after
replacing P03.
10.12.8 Removing and installing the balancing chamber
To uninstall the balancing chamber, remove

the tubings and close them with closing
1 plugs.
Remove valve controls VG1_OS2 and
VG2_OS2 or remove the connectors directly
on the valves.
Remove the mounting nut (1) of the balancing
chamber.
Remove the balancing chamber from the
SNAPLOC-attachment.
To install the balancing chamber, insert it into

the SNAPLOC attachment and secure it with
the mounting nut.
Connect the tubings.
Connect the valve controls VG1-OS2 and
VG2_OS2 or the individual valves.
Read the Volume on the type label (in this
example 30.87 ml) and enter it in the
Calibrate / Volumes field in the Service menu
(see Volumes, page 9-6).

Chapter 10: Repair
Check the position of the valves after a

replacement.
V13
V14
V12 V11
V17
V18
V15
V16

Chapter 10: Repair
10.12.9 Removing and installing the heat exchanger
Note
The heat exchanger operates using the countercurrent principle.
If it is repaired, it is imperative to ensure that the inlet and outlet are not
connected incorrectly, since swapping over the tubing considerably
reduces efficiency.
Caution
Disinfectant, risk of caustic burning.
Remove the tubing from the right inlet of the

waterinlet block.
Allow approx. 100 ml of fluid to flow into a
collection beaker.
Mark and close the water inlet block and the
tubing with closing plugs (1).
Detach the disinfection block from the
SNAPLOC attachment.
Remove the tubing from the water inlet
chamber.
1
Mark and close the tubing and the water inlet
2 chamber with closing plugs (2).
Pull both tubings to the right side of the
hydraulics and allow fluid to flow into a
collection beaker.

Chapter 10: Repair
Remove the power supply unit.

Remove the bicarbonate pump.
Remove the heat exchanger from the
SNAPLOC attachment.
Remove the 2 tubings from the connectors of
the heat exchangers one-by-one and allow
the fluid to flow into a collection beaker.
Mark and close the tubing and the connectors
with closing plugs.
Ensure that the two pieces of tubing are
not swapped over by mistake.
Remove the heat exchanger.
installation.

Chapter 10: Repair
10.12.10Removing and installing the heater rod
Caution
Observe the following when replacing the heater rod:
The nominal voltage of the heater rod must match the line power
voltage.
The voltage and resistance values indicated on the heater rod must
match the values from the table specified below.
Nominal voltage Nominal Nominal

resistance L1 – L3 resistance L2 – L3
240 V 58 Ω 58 Ω
220 V to 230 V 52 Ω 52 Ω
120 V 24 Ω 24 Ω
110 V 20 Ω 20 Ω
In "Technician's setup", under "Settings Hydraulics", select the

appropriate line voltage for the heater rod (see Heater rod, page 5-31).
 Color code of the

heater rod connector
L1: blue
L2: black
L3: brown
SL: green/ yellow
After installing the heater rod, connect the

grounding cable to the ground measurement
point.

Chapter 10: Repair
10.12.11Removing and installing the bibag® connector
Remove the connector.

Remove the (1) Phillips screw.
Open the closure (2) inside the device.
Remove the 2 tubings.
Unplug the connector for microswitches S21,
S22 and S47 from P.C.B. LP 1140.
Remove the bibag® connector.

For installation, follow the procedure in
reverse order.
the Phillips screw (1 see figure above).
Slightly tighten the Phillips screw with approx.
50 Ncm.
Check whether the flap lid clicks into place
when it is closed.
To check the sensors of the bibag® connector
in the flow diagram:
Microswitch S22 closed without bibag®
Hall sensor S47 for flap detection: closed with
the flap closed without bibag®.
Hall sensor S21 for flap detection:
closed with flap closed with bibag®.

Chapter 10: Repair
10.12.12Removing and installing the flap lid
Remove the 3 protective caps.

1 Open the flap lid.
When installing the lid, it must be ensured

that the connector spring (1) faces
downwards.

Chapter 10: Repair
10.12.13Disinfection valves V20 and V34
Caution
Risk of caustic burning
To prevent any skin contact with the disinfectant, wear protective
gloves.
When working with acidic substances:
Wear goggles!
Observe the safety precautions of the disinfectant used!
In the event of contact with acid:
Eye: Immediately flush with gently flowing water for 15 minutes.
Skin: Use soap under flowing water for neutralization.
Ingestion: Do not induce vomiting, but have the person affected drink
plenty of still water. Seek medical advice.
Caution
Microbiological risks
A defect of the disinfection valve can result in disinfectant in the
container becoming diluted with fluid entering it and thus reducing the
disinfecting effect.
The disinfectant container must be replaced following repair.
Rinse valve V20 or V34 before repairing

V20 them.
In the Flow diagram: Individual control menu,
open valve V20 or V34 and V40, V36, VS1,
V34
VS2 for this purpose.
Using a syringe, slowly inject 60 ml of
permeate, and then 30 ml of air into H20 or
H35. (Fluid can possibly leak from the
overflow.)
Continue to observe all safety measures
applicable to the handling of disinfectants.
Perform the T1 test and a disinfection
following a repair.
Use a new disinfectant for disinfection.

Chapter 10: Repair
10.12.14Removing and installing the degassing orifice
Clamp the tubing (1) with a tube clamp

between the water inlet chamber and the
degassing chamber.
2
Remove the 2 mounting screws of the orifice
adapter fitting(2).
1 Remove the orifice adapter fitting, ensuring
that the degassing orifice and the O-ring do
not fall out.
The orifice adapter fitting and the degassing

orifice are shown on the photo.
To be observed during installation:
– Fit of the O-rings in the orifice adapter
fitting and the degassing chamber.
– Check the degassing orifice. This
degassing orifice must not be used if
damaged.
The degassing orifice and the O-ring are

shown on the photo.
To be observed after replacing the degassing
orifice:
– Check and calibrate the set installation
altitude in the SETUP.
– Calibrate degassing.
– Enter the pressure values in the Medical
Device Register.
The table indicates which degassing orifice should be used at which

operating altitude.
Degassing orifice Part number Altitude above MSL
1.7 mm, marked with a white dot M40 675 1 up to 1200 m
1.85 mm, without marking M37 673 1 above 1200 m

Chapter 10: Repair
10.13 Cart, braking mechanism and concentrate container holder
10.13.1 Removing and installing the braking mechanism
Release the brake.

Remove all 4 brake rollers.
3
Remove the 2 mounting screws(1).
Remove the cable (2) from the cable holders.
Remove the 4 mounting screws(3).
Remove the complete brake with the brake
rollers.
installation.
2 Ensure that a spring washer is put under each
screw.

Chapter 10: Repair
Complete brake with brake rollers.

Chapter 10: Repair
10.13.2 Removing and installing the concentrate container holder
To remove the concentrate container holder,

grip below the 5008S dialysis system,
alternately press down the two holding
springs (1 see next photo), and
simultaneously pull out the holder.
To install the concentrate container holder,

push it into the guide until the holding springs
(1) click into place on both sides.
Only one holding spring is shown on this
photo.

Chapter 10: Repair
10.14 Removing and installing the battery
The cover of the battery is located under the

media supply rail.
Unscrew the 2 screws (1) and remove the
cover.
1
Unplug the connector (1).

Remove the battery.
installation.
1
The correct position of the connector must be
ensured after the installation.

Chapter 10: Repair
10.15 Checking the network interface
On the hemodialysis system:

– Select "Network" under "Setup" in the
Technician's Service Menu:
– Note down the settings.
– Activate PC Direct.
– Turn the hemodialysis system off and on.
On the laptop:
– Start > Control Panel > Network
Connections > Select LAN connection >
Properties.
– Select Internet Protocol (TCP / IP) > and
click the Properties button >
– Enter the IP address as shown in the
illustration to the left > click the OK button.
– Close the "LAN Connection Properties"
dialog.
Network check:
– Connect the laptop and the hemodialysis
system using a "cross cable" (not a
regular network cable).
– Select on the laptop: Start > All Programs
> Accessories > Command Prompt.
– The screen illustrated on the left is
displayed
– Now enter the following command:
ping 192.168.0.5 ↵ .

Chapter 10: Repair
The screen shown on the left is displayed if a

correct connection has been established:
It is thus ensured that the network traffic is
working properly.
Deactivate PC Direct.
Turn the hemodialysis system off and on.
If the network settings have been changed:
Re-establish the original network settings on
the hemodialysis system and turn the
hemodialysis system off and on.
The screen shown on the left is displayed if

no connection is established.

Chapter 10: Repair
10.16 Printed circuit boards
10.16.1 Connector pin assignment on the electronics chassis
P.C.B. LP 1140
Sensors
P.C.B. LP 1141
Actuators

Chapter 10: Repair
10.16.2 P.C.B. LP 1102 SMT/controller board (167)
J1
D1
Note
1 P.C.B. LP 1102-1 part no.: M37 453 1 is installed in the monitor
processor.
A total of 4 printed circuit boards LP 1102 or LP 1102-1 have been
installed in the hydraulics and the EBM of the hemodialysis system,
depending on the delivery status.
The same type of circuit board always have to be installed in pairs in the
EBM and in the hydraulics.
The difference between those boards is that IC2 and IC3 were produced
by different manufacturers.
Only circuit boards LP 1202 are installed from SW version 3.61.1.

Chapter 10: Repair
 Installation site
Hydraulics operating and safety system P.C.B. LP 1102 or LP 1102-1

Monitor processor P.C.B. LP 1102-1
Only circuit board P.C.B. LP 1202 is installed from SW version 3.61.1.
 Jumper
J1: closed for transferring the boot loader

(done during production).
 Copying the software of the monitor safety system M2 to P.C.B. LP 1102-1
The following must be observed when copying the software of the

monitor safety system M2:
Remove jumper J1 on P.C.B. LP 1104 (display of boot messages).
After turning the hemodialysis system on, park the "Internal error"
message and open the "Status field".
Wait until buttons 1 and 2 have appeared.
To move to the Service menu, enter 2 x 112. Then start the update for
M2 in the Service menu.
Re-connect Jumper J1 1-2 operation (to suppress the boot message) to

P.C.B. LP 1104.
 Connector
X4: for transferring the boot loader (done during production).
 LEDs
D1: watchdog flashing cycle
 Calibration after replacement
Hydraulics
If available, transfer current calibration data by means of the PC service
program to the corresponding system (operating or safety system).
Follow the calibration instructions displayed in the service mode.
If the hydraulics operating system has been replaced, the operating
hours must be synchronized via the PC service program.
Monitor safety system:

Calibration is not required.
 Required tests

Chapter 10: Repair
10.16.3 P.C.B. LP 1104 Monitor power supply
X2
P.C.B. LP
1106
X22
PC board assy.
BR1-3
J1
BR4-5
Bumpers
on the
solder side
X7
P.C.B. LP 1145
Voltage supply
Note
When replacing P.C.B. LP1104, it must be ensured that solder bridges
BR1 to BR5 are coded correctly. The coding depends on the display
type used and the background lighting.

Chapter 10: Repair
Monitor front
 Fuses
F1: 3.15 AT, 5V CPU supply voltage

F2: 3.15 AT, display supply voltage
F3: 3.15 AT, background lighting supply voltage
F4: 3.15 AT, 24 V battery supply voltage for the monitor in case of a
power failure
 Jumper
J1: 1-2, operation (suppression of the background lighting when turning

on the system, no boot message)
J1: 2-3, service (background lighting activated immediately)
 Solder bridges
Caution
The solder bridges may only be coded when the hemodialysis system
is turned off.
One solder bridge must be closed at all times since otherwise a 24 V
voltage would be applied that could damage the display.
The selection of the voltage depends on the display used.
Display supply voltage

BR 1: 3.3 V
BR 2: 5.0 V
BR 3: 12 V
When allocating solder bridges BR1-3, please observe the installed

display type.
NEC Display Type: BR1: BR2: BR3:
NL 10276AC30-07 open closed open
NL 10276BC30-17 closed open open
Background lighting supply voltage

BR 4: 12 V
BR 5: 5 V

Chapter 10: Repair
 LEDs
D1: Input switching regulator for CPU supply voltage

D3: Output switching regulator for CPU supply voltage
D4: Input switching regulator for TFT supply voltage
D6: Output switching regulator for TFT supply voltage
D7: Input switching regulator for background lighting supply voltage
D9: Output switching regulator for background lighting supply voltage
D10: 24 V supply voltage
 Required tests

Chapter 10: Repair
10.16.4 P.C.B. LP 1105 Power supply CPU
MP1
D3
D1
D2
J1
Connector green / yellow

Heater rod blue
black

Chapter 10: Repair
power supply unit (power supply unit for processor and heater
regulation)
 Jumper
J1: bridges pin 1+2 for performing a reset
 Measurement points
MP1, GND
 LEDs
D1: not assigned

D2: flashes in the slice cycle
D3: watchdog flashing cycle
Temperature calibration
 Required tests

Chapter 10: Repair
10.16.5 P.C.B. LP 1106 Power supply distribution board
CAN-BUS P.C.B. LP 1104 XAkku RS 232 not used
24 V
GND
18 V
24 V
GND
18 V
Battery 24 V
Battery GND
18 V
Power supply Hydraulics EBM
Rear of the power supply unit (voltage supply and CAN distributor
board).
 Fuses
F1 / SH1: 10 AT, 18 V not assigned

F2 / SH2: 10 AT, 18 V hydraulics supply voltage
F3 / SH3: 10 AT, 18 V EBM supply voltage
F4 / SH4: 10 AT, 24 V not assigned
F5 / SH5: 10 AT, 24 V hydraulics supply voltage
F6 / SH6: 10 AT, 24 V EBM supply voltage
F7 / SH7: 5 AT, 24 V optional CAN modules supply voltage
F8/SH8: 3.15 AT, 24 V monitor supply voltage

Chapter 10: Repair
 Required tests

Chapter 10: Repair
10.16.6 P.C.B. LP 1107 EBM I/O board
1 2 3 4 5
31
7
30
29 8
9
28
10
11
12
27
13
14
26
15
16
17
25
18
19
24
23 22 21 20

Chapter 10: Repair
 P.C.B. LP 1107 EBM I/O board, legend
1. Single-Needle pump
2. ONL pump (substituate pump)
3. Blood pump
4. P.C.B. LP1106 CAN bus
5. P.C.B. LP1106 X11
6. P.C.B. LP1126 X2
7. Compressor
8. Valves Single-Needle option
9. Arterial clamp
10.Venous clamp
11.Compressor valves
12.Valves venous pressure transducer
13.Arterial pressure transducer
14.Venous pressure transducer
15.P.C.B. LP 1111, arterial pressure measurement unit
16.Level detector
17.ABD
18.P.C.B. LP 1144, door sensor
19.Leakage sensor, EBM
20.Optional CAN modules in the EBM
24.P.C.B. LP 1202, SS
25.P.C.B. LP 1202, SS
26.Single-Needle pressure transducer
27.P.C.B. LP 1202, OS
28.P.C.B. LP 1202, OS
29.P.C.B. LP 1112 blood pump ejector
30.P.C.B. LP 1112, substituate pump ejector
31.P.C.B. LP 1112 Single-Needle pump ejector
EBM electronics (I/O board)

Chapter 10: Repair
 Fuses
F1 / SH1: 750 mA polyswitch, compressor supply voltage
 LEDs
D34: Watchdog
LED D34 flashes in case of an error:
1x flashing: SS too slow

2x flashing: SS too fast
3x flashing: OS too slow
4x flashing: OS too fast
5x flashing: overvoltage
6x flashing: undervoltage
7x flashing: WD signal missing
D40: Output switching regulator for 5V supply voltage
 Required tests
T1 test of the EBM when turning the hemodialysis system on.
Completely connect the EBM and simulate a dialysis treatment.
Alternative:
EBM diagnostics mode:
Move the arterial pressure measurement unit out and back in and check
the status displayed (moving out and in performed by pressure applied
to the pressure measurement unit in the diagnostics screen)
Blood pump hall sensor
Substituate pump hall sensor
Hall sensor, substituate pump 2/SN
Blood pump ejector
Substituate pump ejector
Ejector, substituate pump 2/SN
EBM door, right
EBM door, left
Heparin syringe
Level detector
ABD
OD
Leakage sensor
Resistor chain
SN pressure
Arterial pressure
Venous pressure

Chapter 10: Repair
10.16.7 P.C.B. LP 1126 Heparin pump control board
Heparin pump of the EBM (heparin pump control)
 Required tests
In Service mode, check the syringe detector in the EBM diagnostics

screen.

Chapter 10: Repair
10.16.8 P.C.B. LP 1131 / LP 1131-1 Monitor operating mode indicator
Note
The difference between circuit boards LP 1131 and LP 1131-1 is a
ferrite core on the cable.
Monitor front
 LEDs
Red / yellow / green
 Required tests

Chapter 10: Repair
10.16.9 P.C.B. LP 1134 Chipcard reader
Monitor rear
 Required tests
Insert the ServiceCard and switch to Service mode.

Insert the PatientCard and check if data is read.

Chapter 10: Repair
10.16.10P.C.B. LP 1140 Hydraulics sensor board
Electronics chassis (sensors)
Temperature / conductivity calibration.

OCM calibration.
Pressure transducer calibration (S03 / S07 / S16)
Blood leak
 Required tests
Flap switch:
bibag®
check in the flow diagram

Chapter 10: Repair
Hall sensors:
Bicarbonate suction tube
Concentrate suction tube
check in the flow diagram
Switch:
Check the shunt interlock (flap / dialysate inlet port / dialysate outlet
port) in the flow diagram.
Check ONLINEplus (substituate / rinse port) in the flow chart.
Check level sensors for correct function.

Chapter 10: Repair
10.16.11P.C.B. LP 1141 Hydraulics power supply actuators OS/SS
SH2
J3
SH1
Electronics chassis (power supply and actuators)
 Fuses
SH1: 1.5 AT, +-12 V

SH2: 1.5 AT, + 5 V
 Jumper
J3: not connected

Chapter 10: Repair
 LEDs
D55: Watchdog
D56: Output switching regulator for 5V supply voltage.
LED D56 flashes in case of an error:
1x flashing: SS too slow

2x flashing: SS too fast
3x flashing: OS too slow
4x flashing: OS too fast
5x flashing: overvoltage
6x flashing: undervoltage
7x flashing: WD signal missing
 Required tests

Chapter 10: Repair
10.16.12P.C.B. LP 1142 EBM I/O board
X1_EXT/IO
P.C.B. LP 1145 /
LP 1145-1
X8,
PC board
Monitor rear housing (external interface)
 Fuses
F1:
Index A (1 A fuse)

Chapter 10: Repair
 Jumper
Jumper J2 J3 J4
PIN 1 2 3 1 2 3 1 2 3
Port assignment I ---------------- ---------------- ----------------
Port assignment II ---------------- ---------------- ----------------
 Emission of an alarm at the alarm line with the hemodialysis system turned off
Jumper J1
PIN 1 2 3
OFF variant I (active) ----------------
OFF variant II (not active) ----------------

Chapter 10: Repair
 Port assignment and alarm emission
Port assignment I Port assignment II
Hemodialysis Alarm-free
system
Turned on
Alarm and power

failure
Hemodialysis OFF
system variant II
Turned off (no alarm)
OFF
variant I
Legend
RL – K Ring main contact ('Ringleitung Kontakt')
AL – K Alarm line contact ('Alarmleitung Kontakt')
1 PIN 1 of the 5-pin diode port
 Short description of the table
The output signals are determined by two relays.

The first relay is a bistable relay and serves for the detection of the
device state ON or OFF. In the OFF state, it serves for closing the ring
main.
The second relay determines the alarm state. The alarm output is
closed in case of an alarm or during a power failure.
With the hemodialysis system turned off this means that the alarm
contact remains closed (like the OFF variant I of the 4008). An alarm is
emitted in this state.
If this is not desired, the alarm contact can be interrupted via jumper J1
(like OFF variant II).

Chapter 10: Repair
 Required tests
– Staff call
– If available, communication with AquaUno
– Check external 24V supply voltage e.g. with UMED.
– Perform the T1 test and a disinfection.

Chapter 10: Repair
10.16.13P.C.B. LP 1145 / LP 1145-1 Distribution screen
P.C.B. LP 1139 (or LP 1150, depending on

the display type)
LVDS PC board
X33
Backlight
Display
LVDS
LP 1142
X_1145
PC board
X23
PCB 1104
X2
Voltage supply
Loudspeaker/
microphone
P1
Volume control
Touch / buttons
(including LEDs):
Monitor front
 Required tests
T1 test and disinfection

Volume setting at P1

Chapter 10: Repair
10.16.14P.C.B. LP 1202 C167II
Note
First, the circuit boards LP 1102-1 were installed in the EBM and the
hydraulics.
From software version 3.61.1 on, circuit boards LP 1202 are installed in
the EBM, hydraulics and monitor processor.
EBM operating and safety system.

From SW version 3.60 also in the hydraulics
From SW version 3.61.1 also in the monitor processor
EBM:
If the EBM operating system has been replaced, the operating hours
must be synchronized via the PC service program.

Chapter 10: Repair
 Required tests

Chapter 10: Repair
10.16.15PC board
X3
LVDS
LP 1145
X1
LP 1104
X3
Status
indicator
LP 1131-1
X2
Card reader
LP 1129-1
Network
LP 1142
Mouse X2
Keypad LP 1102-1
X1
LP 1102-1
X CPU 2
P.C.B. LP 1145 / LP 1145-1

Chapter 10: Repair
Monitor front
Calibrate touch screen.
Set the date and time.
Synchronization of the operating hours via the PC service program

Chapter 11: Functional description
11 Functional description
11.1 Complete system
Monitor
RS 232
OS SS
CAN_OS CAN_SS
EBM
RS 232
OS SS
Hydraulics
RS 232
OS SS
Power supply unit
OS
Options


11.2 P.C.B.s, overview
Monitor Monitor card reader

Monitor LP 1134
Monitor operating mode indicator
screen failure sensor
Controller board LP 1131
LP 1139* (C167)
Housing rear panel

LP 1202
Monitor,
external
OS connectors
Monitor power supply Monitor
Backlight distribution board
Inverter
PC
LP 1104 LP 1142
LP 1145
Power supply unit
Power supply controller

LP 1105
Power supply distribution board

Power supply LP 1106
E B M (Extracorporeal Blood Module)

Door sensor
EBM (left, right)
EBM I/O Board ejector board Hall sensor
BP Hall sensor
EBM
heparin pump LP 1112 LP 1136 BP
control board LP 1152
Controller board EBM Hall sensor
(C167) LP 1126 ejector board BP
LP 1202 LP 1112 LP 1136 EBM
pressure unit
Controller board EBM Hall sensor position sensor
(C167) ejector board BP
LP 1111
LP 1202 LP 1107 LP 1112 LP 1136
Hydraulics
Controller board Controller board

(C167) (C167)
LP 1202 LP 1202
Sensor board Hall sensor Hall sensor

rinsedoor rinsedoor
LP 1135 LP 1135
LP 1140
Actor board
LP 1141
Pump control Pump control Pump control
LP 952 LP 952 LP 952
P.C.B. LP 1139* refers to P.C.B. LP 1139 or LP 1150, depending on the

display type

11.3 Monitor
 Block diagram
Monitor
red yellow green
Monitor operating mode indicator

LP 1131 Micro-
TFT-Screen phone
Monitor
OI
screen
Touch failure sensor
LP 1139* Loud-
speaker
Monitor
card
reader
LP 1134
Alarm Blood Blood

system system On/Off
Mute
Stop Start
Monitor distribution board

LP 1145
OS OS, SS, CAN LP 1106

24V LP 1106
Monitor
power supply On/Off LP 1106
LP 1104
OS
SS SS
Controller board
(C167)
PC
LP 1202
LAN
Monitor, external connectors

LP 1142
Housing rear panel
CAN
RS 232 24 V
LAN Service/Diagnostics Alarm output

RJ 45 DSUB Diode socket
15-pin 5-pin

P.C.B. LP 1139* refers to P.C.B. LP 1139 or LP 1150, depending on the

display type
 Description
P.C.B. LP 1104 houses the voltage supply for the entire monitor unit.
Independent voltages are generated from the +24 V supplied by the
power supply unit. +5 V for the OS/SS, +12 V or +5 V for the
backlighting, +12 V/+5 V or 3.3 V for the TFT electronics.
P.C.B. LP 1142 provides the signal connections to the peripheral

equipment. It has a LAN interface (Ethernet). A Service/Diagnostics
plug is available for the technician. It has a serial interface (RS232) and
the +24 V voltage. An alarm output for the nurse call is also present.

11.4 EBM (Extracorporeal Blood Circuit Module)
 Block diagram
Sensors Actuators
Leakage detector
Door sensors (left, right)

(LP 1152)
ABD (Air bubble detector)

3/4
OD (optical detector) Docking unit valve 1
1/2
Air pump
Fill level detector
1/2
Pressure dome sensor, arterial Valve 2 select
(LP 1111) 1/2
Spare level up/down venous
Pressure transducer, venous
3/4
Pressure transducer, arterial Select valve (SN)
1/2
Pressure transducer, SN Level up/down valve (SN)
Syringe detection/motor control Syringe detection/motor control

(LP 1126) (LP 1126)
Syringe pump position
Line occlucion clamp, arterial
Ejector (LP 1112),
Line occlucion clamp, venous
Single-Needle pump
Ejector (LP 1112), Single-Needle pump
Substituate pump Ejector(LP 1112),
Ejector (LP 1112), Single-Needle pump
Blood pump
Substituate pump
Rotor hall sensor (LP 1136),
Ejector(LP 1112),
Blood pump
Substituate pump
Rotor hall sensor (LP 1136),
Substituate pump Blood pump
Rotor hall sensor (LP 1136), Ejector(LP 1112),
Single-Needle pump Blood pump
X_ART X_VEN X_SN1 X_SN2

X_HEP_P1 X_HEP_P2 XDOM_PV XDOM_PA X_LD X_LD/SN X_ABD X_DOOR X_LEAK
3/4
X_VALVE_1/2 1/2 1/2
1 1/2 X_VALVE_2 X_VALVE_6
1 1 1
3/4 X_VALVE_5
X_VALVE_3/4
1 1/2
X_BP X_EJECT_BP
X_ART_P1 X_VEN_P1
X_SUB_P1 X_EJECT_SUB1
X_ART_P2 X_VEN_P2
X_SUB_P2 X_EJECT_SUB2
+5 V +12 V linear +12 V_PWR +24 V_SW

DC +12 V DC
LP 1106 +18 V DC linear DC
EBM I/O Board

LP 1106 +24 V WD relay
LP 1107
LP 1106 LP 1106
WD
RS 232
CAN OS CAN SS
OS SS
(C 167) (C 167)
LP 1202 LP 1202

 Description
The power supply unit supplies the P.C.B. LP 1107 with +24 V and
+18 V via P.C.B. LP 1106. The +5 V, +12 V linear and +12 V_PWR
voltages are generated on P.C.B. LP 1107. The +24 V_SW are enabled
via the watchdog.
The sensor signals are routed via P.C.B. LP 1107 to the OS and the SS
where they are evaluated. The OS controls the actuators via P.C.B.
LP 1107. The 24_V_SW are controlled independently by the SS via
P.C.B. LP 1107.
Distribution of the CAN bus of the OS and the SS is done via P.C.B.
LP 1107. P.C.B. LP 1107 is connected to the P.C.B. LP 1202, OS via
the plug connectors X1_OS, X2_OS and to the P.C.B. LP 1202, SS via
the plug connectors X1_SS, X2_SS.
The serial connection between the OS and the SS is also established

via P.C.B. LP 1107.

11.5 Hydraulics (block diagram / description)
 Block diagram
SS OS
Connector PIN
Example XXX XXX
1 2 3 4 5

(C167) (C167)
LP 1202 LP 1202
RS 232
LP 1135 ---------- S21, S47

(OS/SS)
----------------Sensors (SS)-------------------
CD4, CD7,
PT4, PT7,
S03, S04, S05, S06, S07, S08, S10,
S11, S16, S27, S28, S29, S30, S35,
S36, S38, S42, S43, S44, S45
----------------Sensors (OS)-------------------
CD5, CD9,
PT2, PT5, PT8, PT9,
Sensor S01, S09, S15, S17, S18, S19, S20,
S22, S50, S51, S53
board
LP 1140
- - - - - - - Actuators - - - - - - -
P01, P03
- - - - - - - Actuators - - - - - - -
P04, P05, P06
CAN SS (OS/SS) VG1 SS1
(+5 V and +24V_SW on LP 1141)
VG2 SS1
LP 1106 VG1 SS2
+24 V_SW +5 V
VG2 SS2
+24 V_SW VG1 OS5

VG2 OS5
+5 V
+24 V
VG1 OS4
+12 V, -12 V
+18 V
VG2 OS4
+24 V_SW
VG1 OS3
+18 V_SW
VG2 OS3
VG1 OS2
Actor VG1 SS1
board VG2 OS2 V40 V24 V22 V35s 24/18V
VG1 OS1 VG2 SS1
LP 1141 VG2 OS1
V41 V09 V25 V26 24/18V
VG1 SS2
V31 VS4s n. c. n. c. 24/18V
VG2 SS2
n. c. n. c. n. c. n. c. 24/18V
VG1 OS5
V21 V23 V33 V32 24/18V
VG2 OS5
V50 VS2 V51 n. c. 24/18V
VG1 OS4
VS1 VB1 VB2 V36 24/18V
VG2 OS4
n. c. VS3s VS5s VS6s 24/18V
VG1 OS3
V34 V30 V29s V28 24/18V
VG2 OS3
n. c. n. c. n. c. n. c. 24/18V
VG1 OS2
V11 V12 V13 V14 24/18V
VG2 OS2
V15 V16 V17 V18 24/18V
VG1 OS1
V38 V19 V03 V02 24/18V
VG2 OS1
VF2 V20 V04 VF1 24/18V

 Description
The power supply unit supplies the P.C.B. LP 1141 with +24 V and
+18 V via P.C.B. LP 1106. The +5 V, ±12 V voltages are generated on
P.C.B. LP 1141. The +24 V_SW and the +18 V_SW are enabled via the
watchdog. P.C.B. LP 1141 controls all actuators (valves, pumps) of the
hydraulics. P.C.B. LP 1141 is connected to the OS and the SS via
P.C.B. LP 1140.
P.C.B. LP 1140 includes the evaluation circuits for the sensors of the
OS and SS, e.g. temperature, conductivity, pressure, blood leak, optical
sensors. P.C.B. LP 1141 transmits the voltage supplies of the
processors as well as the activation signals for the actuators to the two
processors on P.C.B. LP 1202.
P.C.B. LP 1202 houses the central processing unit with the CPU
(C 167), a data memory with calibration data, a CAN bus driver, an
analog reference voltage source and a serial interface. P.C.B. LP 1202
requires the operating voltage +5 V, GND, +24 V and the Reset signal.

11.6 Power supply unit
 Block diagram
90 - 264 V/ AC
Output 1
(+24 V/20 A) Rating
Output 1+2
Output 2 480 W
(+18 V/14 A)
Battery
(+24 V/7 Ah)
Power supply
90 - 264 V/AC
Output 3 (+5 V / Standby)
Power Fail
+24 V
Battery test
On/Off
Power supply
distribution board
LP 1106
Push-button 0-100 % Heater

OS
On/Off control
CAN
ON/OFF
Heater
relay
Heater
(of hydraulics)
Power supply
control
LP 1105
Power supply unit

Heater rod

 Description
The voltage is supplied by a primary-switched power supply unit. It does

therefore not require a power transformer and can be connected to all
common line voltages without switching. The charging circuit integrated
in the power supply unit, charges the batteries to provide battery-
backup in the event of a power failure. If a power failure occurs, the
+24 V supply is buffered by the batteries.
P.C.B. LP 1105 includes a processor C515. This processor provides for

the regulation and control of the heater and the On/Off logic for the
entire device. A control chip with pulse-duration modulation controls the
heater rod via two triacs. The data required for the control is sent via the
CAN bus to the processors.

11.7 Pneumatics
 Block diagram
Arterial pressure
Compressor measurement unit
Venous bubble catcher

deaeration/ventilation
SN chamber
ventilation
Hydraulics

 Description
The pneumatic unit is located in the EBM. In the EBM it is used for
controlling the arterial pressure measurement unit, for raising and
lowering the fluid level in the venous bubble catcher and for lowering the
fluid level in the SN chamber. In the hydraulics unit, the pneumatic unit
is required for the membrane integrity test and for the filter change
program.


11-14
Water inlet Flush Drain
H01 H02
Drain
F01
H19
VF2
A04
V02 Compressor
EBM
V19 V21
S03 F06
PT7 PT8
A05 V11 V12 V13 V14 P
V30 V23 H15
Temp
Flow diagram
F04
CD7 V24 H42

H16
V38 H04
H14
F05 H36
A02
H09
PT4 V22 V26 V31

VF1 V29s
V03 Temp S10
CD4 S27 Shunt
V15 V16 V17 V18 V28 H32
S28
S04
S05
H03 S09
Dialyzer
H07 S06
PT2 P05 P06
Temp
V32
S01 S15 P H18
S36
S16
P04 CD9
S29
M S07 H33
P S38 S30 H37
H08
CD5 A03 S11 PT9 P
P03 V33
F08 V25 F07
Temp
H43
V09 H17
P01 S08 H42
PT5
Temp
H06
V50 V51
V04 S50 S51
H50 H51
H05
S35
V35s
V41 V40 V36

S53
VB1 VS1
F12 F11
V20 V34 H23
S20 S18
VB2 VS2
F10 F16
S19 S17
H20 H35 bibag H22 H21 Safety System

D1 D2 S22 Operating System
S21
S47
VS3s
VERSION 1.3
VS4s
VS5s
VS6s

F14
H29
CDS
11.8 Hydraulics (flow diagram / legend / description)
5008S
SM-EN
9/01.11
 Legend
Explanation of symbols
Axx Elements for adjustment PTx Temperature sensors

CDx Conductivity cells Sxx Other sensors
Fxx Filters Vxx Valves
Hxx Hydraulic components Vxxs Small valves (s)
Pxx Pumps
Legend
A02 Loading pressure valve, balancing chamber H50 Air separation chamber, bicarbonate
A03 Relief valve H51 Air separation chamber, concentrate
A04 Pressure reducing valve, water inlet P01 Degassing pump
A05 Check valve, water inlet P03 Flow pump
P04 UF pump
CD4 Conductivity cell, bicarbonate P05 Bicarbonate pump
CD5 Conductivity cell, bicarbonate P06 Concentrate pump
CD7 Conductivity cell, overall conductivity
CD9 Conductivity cell, OCM PT2 Sensor, temperature control
PT4 Temperature sensor, CD bicarbonate
F01 Filter, water inlet PT5 Temperature sensor, CD bicarbonate
F04 Filter 1 - DIASAFE®plus PT7 Temperature sensor, overall CD and temperature display
F05 Filter 2 - DIASAFE®plus PT8 Sensor, temperature re-adjustment
F06 Hydrophobic filter, compressor EBM PT9 Temperature sensor, CD OCM
F07 Particle filter, dialysate
F08 Filter, UF pump S01 Float switch, water inlet chamber
F10 Filter, disinfectant S03 Pressure transducer, dialyzer inlet
F11 Concentrate suction tube with filter S04 Sensor, shunt interlock inlet
F12 Bicarbonate suction tube with filter S05 Sensor, shunt interlock open
F14 Filter, CDS S06 Sensor, shunt interlock outlet
F16 Filter, disinfectant 2 S07 Pressure transducer, dialyzer outlet
S08 Blood leak detector
H01 Male connector, water inlet S09 Level sensor, secondary air separator
H02 Male connector, Flush S10 Sensor, air separation valve
H03 Water inlet chamber S11 UF pump, CD inlet
H04 Heat exchanger S15 Pressure transducer, balancing chamber switching
H05 Degassing orifice S16 Pressure transducer, fill dry concentrate bag
H06 Degassing chamber S17 Level sensor, concentrate rinse chamber
H07 Heater rod chamber S18 Sensor, concentrate rinse chamber lock
H08 Heater rod S19 Level sensor, rinse chamber, bicarbonate
H09 Primary air separator S20 Sensor, bicarbonate rinse chamber lock
H14 Balancing chamber S21 bibag® flap, bag operation position
H15 Sampling valve S22 bibag® connected
H16 Dialyzer coupling, to dialyzer S27 Sensor 1, substituate port
H17 Dialyzer coupling, from dialyzer S28 Sensor 2, substituate port
H18 Secondary air separator S29 Sensor 1, rinse port
H19 Male connector, drain S30 Sensor 2, rinse port
H20 Male connector, disinfectant S35 Leakage sensor, hydraulics
H21 Rinse chamber, concentrate S36 UF pump, CD outlet
H22 Rinse chamber, bicarbonate S38 UF pump, monitoring
H23 Connector, bibag® S47 bibag® flap, cleaning position
H29 Male connector, CDS S50 Sensor, bicarbonate air separator
H32 Substituate port S51 Sensor, concentrate air separator
H33 Rinse port S53 Sensor, flap for suction tube
H34 Male connector, compressor EBM
H35 Male connector, disinfectant 2
H36 Male connector, dialyzer coupling, to dialyzer
H37 Male connector, dialyzer coupling, from dialyzer
H42 Connector, potential equalization
H43 Male connector, vent water inlet chamber (continued next page)

V02 Water inlet valve

V03 Recirculation valve, cleaning
V04 Degassing orifice bypass valve
V09 Fill valve, dry concentrate bag
V19 Drain valve
V21 Vent valve, filter stage 1
V22 Retentate valve
V23 Test valve
V24 Dialyzer inlet valve
V25 Dialyzer outlet valve
V26 Bypass valve
V28 Fill valve, secondary air separator
V29s Air separation valve
V30 Outlet valve
V31 Substituate valve
V34 Disinfection valve 2
V35s Negative pressure valve 2
V36 Rinse valve
V38 Bypass valve, heat exchanger
V40 Shutoff valve, disinfection
V41 Rinse valve, disinfection
V50 Sensor, bicarbonate air separation valve
V51 Sensor, concentrate air separation valve
VB1 Fill valve, bibag®

VB2 Deaeration valve, bicarbonate rinse chamber
VF1 Flush valve

VF2 Flush valve, drain
VS1 Rinse valve, concentrate rinse chamber

VS2 Deaeration valve, concentrate rinse chamber
VS3s CDS shutoff valve, OS
VS4s CDS shutoff valve, SS
VS5s CDS valve, test
VS6s CDS valve, inlet

 Description
Turning power on To ensure regular rinsing of the water inlet tubing, flushing is started
after turning the device on. (Only if the Flush device option exists.)
The flush is diverted between the heat exchanger (H04) and the flush
valve (VF1).
When the flush valve 1 (VF1) is closed, a clocked circuit will open the
flush valve 2 (VF2). The permeate is rinsed via the water inlet tubing,
the flush valve 2 (V02) and the water outlet tubing into the flush drain.
Degassing Controlled by the float switch (S01) in the water inlet chamber (H03) the
permeate flows into the degassing chamber (H06). A negative pressure
is created due to the volumetric capacity of the degassing pump (P01)
and the restriction of the degassing orifice (H05). This negative
pressure is sufficient to force the air in the permeate to form air bubbles.
These accumulate in the primary air separator (H09). The air bubbles
are discharged via the loading pressure valve (A02) and the air outlet of
the water inlet chamber (H03).
Heating The permeate flowing through the heater rod chamber (H 07) is heated
to the regular dialysis temperature.
Mixing A patient-specific dialysate is prepared by proportional and volumetric

mixing of permeate with different dialysis concentrates.
On its way to the balancing chamber (H14), a volume of bicarbonate
and acid concentrate which matches the proportional mixing ratio is
added (P05, P06) to the permeate at the dosing points (H12).
The acid concentrate can either be drawn in from the respective
canister with the suction tube (F11) or be supplied by a central delivery
system (H29).
The bicarbonate concentrate can be drawn in from the respective
canister over the suction tube (F12) or the bibag®.
Balancing and The design of the hydraulics of the hemodialysis system provides for a
ultrafiltration dialysate circuit which is closed against the atmosphere.
This presents the basis for volumetrically controlled ultrafiltration.
The balancing chambers (H14) are operated at inverse sequences to
ensure that the volume of dialysate which enters the dialyzer equals the
volume which flows back across the balancing chambers. An
impermeable elastic membrane separates the used from the fresh
dialysate.
Reduction of the weight is solely determined by the UF pump (P04). The
UF pump removes a predefined volume (UF goal) from the closed
system which it pumps directly in to the drain, bypassing the balancing
chambers. This volume is removed from the patient's blood and is
replaced by an equal volume flowing through the dialyzer membrane.
Dialysate circuit Via the valves (V11, V13) fresh dialysate is fed in cycles by the
balancing chambers via the filter (F04) and the dialyzer valve (V24) to
the dialyzer.

The flow pump (P03) ensures that the dialysate discharged by the
dialyzer is fed to the balancing chambers via the secondary air
separator (H18).
If the level sensor (S09) detects air, the air separation valve (V29s)
starts its activity. The air is discharged by the negative pressure in the
degassing path and can therefore not enter the balancing chambers.
After the balancing process the dialysate is passed via the outlet valve
(V30), the heat exchanger (H04) and the drain valve (V19) to the drain.
Correct mixing and the temperature of the fresh dialysate are monitored
by the conductivity cells (CD4, CD7) and the temperature sensor (PT7).
If the values are outside the predefined limits, the device will alert the
operator and will switch to the bypass mode. The dialyzer valve (V24)
closes, the bypass valve (V26) opens, which prevents the improper
dialysate from being fed to the dialyzer.
The pressure transducer (S07) and the blood leak detector (S08) are
further safety elements.
11.9 Endless rinse program
The endless rinse program allows rinsing of the hydraulics of the

dialysis system for an unlimited time as well as of the three water inlet
branches V38, VF1 and Flush alternatively as defined.
The other cleaning programs do not allow any defined rinsing of all
water inlet branches.
The endless rinse program can be used for the following purposes (or
modes):
1. Disinfection / sanitization with subsequent rinsing of the
central permeate supply including the supply line and the
dialysis system using the endless rinse program (operation
with a disinfectant through the water inlet).
2. Rinsing free with disinfectant using the endless rinse program,
In case the water inlet branch is contaminated.
Caution
The operator bears the sole responsibility for these operating modes.
The operator must ensure that the system (complete water supply,
installation, devices) is free from disinfectant and is subjected to a
"Mandatory rinse" or "Disinfection" program.
The operator is responsible for the effectiveness of a disinfection of the
water supply and the water inlet.
These operating modes do not represent any disinfection of the device.
The device can only be disinfected with a disinfection program.
The operator must take appropriate measures to prevent any danger for
personnel and patients as well as any damage to the device because
such danger and/or damage may cause risks which cannot be
sufficiently diminished by the dialysis system and the device software.

Note
The endless rinse program can only be started by an authorized
technician using the ServiceCard.
If the Flush path is installed in the device, it must be activated in the
setup menu.
Program sequence Various tests are performed at the beginning of the endless rinse
program (test time approx. 5 minutes). If the endless rinse program is
interrupted during this time or the tests are not passed, it is only possible
to run the endless rinse program. Other cleaning and disinfection
programs are disabled.
While the endless rinse program is executed, the hydraulics of the
dialysis system is rinsed for an unlimited time and the three water inlet
branches V38, VF1 and Flush are rinsed alternatively as defined.
11.9.1 Disinfection / sanitization with subsequent rinsing of the central permeate supply
including the supply line and the dialysis system using the endless rinse program
(operation with a disinfectant through the water inlet)
If the central permeate supply including dialysis system is disinfected

with the endless rinse program, the following requirements must be
met:
– Mixing of disinfectants must be prevented:
Ensure that the device is free from any sucked-in disinfectant, e.g.
after premature termination of a standard disinfection program of the
dialysis system.
– Disconnect the device from the CDS (Central Delivery System).
– Ensure that only approved disinfectants in the usual concentrations
can enter the device.
– While disinfecting / sanitizing the system and subsequently
rinsing the permeate supply system, continue the endless rinse
program until disinfectant is no longer detected in the drain and
the Flush path.
– After the endless rinse program is completed and the device is
provably free from any disinfectant, the device must be subjected
either to the "Mandatory rinse" or the "Disinfection" program. This
rinse or disinfection may only be carried out through a permeate
supply which is also free from disinfectant. Normal operation of the
device is not allowed before these requirements are met.

11.9.2 Rinsing free with disinfectant using the endless rinse program, in case the water
inlet branch is contaminated
Caution
It is imperative to ensure that other devices which are in dialysis mode
with connected patients are not connected to this permeate line while
the endless rinse program is running!
– The endless rinse program is the only program allowed to be used

for rinsing free of the water inlet branches and for proving that the
device is free from disinfectant.
– Disconnect the device from the CDS (Central Delivery System).
– Prevent any contamination of the permeate supply.
– The device may only be rinsed free with the endless rinse program
through a fully operable permeate supply which is free from
disinfectant and at the water pressure specified.
– Rinsing free with the endless rinse program is not allowed during
dialysis operation.
– After completed free rinsing, there must not be any detectable
disinfectant at the permeate supply and the devices connected
thereto.
– Do not mix disinfectants in any way. Start a disinfection program at
the device only after having proven that the device is free from
disinfectant.
– After the endless rinse program is completed and the device is
provably free from any disinfectant, the device must be subjected
either to the "Mandatory rinse" or the "Disinfection" program. This
rinse or disinfection may only be carried out through a permeate
supply which is also free from disinfectant. Normal operation of the
device is not allowed before these requirements are met.

Chapter 12: Service program (option)
12 Service program (option)
Quick Guide
PC Service Software 5008
Index 11/28.09
English


Table of contents
General Information ................................................................................................ 1
Preparation ................................................................................................................. 3
System Requirements............................................................................................. 3
Firewall.................................................................................................................... 4
Software Installation................................................................................................ 5
Hardware Installation .............................................................................................. 7
ServiceCard Description ......................................................................................... 8
Starting the Software .............................................................................................. 9
Changing the IP Address ...................................................................................... 10
Menu/Toolbar ........................................................................................................... 13
Overview ............................................................................................................... 13
Connection............................................................................................................ 14
Diagnostic ............................................................................................................. 19
Extras.................................................................................................................... 21
Settings ................................................................................................................. 22
View ...................................................................................................................... 24
Help / About ... ...................................................................................................... 25
Views ........................................................................................................................ 27
System Information ............................................................................................... 27
NOVRAM/Calibration Data.................................................................................... 29
Setup Data ............................................................................................................ 32
Error Memory ........................................................................................................ 35
Service Data Recorder.......................................................................................... 37
Software Update ................................................................................................... 39
Image from/to Compact Flash............................................................................... 42
Print Preview......................................................................................................... 44
Modification .............................................................................................................. 45
Quick Guide .......................................................................................................... 45
Index......................................................................................................................... 49


General Information
Caution:
After each data transfer from the PC Service Software 5008 to the
dialysis system, the operator of the PC Service Software 5008 must
check the data on the dialysis system for plausibility. The operator
himself or herself is responsible for the correctness of the data.
Caution:
After each data transfer from the PC Service Software 5008 to the
dialysis system, the dialysis system must be turned off and back on
again before treating a patient.
Caution:
This PC Service Software 5008 is intended for service purposes only.
Ensure that the interface cable to the PC is not connected during patient
treatment.
11/28.09 Page 1 from 49

Addresses:
Manufacturer Fresenius Medical Care AG & Co. KGaA

D-61346 Bad Homburg
Germany
Phone: +49 (0) 6172/609-0
www.fmc-ag.com
Service Fresenius Medical Care

Central Deutschland GmbH
Europe Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstraße 24
D-61352 Bad Homburg
Germany
Phone: +49 6172 609-7100
Fax: +49 6172 609-7102
Email: ServicecenterD@fmc-ag.com
International Fresenius Medical Care

Service+++ Deutschland GmbH
Service Support International
Hafenstraße 9
D-97424 Schweinfurt
Germany
Phone: +49 9721 678-333 (hotline)
Fax: +49 9721 678-130
Local Service
Page 2 from 49 11/28.09

Preparation
Preparation
System Requirements
Minimum system requirements:

PC with at least 50 MByte of free hard disk space
Windows 2000 (min. Service Pack 2)
Windows XP (min. Service Pack 2)
Windows Vista (min. Service Pack 1)
256 MByte RAM
1 CD-ROM drive
1 vacant USB port (for ServiceCard reader)
1 free RS232 interface or
1 network card or
1 TAPI compatible modem
(for communication with the system)
11/28.09 Page 3 from 49

Preparation
Firewall
Caution:
The PC Service Software 5008 needs the following firewall exceptions!
Service5008.exe
Free FTP access (Passive Mode)

TCP port 21 and >1024 outgoing
TCP communication port 5008 (outgoing)
Page 4 from 49 11/28.09

Preparation
Preparation
Software Installation
Caution:
Install the PC Service Software 5008 before connecting the ServiceCard
reader to the PC!
Caution:
When installing the software a PC Service Software 5008 version
already installed will automatically be uninstalled.
If an existing PC Service Software 5008 version shall not be uninstalled,

the installation can be started with "setup /noremove".
A different installation path must then be specified to prevent that this
version will be overwritten.
Caution:
Administrator rights are required to install the PC Service Software 5008!
Start Windows on your computer.

Insert the installation CD in the CD ROM drive.
If the setup does not start automatically:
x Start the Windows Explorer.
x Start the Setup.exe file on the CD ROM drive.
11/28.09 Page 5 from 49

In the Installation Code setup dialog, enter the installation code indicated on
the CD cover.
During the installation of the ServiceCard Reader driver under Windows XP

a dialog may appear , informing you that the drivers failed to pass the
Windows Logo test.
Simply click the "Continue Anyway" command button and then the "Finish"
command button, to complete the installation.
The software installation is complete.
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Preparation
Preparation
Hardware Installation
Use the enclosed interface cable to connect the PC to the system.
Caution:
The interface cable for the RS232 connection is not a standard cable. It
must therefore be ensured that the interface cable (M35111 or M28486
with Gender Changer M28487) is used which is supplied with the
product.
Caution:
In case of a direct network connection (PC <-> system) make sure to
use the enclosed Cross-Over patch cable (M36433).
Caution:
Install the PC Service Software 5008 before connecting the ServiceCard
reader to the PC!
Connect the ServiceCard reader to a free USB port.
11/28.09 Page 7 from 49

Preparation
ServiceCard Description
The use of the PC Service Software 5008 requires an appropriate authorization.

This is checked by the PC Service Software 5008 and the associated ServiceCard.
The ServiceCard is:

1. read out via the ServiceCard reader on the PC.
Connect the ServiceCard reader to a free USB port.
Insert the ServiceCard into the ServiceCard reader.
The ServiceCard will be checked when starting the application and while
working with the software. If the card is not inserted or is removed, an error
message will be displayed.
Caution:
If the ServiceCard is read via the PC, only a read access to the system is
possible!
The ServiceCard must be inserted into the system for uploading data
(system information, setup, software update) to the system!
2. read out via the card reader of the system.

Insert the ServiceCard into the card reader of the system.
The system indicates by a T that the ServiceCard
has been read.
The PC Service Software 5008 authorizations will not be set before
communications have been successfully established.
Since the authorization is limited to a specific period of time, the expiration date of
the ServiceCard is checked by a time monitoring function.
The expiration date of the ServiceCard is shown in the About dialog.
30 days prior to expiration, an informational message is displayed when starting the
application.
Once the expiration date is exceeded, the PC Service Software 5008 can no longer
be accessed. In this case the expiration date of the ServiceCard must be prolonged
by an authorized body.
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Preparation
Preparation
Starting the Software
After correct installation of the hardware, the system can be switched on.
The software can now be started on the PC by selecting

Start->Programs->Fresenius->Service 5008->Service 5008 - Vx.yy
.
11/28.09 Page 9 from 49

Changing the IP Address
Caution:
A manual configuration of the IP address on the Service PC is only
required if the automatic configuration with the PC Service Software
5008 fails (see Menu/Toolbar Connection).
Step 1:
Windows:
Select Start->Setting->Network- and Dial-up connections
Step 2:
In this dialog, select the network card used. Then click the right mouse button to
select the Properties pop-up menu.
The following dialog will be displayed:
Page 10 from 49 11/28.09

Preparation
Step 3:
Select Internet Protocol (TCP/IP) and click the Properties button.
The following dialog will be displayed:
Step 4:
Note down the previous settings to be able to restore these settings.
Select the settings for a Direct Connection as shown in the previous screen and click
the OK button.
IP address: 192.168.0.2
Subnet mask. 255.255.255.0
11/28.09 Page 11 from 49


Menu/Toolbar
Menu Options/Toolbar
Overview
Brief explanation of the menu option / toolbar functions:

Connection
Diagnostic
Extras
Settings
View
Help/About ...
Status Bar
Brief explanation of the Status Bar:

Shows, if a ServiceCard could be read from device or if the read ServiceCard is
allready removed. .
Shows, if a ServiceCard could be read from PC.
Tooltip shows more information from ServiceCard.

Network connection.
Communication control (data send, receive)
11/28.09 Page 13 from 49

Connection
Online/Offline Mode (establishing/disconnecting communications):

This menu option is used to establish and disconnect communications with the
system.
x Online (establishing communications):
Caution:
All windows within the PC Service Software 5008 must be
closed to establish communications.
After clicking the menu option, the following dialog will be displayed:
Connection with...
Page 14 from 49 11/28.09

Menu/Toolbar
Here the operator can select the type of connection by clicking the button ,
or . The currently selected type of connection is shown as a pushed
button (in the above example has been selected).
RS232 connection, e.g. via COM1
Modem connection, via a modem installed under Windows
Network connection
Caution:
Make sure that the network option on the system is set to
active in the Technician's setup->Network.
If the configuration was changed, the system must be
restarted for the settings to become effective.
Caution:
A network connection to the system can only be
established if no serial interface cable has been
connected to the system since the start of the system.
Otherwise disconnect the serial interface cable and
restart the system.
The System IP set in the

Technician's setup -> Network
on the system
must be entered in the System IP text box of

the Connection with ... dialog.
Automatic network configuration of the Service PC.
To be able to establish a network connection with the system, it may

be necessary to change the network configuration of the Service PC.
This will be done by the PC Service Software 5008 if checkbox is
checked.
11/28.09 Page 15 from 49

Caution:
Should the automatic Service PC network configuration
with the PC Service Software 5008 fail several times, the
network configuration must be changed manually, see
Changing the IP Address.
Make sure that the checkbox in the Connection with
... dialog is not checked.
The network configuration comprises up to 3 steps:
Dialog 1:
Select whether the network connection with the system is to be
established via direct connection or via a network connection.
Dialog 2:
If Network connection (firm IP address) was selected in dialog 1, the
new IP address of the Service PC must be entered in this dialog box.
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Menu/Toolbar
Dialog 3:
If the Service PC is provided with more than one network adapter,
select in the following dialog which network adapter is used for the
connection of the system.
After clicking the Connect button in the Connection with ... dialog, the
following dialog will be displayed:
The PC Service Software 5008 establishes communications with the system

and synchronizes with the system.
11/28.09 Page 17 from 49

After establishing the connection, the following message informs the

operator that only read access to the system is possible.
x Offline (disconnecting communications):

After clicking this menu option, communications with the system will be
disconnected.
Caution:
It may take several seconds before communications
have been disconnected.
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Menu/Toolbar
Diagnostic
System Information:
Clicking this menu option will open the System Information screen. Here the
operator can view the following system data:
x System number
x Date
x Time
x Equipment
x Filter1 (Filter life, Treatments, Degreasing runs)
x Filter2 (Filter life, Treatments, Degreasing runs)
x Operating hours
NOVRAM/Calibration Data:
Clicking this menu option will open the NOVRAM/Calibration Data view.
Here the operator can
x read, display and save the NOVRAM data of the individual modules of the
system.
x delete the NOVRAM data of individual modules.
x read and display the NOVRAM data from a file, for uploading the
NOVRAM data, the calibration data or individual NOVRAM data to the
system.
Setup:
Clicking this menu option will open the Setup data view.
x read, display and save the setup data of the system.
x edit the setup data.
x read and display the setup data from a file in order to upload them to the
system.
x create new setup data.
Error Memory:
Clicking this menu option will open the Error Memory view.
x read, display and save the error memory of the individual modules of the
system.
x delete the error memory data of individual modules.
11/28.09 Page 19 from 49

Service Data Recorder:

Clicking this menu option will open the Service Data Recorder view.
x read which service data recorder files have been saved to the Compact
Flash of the system.
x save selected service data recorder files.
x delete selected service data recorder files.
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Menu/Toolbar
Extras
Software Update via System:

Clicking this menu option will open the Software Update view.
x read the service report of the system.
This report includes the software versions, the CRC, the creation date of
the individual modules and information on missing/defective files.
x select if files on the Compact Flash and/or modules are to be updated.
x transfer the files required for the software update to the system and
update the selected modules.
Image onto Compact Flash:
Clicking this menu option will open the Image from/onto Compact Flash view.
x make an image of a Compact Flash on a hard disk.
x copy an image (e.g. new software version) to a Compact Flash.
Caution:
Adminsistrator rights are required for this operation!
11/28.09 Page 21 from 49

Settings
Interface Settings:
Clicking this menu option will open the dialog for the selection of the serial
interface or for the selection of the modem for a modem connection.
(see Connection with ... dialog, chapter Menu/Toolbar: Connection)
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Menu/Toolbar
Network Configuration:
Clicking this menu option will open the dialog for the selection of the network
connection.
(see Automatic network configuration of the Service PC,

chapter Menu/Toolbar: Connection)
11/28.09 Page 23 from 49

View
Toolbar:
When clicking this menu option the toolbar of the active window will be shown or
hidden.
Status Bar:
When clicking this menu option the status bar of the active window will be
shown or hidden.
Cascade:
When clicking this menu option all open windows will be displayed as cascading
windows.
Tile Vertically:
When clicking this menu option all open windows will be displayed one next to
the other.
Tile Horizontally:
When clicking this menu option all open windows will be displayed one above
the other.
Open views:
In this field, the currently open views are listed. The active view is checked.
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Menu/Toolbar
Help / About ...
Help Topics:
Clicking this menu option will open the help file.
Context Help:
When clicking this menu option, the software will switch to the context help
mode. In this mode the operator can click with the mouse on dialogs, views, to
obtain context-sensitive on-screen help.
About PC Service Software 5008 ...:
Clicking this menu option will open the About ... dialog.
This dialog provides information about:

software version
source of ServiceCard (e.g. PC, Device)
expiration date of the ServiceCard
operator's ServiceCard ID
operator's name
operator's authorizations
11/28.09 Page 25 from 49

Page 26 from 49 11/28.09

Views
View
System Information
Downloads system information from the system.

Downloads system information from the system and saves it to a file.
Uploads the selected operating hours (example above: complete system) to
the system.
Deletes the selected operating hours (example above: complete system) of
the system.
Opens system information from a file.
Saves system information to a file.
Prints system information.
Displays the Print Preview.
Indicates the filename to which the system information was saved or from which
file the system information was read.
Displays the system number.
Clicking the command button will upload the system number to the system.
11/28.09 Page 27 from 49

Clicking the command button will upload the time set by the operator to the
system.
Clicking the command button will upload the current time of the Service PC
to the system.
Shows the following information:
System type: e.g. 5008
Equipment: e.g. Diasafe, ONLINE Plus .
Shows the filter data for filters 1 and 2:
Filter life: 0 . .84 days
Treatments: 0 .. 100
Degreasing runs: 0 .. 11 .
For editing and transferring the Write Filter Data right is required!
Shows module information:
Module: Module name of the respective module
x OS: Operating system
x SS: Safety system
x ECMP: Eccentric membrane pump
SW version: Software version of the respective module
CRC: Cyclic redundancy check
Serial no.: Serial number of the respective module
Date: Date when the respective module was created
Operating hours: Indicates the operating hours of the modules
Total operating hours: Indicates the total operating hours of the modules
Here the operator can edit the operating hours of the complete system.
This is necessary if the system displays the following error message:

Hour meter deviation detected.
Caution:
It is the operator's responsibility to set the correct operating hours!
To change operating hours there are some authorisation on
ServiceCard necessary.
1. For this purpose, click the appropriate field .

2. The program changes to the Edit mode. It is sufficient to enter the
numerical value of the new operating hours.
Operating hours edited but not yet uploaded are identified by an asterisk
(*).
3. Clicking the button will upload and read back the selected
operating hours.
The operator may deselect the highlighted operating hours or select all.
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Views
View
NOVRAM/Calibration Data
Caution:
Before uploading NOVRAM data to the 5008, a backup of the old
NOVRAM data should be made by downloading the NOVRAM data from
the system and saving them to a file.
Caution:
When uploading NOVRAM data, calibration data may also be
overwritten. The operator must ensure that the NOVRAM data belong to
the respective system .
BVM, BPM, BTM NOVRAM data cannot be uploaded to the system, as
they can only be recalibrated at the factory!
Downloads NOVRAM data of the selected modules from the 5008.

Downloads NOVRAM data of the selected modules from the 5008 and
saves them to a file.
11/28.09 Page 29 from 49

Transfers, depending on the selection of the operator,
the entire NOVRAM data, only the calibration data or only the highlighted
NOVRAM variables to the system.
Opens a file and uploads the entire NOVRAM data or only the calibration data
to the system, depending on the selection of the operator.
Deletes the NOVRAM data of the selected modules.
Opens the NOVRAM data from a file (*.5008nov).
Saves the NOVRAM data that was read to a file (*.5008nov).
Prints the NOVRAM data.

Shows general information (system type, system number, file name, SW version
of the system, download time and date) on the NOVRAM data downloaded from
the system.
Shows general information (system type, system number, file name, SW version
of the system, download time and date) on the NOVRAM data saved to the file.
Checkboxes where the operator can select for which modules the NOVRAM data
are to be downloaded, to be deleted, to be displayed or which data are to be
uploaded to the system.
Dimmed modules have been reported by the system as not present.
Shows the operator the number selected by him and the total number of
NOVRAM variables.
The operator can select if all NOVRAM data or only the calibration data are to be
displayed.
The Show NOVRAM Data right is required for displaying the NOVRAM data!
Shows the NOVRAM data:
Module: module name of the respective module
Variable name: internal name of the NOVRAM variable
Description: brief description of the variable
Type: calibration data are identified by CAL
System value: indicates the NOVRAM value of the system.
x ... [hex]: hexadecimal representation
x ... [bin]: binary representation
x ... : value with associated unit (if available)
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Views
Valid: x empty: NOVRAM variable without validity flag

x [ ]: validity flag present
NOVRAM variable identified as invalid
x [ X ]: validity flag present
NOVRAM variable identified as valid
Value File: indicates the NOVRAM value from the file.
x ... [hex]: hexadecimal representation
x ... [bin]: binary representation
x ... : value with associated unit (if available)
Valid: x empty: NOVRAM variable without validity flag
x [ ]: validity flag present
NOVRAM variable identified as invalid
x [ X ]: validity flag present
NOVRAM variable identified as valid
Explanation of colors:
x black: everything ok.
x red: the NOVRAM value does not correspond with the value of the file.
x blue: the NOVRAM value of the file no longer exists in the software
version of the system.
The sort order can be changed by clicking the column header.

The width of the columns can be changed with the mouse.
If the text inside the column is not shown completely, this will be indicated by
"...".
The operator can undo the selection of the NOVRAM variables or select all
NOVRAM variables.
11/28.09 Page 31 from 49

View
Setup Data
Downloads setup data from the system.

Uploads setup data to the system. (see also )
Caution:
The network settings become active after a system restart only.
Caution:
Check the uploaded data on the system for plausibility.
Page 32 from 49 11/28.09

Views
It is possible to create a new setup for systems for which the setup information
file is saved on the PC.
As the setup may have changed with each software version, use the following
dialog to select the system type (e.g. 5008) and the software version the new
setup is to be created for.
All values are preset to the factory settings.

Opens the setup data from a file (*.5008setup).
Saves the setup data displayed to a file (*.5008setup).
Print setup data.
Displays general information on the setup data:
x System type
x System number
x File name
x SW version of the system
(in versions marked with an asterisk (*), the setup was modified)
x Time
x Date
x Filename with path
Indicates if the setup data must be verified and, if necessary, be adapted.
It is possible to accept the setup data to be verified for the complete setup
(Operator setup/Technician's setup). Clicking one of the following command
buttons will display an overview list with the setup data concerned.
11/28.09 Page 33 from 49

Setup data missing in the setup.

The factory settings have been used. The operator must confirm this
procedure or set a new value.
Setup data out of the admissible minimum/maximum range.
The factory settings have been used. The operator must confirm this
procedure or set a new value.
The setup data have been specified by the manufacturer and should be
set to the factory settings.
Here the operator may select the setup data to be uploaded to the system, i.e.
the data which will be overwritten on the system.
Setup data which will not be uploaded to the system are identified by a
symbol .
The Concentrates, Syringes, Dialyzer classes groups, User interface, Auto, on,
System-specific data, Network settings, Cleaning parameter and Miscellaneous
as well as their respective setup data are defined by the manufacturer and
cannot be modified by the operator.
Shows the operator the setup organization (Operator/Technician's setup and the
respective sub-pages).
The following symbol indicates that setup data still must be verified on a
sub-page (see ).
Sub-pages marked with an asterisk (*) comprise modified setup data.
Resets the modifications on the current setup page.
Sets the setup data on the current setup page to the factory settings.
This symbol indicates that the setup data are not uploaded to the system.
This may be caused by the selection made above or missing
authorisation on ServiceCard.
Indicates that this setup data must be verified and, if necessary, be adapted
(see ).
The operator can modify the values by entering text via the keyboard, by making
a selection via the checkboxes or by changing the position of the slider controls.
The position of the slider controls shows the operator the admissible
minimum/maximum range.
The admissible minimum/maximum range can be restricted/extended by
modifying the appropriate setup data.
Caution:
Systems which, due to the software version, do not yet support the
setup information file, are not displayed completely and can only be
edited in part, e.g. system type 5008 V3.36.
Support of the setup information file for system type 5008, version
V3.52 and higher.
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Views
View
Error Memory
Downloads error memory data of the selected modules from the system.
Downloads error memory data of the selected modules from the 5008 and
saves them to a file (*.5008error).
Deletes the error memory data of the selected modules .
This should not be done before a backup of the error memory data has been
created.
Copies the selected error memory rows into clipboard.
Opens the error memory from a file (*.5008error).
Saves the error memory to a file (*.5008error).
Prints the error memory data.
Displays general information on the setup data:
x System type
x System number
x File name
x Time
x Date
11/28.09 Page 35 from 49

Full text search

Updates the search run and highlights the text found in yellow. (see
example "battery").
The Search function is not case-sensitive.
To deselect the highlighted text, clear the contents of the search text
box and click the search command button again.
Returns to the previous result.
Advances to the next result.
Checkboxes where the operator can select for which modules the error
memory data are to be downloaded, displayed or to be deleted.
Dimmed modules have been reported by the system as not present.
Shows the error memory data:
Error code: error code of the system
Module: module name of the respective module
Mode: current mode when the error occurred.
Error error message in plain text.
message: Explanation of colors:
x black: text for the operator is displayed in a message box
on the system and written into the error memory.
x red: text is only written into the error memory.
Date: date when the problem occurred.
01.01.2001 means: the problem occurred prior to the initialization
Time: time when the problem occurred.
Pos: consecutive number as the data were downloaded from the
system.
The sort order can be changed by clicking the column header.
The width of the columns can be changed with the mouse.
If the width of the column is too small for the text, this will be indicated by "...".
The complete text will be displayed in a tool tip as soon as the mouse pointer is
on the respective field.
Highlighted lines may be copied onto the Clipboard, using the keyboard
shortcut Ctrl+C.
Page 36 from 49 11/28.09

Views
View
Service Data Recorder
Downloads service data recorder file information from the system.
Caution:
The service data recorder files have not yet been downloaded
from the system.
Deletes the service data recorder files selected under from the Compact-
Flash.
Downoads the service data recorder files selected under from the system
and saves them to a compressed file (*.5008fly).
Caution:
To increase the data transfer rate in case of larger service data
recorder files, the system is restarted and the service data
recorder files are downloaded during the restart.
11/28.09 Page 37 from 49

Caution:
Ensure that no firewall blocks the download (e.g. VPN – Client
from Cisco).
Displays general information on the service data recorder data downloaded

from the system:
x System type
x System number
x File name
x Time
x Date
Displays information on the service data recorder file on the Compact-Flash:
Folder: indicates where the service data recorder files are saved
File name: indicates the file name of the service data recorder file.
Size: indicates the size of the service data recorder file in bytes.
Date: indicates the date when the service data recorder file was saved.
Time: indicates the time when the service data recorder file was saved.
Number of the selected and total number of service data recorder files.
Current file size of the selected service data recorder files.
Deselects the selected service data recorder files or selects all.
Page 38 from 49 11/28.09

Views
View
Software Update
11/28.09 Page 39 from 49

Downloads the service report from the system.

This report includes the software versions, the CRC, the creation date of the
individual modules and information on missing files.
Starts the software update of the system in accordance with the operator's
selection .
Caution:
To increase the data transfer rate in case of larger data files, the
system is restarted and the update data are uploaded to the
system during the restart.
Caution:
Ensure that no firewall blocks the upload (e.g. VPN – Client from
Cisco).
Opens the software update file.

Saves the software status to a file (*.5008sws).
Prints the software status.

Shows general information on the software update:
x System type
x System number
x File name
x Time
x Date
Shows information on the software versions of the individual modules:
Module: Symbols:
The module shall not be updated.
The module shall be updated.
The module shall be updated but with an older version!
The update status can be changed by double-clicking the symbols.
Module name of the respective module, e.g. Monitor-OS
Type: x File: the information in this line refers to the version in the
software update file for the respective module.
x Flash: the information in this line refers to the version on the
CompactFlash of the system for the respective module.
x Module: the information in this line refers to the version installed
in the respective module.
Page 40 from 49 11/28.09

Views
Version: Version
CRC: Cyclic redundancy check
Date: Date and time of compilation
Allows selection of optional packages.
e.g. standard setup, regional fonts
Allows selection of manufacturer defined base update.
The device will update the modules 'offline', without connection to Service PC.
(System software V4.00 necessary)
More service report information for the operator:
x e.g.
Files which are required by the system but which are missing or defective.
11/28.09 Page 41 from 49

View
Image from/to Compact Flash
Creates an image of the removable media found.

Writes the open image to a removable media.
Caution:
The size of the image file must match the size of the Compact
Flash.
This means: a 64MB image cannot be written onto a 128MB
Compact Flash.
Opens an image file (*.5008img)
Caution:
After opening an image file the CRC will be calculated.
The calculated CRC should be compared with CRC from image
file. Only if the CRC matches you should transfer the image data.
General image file information:

x System type
x File name
x Size of the image file
x Calculated CRC over the total image
Page 42 from 49 11/28.09

Views
Status information about the removable media found:

x No removable media found:
Check that the Compact Flash reader is correctly connected and that the
Compact Flash has been inserted into the reader.
In this case the Compact Flash should be removed and reconneced.
x Removable media found:
x More than one removable media found:
Remove all removable media except the Compact Flash of the system.
11/28.09 Page 43 from 49

View
Print Preview
Clicking the Print Preview command button displays the print preview of the
selected view.
Selects individual pages
Zooms the size.
Prints the pages.
Page overview
Page 44 from 49 11/28.09

Modification
List of Modifications
Quick Guide
Release Modification
0/04.03 First edition
1/09.03 Help adapted to version V1.01
x Layout revised
x Caution: Software for service purposes only, added on cover
page
x Table of contents added
x Item 1 - Preparation - amended
x Item 2.8 - Software Update - revised
x Graphics updated
x NOVRAM/calibration data description adapted
x Software update description adapted
x System information description (operating hours) adapted
x List of Modifications: Software added
x System Requirements
Network card added
x Hardware Installation
Part numbers of interface cables added
x Starting the Software:
Network access description added
x Description of the Service Card (Access Protection)
Note on ServiceCard expiration date added
x Menu Options/Toolbar: Settings
Network access description adapted
x Menu/Toolbar: View added
x View: System Information
Setting/deleting operating hours added
x View: Error Memory
Error memory view description extended
x View: Setup Data
Note: Operator/Technician's setup added
Description for Service PC active added
x View: Software Update
Release number omitted
11/28.09 Page 45 from 49


x System requirements adapted
x Software installation adapted
x Additional note for establishing communications
x Information regarding transfer of NOVRAM data to the system
x Screenshots updated
x View: System Information
Total operating hours
x View: Setup Data
x View: Image from/to Compact Flash added
x Screenshots updated
x View: Service Data Recorder Data
8/39.05 Help updated to version V1.40
x General Information:
Adaption of the legal form
x ServiceCard Description:
Remote access only if ServiceCard has been inserted into the
system
x System Information
Filter data changed
x NOVRAM/Calibration Data
x Setup Data
Display, Edit, New
x Error Memory
Search function, copying onto the Clipboard
x Literial Errors
x Menu Overview:
Description for Status Bar
x About-Dialog:
Information about ServiceCard source
x View Service Data Recorder:
Comment firewall
x View Software Update:
Comment firewall
x View System Information:
Comment operating hour authorisation on ServiceCard
x View Setup Daten:
Screenshots updated
Additional comments miscellaneous parameter.
x View Image CF:
Comment CRC calculation
Page 46 from 49 11/28.09

Modification

x View: Print Preview
x View: Error Memory
Copy to clipboard
x View: Setup Data
Print / Print preview
x View: Software Update
Base update, modulupdate 'offline', optional packages
x Menu: Connection
Connection dialog
11/28.09 Page 47 from 49


Index
D Overview ...................................... 13
Description of the Service Card Settings ........................................ 22
(Access Protection) .........................8 S
F Screen
Firewall ...............................................4 Error Memory ............................... 35
G Image from/to CF ......................... 42
General Information............................1 Machine Info................................. 27
H NOVRAM/Calibration data ........... 29
Hardware Installation ..........................7 Print Preview ................................ 44
M Service Data Recorder ................. 37
Menu Options/Toolbar Setup Data ................................... 32
Connection....................................14 Software Update .......................... 39
Diagnosis ......................................19 Software Installation .......................... 5
Extras............................................21 Starting the Software ......................... 9
Help/About ....................................25 System Requirements ....................... 3
11/28.09 Page 49 from 49


5008S Fresenuis Service Manual

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5008S

Fresenius Medical Care

Fresenius Medical Care 5008S SM-EN 9/01.11 iii

4.19 Network..................................................................................................................................... 4-16

8 Tools (service equipment)

iv Fresenius Medical Care 5008S SM-EN 9/01.11

10.3 Assembly of components..................................................................................................... 10-10

12 Service program (option)

Fresenius Medical Care 5008S SM-EN 9/01.11 v

vi Fresenius Medical Care 5008S SM-EN 9/01.11

A BVM 5-27 EMC 4-3

Air bubble detector 4-12 Calibrate 9-2 Equipment 10-12

Alarm override 4-7 Cleaning programs 4-8 Extracorporeal Blood Circuit

Fresenius Medical Care 5008S SM-EN 9/01.11 1-1

1-2 Fresenius Medical Care 5008S SM-EN 9/01.11

Fresenius Medical Care 5008S SM-EN 9/01.11 1-3

1-4 Fresenius Medical Care 5008S SM-EN 9/01.11

2.1 Important information on the Service Manual

2.1.1 How to use the Service Manual

Changes Document changes will be released as new editions or supplements. In

Reproduction Reproduction, even of extracts, may only be performed with written

2.1.2 Significance of the safety precautions

Explanation of the Caution and Note symbols used:

Fresenius Medical Care 5008S SM-EN 9/01.11 2-1

2.2 Important information on the device

2.2.1 Technician's qualification

Purpose This technical document is intended for service technicians and is to be

Requirements Knowledge of the current Operating Instructions of the respective

2.2.2 Precautions for working on the device

Authorized persons Assembly, extensions, adjustments, modifications or repairs may only

Specifications Any information on the specifications must be observed.

Precautions Before turning power on, repair any visible damage.

2-2 Fresenius Medical Care 5008S SM-EN 9/01.11

Please address any inquiries to:

Manufacturer Fresenius Medical Care AG & Co. KGaA

International Fresenius Medical Care

Fresenius Medical Care 5008S SM-EN 9/01.11 2-3

2-4 Fresenius Medical Care 5008S SM-EN 9/01.11

3.1 Important information on the installation / initial start-up

Environmental conditions Variations in temperature during transport may lead to condensation

Specifications Any information on the specifications must be observed.

Precautions Before turning power on, repair any visible damage.

3.2 Initial start-up report

See following pages.

Fresenius Medical Care 5008S SM-EN 9/01.11 3-1

3-2 Fresenius Medical Care 5008S SM-EN 9/01.11

5008S Initial start-up report Fresenius Medical Care

Technician's name: Customer / customer no.:

Type including option(s) / Device no.: Inventory no.:

Service report number: Operating hours: Equipment code:

No. Description Oper. cond. Correct. Meas. 

Fresenius Medical Care 5008S SM-EN 9/01.11 3-3

No. Description Oper. cond. Correct. Meas. 

3-4 Fresenius Medical Care 5008S SM-EN 9/01.11

No. Description Oper. cond. Correct. Meas. 

Fresenius Medical Care 5008S SM-EN 9/01.11 3-5

No. Description Oper. cond. Correct. Meas. 

Test equipment used:

Date: Signature: Stamp:

Date of next inspection:

Date: Signature: Stamp:

3-6 Fresenius Medical Care 5008S SM-EN 9/01.11

3.3 Explanations on the initial start-up report