Operating Manual

4008 S
Hemodialysis Machine
Operating Instructions
Software Version 4.1
0123
Fresenius Medical Care

Operating Instructions 4008 S
These Operating Instructions have been updated to
11/02.01 = 11th edition, February 2001

To save costs, only pages which have been corrected will be replaced.
Refer to the table below to verify that the Operating Instructions are up-to-date.
Page(s) Current version
0-1 – 0-6 11/02.01
1-1 – 1-132 11/02.01
2-1 – 2-50 11/02.01
3-1 – 3-40 11/02.01
4-1 – 4-46 11/02.01
5-1 – 5-22 11/02.01
6-1 – 6-30 11/02.01
7-1 – 7-26 11/02.01
Part No.: M32 327 1 Fresenius Medical Care 4008 S 11/02.01 (OP) 0-1
0-2 Fresenius Medical Care 4008 S 11/02.01 (OP)
OPERATING INSTRUCTIONS
HEMODIALYSIS MACHINE 4008 S
These Operating Instructions are part of the machine documentation and thus an integral part of the 4008 S
hemodialysis machine. They contain any information necessary for the use of the 4008 S hemodialysis
machine. Before operating the machine, the operator must have been instructed by the manufacturer on
how to use the machine and must be thoroughly familiar with the contents of the Operating Instructions.
The machine may only be operated by persons who have been instructed on the proper operation and
handling of the unit.
The Operating Instructions must be carefully studied before attempting to operate the machine.
The Brief Operating Instructions are intended as a reference only and do not replace the Operating
Instructions manual with which the operator must be fully familiar.
Explanation of symbols used in the Operating Instructions:
☞ Note
Informs the operator that in case of a
failure to follow the steps as de-
scribed, a specific function will be
executed incorrectly or will not be
executed at all, or will not produce
the desired effect.
Caution
Advises the operator against certain
procedures or actions that could
cause damage to the equipment or
may have adverse effects on opera-
tors and patients.
The parameters entered must be verified by the operator, i.e. the operator must check, if the values entered
are correct. Should the desired value deviate from the parameters displayed, the setting must be corrected
before activating the function.
The actual values displayed must be compared with the desired values specified!
The 4008 S hemodialysis machine reflects the latest state of technology and complies with the regulations
of EN 60601-1 (IEC 601-1).
The 4008 S hemodialysis machine is classified as Class IIb equipment (MDD).
Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer
or persons authorized by him.
Please send any inquiries to (see next page):
Fresenius Medical Care 4008 S 11/02.01 (OP) 0-3

Manufacturer:
Fresenius Medical Care AG
D-61346 Bad Homburg
Tel.: 0049 (0) 61 72/ 6 09-0
Local Service:

Table of Contents
Chapter Page
0 General Notes ................................................................................................................ 0-
1 General Machine Description ...................................................................................... 1-

1.1 Intended Use ................................................................................................................... 1-5
1.2 Transportation and Storage ............................................................................................ 1-9
1.3 Structure and Function of Individual Machine Components .......................................... 1-12
1.4 Description of the Procedure .......................................................................................... 1-36
1.5 Description of the Extracorporeal Blood Circuit ............................................................. 1-53
1.6 Initial Start-Up ................................................................................................................. 1-59
1.7 Menu Description ............................................................................................................ 1-73
1.8 Cleaning Programs ......................................................................................................... 1-90
1.9 Maintenance ................................................................................................................... 1-93
1.10 Disposables and Consumables ...................................................................................... 1-93
1.11 Technical Data ................................................................................................................ 1-103
1.12 Definitions and Terms ..................................................................................................... 1-117
1.13 Abbreviations and Symbols ............................................................................................ 1-120
1.14 Technical Safety Checks ................................................................................................ 1-121
1.15 Certificates ...................................................................................................................... 1-123
1.16 Literature ......................................................................................................................... 1-132
2 Preparation .................................................................................................................... 2-
2.1 Dialysis Machine ............................................................................................................. 2-3
2.2 Functional Check ............................................................................................................ 2-12
2.3 Blood Pump .................................................................................................................... 2-26
2.4 Heparin Pump ................................................................................................................. 2-28
2.5 Air Detector ..................................................................................................................... 2-32
2.6 Extracorporeal Blood Circuit ........................................................................................... 2-34
2.7 Priming the Extracorporeal Blood Circuit With a Saline Bag ......................................... 2-36
2.8 Dialysate Side ................................................................................................................. 2-41
3 Treatment ....................................................................................................................... 3-
3.1 Ultrafiltration .................................................................................................................... 3-3
3.2 Double Needle Dialysis ................................................................................................... 3-11
3.3 Single-Needle Dialysis .................................................................................................... 3-18
3.4 Single-Needle Click-Clack .............................................................................................. 3-23
3.5 Isolated Ultrafiltration ISO UF ......................................................................................... 3-25
3.6 Sodium and UF Profiles .................................................................................................. 3-30
3.7 DIASAFE ®plus (option) ..................................................................................................... 3-39
4 Alarm Processing ......................................................................................................... 4-

4.1 Management of Alarm Limits .......................................................................................... 4-3
4.2 Needle Adjustment .......................................................................................................... 4-6
4.3 Blood Alarms ................................................................................................................... 4-8
4.4 Dialysate Alarms ............................................................................................................. 4-26
4.5 Warnings ......................................................................................................................... 4-29
4.6 Emergency Operation ..................................................................................................... 4-35
4.7 Error Messages During Cleaning Programs ................................................................... 4-37
4.8 Error Messages After Turning Power On ........................................................................ 4-44
4.9 Error Messages When Using the Download Function ................................................... 4-45

Chapter Page
5 Disconnection ............................................................................................................... 5-
5.1 End of Treatment ............................................................................................................ 5-3
5.2 Reinfusion ....................................................................................................................... 5-6
5.3 Stopping Treatment ........................................................................................................ 5-11
5.4 Emptying the bibag® (option) .......................................................................................... 5-18
5.5 Emptying the Dialyzer ..................................................................................................... 5-20
6 Cleaning ......................................................................................................................... 6-
6.1 General Overview ........................................................................................................... 6-3
6.2 External Cleaning ........................................................................................................... 6-5
6.3 Basic Conditions for Cleaning Programs ........................................................................ 6-5
6.4 Disinfection, Decalcification ............................................................................................ 6-6
6.5 Cleaning / Degreasing Program ..................................................................................... 6-11
6.6 Hot Rinse ........................................................................................................................ 6-15
6.7 Rinsing ............................................................................................................................ 6-18
6.8 Priming During Cleaning Programs ................................................................................ 6-22
6.9 Precirculation During the Cleaning Programs ................................................................. 6-27
7 Special Menu Functions ............................................................................................... 7-

7.1 Changing the DIASAFE®plus (option) on Machines with Basic Hydraulics ..................... 7-3
7.2 Changing the DIASAFE®plus (option) on Machines with Advanced Hydraulics .............. 7-7
7.3 bibag® (option) ................................................................................................................ 7-17
7.4 Transferring Treatment Parameters (Download) ........................................................... 7-22

Table of Contents 1 General Machine Description
Chapter Page
1.1 Intended Use ................................................................................................................. 1-5

1.1.1 Fields of Application ........................................................................................................ 1-5
1.1.2 Side Effects ..................................................................................................................... 1-5
1.1.3 Contraindications ............................................................................................................ 1-5
1.1.4 General Description ........................................................................................................ 1-6
1.1.5 Accessories ..................................................................................................................... 1-8
1.2 Transportation and Storage ......................................................................................... 1-9

1.2.1 Transportation ................................................................................................................. 1-9
1.2.2 Storage ........................................................................................................................... 1-11
1.3 Structure and Function of Individual Machine Components ................................... 1-12

Fig.: Hemodialysis Machine – front view ........................................................................ 1-12
Fig.: Hemodialysis Machine – rear view ......................................................................... 1-13
1.3.1 Monitor ............................................................................................................................ 1-14
Fig.: Hemodialysis Machine – monitor front .................................................................... 1-14
Fig.: Hemodialysis Machine – monitor rear and power supply unit ............................... 1-16
1.3.2 Modules .......................................................................................................................... 1-18
Fig.: Blood pump (arterial) .............................................................................................. 1-18
Fig.: Heparin pump ......................................................................................................... 1-19
Fig.: Air detector ............................................................................................................. 1-20
Fig.: Flow diagram of basic hydraulics incl. DIASAFE ®plus (option) ............................... 1-22
1.3.3 Description of the Basic Hydraulics incl. DIASAFE ®plus (option) .................................... 1-24
Fig.: Flow diagram 4008 S with advanced hydraulics .................................................... 1-26
1.3.4 Description of the Advanced Hydraulics ......................................................................... 1-28
1.3.5 Central Delivery System (CDS) – optional ...................................................................... 1-30
1.4 Description of the Procedure ...................................................................................... 1-36

1.4.1 Description of Bicarbonate Dialysis ................................................................................ 1-36
Fig.: Concentrate connectors .......................................................................................... 1-38
Fig.: Preparation of the dialysate (schematic)
Fig.: for 4008 dialysis machines with basic hydraulics .................................................. 1-40
Fig.: for 4008 dialysis machines with advanced hydraulics ........................................... 1-41
1.4.2 Description of the Variation Function .............................................................................. 1-44
Fig.: Possibilities of combining sodium and UF profiles ................................................ 1-44
1.4.3 Description of DIASAFE®plus (option) with Basic Hydraulics .......................................... 1-45
Fig.: System components ............................................................................................... 1-45
Fig.: Filter test procedure ................................................................................................ 1-46
Fig.: Dialysis procedure .................................................................................................. 1-47
Fig.: Cleaning procedure ................................................................................................ 1-48
1.4.4 Description of DIASAFE®plus (option) with Advanced Hydraulics ................................... 1-49
Fig.: System components ............................................................................................... 1-49
Fig.: Membrane integrity test procedure (DIASAFE®plus) ............................................... 1-50
Fig.: Dialysis procedure .................................................................................................. 1-51
Fig.: Cleaning procedure ................................................................................................ 1-52

Chapter Page
1.5 Description of the Extracorporeal Blood Circuit ...................................................... 1-53

Fig.: Extracorporeal blood circuit – double needle dialysis ............................................ 1-53
1.5.1 Double Needle Dialysis ................................................................................................... 1-54
1.5.2 Single Needle Click-Clack Dialysis ................................................................................. 1-54
Fig: Extracorporeal blood circuit – single needle dialysis (optional) .............................. 1-55
1.5.3 Single Needle Dialysis (optional) .................................................................................... 1-56
1.5.4 Effective Blood Flow and Accumulated Blood Volume .................................................. 1-57
Fig.: Blood pump (SN) .................................................................................................... 1-58
1.6 Initial Start-Up ............................................................................................................... 1-59

1.6.1 Relevant Instructions Before Initial Start-Up ................................................................... 1-59
1.6.2 How to Connect the Hemodialysis Machine ................................................................... 1-63
1.6.3 Inserting / Priming the DIASAFE®plus (option) on Machines with Basic Hydraulics ....... 1-66
1.6.4 Inserting / Priming the DIASAFE®plus (option) on Machines with Advanced Hydraulics 1-69
1.7 Menu Description .......................................................................................................... 1-73

1.7.1 General Notes ................................................................................................................. 1-73
Fig.: Data entry fields ...................................................................................................... 1-73
Fig.: Screen (e.g. Ultrafiltration menu) ............................................................................ 1-74
Fig.: Screen (e.g. Dialysate menu) ................................................................................. 1-75
1.7.2 Using the Menus – Examples ......................................................................................... 1-76
1.7.3 Menu Description ............................................................................................................ 1-79
1.7.4 Description of Messages Displayed in the Menus ......................................................... 1-88
1.8 Cleaning Programs ....................................................................................................... 1-90

1.8.1 General Information on the Cleaning Programs ............................................................ 1-90
1.8.2 Disinfection and Removal of Calcium Deposits ............................................................. 1-91
Fig.: Disinfection flow chart ............................................................................................. 1-92
1.9 Maintenance .................................................................................................................. 1-93
1.10 Disposables and Consumables ................................................................................... 1-93

1.10.1 Disposables .................................................................................................................... 1-93
1.10.2 Consumables .................................................................................................................. 1-95
1.10.3 DIASAFE®plus (option) ..................................................................................................... 1-100
1.10.4 Part Numbers .................................................................................................................. 1-101
1.11 Technical Data ............................................................................................................... 1-103

1.11.1 Dimensions, Weight and Housing Material ..................................................................... 1-103
1.11.2 Electrical Safety ............................................................................................................. 1-103
1.11.3 Electrical Supply ............................................................................................................. 1-104
1.11.4 Type Label ...................................................................................................................... 1-104
1.11.5 Fuses .............................................................................................................................. 1-105
1.11.6 Operating Conditions ...................................................................................................... 1-105
1.11.7 Optional External Connections ....................................................................................... 1-106
1.11.8 Override Conditions ........................................................................................................ 1-107
1.11.9 Operating Programs ........................................................................................................ 1-108
1.11.10 Dialysate Circuit and Safety Systems ............................................................................. 1-109
1.11.11 Extracorporeal Blood Circuit and Safety Systems ......................................................... 1-113
1.11.12 Environmental Compatibility and Recycling.................................................................... 1-115
1.12 Definitions and Terms .................................................................................................. 1-117
1.13 Abbreviations and Symbols ......................................................................................... 1-119

1.13.1 Abbreviations .................................................................................................................. 1-119
1.13.2 Symbols .......................................................................................................................... 1-120

Chapter Page
1.14 Technical Safety Checks .............................................................................................. 1-121
1.15 Certificates .................................................................................................................... 1-123

1.15.1 CE Declaration of Conformity for 4008 B ........................................................................ 1-123
1.15.2 CE Declaration of Conformity for 4008 S (option) ......................................................... 1-124
1.15.3 CE Declaration of Conformity for Diasafe ®plus (option) .................................................. 1-125
1.15.4 CE Declaration of Conformity for bibag® (option) .......................................................... 1-126
1.15.5 ISO 9001 (EN 46001) Certificate .................................................................................... 1-127
1.15.6 EN ISO 14001 Certificate ............................................................................................... 1-128
1.15.7 EC Certificate .................................................................................................................. 1-130
1.16 Literature ....................................................................................................................... 1-132

1.16.1 Hemodialysis in General ................................................................................................. 1-132
1.16.2 Dialysate Filter and ON-LINE HDF ................................................................................. 1-132
1.16.3 Blood Temperature Monitor (BTM) ................................................................................. 1-132

1.1 Intended Use
1.1.1 Fields of Application
The 4008 H dialysis machine is designed for performing chronic and acute hemodialysis. It can be
used in home dialysis, limited care centers and clinical hemodialysis.
1.1.2 Side Effects
Dialysis therapy occasionally causes hypotension, nausea, vomiting and cramping in some
patients. Please take note of the package inserts enclosed with the hemodialysis concentrates,
dialyzers, etc.
1.1.3 Contraindications
– Hyperkalemia (for potassium-containing hemodialysis concentrates only)

– Hypokalemia (for potassium-free hemodialysis concentrates only)
– Uncontrollable coagulation anomalies
A different method of extracorporeal treatment may be indicated in hemodynamically unstable

patients.

1.1.4 General Description
The hemodialysis machine allows dialysis treatments without any additional equipment. The
machine operates and monitors the dialysate circuit and the extracorporeal blood circuit.
The required treatment parameters can be entered via various menus provided for programming
and displayed on a high-resolution LC display. The current treatment data are shown on the
display.
In the dialysate circuit, purified water is mixed with hemodialysis concentrate, heated, degassed
and delivered to the dialyzer. Inflowing and outflowing quantities are balanced volumetrically. The
pressure at the dialyzer is adjusted depending on the ultrafiltration rate selected and the type of
dialyzer used.
The DIASAFE®plus option permits hemodialysis treatment with high-purity dialysate. The
DIASAFE®plus option basically consists of one filter stage. For the entire time of its use the filter is
an integral part of the hemodialysis machine and is rinsed and disinfected in conjunction with the
machine. The integrity of the filter is tested by means of a pressure holding test which is
integrated in the functional test of the hemodialysis machine. The filter can be used for a
maximum of 100 treatments or for a period of 12 weeks, whichever comes first. Should the filter
fail to pass the filter test, it must be replaced at an earlier date. For the use of this option, the
quality of the water and the dialysate must comply with the applicable standards. (See Chapter
1.6 Initial Start-Up.)
In the extracorporeal blood circuit, the blood is continuously heparinized and passes through the
dialyzer. An air detector prevents infusion of air . Any dangerous loss of blood is prevented by a
blood leak detector and a device monitoring the venous return pressure. The arterial pressure
monitoring unit detects any intake of the needle in the vessel.
The hemodialysis machine is designed for both acetate dialysis and bicarbonate dialysis.
The mixing ratio of concentrate to purified water can be programmed (default setting 1+34 –
selection of other mixing ratios is possible).
Depending on the concentrate used, the Na+ concentration can be readjusted within a range of 125
to 150 mmol.
The bicarbonate concentration can be readjusted within a range of ±8 mmol.
With the bibag® option the bicarbonate solution is produced from a bag (sodium hydrogen
carbonate powder, NaHCO3). The powder is diluted in the machine to obtain ready-to-use
bicarbonate.
Na+ and UF profiles can be programmed by using the built-in variation function.
It is possible to perform ultrafiltration without dialysate flow (sequential dialysis/isolated ultrafiltration,

ISO-UF).

The dialysate flow is variable (3 levels: 300, 500, 800 ml/min).
The basic version of the hemodialysis machine is designed for double needle dialysis.
Freely selectable programs are available for cleaning and disinfecting the machine.
The hemodialysis machine is equipped with all safety systems required for proper function and
patient safety EN 60601-1 (IEC 601-1).
The automatic test of the safety systems (functional test, also called T1 test) must be performed
prior to each dialysis treatment. This test also checks the integrity of the closed system (pressure
holding test PHT).
In the following cases, the hemodialysis machine will request the user to perform the functional test:
– after a start with external power supply (not power failure),
– after one of the cleaning programs.
For additional safety, cyclic pressure holding tests (CPHT) are also performed during the dialysis
treatment to detect possible leakages in the closed system.
The CPHT is performed automatically every 12.5 minutes. For the CPHT the dialysis machine is
switched for a few seconds into bypass and ultrafiltration is stopped. Balancing is not affected by
these CPHTs, but the effective dialysis time will be reduced by approx. 2 minutes per hour of
treatment.

1.1.5 Accessories
Caution
Any additional equipment connected to the analog and digital interfaces of the
machine must comply with the applicable EN specifications (e.g. EN 60950 for
data processing equipment, and EN 60601 (IEC 601) for electro-medical equip-
ment). Apart from this requirement, all configurations must comply with the
system standard EN 60601-1-1 (IEC 601-1-1). The connection of additional
equipment to the signal input or output component affects the system configura-
tion and anyone connecting additional equipment is therefore responsible for
compliance with the system standard EN 60601-1-1 (IEC 601-1-1).
● The hemodialysis machine can be supplied with the following modules:
1. A blood pump for performing single needle dialysis.

2. A heparin pump for the use of 50 ml syringes as well as a heparin pump for the use of 20 ml
syringes.
3. An air detector for a 22 mm bubble catcher.
● The following accessories (options) are available:
These accessories have been approved within the scope of an EC prototype test.
1. BPM 4008 Blood Pressure Monitor [including separate Operating Instructions]

2. DIASAFE®plus
3. ONLINEplus ™ [including separate Operating Instructions]
4. Interface Commco
5. CDS (central delivery system)
6. bibag ®
7. Status indicator ("traffic light")
8. BTM 4008 Blood Temperature Monitor [including separate Operating Instructions]
9. BVM 4008 Blood Volume Monitor [including separate Operating Instructions]
10. 4008 Remote Control [including separate Operating Instructions]
11. Arterial Clamp [including separate Operating Instructions]
12. Finesse [including separate Operating Instructions]
13. ON-LINE HDF [including separate Operating Instructions]
(for dialysis machines without
ONLINEplus ™ only)
14. 4008 HDF [including separate Operating Instructions]
(for dialysis machines without
ONLINEplus ™ only)
15. Water inlet filter
16. Rinsing the water supply hose (Flush)
17. OCM (Online Clearance Monitor) [including separate Operating Instructions]
● In addition, the following accessories are available:
RO 08 (single-place reverse-osmosis system) [including separate Operating Instructions]

1.2 Transportation and Storage
1.2.1 Transportation
● Inside buildings
Lift the brake lever.
The hemodialysis machine can be tilted,

turned or pushed in any direction.
To overcome uneven surfaces (e.g. ele-

vator entry):
Always push the hemodialysis machine
slowly across uneven surfaces to avoid
damage or prevent the machine from
turning over.

At least two persons are required for
overcoming steps or stairs.
Proceed as follows:
Lock the brake.
Clamp the vent tubing by means of arter-
ial forceps.
Tilt the machine.
Lift the machine and transport it (never
hold the machine at the IV pole or at one
of the modules when lifting it).
Put the machine down and set it up in re-
verse order.
● Outside buildings
– Never push the hemodialysis machine across an uneven paving (e.g. cobblestone pavement).
Always lift it.
– When transporting the hemodialysis machine in vehicles, accommodate it vertically or hori-
zontally and protect it with an appropriate padding.
– When transporting the hemodialysis machine outside of buildings for a prolonged period of
time, the range of storage temperature must be observed (if necessary, fill the machine with
an antifreezing solution).

1.2.2 Storage
The hemodialysis machine must be stored vertically in a well-ventilated room with low variations
in temperature.
Storage temperature:
– without antifreeze +5 °C up to +60 °C
– with antifreeze –20 °C up to +60 °C
When storing the hemodialysis machine with antifreeze, make sure to use antifreeze of the
following composition:
– 48.75 % water
– 48.75 % glycerine
– 2.5 % Teta-plus
Charging the integrated batteries:

Upon receipt of the hemodialysis machine, the integrated batteries must be charged as follows:
– Connect the machine to the power supply system by means of the power cord.
– Turn power on and leave the machine on for approx. 10 hours.
If the machine is not in use, this procedure should be repeated every six months.

1.3 Structure and Function of Individual Machine Components
Fig.: Hemodialysis machine – front view
1 Fresenius Medical Care 4008 S

Ein/Aus Luftdetektor Blutleck
Arterieller Venöser
Druck Druck TMP
Reinigen mmHg mmHg mmHg
280 500 500
200
400 400
SN 100
300 300
0
9
200 200
–100
100 100
–200
0 0
–300
Test
Leitfähigk.
mS/cm
Vorbereiten 15,5
Fluß UF
15 I/O I/O
Start/Reset 14,5
7 8 9 0 Esc
14
Dial. 4 5 6
Ton aus 13,5 UF
Flüssigk.
13 Menü Menü 1 2 3 C Best
Rate: ml/min Rate: ml/min

(Ø: mm) (Ø: mm)
Pven. 8
Start Start
Stop Stop
2
Rate: ml/h
(Bolus: ml)
( :h.min)
Bolus
Rate
Start
Stop
2a
7
3 6
Legend
1 Monitor 3 Hydraulics
2 Modules – Level 1 4 Brake
(from left to right) 5 Bicarbonate suction tube (blue)
Blood pump (arterial) 6 Concentrate suction tube (red)
Blood pump (SN) 7 Rinse chamber
Air detector 8 Interlock shunt for dialyzer connecting tubes
2a Modules – Level 2 9 IV pole
(from left to right)
Heparin pump
Rinse chamber, bibag®-Connector (option)
not used

Fig.: Hemodialysis machine – rear view
3 14
4
5
15
13
12
6 11
10
9
8
Legend
1 Monitor (rear) 9 Concentrate connector for central delivery

2 Sample collection valve system (red), optional
3 Filter 10 Drain
4 Dialyzer supply line with external flow indic- 11 Water connector (permeate) or connector for
ator water inlet filter
5 Dialyzer return line 12 DIASAFE ®plus (filter 1) option
6 Disinfection connector 13 Vent tubing
7 Water inlet filter, optional 14 Power supply unit
8 Bicarbonate connector for central delivery 15 Holder for dialyzer connecting lines
system (blue), optional

1.3.1 Monitor
Fig.: Hemodialysis machine – monitor front
Fresenius Medical Care 4008 S 18a 18b 18c

On/Off Air detector Blood leak
8a 9a
1a Arterial Venous
1b Pressure Pressure TMP
10a 11a 12a
Cleaning mmHg mmHg mmHg
280 500 500
2a
200
2b 400 400
SN 100
300 300
3a
0
3b 200 200
–100 19a
100 100
–200
0 0
–300
Test 10b 11b 12b
4a Conductivity
4b 15a
mS/cm 17a 14a
Prime 15,5
Flow UF
5a 15 On/Off On/Off
5b
Start/Reset 14,5 17b 14b
7 8 9 0 Esc
6a 14
6b 20d
13,5 Dialysate
4 5 6 20a 20c
Tone Mute UF 20b 20e
7a 13 Menu Menu 1 2 3 C Conf
7b 15b 16a 13a

● Monitor front description
The complex functions of the controls on the monitor are illustrated and explained in Chapter 2,
where operation of the machine is described in detail.
Function keys (pos. 1 – 7) Dialysate monitor (pos. 15 – 18)

1a On/Off key 15a Conductivity alarm indicator
1b On/Off LED 15b Conductivity display
2a Cleaning key 16a Dialysate Menu key
2b Cleaning LED
17a Flow LED
3a SN key 17b Flow On/Off key
3b SN LED
4a Test key Status indicators (pos. 18)
4b Test LED 18a Green status indicator (operation)
5a Prime key 18b Yellow status indicator (warning/info)
5b Prime LED 18c Red status indicator (alarm)
6a Start/Reset key
6b Start/Reset LED Screen / data entry (pos. 19 – 20)
7a Tone Mute key 19a Screen

7b Tone Mute LED 20a Numeric keys for data entry (0 to 9, +, –)
20b C key
Blood monitor (pos. 8 – 12) 20c Arrow keys ▲, ▼, and
and ultrafiltration unit (pos. 13 – 14) 20d Esc key
20e Conf key
8a Air Detector alarm indicator
9a Blood Leak alarm indicator
10a Arterial Pressure alarm indicator
10b Arterial Pressure display
11a Venous Pressure alarm indicator
11b Venous Pressure display
12a TMP alarm indicator
12b TMP display
13a UF Menu key
14a UF LED
14b UF On/Off key

Fig.: Hemodialysis machine – monitor rear and power supply unit
1 2 3 4 5 6 7 8 9 10 11
15
16
17
14 13 12

● Description of monitor rear panel and power supply unit
Caution
Apart from the options mentioned on page 1-8, additional equipment should only
be connected to the ports on the rear of the monitor if the resulting overall system
complies with the requirements of EN 60601-1-1 (IEC 601-1-1), or if their
applicability with regard to technical safety has been proven by a certificate
issued by a testing agency authorized to test the ready-for-use machine.
1 Fan
2 Service switch
3 Audible alarm volume control
4 Connection socket for status indicator/traffic light (optional)
5 RS232 interface (galvanically decoupled by optocoupler) (optional)
6 Input/output port (for external equipment)
7 Screen socket
8 Time meter
9 ALARM IN port (for connection of an external pushbutton switch, which can be used to
initiate a machine stop).
10 ALARM OUT port (for connection of an external alarm indicator, nurse call)
11 Symbols. Caution: consult accompanying documents.
12 Power supply unit (voltage supply for the hemodialysis machine)
13 Power switch (main switch)
14 Power cord (supplies the hemodialysis machine with line voltage, 230 V AC; 50 – 60 Hz)
15 Loudspeaker for audible alarm
16 Port for connection of the remote control (optional)
17 Key interface (patient identification in conjunction with FINESSE) (optional)

1.3.2 Modules
Fig.: Blood pump (arterial)
1 Rate: ml/min
(Ø: mm)
2
11
3
10
4 Start
Stop 9
● Description of the blood pump (arterial)
1 Display (indicates the delivery rate, the line diameter or an error code)
2 Alarm LED (red)
3 Operation LED (green)
4 Pressure connector (Luer-lock connector of the arterial pressure measuring line)
5 Clamping piece (holds the installed line segment securely in place)
6 Blood pump cover
7 Rotor (delivers the patient’s blood by means of the rollers and the present line set; the rotor
can be removed for cleaning purposes)
8 Sensor (blood pump cover open or closed)
9 Start/Stop key (to turn the blood pump on and off)
10 ▼ key (to reduce the delivery rate or the value of the line diameter)
11 ▲ key (to increase the delivery rate or the value of the line diameter)

Fig.: Heparin pump
12
Rate: ml/h
(Bolus: ml)
1
11
( :h.min)
10
2 Bolus 9
3 Rate 8
Start
4 Stop 7
● Description of the heparin pump
1 Slide carriage (moves the syringe plunger)

2 Bolus key
3 Rate key (to set the delivery rate)
4 key (to set the stopwatch time)
5 Syringe holder
6 Stop-watch time indicator (green)
7 Start/Stop key (to turn the heparin pump on and off)
8 ▼ key (to reduce the delivery rate or to decrement the stop-watch time, and to move the
slide carriage down)
9 ▲ key (to increase the delivery rate or to increment the stop-watch time, and to move the
slide carriage up)
10 Power indicator (green)
11 Display (displays the delivery rate, the stop-watch time, the bolus amount or an error code)
12 Alarm indicator (red)

Fig.: Air detector
Pven. 1
● Description of the air detector
1 Keys (to raise (▲) and lower (▼) the fluid level in the venous bubble catcher)
2 Venous pressure connector (Luer-lock connector of the venous pressure measuring line)
3 Holder for the venous bubble catcher with ultrasonic sensors
4 Venous line clamp
5 Optical detector

Next page:
Fig.: Flow diagram of basic hydraulics incl. DIASAFE®plus (option)

Fig.: Flow diagram of basic hydraulics incl. DIASAFE®plus (option)

Legend
2 Temperature sensor 87 Drain valve

3 Temperature sensor 88 Multifunction block
5 Float switch 88a Degassing chamber
6 Level sensor 88b Secondary air separator
7 Conductivity cell 88c Primary air separator
8 Blood leak detector 89 Degassing orifice
9 Pressure transducer 90a Rinse chamber concentrate
10 Reed contact for concentrate 90b Rinse chamber bicarbonate
12 Reed contact for bicarbonate 91 Rinse valve
21 Flow pump 92 Vent valve
22 UF pump 94 Concentrate suction tube
23 Concentrate pump 95 Bicarbonate suction tube
24 Dialyzer valve 1 97 Air separation pump
24b Dialyzer valve 2 99 Rinse valve
25 Bicarbonate pump 100 Rinse valve
26 Bypass valve 102 Central concentrate delivery valve
29 Degassing pump 104 Central bicarbonate delivery valve
30 Outlet valve 109 Temperature sensor
31 Balancing chamber valve 1 111 Hydrophobic filter
32 Balancing chamber valve 2 112 Vent valve
33 Balancing chamber valve 3 114 Dialysate filter
34 Balancing chamber valve 4 115 Sensor disinfection valve
35 Balancing chamber valve 5 116 Sampling valve
36 Balancing chamber valve 6 117 Check valve (concentrate)
37 Balancing chamber valve 7 118 Check valve (bicarbonate)
38 Balancing chamber valve 8 119 Filter (concentrate)
41 Water inlet valve 120 Filter (bicarbonate)
43 Fill valve 121 Central concentrate delivery connector
54 Heater rod 122 Central bicarbonate delivery connector
61 Pressure reducing valve 123 Pressure switch for V102
63 Water inlet filter 124 Pressure switch for V104
65 Loading pressure valve 125 Temperature compensation plate
66 Heater block 130 bibag ® drain valve
66a Water inflow chamber 131 bibag ® block
66b Heater rod chamber 131a bibag ® air sep. chamber
66c Float chamber 131b bibag ® mixing chamber
68 Balancing chamber 132 bibag ® conductivity cell
71 Filter/concentrate 133 bibag ® temperature sensor
72 Filter/bicarbonate 134 bibag ® pressure transducer
73 Filter/dialysate ext. 135 bibag ® level sensor
74 Filter/UF 136 bibag ® connector
75 External flow indicator 137 bibag ® microswitch 1
76 Filter/fill valve 138 bibag ® microswitch 2
77 Heat exchanger 148 Filter/rinse valve 100
78 Relief valve 149 Filter/rinse valve 99
84 Disinfectant valve 150 Filter
85 Disinfectant connector 151 Orifice
86 Recirculation valve 210 Filter (degassing orifice)
Hydraulics measuring points
A Reduced water inlet pressure

B Balancing chamber loading pressure
C Flow pump pressure
D Degassing pump pressure

1.3.3 Description of the Basic Hydraulics incl. DIASAFE®plus (option)
The hydraulic compartment of the hemodialysis machine consists of a volumetric dialysate

balancing system, which is closed against the atmosphere. In the balancing chambers, the used
dialysate is displaced by fresh dialysate (and vice versa). This assures that equal amounts of
dialysate enter and exit the dialyzer. The fresh and the used dalysate are separated by an elastic
membrane.
The float switch (5) located in the heater block (66) controls the inflow of fresh water via the water
inlet valve (41).
The upstream pressure reducing valve (61) ensures a constant water inlet pressure.
In the chamber (88c) of the multifunction block (88), the concentrate pump (23) adds acetate-
containing concentrate. During bicarbonate dialysis, it adds acid concentrate.
When peforming bicarbonate dialysis the bicarbonate is pumped by the membrane pump (25)
from the bicarbonate suction tube (95) via the air separation chamber (131a) into the chamber
(88c) of the multifunction block (88) adding exact quantities of bicarbonate. The conductivity
measuring cell (132) and the temperature sensor (133) measure and monitor the bicarbonate
conductivity.
The heat exchanger (77) transmits part of the heat of the outflowing dialysate to the cold inflowing
water.
The dialysate is heated in the heater rod chamber (66b). The degassing pump (29) and the orifice
(89) generate a negative pressure for deaeration of the dialysate. The air removed is collected in
the air separating chamber from where it passes to the heater block (66) via the loading pressure
valve (65). The air is then discharged into the atmosphere via the float chamber (66c).
The dialysate flows from the chamber (88c) via the mixing chamber (131b) to the balancing
chamber (68) from where it passes through the conductivity measuring cell (7) and the dialyzer
valve (24) to the dialyzer.
In the conductivity cell (7), both the conductivity and the temperature (temperature sensor 3) are
measured and indicated on the monitor.
If temperature and conductivity are inside the alarm limits, the two dialyzer valves (24 and 24b)
are open and the bypass valve (26) is closed.
Should one of the two values be outside the alarm limits (temperature or CD alarm), the bypass
valve (26) opens and the dialyzer valve (24) closes.
The used dialysate coming from the dialyzer is monitored by a blood leak detector (8), from where
it flows into the secondary air separator (88b) of the multifunction block (88). The fluid coming
from this chamber is forced through the flow pump (21) into the balancing chamber (68). This
ensures that the spent dialysate discharged by the dialyzer is always replaced by the same
amount of fresh dialysate.
The pressure transducer (9) is located in the secondary air separator (88b) of the multifunction
block (88). The pressure measured here is taken as a quantity in the computation of the TMP.
A membrane pump (UF pump 22) with a volume of 1 ml per stroke withdraws fluid from the
system at a specified rate. Since the system is closed, the same volume of ultrafiltrate reflows
from the blood via the dialyzer.
After the balancing chamber (68), the used dialysate is directed to the drain via the valve (30), the
heat exchanger (77) and the drain valve (87).

Larger amounts of air entering the system, as a result of major deaeration or during priming, are
detected by the level sensor (6). The air is discharged into the atmosphere via the air separation
pump (97).
The sampling valve (116) is located in the dialyzer inflow line.

Here, dialysate can be withdrawn with a Luer-lock syringe.
With the dialysate filter (114), the dialysate passes through a capillary filter with a polysulfone
membrane and then flows to the dialyzer. The filter holds back pyrogenic substances and
microorganisms.
The pressure measuring points A, B, C, and D allow direct measurement of various pressures,
without the need to separate lines and tubing. Measuring point A measures the water inlet
pressure; B the loading pressure of the balancing chamber; C the pressure of the flow pump; and
D the negative degassing pump pressure.
During the hot rinse and disinfection programs, the machine is operated in recirculation mode. In
this case, the drain valve (87) is closed and the recirculation valve (86) open. This method of
recirculation serves to save energy (hot rinse) and disinfectant. The disinfectant is introduced into
the circuit by the UF pump (22) via the disinfectant valve (84) and the sensor (115). The sensor
(115) detects whether disinfectant is present or not.
Rinsing the water supply hose (Flush) – option:

The water supply hose is rinsed during the test phase (watchdog) each time the dialysis machine
is turned on. For this rinse procedure a special valve, V-Flush, (parallel to V41) and a 2nd drain
hose are required.

Fig.: Flow diagram 4008 S with advanced hydraulics

Legend
2 Temperature sensor 92 Vent valve

3 Temperature sensor 94 Concentrate suction tube
5 Float switch 95 Bicarbonate suction tube
6 Level sensor 97 Air separation pump
7 Conductivity cell 99 Rinse valve
8 Blood leak detector 100 Rinse valve
9 Pressure transducer 102 Central concentrate delivery valve
10 Reed contact for concentrate 104 Central bicarbonate delivery valve
12 Reed contact for bicarbonate 109 Temperature sensor
21 Flow pump 111 Hydrophobic filter
22 UF pump 112 Vent valve
23 Concentrate pump 114 Dialysate filter
24 Dialyzer valve 1 115 Sensor disinfection valve
24b Dialyzer valve 2 116 Sampling valve
25 Bicarbonate pump 117 Check valve (concentrate)
26 Bypass valve 118 Check valve (bicarbonate)
29 Degassing pump 119 Filter (concentrate)
30 Outlet valve 120 Filter (bicarbonate)
31 Balancing chamber valve 1 121 Central concentrate delivery connector
32 Balancing chamber valve 2 122 Central bicarbonate delivery connector
33 Balancing chamber valve 3 123 Pressure switch for V102
34 Balancing chamber valve 4 124 Pressure switch for V104
35 Balancing chamber valve 5 125 Temperature compensation plate
36 Balancing chamber valve 6 130 bibag ® drain valve
37 Balancing chamber valve 7 131 bibag ® block
38 Balancing chamber valve 8 131a bibag ® air sep. chamber
39 Negative pressure valve 131b bibag ® mixing chamber
41 Water inlet valve 132 bibag ® conductivity measuring cell
43 Fill valve 133 bibag ® temperature sensor
54 Heater rod 134 bibag ® pressure transducer
61 Pressure reducing valve 135 bibag ® level sensor
63 Water inlet filter 136 bibag ® connector
65 Loading pressure valve 137 bibag ® microswitch 1
66 Heater block 138 bibag ® microswitch 2
66a Water inflow chamber 148 Filter/rinse valve 100
66b Heater rod chamber 149 Filter/rinse valve 99
66c Float chamber 150 Filter
68 Balancing chamber 151 Orifice
71 Filter/concentrate 181 Temperature compensation plate 2
72 Filter/bicarbonate 182 Pressure transducer 2
73 Filter dialysate external 183 Test valve
74 Filter/UF 184 Test valve filter
75 External flow indicator 185 Compressor
76 Filter/fill valve 188 Evacuation valve
77 Heat exchanger 189 Retentate valve
78 Relief valve 201 Air separator
84 Disinfectant valve 202 Level sensor
85 Disinfectant connector 203 Air separator
86 Recirculation valve 204 Level sensor
87 Drain valve 205 Concentrate / bicarbonate mixing point
88 Multifunction block 206 Buffer volume chamber
88a Degassing chamber 210 Filter (degassing orifice)
88b Secondary air separator
88c Primary air separator Hydraulics measuring points
89 Degassing orifice A Reduced water inlet pressure
90a Rinse chamber, concentrate B Balancing chamber loading pressure
90b Rinse chamber, bicarbonate C Flow pump pressure
91 Rinse valve D Degassing pump pressure

1.3.4 Description of the Advanced Hydraulics
The hydraulic compartment of the hemodialysis machine consists of a volumetric dialysate

balancing system, which is closed against the atmosphere. In the balancing chambers, the used
dialysate is displaced by fresh dialysate (and vice versa at the inverse sequence). This assures
that equal amounts of dialysate enter and exit the dialyzer. The fresh fluid is separated from the
used fluid by an elastic membrane.
The float switch (5) provided in the heater block (66) regulates the inflow of fresh water via the
water inlet valve (41).
The pressure reducing valve (61) ensures a constant water inlet pressure.
The fresh water is heated in the heater rod chamber (66b). The degassing pump (29) and the
degassing orifice (89) are used to generate a negative pressure, to deaerate the water. The air is
collected in the primary air separator (88c). From there, it is directed into the heater rod chamber
(66b) via the loading pressure valve (65) and then discharged into the atmosphere via the float
chamber (66c).
The preheated and deaerated water is delivered from the primary air separator (88c) to the
concentrate / bicarbonate mixing point (205).
Concentrate containing acetate (or in bicarbonate-based dialysis acid concentrate) flows from
the concentrate suction tube (94) through the concentrate air separator (201) and the concen-
trate pump (23) to the concentrate/bicarbonate mixing point (205). In bicarbonate-based dialysis,
bicarbonate is transported via the bicarbonate suction tube (95), the air separator (203) and the
bicarbonate pump (25) to the concentrate / bicarbonate mixing point (205).
The evacuation valve (188) and the bibag® drain valve (130) are provided for deaeration.
The conductivity measuring cell (132) und the temperature sensor (133) measure and monitor the
bicarbonate conductivity.
At the concentrate/bicarbonate mixing point (205) the appropriate concentrates are mixed with
water. The dialysate then flows across the balancing chamber (68), the dialysate filter (114) and
the conductivity cell (7) to the dialyzer.
The dialysate filter (114) holds back pyrogenic substances and microorganisms.
In the conductivity cell (7), both the conductivity and the temperature (temperature sensor 3) are
measured and indicated on the monitor. The temperature sensor (109) controls the temperature.
If temperature and conductivity are within the alarm limits, the two dialyzer valves (24 and 24b)
are open and the bypass valve (26) is closed.
Should one of the two values be outside the alarm limits (temperature or CD alarm), the bypass
valve (26) opens and the dialyzer valve (24) closes.
The integrity of the DIASAFE®plus (114) membrane is checked by ventilating the internal capillary
space via the vent valve.
The retentate valve (189) is used to rinse retentate from the internal capillary space of the
DIASAFE®plus (114).

The used dialysate coming from the dialyzer is monitored by a blood leak detector (8). From
there, it flows into the secondary air separator (88b) of the multifunction block (88). The fluid
coming from this chamber is forced by the flow pump (21) into the balancing chamber (68). Thus,
it is ensured that the outflowing dialysate is always replaced by the same volume of fresh
dialysate.
The pressure transducer (9) is provided in the secondary air separator (88b) of the multifunction
block (88). The pressure measured there is used as a quantity in the computation of the TMP.
A membrane pump (UF pump 22) with a volume of 1 ml per stroke withdraws fluid from the
system at a specified rate. Since the system is closed, the same volume is removed as
ultrafilatrate from the blood across the dialyzer.
After the balancing chamber (68), the used dialysate is directed to the drain via the valve (30), the
heat exchanger (77) and the drain valve (87).
Part of the heat of the dialysate flowing to the drain is dissipated by the heat exchanger (77) into
the cold, inflowing water.
Any penetration of a larger volume of air into the system, caused by strong degassing or during
priming, is detected by the level sensor (6). This air is discharged into the atmosphere via the air
separation pump (97).
The sampling valve (116) is located in the dialyzer inflow line.

Here, dialysate can be withdrawn using a Luer-lock syringe.
The pressure measurement points A, B, C, and D allow direct measurement of various pressures,
without having to separate lines and tubings. Measurement point A measures the water inlet
pressure; B the balancing chamber loading pressure, C the flow pump pressure, and D the
negative pressure created by the deaeration pump.
In the hot rinse and disinfection programs, the machine is operated in the recirculation mode.
Here the drain valve (87) is closed and the recirculation valve (86) opens. The recirculation mode
saves energy (hot rinse) and disinfectant. The circuit is supplied with disinfectant via the
disinfectant valve (84) and the sensor (115) of the UF pump (22). The sensor (115) detects
presence or absence of disinfectant.
When using the CDS option (central concentrate delivery), concentrate containing acetate, or in
bicarbonate-based dialysis acid concentrate, flows from the concentrate connector (121) through
the valve (102) to the rinse chamber (90a). Bicarbonate is delivered in the same way from the
bicarbonate connector (122) through the valve (104) to the rinse chamber (90b).
Rinsing the water supply hose (Flush) – option:

The water supply hose is rinsed during the test phase (watchdog) each time the dialysis machine
is turned on. For this rinse procedure a special valve, V-Flush, (parallel to V41) and a 2nd drain
hose are required.

1.3.5 Central Delivery System (CDS) – optional
The desired type of concentrate supply must be selected in the „SETUP menu“ (see Technical
Manual). The following 5 options are available:
1. No central delivery system (factory setting)
2. Central bicarbonate supply
3. Central acid supply
4. Central bicarbonate and central acid supply
5. Central acetate supply
When selecting a type of central delivery, the user is not restricted to the centrally supplied
concentrate. Other concentrates can also be connected by disconnection or connection of the
concentrate suction tubes. The valves V102 and V104 are controlled automatically. The hemodialysis
machine also recognizes the type of dialysis performed (acetate or bicarbonate dialysis) and uses
this information to control the concentrate or the bicarbonate pump respectively.
☞ Note
Aspiration of concentrates from the containers has priority (see illustration on the
following pages).
If, with central delivery, the concentrate suction tube is repeatedly pulled off, the
rinse chamber will flow over. The rinse chamber will not be drained before the
next cleaning program.
The user has the option to switch off the central delivery system. (See Chapter 2.1.4 Concentrate
Supply.)
☞ Note
The operator is responsible for the proper installation and function of the CDS.
The following illustrations show the possible combinations of connection for CDS.
(The bibag ® option can be used as an alternative to bicarbonate from containers.)

1. No central concentrate supply

2. Central bicarbonate supply

3. Central acid supply

4. Central bicarbonate and central acid supply

5. Central acetate supply

1.4 Description of the Procedure
1.4.1 Description of Bicarbonate Dialysis
● Mode of operation
The hemodialysis machine permits the optional performance of acetate or bicarbonate dialysis.
The type of treatment is determined by:
– the concentrate(s),
– the positioning of the concentrate suction tubes.
For bicarbonate dialysis two concentrates are required:

– acid concentrate,
– bicarbonate concentrate (concentrate from containers or bibag® (option)).
The concentrates are delivered by two pumps and are mixed with RO (reverse osmosis) water in
the hemodialysis machine. The concentrate suction tubes are connected to the appropriate
containers.
With CDS, the appropriate concentrates are delivered by the central delivery system.
The mixing process is volumetric and proportional, i.e. the concentrate pumps add an exact
quantity of concentrate to a fixed volume of water.
The mixing ratio can be varied. The desired ratio can be selected in the dialysate menu. To change
the ratio, the operator must press the Dialysate Menu key.
During bicarbonate dialysis, precipitation of calcium and magnesium salts can occur. The machine
should therefore be decalcified and disinfected after each bicarbonate dialysis, using a suitable
agent (e.g. Puristeril® 340 or Citrosteril®).
During a cleaning program, the concentrate suction tubes must be inserted in the rinse ports
located on the hemodialysis machine.

● Concentrates for bicarbonate dialysis
The correct ion concentration in the dialysate can only be achieved with concentrates that
match the mixing system.
Acid concentrate
SK-F 203 (PGS 21)/SK-F 003 (PGS 01), 35-fold, 6 l in 10-l container.
Bicarbonate concentrate
8.4% sodium hydrogen carbonate solution, 8 l in 10-l container.
☞ Note
The contents of opened bicarbonate concentrate containers cannot be stored.
Bicarbonate Concentrate (bibag® – option)
Sodium hydrogen carbonate powder, 650 g, 700 g or 950 g bag.

● Dialysate for bicarbonate dialysis
After mixing, the acetic acid from the acid concentrate reacts with the equivalent quantity of
bicarbonate, producing carbonic acid and sodium acetate.
With the pumps at standard setting, this produces dialysate, which has the following ion
composition:
a) SK-F 203 (PGS 21) and 8.4% sodium hydrogen carbonate

Sodium 138.00 mval/l 138.00 mmol/l
Potassium 2.00 mval/l 2.00 mmol/l
Calcium 3.50 mval/l 1.75 mmol/l
Magnesium 1.00 mval/l 0.50 mmol/l
Chloride 109.50 mval/l 109.50 mmol/l
Acetate 3.00 mval/l 3.00 mmol/l
Bicarbonate 32.00 mval/l 32.00 mmol/l
b) SK-F 003 (PGS 01) and 8.4% sodium hydrogen carbonate

Sodium 138.00 mval/l 138.00 mmol/l
Potassium 0.00 mval/l 0.00 mmol/l
Calcium 3.50 mval/l 1.75 mmol/l
Magnesium 1.00 mval/l 0.50 mmol/l
Chloride 109.50 mval/l 109.50 mmol/l
Acetate 3.00 mval/l 3.00 mmol/l
Bicarbonate 32.00 mval/l 32.00 mmol/l
Fig.: Concentrate connectors
Rate: ml/h Rate: ml/h Rate: ml/h

(Bolus: ml) (Bolus: ml) (Bolus: ml)
( :h.min) ( :h.min) ( :h.min)
Bolus Bolus Bolus
Rate Rate Rate
Start Start Start

Stop Stop Stop
Acetate Bicarbonate Acid Acid

concentrate concentrate concentrate concentrate
Acetate dialysis Bicarbonate dialysis Bicarbonate dialysis

(bicarbonate from (bibag ® option)
containers)

● Safety in bicarbonate dialysis
Safety of the procedure is ensured by:

– two independent volumetric mixing systems,
– the temperature-compensated conductivity control,
– color-coded suction tubes and containers,
– keyed suction tubes and containers.
– automatic detection of the connected supply type
Procedure
The dialysate is continuously prepared from bicarbonate concentrate, acid concentrate, and
reverse-osmosis water.
Two membrane pumps, which are independent of each other, deliver the acid concentrate solution
and the bicarbonate solution in a volumetrically proportional mixing system.
Concentrate container coding

The container openings are specially keyed to reduce the risk of concentrate errors.
The suction tubes are also keyed to prevent them from being attached to the wrong container.
Caution
Use only specially keyed containers and mating suction tubes.
This system does, however, not exclude the possibility of incorrect use of
uncoded containers.
Only the dedicated bibag® may be connected to the bibag® connector.

Fig.: for 4008 dialysis machines with basic hydraulics
to dialyzer
Degassing
via balancing chamber
pump
Concentrate Bicarbonate
pump pump
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○ ○ ○ ○ ○ ○ ○
RO Concentrate A Concentrate B
water (acetate or acid) (Bicarbonate) or (bibag ® Option)

Fig.: for 4008 dialysis machines with advanced hydraulics
to dialyzer
via balancing chamber
Concentrate Bicarbonate
pump pump
Degassing
pump
○ ○ ○ ○ ○ ○ ○ ○ ○ ○
○ ○ ○ ○ ○
RO Concentrate A Concentrate B or (bibag®)

water (acetate or acid) (Bicarbonate) (option)

● Safety system
Measurement of the conductivity and the bypass function prevent that dialysate of the wrong
concentration will enter the dialyzer.
Monitoring of the rated conductivity to within ±5% by setting alarm limits provides a safeguard
against errors in the mixing system.
In the event of dialysate of the wrong composition, the conductivity will be outside the alarm limits.
The CD alarm, which is then generated, will cause the machine to go into bypass, accompanied
by an audible and a visual alarm.
An initial error in the mixing system will be detected before the deviation of the dialysate values from
the rated value becomes dangerous.
Error Maximum deviation
Defect in acid concentrate supply CD: –0.4 mS/cm

(defective pump, clogged filter) Na: –4 mmol/l
always leads to a reduction in Bic: ±0 mmol/l
concentration. pH: +0.04
Defect in bicarbonate supply CD: –0.4 mS/cm

(defective pump, clogged filter) Na: –6 mmol/l
always leads to a reduction in Bic: –6 mmol/l
concentration. pH –0.19
Defect in water supply or in the CD: ±0.4 mS/cm

balancing chamber: the maximum change Na: ±6 mmol/l
in the overall concentration is approximately Bic: ±1 mmol/l
0.4 / 13.5 = 0.03 = 3% pH: ±0.05
Defect in the CD monitor: No deviation

incorrect indication The defect will be detected during the
next T1 test.
Defect in the CD monitor: No deviation

defective alarm evaluation The defect will be detected during the
next T1 test.
Mistaking bicarbonate concentrate for CD outside alarm limits.

acid concentrate and vice versa (Expected value!)
Minimized by keyed containers.
Use of wrong concentrates CD: ±0.4 mS/cm

● Mixing ratios
Selectable in H2O Acid Bic. Mixture Mixture Displayed

Setup in l in l in l Concentrate Bicarbonate in menu
1+34 32.775 1 1.225 35 28.57 1+34

1+35.83 (NaCl 20) 34 1 1.83 36.83 20.13 1+35.83(A)
1+35.83 (NaCl 26) 34 1 1.83 36.83 20.13 1+35.83(C)
1+35.83<B*> 33.8 1 2 36.83 18.42 1+35.83(B)
1+44 ACF 42.425 1 1.575 45 28.57 1+44 ACF
1+44 C 42.225 1 1.775 45 25.35 1+44 C
FREELY PROGRAMMABLE1 – – – – – –
B* Belgian bicarbonate
1
for detailed information refer to the Technical Manual
☞ Note
For treatment with the bibag ® (option) the mix ratio must be set to 1+34 or 1+44.
● Total conductivity of the ready-to-use dialysate
The total conductivity of the ready-to-use dialysate (in mS/cm) is determined by the acidic and
basic part of the bicarbonate hemodialysis concentrates.
The total conductivity of the ready-to-use dialysate with the appropriate mixing ratio is indicated
on each package of the acidic bicarbonate hemodialysis concentrate from Fresenius Medical
Care.
In the event of a ready-to-use dialysate with 32 mmol/l bicarbonate and 3 mmol/l acid (e.g.
acetate content), the contribution of the basic component of the bicarbonate concentrate to the
total conductivity is 2.2 mS/cm. The contribution of the acidic component of the bicarbonate
concentrate to the conductivity depends on the different electrolytic contents.
● Change in conductivity
Based on a basic sodium value of e.g. 140 mmol, the sodium value changes by 5%, if the desired
sodium value is increased to 147 mmol. The total conductivity of the ready-to-use dialysate then
also increases by 5 %.
If the bicarbonate proportion is changed, the acid proportion is changed in the opposite direction,
in order to maintain the desired sodium at a constant value. This may result in a minor CD
alteration.
Example:
A rated sodium value of 140 mmol/l corresponds to 105 mmol/l from the acid concentrate and
35 mmol/l from the bicarbonate concentrate. If the bicarbonate is readjusted by + 3 mmol/l
(= 38 mmol/l on the bicarbonate pump), the acid concentrate pump is readjusted by –3 mmol/l to
102 mmol/l. The rated sodium value of 102 + 38 = 140 mmol/l is preserved.

1.4.2 Description of the Variation Function
In order to improve the individual tolerance to dialysis treatments, ultrafiltration profiles and sodium
profiles can be combined either mutually dependent (e.g. high ultrafiltration with high sodium
concentration) or independent.
Separate documentation is available from the manufacturer on request.
Fig.: Possibilities of combining UF and sodium profiles
Sodium
1 2 3 4 5 6
1
Ultrafiltration

1.4.3 Description of DIASAFE®plus (option) with Basic Hydraulics
● System Components
Vent Valve / Hydrophobic Filter

The vent valve opens during the pressure holding test to ensure ventilation of the
DIASAFE ®plus . A pre-valve hydrophobic filter prevents contamination.
Dialysate Filter (DIASAFE®plus)

The DIASAFE ®plus is a hollow-fibre filter. Its excellent filtering characteristics can be attributed to
the Fresenius Polysulphon ® membrane used.
Fig.: System components
Hydrophobic filter
Balancing Cond./Temp.
chamber monitoring Vent valve
DIASAFE® plus
Dialyzer Venous
valve 1 bubble catcher
Air detector
V24
UF Flow
pump pump Dialyzer
V24b
V26 Bypass Venous
valve line
clamp
Dialyzer
valve 2
Arterial
blood
pump

● Filter Test
The filter test (DIASAFE®plus test) is incorporated in the functional test provided it has been
preselected by the DIP switch setting on LP 632.
When the filter test is started, the internal capillary spaces of the DIASAFE®plus must be ventilated
by the vent valve. A special balancing chamber switching cycle is employed to remove fluid from
the interal capillary space across the membrane. The hydrophylic membrane rejects air so that a
negative pressure builds up in the system. Balancing chamber switching stops at a negative
pressure of about – 300 mmHg (peak value). The UF pump increases the negative pressure to
about – 450 mmHg. A differential pressure measurement is started. The result computed by the
microprocessor must not exceed a pressure change of ± 16.7. The maximum duration of the test
is 5 minutes. In the event of a more significant change in pressure, the UF pump will adjust the
negative pressure to the initial pressure. Differential measurement is then restarted.
Another test criterion is the fluid volume removed. A deviation of ± 30 ml from the expected value
of 145 ml will cause the test to stop.
An error message will be displayed if the filter fails to pass the test.
On successful completion of the functional test the hemodialysis machine switches into bypass
mode for a defined period of time. During this period the internal capillary space of the
DIASAFE®plus is automatically refilled with fluid.
Fig.: Filter test procedure
Hydrophobic filter
DIASAFE® plus
Dialyzer
valve 1
V24
UF Flow
pump pump Interlock shunt
V24b
V26 Bypass
valve
Dialyzer
valve 2

● Dialysis
The fresh dialysate flows from the balancing chamber via the conductivity and temperature
monitoring system to the DIASAFE ®plus .
This filter is integrated in the hydraulic system to ensure that in a no alarm state (no dialysate
alarm: V26 closed, V24 and V24b open) the "fresh" dialysate flows across the filter membrane.
Ultrapure dialysate enters the dialyzer via valve V24.
In bypass mode (dialysate alarm: V26 open, V24 and V24b closed) fluid flows through the inner
capillary space of the DIASAFE ®plus . Possible retentate is rinsed from the capillaries and
transported to the drain thus overcoming the disadvantages of a dead end filtration.
Fig.: Dialysis procedure
Hydrophobic filter
DIASAFE® plus
Dialyzer Venous
valve 1 bubble catcher
Air detector
V24
UF Flow
pump pump Dialyzer
V24b
V26 Bypass Venous
valve line
clamp
Dialyzer
valve 2
Arterial
blood
pump

● Cleaning
During the cleaning programs the dialysate lines (red/blue) are connected to the interlock shunt.
The cleaning agent flows through the balancing chamber to the DIASAFE®plus . Valves V24, V24b
and V26 are clocked so that the fluid alternately flows through the internal capillary space
(bypass) and across the filter membrane.
This ensures that in the bypass mode possible retentate is rinsed from the capillaries and is
transported to the drain. The filter is thus thoroughly cleaned, disinfected or rinsed.
Fig.: Cleaning procedure
Hydrophobic filter
DIASAFE® plus
Dialyzer
valve 1
V24
UF Flow
pump pump Interlock shunt
V24b
V26 Bypass
valve
Dialyzer
valve 2

1.4.4 Description of DIASAFE®plus (option) with Advanced Hydraulics
● System components
DIASAFE ®plus
The DIASAFE ®plus is a hollow-fibre filter. Its excellent filtering characteristics can be attributed to
the Fresenius Polysulfon ® membrane.
Pressure transducer 2
This transducer is a sensor mounted as a standard component in the hydraulic unit. It is used to
control and evaluate the membrane integrity test.
Compressor
The compressor is required for testing the integrity of the membrane of the DIASAFE®plus. Within
a minimum of time it ventilates one side of the filter membrane until the test pressure is achieved.
Test valve
The test valve is only open as long as the compressor ventilates the filter membranes and the test
pressure has built up.
Fig.: System components
Balancing Hydrophobic filter (111)

chamber
(68) Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)
Drain Pressure Air detector

valve DIASAFE® P transducer 2 Monitor
plus Cond./Temp. (182)
(87) P for venous
(114) monitoring return
(3/7/109) pressure
Retentate Bypass Venous

valve valve bubble catcher
(189) (26)
Air detector
Fill UF Flow Dialyzer

valve pump pump valve 1 Dialyzer
(43) (22) (21) (24)
Venous
Pressure line clamp
transducer Dialyzer
(9) valve 2
P (24b) P
Arterial Arterial Arterial

bubble blood pressure
catcher pump monitor

● DIASAFE ®plus membrane integrity test
The integrity of the membrane of the DIASAFE®plus is tested by means of a pressure holding test.
This test is integrated in the functional test. For this test, the outer capillaries of the DIASAFE ®plus
are ventilated. This is done by the compressor which pumps air via the test valve into the
hydraulic system. The inflowing air displaces the fluid in the system via the hydrophilic filter
membrane and the retentate valve into the drain. This process continues until the entire outer
capillary space is filled with air. As air cannot pass across an intact membrane, a positive
pressure will build up on the ventilation side. The pressure transducer 2 controls the compressor
and evaluates the integrity test. When the test pressure has been achieved, the compressor is
switched off and the test valve closes. The pressure drop per unit of time is used as a measure for
the evaluation of the integrity of the membrane.
Fig.: Membrane integrity test procedure (DIASAFE®plus )

chamber
Compressor (185)
Test valve (183)
Drain Pressure
valve DIASAFE® P transducer 2
(87) monitoring
(114)
(3/7/109)
Retentate Bypass
valve valve
(189) (26)

valve pump pump valve 1 Interlock shunt
(43) (22) (21) (24)
Pressure
transducer Dialyzer
(9) valve 2
P (24b)

● Dialysis
The fresh dialysate flows from the balancing chamber to the DIASAFE®plus.
This filter is integrated in the hydraulic system to ensure that in a no alarm state (no dialysate
alarm: V26 closed, V24 and V24b open) the "fresh" dialysate flows across the filter membrane.
Ultrapure dialysate enters the dialyzer via valve V24.
In bypass mode (dialysate alarm: V26 open, V24 and V24b closed) fluid flows through the inner
capillary space of the DIASAFE ®plus . Possible retentate is rinsed from the capillaries and
transported to the drain thus overcoming the disadvantages of a dead end filtration.
Fig.: Dialysis procedure

chamber
Compressor (185)
Test valve (183)
Drain Pressure Air detector

valve DIASAFE® P transducer 2 Monitor
(87) monitoring P for venous
(114) return
(3/7/109)
pressure
Retentate Bypass Venous

valve valve bubble catcher
(189) (26)
Air detector

valve pump pump valve 1 Dialyzer
(43) (22) (21) (24)
Venous
Pressure line clamp
transducer Dialyzer
(9) valve 2
P (24b) P
Arterial Arterial Arterial

bubble blood pressure
catcher pump monitor

● Cleaning
In all cleaning programs the dialyzer lines (red / blue) must be connected to the interlock shunt.
The cleaning agent, water or disinfectant flow via the balancing chamber to the DIASAFE®plus. As
the retentate valve, V26 and V24/24b open alternatingly, fluid flows alternatingly through the
inner capillary space and the membrane of the filter.
Fig.: Cleaning procedure

chamber
Compressor (185)
Test valve (183)
Drain Pressure
valve DIASAFE® P transducer 2
(87) monitoring
(114)
(3/7/109)
Retentate Bypass
valve valve
(189) (26)

valve pump pump valve 1 Interlock shunt
(43) (22) (21) (24)
Pressure
transducer Dialyzer
(9) valve 2
P (24b)

1.5 Description of the Extracorporeal Blood Circuit
Fig.: Extracorporeal blood circuit – double needle dialysis
Legend
1a External hydrophobic filter 8 Vent valve

2 Arterial pressure monitor 9 Monitor for venous back pressure
3 Arterial blood pump 10 Ventilation pump
4 Heparin pump 11 Hydrophobic filter
5 Arterial bubble catcher 12 Air detector
6 Dialyzer 13 Venous line clamp
7a External hydrophobic filter 14 Optical detector
7b Internal hydrophobic filter

1.5.1 Double Needle Dialysis
The arterial blood pump pumps the blood from the patient’s vascular access to the dialyzer. The
pressure on the suction side of the pump is measured and monitored by the arterial pressure
monitor, which is separated by a hydrophobic filter. Should the pressure exceed or fall below the
set limits, a blood alarm is released: the arterial blood pump stops, the venous line clamp is closed,
a visual and audible alarm is emitted. Ultrafiltration is stopped.
The heparin pump is used to administer heparin doses to the blood at an adjustable rate.
After the dialyzer, the blood enters the venous bubble catcher. There, the venous return pressure
is measured and monitored within tight limits. The monitor for the venous return pressure is
separated by two hydrophobic filters. The venous bubble catcher is located in the air detector as
a safeguard against infusion of air. Should the level drop or should there be frothy blood in the
venous bubble catcher, a blood alarm is emitted: the arterial blood pump stops, the venous line
clamp is closed, a visual and audible alarm is emitted. Ultrafiltration is stopped.
After the bubble catcher, the blood passes the optical detector (OD), which differentiates as
follows:
– OD light (saline or air in the line set) or
– OD dark (blood in the line set).
From the optical detector, the blood is then returned to the patient (venous needle).
1.5.2 Single Needle Click-Clack Dialysis
☞ Note
This procedure should be used in exceptional cases only, since the stroke
volumes and, thus, the corresponding recirculation shares can be very unfavor-
able.
Example for the application of this procedure
Should blood flow problems arise in one of the vascular accesses during double needle dialysis,
it is still possible to continue the treatment using the installed line set, by selecting SN click-clack.
After the switching pressure values have been entered, the venous pressure transducer controls
the blood pump and the venous line clamp. Both the arterial and the venous blood line are
connected to the remaining vascular access by means of a Y-piece.
The venous line clamp is closed, as long as the arterial blood pump is delivering blood. As soon
as the upper limit at the venous pressure transducer has been reached in the blood line set, the
blood pump stops and the venous line clamp opens. The pressure, which has developed in the line
set, returns the stored blood to the patient. As soon as the set lower limit has been reached, the
venous line clamp closes, the arterial blood pump starts running, and the same procedure is
repeated periodically.
Should the cycle time be exceeded by 15 s, an alarm will be emitted. The venous line clamp is
closed. The blood pump and the UF pump stop running.

Fig.: Extracorporeal blood circuit – single needle dialysis (optional)
Legend
1a External hydrophobic filter 11 Hydrophobic filter

2 Arterial pressure monitor 12 Air detector
3 Arterial blood pump 13 Venous line clamp
4 Heparin pump 14 Optical detector
5 Arterial bubble catcher 15a External compliance chamber
6 Dialyzer 15b Internal compliance chamber
7a External hydrophobic filter 16a External hydrophobic filter
7b Internal hydrophobic filter 16b Internal hydrophobic filter
8 Vent valve 17 Monitor for SN control pressure
9 Monitor for venous return pressure 18 SN blood pump
10 Ventilation pump

1.5.3 Single Needle Dialysis (optional)
During SN dialysis, blood is alternately collected from and returned to the patient through one
needle. This is achieved by means of an additional blood pump module, which includes the single
needle control electronics (2-pump procedure with pressure-pressure control).
With SN (QSN) in the twin-pump SN system, the mean blood flow is computed as follows:
QSN = (BPRart x BPRSN) / (BPRart + BPRSN) [theoretical value]
The following approximation formula is sufficient for practical use:
QSN = (BPRart + BPRSN) / 4
The arterial blood pump pumps blood into the external compliance chamber. The blood volume is
dependent upon the set stroke volume (10 to 50 ml). The SN blood pump is not running. The venous
line clamp is closed. The external compliance chamber is connected to a pressure transducer in
the SN blood pump. The compliance chamber, which is filled with air, is located inside the SN blood
pump. As soon as the pressure exceeds the set upper limit, the arterial blood pump stops. The SN
blood pump starts and pumps the blood through the dialyzer, the venous bubble catcher and the
venous line clamp into the patient. As soon as the pressure in the internal compliance chamber
drops below the set lower limit, the described procedure is restarted.
The lower changeover point is fixed to 75 mmHg. The upper changeover point depends on the
stroke volume entered.
Stroke volume (ml) 10 15 20 25 30 35 40 45 50

Upper changeover point (mmHg) 110 130 150 172 195 219 244 270 299
The position of the SN blood pump before the dialyzer prevents level fluctuations in the venous
bubble catcher and improves stability of the TMP.
The therapeutical result (clearance) depends on the effective blood flow and the stroke volume.
The higher the stroke volume, the lower the proportionate recirculation.
For this reason, the largest possible blood flow and the largest possible stroke volume should be
set. These settings differ from patient to patient and, owing to the individual vascular accesses,
have different limits.
All other components and their functions correspond to those already described for double needle
dialysis.
The stop detection of both blood pumps is activated. Should one of the pumps stop for longer than
the set time (30 seconds), a blood pump stop alarm is emitted.
☞ Note
The design (closed system) of 4008 hemodialysis machines ensures that pres-
sure fluctuations during SN operation will not affect the UF rate or the UF
volume.

1.5.4 Effective Blood Flow and Accumulated Blood Volume
The delivery rate display on the blood pump indicates the theoretical blood flow. This value is
computed from the rotor speed and the inside diameter of the blood line used.
The actual blood flow (effective blood flow) may deviate slightly from this value, because it
depends on the different input pressures (arterial pressure) on the pump.
The computer of the monitor contains an algorithm which corrects the theoretical blood flow,
dependent on the arterial pressure. The value is displayed in the current dialysis menu (Eff. Bld.
Flow).
Using the actual blood flow and the elapsed treatment time, the monitor computes the accumu-
lated blood volume. This information is displayed in the Cum.bld.vol. field in the Dialysis menu.

Fig.: Blood pump (SN)
1 Rate: ml/min
(Ø: mm)
2
11
3
10
4 Start
Stop 9
● Description of the blood pump (SN)
1 Display (indicates the delivery rate, the line diameter, the SN stroke volume, or an error
code)
2 Alarm LED (red)
3 Operation LED (green)
4 Pressure connector (Luer-lock connector of the SN pressure measuring line)
5 Clamping piece (holds the installed line segment securely in place)
6 Blood pump cover
7 Rotor (delivers the patient’s blood by means of the rollers and the present line set; the rotor
can be removed for cleaning purposes)
8 Sensor (blood pump cover open or closed)
9 Start/Stop key (to turn the blood pump on and off)
10 ▼ key (to reduce the delivery rate, the value of the line diameter, or the SN stroke volume)
11 ▲ key (to increase the delivery rate, the value of the line diameter, or the SN stroke volume)

1.6 Initial Start-Up
1.6.1 Relevant Instructions Before Initial Start-Up
The following points must be strictly observed to assure safe operation of the hemodia-
lysis machine:
● Electric installation
– The national standards and regulations (e.g. in Germany VDE 0107) are to be observed when
connecting the machine to the local power supply system.
– The use of machines of safety classification I, the quality grade of the protective conductor of
the electric installation represents an essential factor. In many countries, pertinent regulations
have been specified by national authorities, which must be adhered to.
– If the power cord needs to be replaced, use only the original power cord listed in the spare
parts catalog.
– Connect the equipotential bonding to the rear of the machine, if this is required by the legal
regulations of the place of installation (e.g. according to VDE 0107 in rooms of application
group 2) or special applications (e.g. according to VDE 0753 relating to intracardiac surgery).
Caution
When using central venous catheters it is imperative that the potential equillisa-
tion be connected.
With this special type of application all other applied parts (other medical
products) must be of the CF type (isolated applied parts that are approved for
use on the heart).
Apart from this, applied parts of the CF type (e.g. defibrilators) where the patient
currents exceed the maximum allowable CF patient leakage currents may not be
used.
– If additional devices, which are not included in the accessories, are connected to the
hemodialysis machine, there will be the danger of exceeding the permissible leakage
currents.
– Do not operate machines or devices, radiating electromagnetic waves (e.g. walkie-talkies,

wireless phones, wireless CB transmitting sets), in the vicinity of running hemodialysis
machines. The use of this equipment may cause malfunctions in the respective hemodialysis
machine.
● Batteries
Servicing the built-in batteries:

Upon receipt of the hemodialysis machine, the batteries must be charged as follows:
– Connect the machine to the external power supply by means of the power cord.
– Then turn the machine on for approx. 10 hours.
If the machine is not used, this procedure should be repeated every six months.

● Water supply
– Only water, which is suitable for hemodialysis, should be used for operating the hemodialysis
machine. The quality of the water should fulfill the AAMI regulations for hemodialysis systems,
RD5, 1981, part 3.2.
– The ranges of the following parameters are specified in Chapter 1.11 Technical Data: water
inlet pressure, supply pressure of the dialysate concentrate, temperature, and flow rates,
which are required for operating the hemodialysis machine.
– The national rules and regulations with regard to the prevention of reverse flow into the water
supply network and the air gap between drain connection and sewage connection must be
observed when installing and operating the machine (e.g. in Germany VDE 0753, part 4). For
further information refer to Chapter 1.11 Technical Data.
● DIASAFE ®plus (option) water supply
When using the DIASAFE®plus attention should be given to the points listed below with
regard to the quality of product water, concentrate and dialysate:
Caution
Use only reverse osmosis water.
Always ensure that both product water and dialysate meet the applicable
standard (see below).
For microbiologic quality standards / recommendations refer to the table below.
General notes
The microbiologic purity of dialysate prepared in the dialysis center is of critical importance.
Product water quality

The „European Pharmacopoeia“ (1997) lists maximum limits for chemical and microbiological
quality.
Modern reverse osmosis units and the appropriate design of water storage and delivery systems
(e.g. short distribution loops avoiding stagnant flow zones) enable compliance with this standard.
Concentrate quality
While acid concentrate may be considered bacteriostatic, bicarbonate concentrate is an ideal
nutrient medium for microorganisms. The use of sterile or microorganism-poor concentrates is
recommended. On-line dry concentrates (bibag®) aid the preparation of dialysate with high
microbiological quality. The use of residues from open canisters and the preparation of bicarbo-
nate concentrate in the dialysis centre are not recommended. Central delivery systems for
concentrate or dialysate must meet high hygienic standards and demand regular inspection.

Dialysate quality
The DIASAFE ®plus removes bacteria and endotoxins from dialysate thus enabling the preparation
of ultrapure dialysate.
Even when using the DIASAFE®plus, it must still be ensured that the microbiological quality
standards are complied with.
Microbiological quality standards/recommendations
Product Concentrate Dialysate High-purity

water (not filtered) dialysate
Microbial <100 <1000 <1000 <1

counts
(in CFU/ml)
Endotoxins <0.25 <1 <1 <0.03

(in IU/ml)
CFU: Colony-Forming Units

IU: International Units

● Functional checks
– Prior to each treatment, the prescribed functional checks must be performed. (See Chapter
2.8.1 Functional Checks Prior to Each Dialysis Treatment.)
● Important documents
– On request, circuit diagrams, descriptions, spare parts lists, and other documents are made
available by the manufacturer. These are intended to support trained personnel in servicing
and repairing the machine.
– The following is also available on request:

– Test procedures to be used for proving the effectiveness of sterilization or disinfection.
– Data on the recirculation share of blood flow in the extracorporeal circuit to be expected
when using the recommended line sets, dialyzers, and puncture cannulae and/or cath-
eters.
☞ Note
The machine may only be used as specified in the machine documentation.
Only under these conditions will the manufacturer consider himself responsible
for any effects on the safety, the reliability, and the performance of the machine.

1.6.2 How to Connect the Hemodialysis Machine
Initial start-up of the machine should be performed by the Fresenius Medical Care technical
customer service or a person authorized by them.
– When bringing the hemodialyis machine from a cooler into a warmer room, allow approx. 2
hours for the machine to adjust to the ambient temperature before turning the unit on.
– Prior to first use of the machine, check the position of the DIP switches, and adjust them, if
necessary. Also verify the setup settings.
(Refer to the Technical Manual)
The current DIP switch settings must then be entered in the Medical Device Register.
– Connect the machine to the water supply.

The accessories include a fabric-enforced PVC hose (red), 10 x 16 mm in size, with 3/4"
screw cap and hose clips.
– Connect the machine to the drain.

The accessories include a fabric-enforced PVC hose (black).
The drain should be located 0 to 100 cm above the ground (no less than 5 cm free fall).
– Connect the machine to the power source.
– With central delivery system (CDS):

Use the enclosed connecting tubes for connection to the central delivery system.
Caution
When connecting the hemodialysis
machine for the first time, make sure
to observe the technical specifica-
tions in Chapter 1.11.
Turn on the water supply.
Press the power switch (main switch).

☛

Fresenius Medical Care 4008 S Press the On/Off key.
Turn the hemodialysis machine on!
Arterial Venous
The On/Off LED is illuminated.
Pressure Pressure TMP
☛ Cleaning mmHg mmHg mmHg
280 500 500
200
Rinse required! Display message

The Cleaning LED is flashing.
Connect the dialyzer connecting tubes to
the interlock shunt, close the shunt door.
Place the red concentrate suction tube in
the rinse port.
Place the blue bicarbonate suction tube
in the rinse port.
☞ Note
To avoid problems during the man-
datory rinse (to remove the anti-
freeze) the service switch must be
set to ON (up).
On completion of the mandatory
rinse set the service switch back to
OFF (down) again.
Fresenius Medical Care 4008 S Press the Cleaning key.

On/Off Air detector Blood leak The Cleaning LED is flashing.
Arterial Venous
280 500 500
200
☛

Rinse required! Cleaning Menu
Mandatory rinse
Use the arrow keys
to select the desired cleaning program.
Press the Conf key.
The Cleaning LED lights.
>M< The selected cleaning program in pro-

gress is displayed (e.g. mandatory
rinse).
Mandatory rinse end At the end of the rinse program, the pro-
gram is automatically terminated .
The Cleaning LED stops lighting.
If no DIASAFE ®plus (option) is used, the

user can now perform the technical safe-
ty checks (TSC). (See Chapter 1.14
Technical Safety Checks.)

1.6.3 Inserting / Priming the DIASAFE®plus (option) on Machines with Basic Hydraulics
☞ Note
Installation of the DIASAFE®plus must
be entered in the Medical Device Re-
gister (date, batch number).
Verify, and if necessary adjust, the
DIP switch settings prior to initial
start-up. Record the settings in the
Medical Device Register.
● Basic requirements
– The optical detector senses clear fluid.

– Both dialysate lines are in the interlock shunt.
– The shunt door is closed
– The concentrate suction tubes must be locked in the rinse chamber.
● Operator steps

Turn the hemodialysis machine off!
The On/Off LED stops lighting.
Arterial Venous
☛
➀ Open the locking levers.

➁
➁ Slide the protective caps up and out
of the guide slot.
➀

Remove the protective straps ➀ and ➁
from the new filter by pulling the lug.
➀ ➀ Slide the new filter from the top into

the guide slot.
➁ Close the locking levers.
➁

Arterial Venous
☛
–300
Test The Test indicator is flashing.
Conductivity If the Test indicator is not flashing,
mS/cm one of the conditions for the test to
Prime 15,5 start is not fulfilled.
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
Tone Mute 13,5 Dialysate UF
13 Menu Menu 1 2 3
–300
Test Press the Test key.
Conductivity
The Test indicator is illuminated.
☛
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☞ Note
If the machines fails to pass the
functional test, repeat the test by
pressing the Test key.
If a DIASAFE®plus failure (FXX) is
displayed after the functional test,
this test step has to be skipped.
Then run a heat disinfection program
or a disinfection program followed by
a hot rinse.
Caution
Disinfect prior to the first treatment.
Perform the technical safety checks

(TSC). (See Chapter 1.14 Technical
Safety Checks.)

1.6.4 Inserting / Priming the DIASAFE®plus (option) on Machines with Advanced Hydraulics
☞ Note
Installation of the DIASAFE®plus must
be entered in the Medical Device Re-
gister (date, batch number).
Verify, and if necessary adjust, the
DIP switch settings prior to initial
start-up. Record the settings in the
Medical Device Register.
● Basic requirements

– Both dialysate lines are in the interlock shunt.
– The shunt door is closed
– The concentrate suction tubes must be locked in the rinse chamber.
● Operator steps

Arterial Venous
280 500 500
200
☛
Cleaning Menu
Use the arrow keys

to select the
Filter change
program.

Esc Press the Conf key.
C Conf
☛
Info message An Info message displays.
Empty filter

Filter changed?

➁
➁ Slide the protective caps up and out
of the guide slot.
➀

➀ ➀ Slide the filter from the top into the

guide slot.
➁

C Conf
☛
Filling filter
Cleaning menu
Disinfect as specified in the Operating
Instructions.
Caution
Disinfect prior to the first treatment.
Perform the technical safety checks

(TSC). (See Chapter 1.14 Technical
Safety Checks.)

1.7 Menu Description
1.7.1 General Notes
Fig.: Data entry fields
7 8 9 0 1 5 Esc
4 5 6
3 4
2
1 2 3 C 6 Conf
● Description of the keypads
1 Entering data (numerical values).

2 Changing data (numerical values) or functions.
3 Resetting data (numerical values) to 0 or to a preset value.
4 Selecting a menu or the fields to be changed.
5 Exiting a menu without saving the data.
6 After all data of a menu have been changed, the changes are saved by pressing the Conf
key once.

Fig.: Screen (e.g. Ultrafiltration menu)
1 2
● Description of screen fields
1 Currently selected menu

2 Text field
3 Menu field
4 Menu bar (shows the menus which can be selected with the arrow keys)

Fig: Screen (e.g. Dialysate menu)
● Description of screen colors
The currently selected menu and the text are always displayed as follows:
white characters on blue background
The following colors are used in the menu field and the menu bar:
Background Characters Data (numerical values), function or menu
blue white can be selected
green black can be changed
grey white cannot be selected or changed

1.7.2 Using the Menus – Examples
● Example 1: Changing the venous alarm limits
Dialysis menu
Press the key to select the
Alarm limits menu.
7 8 9 0 Esc
4 5 6
1 2 3 C ☛ Conf
C Conf
☛
Press the key
to move to the Position field of the
venous pressure display.
7 8 9 0 Esc
4 5 6
1 2 3 C ☛ Conf

Use the keys
7 8 9 0
to change the venous alarm limits.
4 5 6
1 2 3 ☛
C

The screen returns to the Dialysis
C Conf
menu.
☛

● Example 2: Changing the dialysate flow
–300
Test Press the Dialysate Menu key.
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
The Dialysate menu displays.
Use the keys

to select Flow.
7 8 9 0 Esc
4 5 6
1 2 3 C ☛ Conf
Use the keys

7 8 9 0
to set the desired dialysate flow.
4 5 6
1 2 3 ☛ C

The screen returns to the Dialysate
C Conf
menu.
☛

1.7.3 Menu Description
● Power-up screen
** 4008S / VX.X ** Shows the machine type and, in the up-

per right text field, the software version.
● T1 Test
The following colors identify the individual test steps / results:
Test step Background Characters OK Error

Prior to the test blue white
during the test green black
successfully completed blue white ✓
failed red white ✗
skipped red white
The test step currently in progress is shown in the text field.

● Dialysis menu
The Dialysis menu shows the current status of the machine during dialysis.
The Dialysis menu also provides the option to graphically display parameters of a treatment in
progress or of recorded data (see also Dialysis representation).
If other menus are selected and no key is pressed for approx. 30 seconds, the screen automat-
ically returns to the Dialysis menu (exception: UF menu).
If only a UF profile is selected, the

1 graphical display will show:
1 the preset concentrate
2 (black dashed line)
3 2 the actual sodium curve (blue)
3 the UF volume already removed
4
(yellow)
4 the theoretical UF rate curve (black)
If only a sodium profile is selected, the

1 graphical display will show:
1 the actual sodium curve (blue)
2
2 the theoretical sodium curve (black)
3 the UF volume already removed
3 (yellow)
If a UF and a sodium profile are selected

1 the graphical display will show:
3 2 the actual sodium curve (blue)
3 the UF volume already removed (yellow)
4
4 the theoretical UF rate curve (black)
6 Except for Single Needle mode, the

7 graphical display will always show the
pressure recording:
6 arterial pressure (red)
7 venous pressure (blue)
The data will be erased when:

– a power failure occurs without battery backup
– treatment data are erased
– a cleaning program is selected

● Dialysate menu
The dialysate menu displays the dialy-

sate parameters.
With the exception of the dilution (mixing
ratio), the values for all other parameters
displayed can be entered or edited.
In the Base Na+ field, entry of the value
indicated on the container is required.
● Dialysate menu with bibag® (option)
Preparation The menu permits selection of the follo-

wing additional function:
Empty BIBAG?
● Ultrafiltration menu
The Ultrafiltration menu displays the ul-

trafiltration parameters.
With the exception of the Max. Rate,
UF Volume and ISO Volume, the values
for all other parameters displayed can be
entered or edited.

● Dialysate menu
The dialysate menu displays the dialy-

sate parameters.
With the exception of the dilution (mixing
ratio), the values for all other parameters
displayed can be entered or edited.
In the Base Na+ field, entry of the value
indicated on the container is required.
● Dialysate menu with bibag® (option)
Preparation The menu permits selection of the follo-

wing additional function:
Empty BIBAG?
● Ultrafiltration menu
The Ultrafiltration menu displays the ul-

trafiltration parameters.
With the exception of the Max. Rate,
UF Volume and ISO Volume, the values
for all other parameters displayed can be
entered or edited.

● Treatment mode
This menu permits selection of the fol-

lowing treatment modes:
– HDF (optional) (not yet implemented)
– SN Click-Clack

● Alarm limits menu
Preparation The Alarm limits menu permits selec-

tion and deselection of the reinfusion
and the needle adjustment function.
This menu also includes the fields for
changing the position and size of the ar-
terial, the venous and the TMP alarm
window.

● System parameters
Preparation The following settings can be defined in

the System parameters menu:
– Reset treatment parameters
– Brightness
– Auto-On Program:
to program rinse programs and
power-up time for each day of the
week
– System time:
to set the current date and time
Setting the system parameters:

Use the keys to select the desired
parameter.
– Reset treatment parameters:
Use the keys to select Yes.
– Brightness:
Use the keys to change the bright-
ness.
– Auto-On Program:
7 8 9 0
Use the 4
1
keys or the keys to
5
2
6
select the desired program and to set

the time.
– System time:7 8 9 0
Use the 4
1
keys or the keys to
5
2
6
set the date and time.

Save with the Conf. key.

● Dialysis graphics
The Dialysis representation menu lists

several diagrams for selection, such as,
for example, displaying the arterial /
venous pressure and blood pressure
values in the Dialysis menu.
If the same diagram has been selected
for both display fields or if “No diagram”
has been selected for one of the two dis-
play options, the diagram actually select-
ed will be displayed over the full size of
the screen.
(Factory setting: upper diagram 1, lower
diagram 2)
The cumulated blood volume and the ef-
fective dialysis time are shown in the
Dialysis data field.
Selecting the diagrams:
Use the keys to select the upper or
the lower diagram.
7 8 9 0
Use the 4
1
5
2
keys or the keys to se-
6
lect the desired type of diagram.

Save the selection with the Conf key.
Preparation Two diagrams displayed in the Dialysis

menu, e.g. Profiles and BPM
Preparation One diagram displayed in the Dialysis

menu, e.g. Profiles, displayed over the
full screen size

● Cleaning menu
The cleaning menu displays the avail-

able cleaning programs. The desired
cleaning program is selected and started
via the menu.
The cleaning menu also includes:
– The Filter change function.
(applicable for advanced hydraulics
only)
– The Last disinfection function.
Here the date and time, and the pro-
gram of the last disinfection that was
fully completed (arrow) is displayed.
● Cleaning process menu (e.g. heat disinfection)
Each cleaning program has its own

menu which shows a schematic repres-
entation of the cleaning process with in-
dication of the time left and the temper-
ature.
Yellow area: concentration of disinfec-
tant
Red-blue area: temperature curve

1.7.4 Description of Messages Displayed in the Menus
● Alarm
Chapter 4, Alarm Processing, contains a

list of possible alarm messages.
☞ Note
To enter values while messages are displayed, the message can be temporarily
cleared from the screen by pressing the keys.
● Warning

list of possible warnings.
☞ Note
To enter values while messages are displayed, the message can be temporarily
cleared from the screen by pressing the keys.

● Info

list of possible information texts.

1.8 Cleaning Programs
1.8.1 General Information on the Cleaning Programs
The length of the individual cleaning programs can be freely selected (see Technical Manual,
adjustment instructions in the SETUP menu).
☞ Note
Flow alarms during cleaning programs will increase the length of the cleaning
program by the time of the alarm. Should the hemodialysis machine remain in
the no-program state for more than 10 minutes after completion of a cleaning
program, the machine turns off automatically.
Exception: The cleaning program was started with the Auto-On function.
The cleaning program was stopped (e.g. by turning the suction tube).
The following components and functions are monitored during the cleaning programs:
– Dialyzer valve
– Bypass valve
– Balancing chamber switching pulse (flow)
– Float switch
– UF pump
– Temperature
– 24 V and 12 V supply voltages
– Software watchdog
– Shunt door
– Dialyzer lines connected
– Concentrate and bicarbonate suction tubes connected
– CDS
– V84
– Retentate valve

1.8.2 Disinfection and Removal of Calcium Deposits
Caution
Disinfect the machine after each dialysis treatment.
☞ Note
If the machine has been idle for more than 72 hours, it is recommended to run a
disinfection program before initiating the next treatment.
During these programs, the hemodialysis machine is

– thermally disinfected and decalcified (using Fresenius Citrosteril® or Fresenius Diasteril®),
– disinfected and decalcified (using Fresenius Puristeril® 340),
– disinfected (with Fresenius Sporotal® 100).
The agents for disinfection (Puristeril® 340) and for heat disinfection (Citrosteril® or Diasteril®) are
connected on the rear of the machine (disinfection programs 1 through 4).
Irrespecitve of the container connected to the rear of the machine, the special program 5 can be
used , if necessary, to draw in a hypochlorite-containing disinfectant (e.g. Sporotal® 100) from the
front via the concentrate suction tube.
☞ Note
The heat disinfection program may only be performed with Citrosteril® or Dia-
steril®. If a different type of disinfectant is connected to the rear of the machine
when changing the program (e.g. Puristeril® 340 instead of Citrosteril® or Dia-
steril®), the previously used disinfectant must be thorougly rinsed from the
suction tube.
When the disinfectant is to be drawn in from the front (PGM 5), ensure that a
container with a sufficient amount of disinfectant is connected. Avoid aspiration
of air.

Fig.: Disinfection flow chart
Disinfection Hot disinfection Disinfection Hot disinfection Rinse

PGM 2: –F–HDIS–M– with hot rinse with hot rinse (drawn in from the front)
PGM 1: –F–D–M– PGM 3: –F–D–M–HR– PGM 4: –F–HDIS–M–HR– PGM 5: –F–D(F)–M–
–F– –F– –F– –F– –F–

Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C Temp.: 37 °C
Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min Flow: 600 ml/min
Time: adjustable from Time: adjustable from Time: adjustable from Time: adjustable from Time: adjustable from
4 to 10 min in the 4 to 10 min in the 4 to 10 min in the 4 to 10 min in the 4 to 10 min in the
SETUP menu SETUP menu SETUP menu SETUP menu SETUP menu
–D– –HDIS– –D– –HDIS– –D(F)–

Temp.: 37 °C Temp.: 84 °C Temp.: 37 °C Temp.: 84 °C Temp.: 37 °C
Timing: Timing:
from > 80 °C from > 80 °C
–M– –M– –M– –M– –M–

Temp.: 37 °C Temp.: 84 bis 37 °C Temp.: 37 °C Temp.: 84 bis 37 °C Temp.: 37 °C
–HR– –HR–
Temp.: 84 °C Temp.: 84 °C
Flow: 450 ml/min Flow: 450 ml/min
Time: adjustable from Time: adjustable from
15 to 30 min in the 15 to 30 min in the
SETUP menu SETUP menu
Timing: Timing:
from > 80 °C from > 80 °C

1.9 Maintenance
Perform the maintenance procedures specified in the Technical Manual. The technical safety
checks (TSC) are included in the maintenance intervals.
1.10 Disposables and Consumables
The items listed in this chapter are an extract from our extensive product range. Further
products on request.
1.10.1 Disposables
Caution
The dialyzers, blood line sets and syringes listed in this chapter are disposables,
identified by the symbol: 2 = do not re-use.
The 4008 H hemodialysis system has been approved for use with the disposables listed below
within the scope of the EC design certification.
● Dialyzers
Fresenius Cuprophan® hollow-fibre dialyzers

E 1, E 2, E 3, E 4
Fresenius Cuprophan® hollow-fibre dialyzers (heat-sterilized)

E 1S, E 2S, E 3S, E 4S
Fresenius Polysulfon ® hollow-fibre dialyzers

F 4, F 5, F 6, F 7, F 8 (low-flux) – F 40, F 50, F 60, HF 80 (high-flux)
Fresenius Polysulfon ® hollow-fibre dialyzers (steam-sterilized) (high-flux)

F 40S, F 50S, F 60S, HF 80S
Fresenius Polysulfon ® hollow-fibre dialyzers (steam-sterilized) (low-flux)

F 4 HPS, F 5 HPS, F 6 HPS, F 7 HPS, F 8 HPS

● Blood line sets
Type FA 104: Arterial (Double Needle dialysis)

Type FA 127 S: Arterial (Double Needle dialysis) (steam-sterilized)
Type FA 514-SN: Arterial (Single Needle dialysis)
Type FA 514-SN S: Arterial (Single Needle dialysis) (steam-sterilized)
Type FV 104: Venous (22 mm bubble catcher)
Type FV 168 S: Venous (22 mm bubble catcher) (steam-sterilized)
Type FV 134: Venous (30 mm bubble catcher)
Type FV 124 S: Venous (30 mm bubble catcher) (steam-sterilized)
Caution
These line sets match the pressure limiting system of the blood pumps.
In order to avoid cross infections at the pressure connectors, the use of
hydrophobic filters is required.
Optimum single needle operation is achieved by using the original line sets only.
During continuous operation, the blood line systems must be exchanged after 24
hours at the latest.
● Disposable syringes
Type Fresenius 30-ml heparin syringe (Luer-Lock)
Optional to the 50-ml heparin pump

Type Fresenius 50-ml heparin syringe (Luer-Lock)
Optional to the 20-ml heparin pump

The heparin syringe used must have been approved for use within the scope of the design
approval for the machine. For further information contact the sales representative.

1.10.2 Consumables
● Hemodialysis concentrates
Fresenius solutions for acetate dialysis:

Fresenius hemodialysis concentrate, 35-fold, HD 01 to HD 75, with specification of the electrical
conductivity.
Fresenius solutions for bicarbonate dialysis:

Acid concentrate, 35-fold, e.g. SK-F 003 (PGS 01), SK-F 203 (PGS 21), and SK-F 213 (PGS 22)
8.4% sodium hydrogen carbonate
Fresenius bibag® (option) for bicarbonate dialysis:

– 650 g, 700 g or 950 g sodium hydrogen carbonate powder
– Maximum treatment times per bibag® determined by the dialysate flow:
Dialysate Flow 650 g / 700 g 950 g
300 ml/min approx. 10 hours approx. 15 hours

● Calibration concentrate
Fresenius UHB calibration concentrate:

To be used for calibrating the conductivity measurement equipment.
● Saline solution
Isotonic saline solution available in various bag sizes:

– Fresenius PVC bag with plug
– Fresenius Freka-Flex bag
– Fresenius Duoflex bag

● Disinfectants
Solutions for disinfecting and removing calcium deposits from the dialysate circuit
Caution
Strictly observe the following information:
1. The "use before" date printed on the container.
2. The storage conditions for the disinfectant concentrates.
3. The manufacturer’s instructions for use.
Caution
Prior to the use of disinfectants other than those listed below, their efficacy and
compatibility with the materials affected in the hemodialysis machine and the
DIASAFE ®plus (option) must be ensured.
Improper use of disinfectants (concentration, temperature range, dwell time)
may result in damage to the dialysis machine and the DIASAFE ®plus (option).
Disinfection
Dilution: Container concentrate is diluted with product water in the hemo-

dialysis machine at a ratio of 1+25 (cleaning programs 1 through
4) or 1+34 (cleaning program 5).
1. Fresenius Puristeril® 340:

(Water temperature in the cleaning program: 37 °C)
Active substance base: peracetic acid
Active substance concentration: approx. 0.15% (diluted)
2. Fresenius Sporotal® 100:

Active substance base: sodium hypochlorite
Active substance concentration: approx. 0.1% (diluted) (cleaning program 5 only)
☞ Note
After installation, the DIASAFE ®plus can be cleaned with Sporotal® 100 for a
maximum of 11 times.
In machines with basic hydraulics, the cleaning procedures with Sporotal® 100
must be documented.
In machines with advanced hydraulics the cleaning procedures with Sporotal ®
100 will be monitored by the hemodialysis machine.

3. Fresenius Citrosteril®:
Active substance base: citric acid hydrate
4. Fresenius Diasteril®:
Active substance base: hydroxyacetic acid
Removal of calcium deposits
1. Fresenius Puristeril® 340:

Active substance base: peracetic acid
Use concentration: approx. 0.15% (diluted)
2. Fresenius Citrosteril®:
Active substance base: citric acid hydrate
3. Fresenius Diasteril®:
Active substance base: hydroxyacetic acid

Indicator for disinfectants
Potassium-iodide-starch paper:
Detection of residual Puristeril or Sporotal (violet coloring – iodine precipitation).
Caution
Always use fresh (white) indicator paper.
Testing for peracetic acid
Checking for peracetic acid (Merckoquant 10084)

Test on the dialysis machine drain fluid.
Caution
Applicable for Diasafe®plus (option) only:
After a disinfection with peracetic acid the following must be observed:
After termination of the rinse program (mandatory rinse) the hemodialysis
machine must be checked for residual disinfectant using the peracetic acid test.
If the test shows a residual concentration of peracetic acid the rinse program
must be restarted. (In this case it is not necessary to run the entire rinse
program.)
Determination of the pH
Checking for Diasteril® (pH test strips).
Caution
Test on the dialysis machine drain fluid for approx. 10 to 15 sec.
If the pH is too high (yellow color pH ≤ 4.1), run a rinse program for a minimum of
5 min., then re-determine the pH.

Solutions for external disinfection and cleaning of the machine
and the filter housing of the DIASAFE ®plus (option)
Fresenius Freka®-NOL:
Type of disinfection: spraying
Active substance base: alcohol (42%)
Use concentration: as concentrate

1.10.3 DIASAFE ®plus (option)
Caution
Use only the original DIASAFE ®plus specified herein.
Observe the “use by” date printed on the packaging.
“Use by” symbol:

1.10.4 Part Numbers
Part Part number Information
Dialyzers
Fresenius Cuprophan ® E1 500 196 1
hollow-fibre dialyzers E2 500 197 1
E3 500 198 1
E4 500 199 1
Fresenius Cuprophan ® E1S 500 181 1

hollow-fibre dialyzers E2S 500 182 1
(heat-sterilized) E3S 500 183 1
E4S 500 184 1
Fresenius Polysulfon® F4 500 161 1 Low-flux

hollow-fibre dialyzers F5 500 162 1 Low-flux
F6 500 145 1 Low-flux
F7 500 163 1 Low-flux
F8 500 164 1 Low-flux
F40 500 141 1 High-flux
F50 500 135 1 High-flux
F60 500 136 1 High-flux
HF80 500 160 1 High-flux
Fresenius Polysulfon ® F40S 500 714 1 High-flux

hollow-fibre dialyzers F50S 500 715 1 High-flux
(steam-sterilized) F60S 500 716 1 High-flux
HF80S 500 718 1 High-flux
Fresenius Polysulfon® F4 HPS 500 704 1 Low-flux

hollow-fibre dialyzers F5 HPS 500 705 1 Low-flux
(steam-sterilized) F6 HPS 500 706 1 Low-flux
F7 HPS 500 707 1 Low-flux
F8 HPS 500 708 1 Low-flux
Blood line sets

Type FA 104 (Double Needle dialysis) 504 204 1
Type FA 127 S (Double Needle dialysis) 604 727 1
(steam-sterilized)
Type FA 514-SN (Single Needle dialysis) 505 214 1
Type FA 514-SN S (Single Needle dialysis) 605 014 1
(steam-sterilized)
Type FV 104 (22 mm bubble catcher) 504 304 1
Type FV 168 S (22 mm bubble catcher) 604 868 1
(steam-sterilized)
Type FV 134 (30 mm bubble catcher) 504 334 1
Type FV 124 S (30 mm bubble catcher) 604 824 1
(steam-sterilized)

Part Part number Information
Disposable syringes
Type Fresenius 30-ml heparin syringe 503 032 1
Type Fresenius 50-ml heparin syringe 900 071 1
biBag® (option)
Sodium bicarbonate 700 g 508 507 1 GB, D, F, NL, E, P, I
Sodium bicarbonate 650 g 508 727 1 S, SF, DK, N
Sodium bicarbonate 950 g 508 732 1 S, SF, DK, N
Calibration concentrate
Fresenius UHB calibration concentrate 193 615 1 1000-ml bottle
Desinfection and decalcification

Fresenius Puristeril® 340 508 551 1 5-kg container
Fresenius Puristeril® 340 508 550 1 10-kg container
Fresenius Sporotal® 100 508 542 1 5-kg container
Fresenius Citrosteril® 492 120 1 5-kg container
Fresenius Diasteril™ 508 564 1 6 liters
Indicator for disinfectants

Potassium-iodide-starch paper 508 521 3 6 x 100 strips
Peracetic acid test Merckoquant 10084 629 916 1
pH test strips 628 816 1
Solutions for disinfecting

and cleaning the machine outside
Fresenius Freka®-NOL 491 678 1 1 liter
DIASAFE ®plus (option)

Dialysate filter (DIASAFE®plus) 500 820 1 12 filters per box

1.11 Technical Data
1.11.1 Dimensions, Weight and Housing Material
Dimensions: Height: Approx. 133 cm (without IV pole)

Width: Approx. 39 cm
Depth: Approx. 34 cm (without housing foot)
Base: Approx. 48 x 63 cm2
Weight: Approx. 80 kg (without options)
Housing material: Rigid polyurethane foam
1.11.2 Electrical safety (classifications according to EN 60601-1, IEC 601-1)
Type of protection Safety class I

against electrical shock:
Degree of protection Type B Symbol:

against electrical shock:
Protection against Drip-proof Symbol: IPX1

ingress of liquids:
Leakage currents: See TSC
Electromagnetic RFI emissions: Limit class B according to

compatibility EN 55011, Group 1
according to EN 60601-1-2 Immunity: – Electrostatic discharges:
(IEC 601-1-2) Atmospheric discharge: 12 kV
– Electromagnetic fields:
27 MHz – 1000 MHz: 6 V/m
– Quick transient bursts
Power line (alternating current): 2 kV
– Surge voltage:
Power line (alternating current): 2 kV

1.11.3 Electrical Supply
Line voltage 230 V AC, +6%, –10%, 50/60 Hz Symbol: (alternating current)
240 V AC, ±10%, 50/60 Hz Symbol: (alternating current)
110 V AC, ±10%, 50/60 Hz Symbol: (alternating current)
External power supply: 16 A
Operating current:
– Dialysis: Approx. 6 A, at a water inlet temperature of 17 °C
dialysate temperature: 37 °C
dialysate flow: 500 ml/min
– Hot rinse: Approx. 9 A, hot rinse temperature: 84 °C

hot rinse flow: 450 ml/min
Power supply: + 5 V, +0.2 V (short-circuit-proof)

(internally) +12 V, ±0.3 V (short-circuit-proof)
+24 V, ±0.7 V (short-circuit-proof)
Battery: Lead-acid battery (maintenance-free)

18 V (= 3 x 6 V)/3 Ah
1.11.4 Type Label
4008 B (Option 4008 S)

1
230 V~ 50/60 Hz
2 11 A
3 7
4 6
5
Fresenius Medical Care AG
D-61346 Bad Homburg
Tel.: ++49 (0) 61 72 / 609-0
Legend
1 Type identification, 4 Caution: consult accompanying documents

Serial number 5 Equipment code (EC)
2 Power requirements 6 Degree of protection against electrical
3 Protection against ingress of liquids: shock: type B
drip-proof 7 CE mark

1.11.5 Fuses
Main switch: 2 x G 16 A Circuit-breaker Rear of power supply unit

Power transformer: 2 x T 2,5 A Fuse link Power supply unit, LP 639/SI1, SI2
Auxiliary socket: 2 x T 2,5 A Fuse link Power supply unit, LP 639/SI3, SI4
+5 V, +12 V: 1 x T 2,5 A Fuse link Power supply unit, LP 638/SI2
+24-V regulator: 1 x T 12,5 A Fuse link Power supply unit, LP 638/SI1
Standby function: 1 x T 0,2 A Fuse link Power supply unit, LP 639/SI6
Battery: 1 x T 3,15 A Fuse link Power supply unit, LP 639/SI5
1.11.6 Operating Conditions
Water inflow pressure: 1.5 up to 6.0 bar
Water inflow temperature: 5 °C up to 30 °C
Water inflow rate: 1.3 l/min; at 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 that of the dialyzer
position.
Concentrate supply: 0 to –100 mbar; max. suction height: 1 m, max. height of fall: 0 m
(with central delivery system – optional: 0 up to 500 mbar)
Heat dissipation: Dialysis: approx. 400 watts (at an ambient temperature of 20 °C)
Hot rinsing: approx. 520 watts (at an ambient temperature of 20 °C)
Range of operating 15 °C up to 35 °C
temperature:
Relative humidity: According to EN 60601-1 (IEC 601-1): 95% temporarily
Temporary downtime: It is recommended to run a hot rinse program without cooling rinse
(PGM 2) before putting a machine temporarily out of use and to run
a disinfection program prior to reuse.
Storage and In both cases, the machine must be filled with

transportation: antifreeze containing a disinfectant additive.
Composition: 48.75 % water
48.75 % glycerine
2.5 % Teta-plus
Frost resistance: Down to approx. –20 °C
Storage temperature: –20 °C up to +60 °C (with antifreeze)

+ 5 °C up to +60 °C (without antifreeze)
Stability: 10°
IV pole load capacity: Maximum 20 kg

Maximum load capacity of one hook: 6 kg

1.11.7 Optional External Connections
Caution
Any additional equipment connected to the analog and digital interfaces of the
machine must comply with the applicable EN specifications (e.g. EN 60950 for
data processing equipment, and EN 60601 (IEC 601) for electro-medical equip-
ment). Apart from this requirement, all configurations must comply with the
system standard EN 60601-1-1 (IEC 601-1-1). The connection of additional
equipment to the signal input or output component affects the system configura-
tion and anyone connecting additional equipment is therefore responsible for
compliance with the system standard EN 60601-1-1 (IEC 601-1-1).
RS232: Interface for data transfer to FINESSE (optional).
Status indicator: For connection of a status indicator (optional).
Input/output: For connection of external auxiliary equipment

(no more than 24 V/24 W).
Auxiliary socket: Supply voltage: 230 V AC; 50 to 60 Hz; 550 W
Screen: For connection of a screen (optional) to display UF and sodium

profiles.
Alarm in: External make contact.

(Alarm input)
Can be used for the connection of an external pushbutton switch, used to release
an alarm.
Alarm out: Potential-free alarm output. Alternating contact

(Alarm output) (no more than 24 V/24 W).
For connection of an external alarm indicator (lamp) (nurse call).
Connection by means of a 5-pin diode plug (stereo 180°) via a shielded line.
Shield grounded on either side.
Diagnosis: For inhouse computer diagnosis.
HDF: For connection of an ON-LINE HDF system (optional).
ACDA: Not used at the moment.
4008 Remote control: For connection of a remote control (option).

1.11.8 Override Conditions
Suppression of Mute alarm time: adjustable in the SETUP menu from 1 to 2 minutes
audible alarm: (factory setting: 1 minute).
Any new alarm reactivates the silenced audible alarm.
Blood leak override: Override time: 2 minutes
Alarm override: The Start/Reset key overrides

– an arterial and venous pressure alarm for approx. 8 seconds
– a blood leak alarm for approx. 8 seconds
– a TMP alarm for approx. 2 minutes (time determined by the UF
coefficient)
When overriding a safety system, the responsibility for the patient’s
safety rests with the operator of the machine.

1.11.9 Operating Programs
Functional test: Automatic test for checking the safety systems.

Must be started prior to each hemodialysis treatment.
The functional test is mandatory
– after a start with external power supply (not power failure),
– after one of the cleaning programs.
Preparation: Defined by the optical detector below the venous bubble catcher.
Preparation is terminated as soon as the optical detector senses
dark in the blood line set.
Priming the blood line set: Automatic priming of the blood line set upon pressing a key (Prime).
Priming is automatically terminated as soon as the venous bubble
catcher is filled, however, not later than after 1 to 5 minutes (time
adjustable in the SETUP menu).
Hemodialysis: Acetate dialysis or bicarbonate dialysis.
Sequential ultrafiltration: Ultrafiltration without dialysate flow / ISO-UF ( Bergström method).
Single needle With arterial blood pump and venous line clamp; pressure-pressure-
click-clack dialysis: controlled with adjustable pressure reverse values.
Exceptional procedure in case of problems with the vascular access
during double needle dialysis.
Single needle dialysis Two-pump procedure with adjustable upper pressure reverse value
(optional): (adjustable via stroke volume).
Cleaning programs: Rinse and chemical disinfection:

Time adjustable in the SETUP menu, temperature: approx. 37 °C,
flow: 600 ml/min
Hot rinse / hot disinfection:
Time adjustable in the SETUP menu, temperature: approx. 84 °C,
flow: approx. 450 ml/min
Timer counter stops in the event of a lower temperature alarm.
In all cleaning programs:
The blood pumps stop, the venous line clamp is closed.
The program run (timing) is interrupted by a flow alarm.
The cleaning programs can be prematurely terminated.
The chemical disinfection program is followed by a mandatory rinse.

1.11.10 Dialysate Circuit and Safety Systems
Blood leak detector: Threshold of response less than or equal to 0.5 ml blood loss per
minute to the dialysate at a hematocrit of 0.25.
(Flow rate 300 ml/min to 800 ml/min)
With the dialysate flow turned off, a blood leak alarm response is delayed. The
delayed response is dependent upon the fluid volume in the hydraulic compart-
ment between dialyzer and blood leak detector (approx. 110 ml total fluid volume)
as well as upon the size of the membrane rupture in the dialyzer. The response of
a blood leak alarm is, in addition, dependent upon the set ultrafiltration rate.
Transmembrane pressure:Range of indication: –60 up to 520 mmHg

Resolution: 20 mmHg
The OD in the LD senses light: Alarm window width: wide window,
uppermost and bottommost LED
The OD in the LD senses dark: Alarm window width: dependent on
the UF coefficient
During dialysis the TMP will drift within certain limits due to the change in blood
viscosity caused by fluid removal. To maintain the monitoring sensitivity without
creating nuisance alarms, the TMP alarm limits will track up to a maximum of
120 mmHg.
SN click-clack: Limits extended by ±10 mmHg

TMP measuring equipment with adjustable limits.
Definition of TMP = Pbo – Pdo + offset
TMP = transmembrane pressure
Pbo = blood pressure on the outlet side of the dialyzer
Pdo = dialysate pressure on the outlet side of the dialyzer
Offset = flow-dependent pressure variations
Ultrafiltration: Selectable UF rate: 0.00 l/h up to maximum rate

Resolution: 1 ml/h
Pump volume accuracy: ±1%
Maximum rate internally adjustable to 1, 2, 3, or 4 l/h.
Safe condition: pressure equalization via the dialyzer membrane, ultrafiltration = 0
Cyclical pressure V24 and V24b closed; bypass operation

holding test: Activated every 12.5 minutes for 8 seconds on the outlet side of the
dialyzer.
Balancing: Accuracy: ±0.1 % related to the total dialysate volume

Maximum F = FUF + Fbil
balancing error:
F = maximum balancing error
FUF = ultrafiltration error
Fbil = balancing error
Example:
Ultrafiltration error: at 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 + F bil = (±10 ml/h) + (±30 ml/h) = ±40 ml/h
Degassing: Residual gas volume in the dialysate at the inlet to the dialyzer
approx. 11 ml air per 1 liter of water (at 1000 hPa and 0 °C)
When operating with reverse osmosis water of 22 °C and an air
content of approx. 21 ml air per 1 liter of water (at 1000 hPa and
0 °C)
Method: negative pressure
Dialysate Display range: 12.8 to 15.7 mS/cm

concentration: Resolution: 0.1 mS/cm
(Conductivity) Accuracy: 0.1 mS/cm
Alarm window width: – with OD dark or
OD light and dialysate connectors
connected to dialyzer:
0.8 mS/cm
(< ±5 % around the actual value)
– with OD light and
dialysate connectors in interlock shunt:
top and bottom LED
Alarm window position: 12.8 to 15.7 mS/cm
(adjustable in the SETUP menu)
Temperature-compensated electronic conductivity meter with adjustable alarm
limits.
– Acetate: Standard setting 1+34 (other mixing ratios can be selected in the
SETUP menu). Setting range : 125 up to 150 mmol/l, depending
upon the concentrate used.
Volumetric proportional mixing system. The rated concentration is achieved not
later than after 10 minutes.
– Bicarbonate: Standard setting 1+27.6; range of readjustment: ±8 mmol/l
– bibag® (option) Bicarbonate concentrate preparation from the bibag®

Temperature range: 15 to 35 °C

Temperature:
– Dialysate temperature, Display range: 33.5 °C to 41.0 °C
rinse and chemical Range of adjustment: Dialysis (Rated temperature):
disinfection 35.0 °C to 39.0 °C
temperature: Cleaning programs: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.5 °C
Alarm window width: Dialysis: 33.0 °C and 40.0 °C
(internal) Cleaning programs: 33 °C and 41 °C
Temperature measuring equipment independent of regulation and provided with
limits. During each functional test, it is checked whether switching into the safe
state (bypass operation) is performed. The rated temperature is achieved not later
than after 10 minutes.
– Hot rinse Display range: 72 °C to 99 °C

temperature: (text display)
Rated temperature: 84 °C
Resolution: 1 °C
During the hot rinse program, timing starts as soon as 80 °C are exceeded.
In case of an error, the heater is turned off at 90 °C.
Flow: Display range: 100 to 1000 ml/min

– Dialysate flow: Resolution: 100 ml/min
Rated values: 300, 500, 800 ml/min
Accuracy: Flow: ±10%
Flow indicator: ±100 ml/min
Measurement by means of time pulse monitoring.
– Rinse and chemical Rated value: 600 ml/min

disinfection flow:
– Hot rinse flow: Rated value: 450 ml/min
– Flow alarm: The dialysate flow is below 180 ml/min.
– With water deficiency: Visual alarm, heater turned off,

audible alarm, only if the OD in the LD senses dark fluid

DIASAFE ®plus (option): Filter service life: Maximum of 12 weeks or 100 treat-
ments.
In machines with basic hydraulics the fil-
ter service life is not monitored.
In machines with advanced hydraulics
the filter service is monitored by the dia-
lysis machine and indicated by a warning
(filter change).

1.11.11 Extracorporeal Blood Circuit and Safety Systems
Arterial range:
– Arterial pressure Display range: –300 to +280 mmHg
measurement: Resolution: 20 mmHg
Accuracy: 10 mmHg
The OD in the LD senses light:
Alarm window width: –300 to +280 mmHg
The OD in the LD senses dark:
Alarm window width: 120 mmHg, adjustable over the entire
display range
With single needle dialysis as well as with single needle click-
clack dialysis: the OD in the LD senses either dark or light; upper
limit fixed to 280 mmHg; lower limit adjustable from 0 up to
–300 mmHg.
Monitoring of the arterial pressure.
– Blood pump (arterial): Delivery rate: 15 to 600 ml/min

Resolution: 5 ml/min (at a line diameter of 8 mm)
Accuracy: ±10%
Line diameter: 2 to 10 mm
Resolution: 0.2 mm
Blood pump stop alarm: 15, 30 seconds
(factory setting: 30 seconds)
Spring-loaded rollers, fully occluding, pressure-limited to 2 bar (when using the
prescribed line sets).
A change in the direction of rotation of the blood pump is electrically excluded.
(Due to its construction – grip shell on rotor –, the blood pump can be operated
manually in clockwise direction only.)
Blood pump (SN) Stroke volume: 10 to 50 ml (factory setting: 30 ml)

(optional): Resolution: 5 ml
Technical data same as specified for the arterial blood pump.
Pressure transducer for single needle operation: pressure reversal.
Venous range:
– Venous pressure Display range: –60 to +520 mmHg
measurement: Resolution: 20 mmHg
Accuracy: 10 mmHg
The OD in the LD senses light:
Alarm window width: –60 to +520 mmHg
The OD in the LD senses dark:
Alarm window width: 40 to 200 mmHg, adjustable within a
range of 20 to 520 mmHg
With single needle click-clack dialysis:
Alarm window width: 80 to 460 mmHg, adjustable
from 20 up to 480 mmHg
Monitoring of the venous back pressure.
– Air detector: Threshold of response: drop in the fluid level, air bubbles, froth or
microfroth (blood/air mixture) over the entire blood flow range from
0 up to 600 ml/min
Procedure: ultrasonic transmission

Heparin pump: Delivery rate: 0.1 up to 10 ml/h
Resolution: 0.1 ml/h
Accuracy: ±5% for delivery rates of 1 to 10 ml/h
and a measuring time of 2 hours, up to
1.2 bar counter-pressure
(calibrated for Fresenius 30-ml
heparin syringes)
With delivery rates <1.0 ml/h, the toler-
ance may exceed the specified ±5 % ac-
curacy.
Stopwatch time: 1 min up to 9 h 59 min
Resolution: 1 minute
Bolus administration: 0.1 up to 5.0 ml
Resolution: 0.1 ml
Maximum accumulating 1 x syringe capacity
bolus dose:
Fresenius 30-ml heparin syringe, optional: 50 ml
20-ml heparin syringe:
In order to compute the delivery rate of the 20-ml syringe, a syringe with an in-
ternal diameter of 19.1 mm has been taken as a basis. Deviating internal dia-
meters result in deviations in the delivery rates. The syringe holder is designed for
an outside diameter of 22 mm.
(Adjustable by technician)
The heparin syringe used must have been approved for use within the design ap-
proval for the machine. For further information contact the sales representative.
Audible alarm:
– Setting range of the Adjustable with the volume control on the rear of the monitor,
loudness of the minimum setting: ≥ 65 dBA
audible alarm:

1.11.12 Environmental Compatibility and Recycling
Only environmentally compatible and recyclable materials are used for the manufacture of
hemodialysis machines.
Prior to the disposal of hemodialysis machines, any possible risk of infection must be eliminated
by appropriate disinfection.
Electronic boards can be disposed of as set forth in the regulation on the disposal of electronic
scrap.
For the disposal of lead-acid batteries, the respective regulations in force at the time of disposal
apply.
Further information on disposal can be obtained on request.
Materials used:
(Materials marked with an asterisk come into contact with water, dialysate and dialysate concen-
trate.)
Plastics
ABS Terluran POM Delrin

EPDM* Ethylene-propylene rubber PP* Hostacom 20% GF
Glass PP* Hostacom M2
Glass* Duran PPH* Hostalen
NBR Nitrile rubber with fiber core PP(E) Noryl
PA (PA 6.6) Polyamide PPO* Noryl 20% GF
(Ultramid, Durethan) PPS* Ryton R4
PBT Valox PPSU* Radel
PBT* Ultradur PPT 1070 natur
PBT/ABS GF 20Pocan PS Hostyren + PS
PC* Makrolon PSU Udel P
PC + ABS Bayblend PTFEE* Teflon
PE* Lupolen PUR Rigid polyurethane foam
(PE, soft) (flame-resistant), Lupolen UL-94 VO
PEEK* Victrex PVC-U
PEI* Ultem PVC Vinyl chloride polymer, gray
PES* Thermocomp PVC line transparent
PES* Radel 10 and 20% GF PVDF* Dyflor
PMP TPX PVDF* Foraflon
Polyester Flexon, Polyscript-Carbo Silicone line* transparent and reinforced
POM* Hostaform H 2320 natur TPE Santoprene
POM Hostaform C VMQ Vinyl methyl polysoloxane
(silicone rubber)
Metals
Aluminum 1.4401*
Sheet metal, Cu55, 1.1203 1.4404*
Sheet metal, DIN 1541, MK75, unhardened Spring steel 1.4568 – DIN 17224
Sheet metal, DIN 1783, AlMg Titanium – TiAl 4 V6*
Sheet metal, DIN 1798, AlMgSi o.5 Spring steel 1.4310 – DIN 59381
DIN 174 – St37K Steel, 1.4300 (for systems)
1.4301 Steel, 9S MnPb, 28K
1.4305 – DIN 178/668 Galvanized steel

Electrical equipment
Motors Cables
Copper Copper
Cast steel PVC
Cast zinc Teflon
Plug connectors Electronic scrap

Copper + zinc P.C.B.base material
Glass-fiber-enforced thermoplast Glass fiber epoxy resin
Ferrite cores
Transformer Lithium batteries
Copper Lead-acid storage battery
Polyester/polyurethane
Casting material, PU 151/20
UP resin
Iron core
Miscellaneous
Various materials Packing

Radox Ethafoam
Lexan (plexiglass) (Polystyrene)
Oxyte 100 Corrugated cardboard
Steel, 1.1121 Cellular rubber
Cadmium-plated and chrome-plated steel Wooden pallet
MS 58
MS 63 Lacquers
Leather (pocket) Covering lacquer: Pehapol
Nylon 6/6 UL 94 V-2 Base: epoxy resin
Paper Prime coat: P 81.914 (base)
Perlon D536/20 (slatted roller blind belt) Hardener: P 85.033 (PUR)
Silbad 400 Insulating lacquer: type FS 190
Thermally conducting paste Dilution: type FS 225
Synchroflex (toothed belt) Screening lacquer:
Sirex, PU foam (insulating boards), Elektro DAG 438/Messrs. Acheson
with open pores, adhesive on one side
Adhesives
Loctite
Scotch-Weld DP 499
Scotch-Weld V 23
Cyanolit
Elastosil

1.12 Definitions and Terms
Special terms used in these operating instructions are explained below.
Arterial pressure Pressure in the extracorporeal circuit between arterial cannula

and blood pump.
Blood alarm Group of alarms which cause the blood systems to stop:
– Arterial pressure
– Venous back pressure
– Transmembrane pressure
– Blood leak
– Air
– BP stop alarm
Blood systems Systems which maintain and control the function of the extracor-
poreal circuit.
Bubble catcher Device integrated into the blood line set for separating gases
which are not dissolved in the blood.
Bypass Process during which the dialysate is diverted away from the
dialyzer.
Compliance chamber Device for levelling variations in pressure and volume, e.g. with
use being made of the single needle method.
Conductivity Reciprocal specific electrical resistance, e.g. of the dialysate.
Dialysate The replacement fluid used in dialysis.
Dialysate pressure The pressure present in a defined section of the system carrying
the dialysate, e.g. at the dialyzer outlet.
Dialyzer blood connector Arterial or venous blood connector provided at the dialyzer.
Extracorporeal circuit A section of the blood circulation which takes place outside of the
body.
Line clamp Device for automatically clamping the blood line set, e.g. in the
event of alarms or during single needle operation.
Pressure measurement Connector for the pressure measuring line, e.g. Luer-Lock.
connector
Pressure measuring line Line connecting the line set to the pressure monitoring unit.
Pump head The pump head comprises pump rotor and pump stator.

Pump line Line segment to be installed in the pump head.
Pump line holder Device for fixing the blood pump line segment.
Pump rotor Driven part of the pump head.
Pump stator Stationary support for the pressure pulleys of the pump rotor.
Sequential therapy Separation of the hemodialysis procedure into two successive

(ISO-UF) treatment phases each including either ultrafiltration only or
diffusion and ultrafiltration (procedure according to the Berg-
ström method).
Single needle method Technique in which the vascular access for the treatment proce-
dure is established by means of one puncture only.
Transmembrane pressure Difference between the pressures acting upon the dialyzer mem-
brane (blood pressure, pressure in the dialysate).
Venous return pressure Pressure in the extracorporeal circuit before the venous cannula
(e.g. in the venous bubble catcher).
Water Water suitable for hemodialysis (e.g. water purified by reverse

osmosis).
Water alarms Group of alarms which do not cause the blood systems to be
turned off: conductivity (bypass operation), temperature (bypass
operation), flow.

1.13 Abbreviations and Symbols
1.13.1 Abbreviations
AC = alternating current
BC = balancing chamber
BIC = bicarbonate
BP = blood pump
CD = conductivity
CDS = central delivery system
DC = direct current
Fig. = figure (diagram)
HD = hemodialysis
HDF = hemodiafiltration
HPU = hydraulic processing unit
IS = interlock shunt
LD = air detector
LED = light emitting diode
OD = optical detector
SN = single needle
SV = solenoid valve
TMP = transmembrane pressure
UF = ultrafiltration

1.13.2 Symbols
Caution: consult accompanying documents.

General danger
IPX1 Protection against ingress of liquids:

drip-proof
Degree of protection against electrical shock: type B
Alternating current
Protective ground connection
Ground/system ground
Ground potential connection
I/O ON / OFF
Start of a specific procedure
Dangerous electrical voltage

1.14 Technical Safety Checks
This chapter includes the technical safety checks (TSC) to be performed.

The checks must be performed every 12 months.
Performance of the technical safety checks must be recorded in the Medical Device Register.
Numbers, which are not listed here, are not included in the TSC, but are part of the maintenance
procedures .
For further details on technical safety checks and maintenance procedures, refer to the Technical
Manual.
Number Procedure Theoretical value / function OK
1 Visual inspections
1.1 Labels and labeling Must be affixed and □

legible
1.2 Mechanical condition Must permit safe operation □
1.3 Contaminations affecting safety Not acceptable □
2 General inspections
2.1 Perform a of functional test Press the Test key □
2.2 Power failure alarm Continuous sound □

(Emergency operation)
2.3 Check level sensor (air Function □

separation or fill program)
Check valves 91, 99, 100 Function □

2.4 Note:
This TSC item is not applicable,
if the „central delivery system“
option is activated.
2.5 Check valves V39 Function □

Note:
This TSC item is not applicable
if DIP switch array 2, LP 632,
switch 5 is set on OFF.
4 Ultrafiltration system
4.1 Delivery volume of UF pump 60 strokes = 60 ml ±1% □

(1 ml/stroke)

Number Procedure Theoretical value / function OK
6 Mixing system
6.1 Conductivity To be measured □
8 Modules
8.1 Blood pump (art./SN)
8.1.1 Set the line diameter to 8 mm; 18 rpm or gauging the capacity □
check the speed at 200 ml/min. of the delivery volume of 200
ml/min in liters
8.1.2 Open the blood pump cover. The blood pump stops; BP stop □
alarm after 30 seconds
8.1.3 Switchover pressure of the Switching points: □

blood pump (SN) (Stroke volume: 30 ml)
195 mmHg (±6 mmHg)
75 mmHg (±6 mmHg)
8.2 Air detector
8.2.1 Clamp and spring Check □
9 Electrical tests
(Values according to
DIN VDE 0751-1)
9.1 Resistance of protective con- No more than 0.3 Ω □

ductor.
9.2 Total current leakage Must fulfill the following two □

conditions:
1. No more than 1.5 times the
“total value first measured”.
(For the “total value first
measured” see machine card
included in the equipment
log.)
2. No more than 1 mA.
10 DIASAFE®plus (option)
10.1 DIASAFE®plus: Prior to each dialysis treatment, □

Filter test integrated in the functional test.
10.2 Test valve (compressor) in ma- Replacement of the hydropho- □

chines with advanced hydraul- bic membrane.
ics

1.15.2 CE Declaration of Conformity for 4008 S (option)

1.15.3 CE Declaration of Conformity for DIASAFE®plus (option)

1.15.4 CE Declaration of Conformity for bibag® (option)

1.15.5 ISO 9001 (EN 46001) Certificate

1.15.6 EN ISO 14001 Certificate

1.15.7 EC Certificate

1.16 Literature
1.16.1 Hemodialysis in General
– Franz, H.E.: “Blutreinigungsverfahren”, Technik und Klinik; Hemodialysis; peritoneal dialysis,

CAPD, hemofiltration, hemodiafiltration, hemoperfusion, membrane plasma separation; 2nd
revised edition / 1991 Georg Thieme Verlag Stuttgart – New York; 1st edition 1973, under the
title “Praxis der Dialysebehandlung”; ISBN 3 13 497702 8
1.16.2 Dialysate Filter and ON-LINE HDF
Publications, investigating report on polysulfone membranes, with the enclosed literature refer-
ences.
– “No evidence for endotoxin transfer across high flux polysulfone membranes”, among others
by Professor Dr. med. Jürgen Bommer from the Ludolf-Krehl-Klinik in Heidelberg.
– “Filtration of dialysate using an ON-LINE dialysate filter”, dated June 5, 1990, among others by
Francise Dumler MD, Division of Nephrology & Hypertension, Henry Ford Hospital, 2799 West
Grand Blvd., Detroit, MI, 48202, USA as well as Fresenius brochures on DIASAFE and
polysulfone high-flux with literature.
– “Hemodiafiltration with ON-LINE Production of Bicarbonate Infusate: a new standard for high
efficiency, low-cost dialysis in elderly and uncompliant patients” among other by Dr. B.
Canaud, Division of Nephrology, Lapeyronie University Hospital, 555, Route de Ganges,
34059 Montpellier, France
1.16.3 Blood Temperature Monitor (BTM)
– “Fresenius Publikation” (EDTNA-Journal 1992) with further literature.

Table of Contents 2 Preparation
Chapter Page
2.1 Dialysis Machine ........................................................................................................... 2-3

2.1.1 Turning Power On ........................................................................................................... 2-3
2.1.2 Blood Pump Self-Test ..................................................................................................... 2-4
2.1.3 Heparin Pump Self-Test ................................................................................................. 2-5
2.1.4 Concentrate Supply ........................................................................................................ 2-6
2.2 Functional Check .......................................................................................................... 2-12

2.2.1 General Notes ................................................................................................................. 2-12
2.2.2 Start of the Test .............................................................................................................. 2-12
2.2.3 Priming During the Test .................................................................................................. 2-15
2.2.4 Test Steps ....................................................................................................................... 2-19
2.2.5 Test Completed ............................................................................................................... 2-20
2.2.6 Malfunctions .................................................................................................................... 2-22
2.2.7 Interruption of the Test .................................................................................................... 2-25
2.2.8 Stopping the Test ............................................................................................................ 2-25
2.3 Blood Pump ................................................................................................................... 2-26

2.3.1 Installing the Arterial Line Set ......................................................................................... 2-26
2.3.2 Selecting the Line Size ................................................................................................... 2-27
2.4 Heparin Pump ................................................................................................................ 2-28

2.4.1 Positioning the Slide Carriage ........................................................................................ 2-28
2.4.2 Setting the Delivery Rate ................................................................................................ 2-30
2.4.3 Setting the Delivery Time ................................................................................................ 2-31
2.5 Air Detector ................................................................................................................... 2-32

2.5.1 Installing the Venous Line Set ........................................................................................ 2-32
2.6 Extracorporeal Blood Circuit ....................................................................................... 2-34

Fig.: Blood line set for double needle dialysis ............................................................... 2-35
Fig.: Blood line set for single needle dialysis .................................................................. 2-35
2.7 Priming the Extracorporeal Blood Circuit With a Saline Bag .................................. 2-36
2.7.1 Priming ............................................................................................................................ 2-36
2.7.2 Setting the Delivery Rate of the Blood Pump ................................................................. 2-37
2.7.3 Stopping Delivery ............................................................................................................ 2-38
2.7.4 Interrupting the Priming Program .................................................................................... 2-40
2.7.5 Stopping the Priming Program ........................................................................................ 2-40
2.8 Dialysate Side ................................................................................................................ 2-41

2.8.1 Functional Checks Prior to Each Dialysis Treatment ..................................................... 2-41
2.8.2 Setting the Mixing Ratio for Acetate Dialysis to 1+34 .................................................... 2-41
2.8.3 Setting the Acetate / Acid Pump ..................................................................................... 2-43
2.8.4 Setting the Bicarbonate Pump ........................................................................................ 2-44
2.8.5 Setting the Conductivity Limits ........................................................................................ 2-45
2.8.6 Collecting a Fluid Sample ............................................................................................... 2-46
2.8.7 Connecting the Dialyzer .................................................................................................. 2-46
2.8.8 Changing the Dialysate Flow .......................................................................................... 2-48
2.8.9 Changing the Dialysate Temperature ............................................................................. 2-48
2.8.10 Rinsing the Dialyzer ........................................................................................................ 2-49

2.1 Dialysis Machine
2.1.1 Turning Power On
Turn on the water supply.

☛
Arterial Venous
** 4008S / VX.X ** The display shows the machine type and

the software version installed.
The yellow status indicator (warning/
info) is illuminated.
Internal RAM test
CRC test
24V safety shutdown test (watch dog)
SCANNING CAN-BUS

2.1.2 Blood Pump Self-Test
Rate: ml/min
The LED segments, the Alarm LED (red)
(Ø: mm)
and the Operation LED (green) light for
1 second.
Start
Stop
Rate: ml/min
The line size displays for approx. 2 se-
(Ø: mm)
conds.
Start
Stop
Rate: ml/min
The delivery rate displays.
(Ø: mm)
Start
Stop

2.1.3 Heparin Pump Self-Test
Rate: ml/h
(Bolus: ml)
The LED segments, the alarm (red)
LED, the operation (green) LED and the
( :h.min)
stop-watch time (green) LED light for
Bolus
1 second.
Rate
Start
Stop
The syringe size displays.
The delivery rate displays.
Start
Stop

Remove the foil from the bibag ®.
Assemble the bibag ® onto the interlock

plate.
Push on both sides of the interlock plate

to connect the bibag ®.
☛

Rate: ml/h
After the bibag ® has been connected, an

(Bolus: ml)
( :h.min)
Bolus
Rate
Start
Stop
automatic program will be started
(lasting approx. 35 seconds).
This program will first remove all air from
the bibag® and will then fill the bag with
water.
Acid
concentrate

Bicarbonate dialysis with a bibag¨
Rate: ml/h
Place the combined concentrate suction

(Bolus: ml)
( :h.min)
Bolus
Rate
Start
Stop
tube for acid and acetate in the acid con-
tainer.
Acid
concentrate
Press the unlock pad to open the inter-

☛ lock plate.
Turn the interlock plate 180°.

Remove the foil from the bibag ®.

plate.

☛

Rate: ml/h
After the bibag ® has been connected, an

(Bolus: ml)
( :h.min)
Bolus
Rate
Start
Stop
the bibag® and will then fill the bag with
water.
Acid
concentrate

● Central delivery system
General notes
☞ Note
When using CDS, connect the con-
centrate suction tubes to match the
selected type of concentrate delivery
(SETUP) (See Chapter 1.3.5, Central
Delivery System).
Default setting in SETUP: CDS off
Acetate dialysis with CDS-supplied acid concentrate and bicarbonate
☞ Note
With CDS-supplied bicarbonate and
acid , CDS must be deactivated in
the user menu when performing ace-
tate dialysis with containers.
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys

to move to the CDS field.
Press the keys
to deselect CDS.
C Conf
☛
2.2 Functional Check
2.2.1 General Notes
– The hemodialysis machine prompts the operator to perform a functional check

䡩 after power on (not following a power failure)
䡩 after a cleaning program
– The functional check can be performed with or without previously installing the line set.
If the line set was filled during the cleaning program, the dialyzer must be deaerated before
starting the functional test. This is done by briefly opening and then closing the upper screw
cap of the dialyzer.
– Depending on the setting defined in the SETUP the functional test will be started automatically
when turning power on or must be started manually by pressing the Test key.
– DIASAFE ®plus (option):

The filter test is integrated in the functional test.
– Start conditions:
– The dialysate connectors (red/blue) are in the interlock shunt.
– The shunt door is closed.
– The optical detector in the air detector module senses clear fluid.
– The concentrate suction tubes are in the appropriate container or, for use with CDS, are
properly connected depending on the type of supply.
2.2.2 Start of the Test
● Automatic Start
–300
Test The Test LED is flashing.
Conductivity Internal tests.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14


–300
Test The functional test is started automatic-
Conductivity ally.
mS/cm
Prime 15,5
Flow UF
The Test LED is illuminated.
15
If one of the starting conditions is not
On/Off On/Off
fulfilled, an audible alarm will be
Start/Reset 14,5 sounded.
7 8 9
14 Use the Test or Tone Mute key to ack-
nowledge the audible alarm.
Make sure all starting conditions are
fulfilled.
Then press the Test key to start the
test.
☞ Note
To prevent an automatic start of the
test proceed as follows:
– Open the shunt door.
– Turn the hemodialysis machine
on.
– Start the functional test as usual.
– Close the shunt door.

● Manual start
–300
Conductivity If the Test LED is not flashing, one of
mS/cm the conditions for the test to start is not
Prime 15,5 fulfilled.
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14

–300
☛
Conductivity
mS/cm The Test LED is illuminated.
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
The test steps are displayed as they are

performed.

2.2.3 Priming During the Test
● Basic condition
The functional check has been selected.
● Start
–300
Test Press the Prime key.
Conductivity
☛
Prime 15,5
Flow UF The Prime LED is illuminated.
15 On/Off On/Off
14,5
For precirculation press the Start/Reset
Start/Reset
7 8 9 key.
14
Precirculation can only be started after
4 5 6 completion of the display test.
13 Menu Menu 1 2 3

T1 Test Prime
Temporary display message
or
T1 Test Prime / Circulation
Rinse volume: XXXX ml If a rinse volume has been defined in the

SETUP:
The screen returns to the test steps dis-
play.

● Setting the delivery rate of the blood pump
Rate: ml/min
The Operation LED (green) is illumin-
(Ø: mm)
ated.
The blood pump is delivering.
Start
☛ The arterial blood pump fills the line set
up to the venous bubble catcher.
Stop A delivery rate > 180 ml/min will auto-
matically be returned to 180 ml/min.
The delivery rate can be changed by
the operator as desired
Use the ▲ or ▼ keys to select the

desired delivery rate.
(Pressing the key for more than 3 sec-
onds will accelerate the change rate)
● Delivery stops
T1-Test Prime end

or
The blood pump stops as soon as the
Rinse volume reached venous bubble catcher is filled or after 1
to 5 minutes at the latest.
Depending on the setting defined in
the SETUP
or if the rinse volume defined in the
SETUP has been reached.
play.
The red status indicator (alarm) is

illuminated.
–300
Test The Test LED is illuminated.
Conductivity
mS/cm
The Tone Mute LED is flashing.
Prime 15,5
Flow UF Audible signal
15 On/Off On/Off cleared automatically
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

It may be necessary to raise the level in
the venous bubble catcher.
Pven. Press the ▲ key on the air detector
☛ module to set the desired level.
–300
Test Press the Start/Reset key.
Conductivity The blood pump starts running and the
mS/cm venous line clamp opens.
Prime 15,5 Fluid is recirculated.
Flow UF
15 On/Off On/Off The Test LED is illuminated.
☛
Start/Reset 14,5
7 8 9 The Prime LED is illuminated.
14
13,5 Dialysate
4 5 6 The Tone Mute LED is dark.
Tone Mute UF
13 Menu Menu 1 2 3

Circulation Temporary display message

play.

● To interrupt priming of the line set
Rate: ml/min
Press the Start/Stop key.
(Ø: mm)
The Operation (green) LED is dark.

Continue priming by pressing the key
again.
Start
Stop
☛
● To stop priming
–300
Test Press the Start/Reset or the Prime key.
Conductivity
Prime
mS/cm
Continue priming by pressing the Prime
15,5
Flow UF key again or press the Start/Reset key
☛
15 On/Off On/Off to continue precirculation.
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

2.2.4 Test Steps
● Parallel test
Test in Progress The test steps are performed in parallel.

The test steps currently in progress are
highlighted.
The test starts with the display test.
Verify the proper function of the status
LEDs.
Verify the proper function of the alarm
LEDs.
Verify the proper function of the bar-
graph displays.
Verify the proper function of the screen.
● Serial test
Test Positive Pressure The test steps are performed conse-

cutively.
The test step currently in progress is
highlighted.
During the display test verify the proper
function of the
– status LED’s
– alarm LED’s
– bargraph displays
– screen

2.2.5 Test Completed
● With the line set not filled
T1 Test passed
Prime Followed by the Dialysis menu
–300
Test The Test LED is dark.
Conductivity
mS/cm The Prime LED is illuminated.
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

● With the line set filled
Preparation
Display message
–300
Test The Start/Reset LED is illuminated.
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

2.2.6 Malfunctions
–300
Conductivity
mS/cm The Tone Mute LED is flashing.
Prime 15,5
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
T1 Test failed
Display message
–300
☛
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
F01 Blood Systems The error code displays in the “Error”

field.
e.g. 1

–300
Press the Test key.
☛
Test
Conductivity
Prime 15,5
Flow UF The Tone Mute LED is dark.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
The test step which the machine failed to

pass is displayed and repeated.
If the test step is successfully passed,

the test will be completed.
If the machine fails to pass the test step

a second time, error and error code will
be displayed.
☞ Note
The following error messages can be
acknowledged with the Test key:
Skip battery?
Skip Diasafe?

Skip battery?
Example: Skip battery.
Display message.
–300
Press the Test key.
☛
Test
Conductivity
mS/cm
The Test LED is flashing.
Prime 15,5
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Are you sure?

Display message
–300
Press the Test key.
☛
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
If the problem persists, call the service.

2.2.7 Interruption of the Test
– Failure to fulfill one of the conditions to start the test listed in Chapter 2.2.2 Start of the Test.
– The test will be continued after the problem has been corrected.
2.2.8 Stopping the Test

☛
Arterial Venous
The test can only be stopped by turning
the machine off.

2.3 Blood Pump
2.3.1 Installing the Arterial Line Set
Rate: ml/min
(Ø: mm)
➀ Open the cover.
➁ Press the Start/Stop key and keep it
pressed until the rotor stops.
Start
Stop
☛
➁
Rate: ml/min
(Ø: mm)
➀ Install the line segment on the left.
Start
Stop ➂ Install the line segment on the right.
➄ ☛ ➃ Close the cover.
➁
➄ Connect the pressure measuring line
to the pressure port.
➀ ➂
➃
Connect the arterial blood line to the

blood inlet port of the dialyzer.

2.3.2 Selecting the Line Size
Rate: ml/min
Should the blood pump rotor be running:
(Ø: mm)
The Operation LED (green) is dark

Start
Stop
☛
Rate: ml/min
Simultaneously press the ▲ and ▼ key.
(Ø: mm)
The current line size is indicated in mm
and flashing digits.
☛
Start
Stop
☛
Rate: ml/min
Use the ▲ or ▼ key to set the desired
(Ø: mm)
value.
onds will increase the change rate).
Start
☛ Selectable range:
2 to 10 mm in 0.2 mm increments
Stop
Rate: ml/min
Press the Start/Stop key to accept the
(Ø: mm)
value.
(The value is displayed for approx. 2
seconds)
The delivery rate of the blood pump is
reset to 0.
Start
Stop
☛
Rate: ml/min
Use the ▲ key to set the delivery rate.
(Ø: mm)
☛
Start
Stop

2.4 Heparin Pump
2.4.1 Positioning the Slide Carriage
Rate: ml/h
(Bolus: ml)
Press the ▲ key.
The slide carriage will move to the fully
open position.
( :h.min)
Bolus
Rate
☛
☞ Note
When the slide carriage moves to the
fully open positon, the bolus data are
reset to 0.
Rate: ml/h
(Bolus: ml)
➀ Connect a syringe filled with heparin
to the heparin line of the arterial line
( :h.min)
set.
Bolus ➁ Insert the syringe.
Rate ➂ Press the ▼ key and keep it pressed

☛ until the slide carriage is in the start
Start
Stop ➂ position.

☞ (
Rate: ml/h
(Bolus: ml)
:h.min)
Note
The plate of the syringe plunger must
engage in the slide carriage.
Bolus
Rate
Start
Stop
☞ Note
The syringe wings must be in the
syringe wing slot.

2.4.2 Setting the Delivery Rate
Rate: ml/h
(Bolus: ml)
Press the Rate key.
The display is flashing.
( :h.min)
Bolus
☛ Rate
Start
Stop
Rate: ml/h
(Bolus: ml)
Use the ▲ and ▼ key to set the desired
rate.
Pressing the key for more than 3 sec-
( :h.min)
onds will increase the change rate.
Bolus
Selectable range: 0.1 to 10 ml/h
in 0.1 ml/h increments
Rate
Start
☛
Stop
Rate: ml/h
(Bolus: ml)
Press the Rate key to accept the value
displayed.
The display will continue flashing until
( :h.min)
the set rate has been accepted by
Bolus
pressing the Rate key.
During this time the heparin pump de-
Rate livers at the previous rate.
☛
Start
Stop
☞ Note
Administer the heparin dose accord-
ing to the physician's instructions!
☞ Note
For the injection of an initial heparin
dose use the Bolus key.

2.4.3 Setting the Delivery Time
Rate: ml/h
(Bolus: ml)
Press the key.
The display is flashing.
( :h.min)
Bolus
Rate
☛ Start
Stop
Rate: ml/h
(Bolus: ml)
Use the ▲ and ▼ key to set the desired
time
( :h.min)
onds will cause the change rate to
Bolus switch from 1-minute to 10-minute
steps.)
Rate ☛ Selectable range: 1 minute to 9 hours
59 minutes in steps of 1 minute.
Start
Stop
Rate: ml/h
(Bolus: ml)
Press the key to accept the selected
time.
The display will continue flashing until
( :h.min)
the set time has been accepted by
Bolus
pressing the key.
During this time, the delivery time pre-
Rate viously set remains active.
☛ Start The stop-watch time indicator (green) is

Stop
illuminated after confirmation of the sel-
ected time.
The stop-watch time indicator (green)
is illuminated until the selected delivery
time has elapsed.

2.5 Air Detector
2.5.1 Installing the Venous Line Set
Connect the venous blood line to the

blood outlet port of the dialyzer.
Pven. Install the venous bubble catcher in the
bubble catcher holder.
☞ Note
Place the clot catcher approx. 1 cm
below the lower edge of the bubble
catcher holder.
Caution
Make sure that no ultrasound-con-
ducting media is used on the air de-
tector.

➃ ➀ Open the flap to the right.
➁ Manually open the venous line clamp
Pven. and install the line.
➂ Check the line for proper installation

and close the flap.
➃ Connect the venous pressure mea-
suring line to the venous pressure
port (Luer-lock).
➁
➀
➂
Caution
Do not remove the blood line from
the optical detector during dialysis
treatment.

2.6 Extracorporeal Blood Circuit
Regarding the regulations for the application of hemodialysis machines the following has
to be observed:
Caution
Use aseptic technique for all blood
side connections.
Use hydrophobic filters in the pres-
sure return lines to prevent contami-
nation. A wetted hydrophobic filter
must be replaced!
Caution
When inserting the line sets make
sure that the blood lines are not
kinked.
Use the line holders provided.
Caution
During the treatment verify at appro-
priate intervals:
– the condition of the patient
– the function of the hemodialysis
machine and the extracorporeal
blood circuit. Pay particular atten-
tion to the venous insertion site,
as a possible dislocation of the
venous cannula may not always
be detected by the pressure
monitoring system.
Caution
It is important to set the lower
venous alarm limit to be as close as
possible to the actual value of the
venous pressure.

Fig.: Blood line set Fig.: Blood line set
for double needle dialysis for single needle dialysis
Fresenius Medical Care 4008 S Fresenius Medical Care 4008 S

Ein/Aus Luftdetektor Blutleck Ein/Aus Luftdetektor Blutleck
Arterieller Venöser Arterieller Venöser

Druck Druck TMP Druck Druck TMP
Reinigen mmHg mmHg mmHg Reinigen mmHg mmHg mmHg
280 500 500 280 500 500
200 200
400 400 400 400
SN 100 SN 100
300 300 300 300
0 0
200 200 200 200
–100 –100
100 100 100 100
–200 –200
0 0 0 0
–300 –300
Test Test
Leitfähigk. Leitfähigk.
mS/cm mS/cm
Vorbereiten 15,5 Vorbereiten 15,5

Fluß UF Fluß UF
15 I/O I/O 15 I/O I/O
Start/Reset 14,5 Start/Reset 14,5

7 8 9 0 Esc 7 8 9 0 Esc
14 14
Dial. 4 5 6 Dial. 4 5 6
Ton aus 13,5 UF Ton aus 13,5 UF
Flüssigk. Flüssigk.
13 Menü Menü 1 2 3 C Best 13 Menü Menü 1 2 3 C Best
Rate: ml/min Rate: ml/min

(Ø: mm) (Ø: mm)
Pven.
Start Start
Stop Stop
Rate: ml/h
(Bolus: ml)
( :h.min)
Bolus
Rate
Start
Stop

2.7 Priming the Extracorporeal Blood Circuit With a Saline Bag
2.7.1 Priming
Connect the arterial connector of the line

set to the saline bag.
Break the cone on the saline bag.
Connect the venous connector of the line
set to the rinse bag.
Fresenius Medical Care 4008 S Press the Prime key.

On/Off Air detector Blood leak The Prime LED is illuminated.
Arterial Venous
Pressure Pressure TMP The Air Detector alarm indicator is
Cleaning mmHg mmHg mmHg illuminated.
280 500 500
200
400 400
SN 100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
☛
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

Prime
Display message
Rinse volume: xxxx ml

Temporary display message if a rinse
volume has been defined in the SETUP.

2.7.2 Setting the Delivery Rate of the Blood Pump
Rate: ml/min
(Ø: mm)
ated.
Start
matically be returned to 180 ml/min.
The operator may select any delivery
rate desired.
Use the ▲ or ▼ key to select the desired

delivery rate.
onds will accelerate the change rate)

2.7.3 Stopping Delivery

venous bubble catcher is filled or after 1
Prime end to 5 minutes at the latest.
the SETUP
or
Dialysis Rinse-volume reached

Display message if the rinse volume
defined in the SETUP has been reached.
Fresenius Medical Care 4008 S The Start/Reset LED is flashing.

On/Off Air detector Blood leak The Tone Mute LED is flashing.
Arterial Venous
Pressure Pressure TMP The Air Detector alarm indicator is
Cleaning mmHg mmHg mmHg flashing.
280 500 500
200 Audible signal
400 400
SN 100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
The red status indicator (alarm) is illumi-

nated.

Pven. ☛ Press the ▲ key on the air detector mo-
dule to set the desired level.
–300
Conductivity The blood pump starts running and the
mS/cm venous line clamp opens.
Prime 15,5 Allow fluid to recirculate until all air has
Flow UF
been removed from the line sets and
15 On/Off On/Off
the dialyzer.
Start/Reset 14,5
☛
7 8 9
14 The Start/Reset LED is illuminated.
4 5 6
Tone Mute 13,5 Dialysate UF The Tone Mute LED is dark.
13 Menu Menu 1 2 3
–300
Test Should the venous bubble catcher not be
Conductivity filled within the time defined in the SET-
mS/cm
UP:
☛
Prime 15,5
Flow UF
15
Press the Prime key a second time.
On/Off On/Off
Start/Reset 14,5 The Prime LED is illuminated.

7 8 9
14
The Start/Reset LED is dark.
4 5 6
13 Menu Menu 1 2 3

2.7.4 Interrupting the Priming Program
Rate: ml/min
(Ø: mm)
The Operation LED (green) is dark.

Continue by pressing the key again.
Start
Stop
☛
2.7.5 Stopping the Priming Program
–300
Test Press the Start/Reset or the Prime key.
Conductivity
mS/cm Press the Prime key a second time to
continue priming.
☛
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

2.8 Dialysate Side
2.8.1 Functional Checks Prior to Each Dialysis Treatment
Caution
The functional checks must be performed by the operator prior to each dialysis
treatment.
1. Concentrate container:
Use only the dedicated keyed containers for bicarbonate dialysis.
2. Verification of the dialysate composition:
Check the conductivity displayed on the monitor with the specifications on the
acid / concentrate container. (Observe the settings for sodium and bicarbon-
ate in the Dialysate menu!)
Caution
If the mixing ratio was set in the SETUP to be individually adjustable, always
make sure:
1. that the mixing ratio set by the technician complies with the mixing specifica-
tions for the concentrates used.
2. to check the dialysate for correct physiological composition before initiating
dialysis.
3. that the individually adjustable mixing ratio and the bibag® option are not used
simultaneously.
2.8.2 Setting the Mixing Ratio for Acetate Dialysis to 1+34
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
☞ Note
For acetate dialysis (mixing ratio
1+34), with the dilution set to a diffe-
rent ratio, verify the basic conditions:
Acetate connected, bicarbonate suc-
tion tube in the rinse port, central bi-
carbonate delivery off, bibag ® not
connected.

Preparation The mixing ratio defined in the SETUP is
displayed.
Use the keys

to move to the Dilution field.
Use the keys
to enter a mixing ratio of 1+34.
Press the Conf key to confirm the mixing
ratio.
Info message
Check Concentrate! Press the Conf key to confirm the safety
(Select with [Confirm] key) prompt.
Caution
Verify proper acetate connection and
make sure that the corresponding
mixing ratio has been selected.
Inadvertant use of an acid concen-
trate intended for a 1+45 mix ratio in-
stead of the acetate and with the mix
ratio set to 1+34 may result in a con-
ductivity that is within the display
range, although the composition of
the dialysate is not physiological.
Use of this dialysate presents a
hazard to the patient.

2.8.3 Setting the Acetate / Acid Pump
–300
Test To set the following parameters press
Conductivity the Dialysate Menu key to display the
Prime
mS/cm
Dialysate menu.
15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
The mixing ratio defined in the SETUP

will be displayed.
Use the keys

to move to the Base Na + field.
7 8 9 0
Use the 4
1
5
2
keys or the
6
3
keys
to enter the Base Na +.
Use the keys

to move to the Concentrate field.
7 8 9 0
Use the 4
1
5
2
keys or the keys
6
to enter the concentrate value.

Selectable range: 125 to 150 mmol/l
Concentrate = Base Na + ± 13 mmol/l
The adjustment range between Base
Na+ and concentrate can be changed
in the SETUP.
(Adjustment range: ±0 mmol/l to
±13 mmol/l)
The base Na+ value is indicated on the

containers or the package inserts.

2.8.4 Setting the Bicarbonate Pump
☞ Note
The respective sodium and bicarbo-
nate ion concentrations are specified
in the product information.
Use the keys

to move to the Bicarbonate field.
Use the keys
to enter the bicarbonate value.
Selectable range: –8 to +8 mmol

2.8.5 Setting the Conductivity Limits
● Repositioning of the CD window
Use the keys

to move to the Position field.
Use the keys
to reposition the conductivity window.
Caution
The alarm limits of the conductivity
display must be set around the ex-
pected value.
The actual value in the conductivity
display must have attained the ex-
pected target value after a maximum
of 10 minutes.
Should this not be the case, the ac-
tual value must first be checked in
the laboratory. If the result turns out
to be negative, the machine and/or
the concentrates should be checked.
● Centering the CD window around the actual value
Use the keys

to move to the Centre field.

The alarm limits are centered around the
C Conf
actual value.
☛
2.8.6 Collecting a Fluid Sample
➀ Connect a syringe (e.g. 10 ml Luer-

➀ lock) to the Luer-lock of the sampling
valve.
➄ This valve is located in the dialyzer
➃
➂ supply line.
➁ Press the key and keep it pressed.
➂ Lock the key with the locking nose.
➁ ➃ Draw up the syringe.
➄ Move the locking nose as shown to
unlock the key. The key will automat-
ically close the valve.
2.8.7 Connecting the Dialyzer
Warning Open the interlock shunt.
! Shunt Cover open A Warning displays.

The cone does not move.
Connect the dialyzer supply line to the

dialyzer (on the venous outlet side)
Connect the dialyzer outlet line to the
dialyzer (on the arterial inlet side)
Close the shunt cover.

The conductivity window is set.
Watch the external flow indicator:
The cone moves up and down.
Flow indicator: permanently lit.
Check the dialysate flow and adjust, if
necessary.

2.8.8 Changing the Dialysate Flow
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys

to move to the Flow field.
7 8 9 0
Use the 4
1
5
2
keys or the
6
3
keys
to enter the flow rate.
Selectable rates:
300, 500, 800 ml/min
2.8.9 Changing the Dialysate Temperature
Use the keys

to move to the Temperature field.
7 8 9 0
Use the 4
1
5
2
keys or the
6
3
keys
to enter the temperature.
Selectable range: 35.0 to 39.0 °C
in 0.5 °C increments
C Conf
☛

2.8.10 Rinsing the Dialyzer
–300
Test If the dialyzer is to be prepared with a
Conductivity UF rate:
mS/cm
Prime 15,5
Flow UF
Press the UF Menu key.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 ☛ Menu Menu 1 2 3
Use the keys

to move to the UF Goal field and press
the C key to reset the value to 0.
Use the keys

to move to the UF Time Left field and
press the C key to reset the value to 0.
Use the keys

to move to the UF Rate field.
7 8 9 0
Use the 4
1
5
2
keys or the
6
3
keys
to enter the desired rate.
☞ Note
When the optical detector senses
clear fluid and the dialysate pressure
is positive during preparation, the UF
rate is automatically set to 500 ml/h.
When entering and starting UF para-
meters, only the values entered are
relevant.
–300
Test Press the UF On/Off key.
Conductivity
mS/cm The UF LED is illuminated.
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

Table of Contents 3 Treatment
Chapter Page
3.1 Ultrafiltration ................................................................................................................. 3-3

3.1.1 Erasing the UF Volume ................................................................................................... 3-3
3.1.2 Entering UF Parameters ................................................................................................. 3-4
3.1.3 Starting Ultrafiltration / Timer .......................................................................................... 3-8
3.1.4 Stopping / Interrupting Ultrafiltration / Timer ................................................................... 3-8
3.1.5 Continuing Ultrafiltration / Timer ..................................................................................... 3-8
3.1.6 Changing UF Data .......................................................................................................... 3-9
3.2 Double Needle Dialysis ................................................................................................ 3-11

3.2.1 Connecting the Patient ................................................................................................... 3-11
3.2.2 Initiating Dialysis ............................................................................................................. 3-14
3.2.3 Administering a Heparin Bolus ....................................................................................... 3-16
3.3 Single-Needle Dialysis ................................................................................................. 3-18

3.3.1 Preparation ..................................................................................................................... 3-18
3.3.2 Setting the Stroke Volume When Using a SN Blood Pump ........................................... 3-19
3.3.3 Connecting the Patient ................................................................................................... 3-20
3.4 Single-Needle Click-Clack ............................................................................................ 3-23

3.4.1 Selecting the Treatment Mode / Entering Treatment Data ............................................ 3-23
3.4.2 Changing Treatment Data / Stopping Treatment ........................................................... 3-24
3.5 Isolated Ultrafiltration ISO UF ...................................................................................... 3-25

3.5.1 Selecting the Treatment Mode ........................................................................................ 3-25
3.5.2 Changing ISO UF Data / Stopping ISO UF ..................................................................... 3-27
3.5.3 Sequential Ultrafiltration – Manual Entry ........................................................................ 3-28
3.6 Sodium and UF Profiles ............................................................................................... 3-30

3.6.1 General Notes ................................................................................................................. 3-30
3.6.2 Entering a UF Profile Without Sodium Profile ................................................................. 3-31
3.6.3 Entering a UF Profile With Sodium Profile ...................................................................... 3-32
3.6.4 Entering a Sodium Profile Without UF Profile ................................................................. 3-34
3.6.5 Entering a Sodium Profile With UF Profile ...................................................................... 3-35
3.6.6 End of Program ............................................................................................................... 3-37
3.6.7 Stopping the Program ..................................................................................................... 3-38
3.7 DIASAFE ®plus (option) ................................................................................................... 3-39

3.7.1 Display During Treatment ............................................................................................... 3-39

3.1 Ultrafiltration
☞ Note
If the dialyzer has been prepared
with a UF rate, the UF volume must
be erased.
3.1.1 Erasing the UF Volume
Select the System parameters menu

from the menu bar.
In the Reset treatment parameters
field, use the keys to select Yes.
Press the Conf key to save the data.
☞ Note
This function erases all treatment
parameters stored in the machine.

3.1.2 Entering UF Parameters
● Maximum values:
UF Rate: max. 4000 ml/h (programmable with DIP switch)

UF Goal: 9990 ml
UF Time: 9 hours 59 minutes
● Starting Position
Press the UF Menu key to display the

Ultrafiltration menu.
Esc If treatment is to be performed with the

UF data displayed (defined in the SET-
UP):
C Conf
Press the Conf key.
☛

● Ultrafiltration with fixed rate
Use the keys

to move to the UF
Goal field.
Enter the UF goal
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
Use the keys

Enter the desired rate
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
The UF time left will automatically be re-

calculated.
● Ultrafiltration with fixed time
Use the keys

to move to the UF Time Left field.
Enter the desired UF time
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
Use the keys

to move to the UF Goal field.
Enter the desired UF goal
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
The UF rate will automatically be recal-

culated.

● Timer rate function
Use the keys

Press the C key to reset the UF goal
to 0.
Use the keys

to move to the UF rate field.
Enter the desired rate
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
Use the keys

Enter the desired time
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
● Rate function
Use the keys

Press the C key to reset the UF goal to
0.
Use the keys

Press the C key to reset the time to 0.
Use the keys

Enter the desired UF rate
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
☞ Note
If only the UF rate is entered for ul-
trafiltration, check the UF rate dis-
played in the dialysis menu for plaus-
ibility after saving the data.

● Timer function (no ultrafiltration)
Use the keys

Press the C key to reset the UF rate to 0.
Use the keys

Enter the desired time
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
Esc After all parameters have been entered:

Press the Conf key.
C Conf
☛

3.1.3 Starting Ultrafiltration / Timer
–300
Conductivity
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
3.1.4 Stopping / Interrupting UItrafiltration / Timer
–300
Conductivity
mS/cm
The UF LED is dark.
Prime 15,5
Flow UF The UF pump stops.
15 On/Off On/Off
Counting of the UF time left stops.
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
3.1.5 Continuing Ultrafiltration / Timer
–300
Test Press the UF On/Off key a second time.
Conductivity
mS/cm
The UF LED is illuminated.
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

3.1.6 Changing UF Data
–300
Test Press the UF On/Off key to interrupt
Conductivity ultrafiltration.
mS/cm
Prime 15,5
Flow UF
The UF LED is dark.
15 On/Off On/Off The UF pump stops.
☛
Start/Reset 14,5
7 8 9 Counting of the UF time left stops.
14
4 5 6
13 Menu Menu 1 2 3
–300
Test Press the UF Menu key to display the
Conductivity Ultrafiltration menu.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys

to move to the desired data field.
Enter the desired value
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
All other parameters will be calculated

automatically.
Esc Press the Conf key to save the data.
C Conf
☛

–300
Test Press the UF On/Off key to continue
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
14,5
☛
Start/Reset
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

3.2 Double Needle Dialysis
3.2.1 Connecting the Patient
Rate: ml/min
Press the Start/Stop on the blood pump
(Ø: mm)
module.
The Operation LED (green) is dark .
The arterial blood pump has stopped.
Start
Stop
☛
Connect the arterial line set to the pa-
tient.
If infusion of the saline contained in the
line is desired, connect now the venous
line set.
Rate: ml/min
Set the delivery rate of the arterial blood
(Ø: mm)
pump to the desired value.
Start
☛
Stop

Rate: ml/min
Press the Start/Stop key on the blood
(Ø: mm)
pump module.
ated.
The blood pump starts „softly“ (provi-
Start
Stop ded there is no blood alarm).
☛
The optical detector senses dark fluid.

Preparation end
Display message.
The alarm limits (arterial, venous) are set
automatically.
The TMP limits are set with a certain
delay (depending on the UF coefficient).
The time delay increases with lower
UF coefficients and decreases with
higher UF coefficients.
Caution
When using high-flux dialyzers make
sure that the alarm limits for monito-
ring the TMP are as narrow as possi-
ble.
–300 The blood pump stops.

Test
The venous line clamp closes.
Conductivity
mS/cm
Audible signal
Prime 15,5 The Start/Reset LED is flashing.
Flow UF
15
On/Off On/Off
Start/Reset 14,5
7 8 9 Connect the venous connector of the line
14
set to the patient (provided this has not
4 5 6
Tone Mute 13,5 Dialysate UF been done yet).
13 Menu Menu 1 2 3

Check the level in the venous bubble
catcher and adjust, if necessary.
Pven.
☛

3.2.2 Initiating Dialysis
–300
Conductivity
mS/cm The Start/Reset LED is illuminated.
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Display message
The green (operation) status indicator
is illuminated.
Dialysis
Caution
When using high-flux dialyzers and
selecting low UF rates there is a pos-
sibility of local backfiltration.
Backfiltration depends on:
– the type of high-flux dialyzer
– the flow resistance on the dia-
lysate and the blood side
– the viscosity of the blood
Rate: ml/h
(Bolus: ml)
Press the Start/Stop key on the heparin
pump module.
( :h.min)
Bolus ated.
The heparin pump is delivering.
Rate
Start
Stop
☛

–300
Conductivity
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

3.2.3 Administering a Heparin Bolus
● Heparin
Rate: ml/h
(Bolus: ml)
Check the bolus volume:
Press the Bolus key on the heparin
( :h.min)
pump module.
☛ Bolus
Rate
The bolus volume already adminis-
tered will be indicated.
Start
Stop
Rate: ml/h
Administering a bolus:
(Bolus: ml)
Press the Bolus key for more than 2

( :h.min) seconds.
☛ Bolus
Rate
Display: 0.0
The heparin pump will administer the
bolus in 0.1 ml increments.
After releasing the key, the display will
Start
Stop show for 5 seconds the bolus volume
injected.
(The bolus volume administered will be
added to the bolus volume stored.)
Then the delivery rate will be displayed
– Max. bolus administration: 5 ml
– Max. bolus volume in total:
1x syringe capacity

● Physiological saline solution
When adding physiological saline solution (saline) in the venous bubble catcher, the blood may
be diluted to a color which the optical detector no longer senses as blood.
The optical detector senses clear fluid.

No blood sensed by OD Menu options

Continue Treatment The blood pump is stopped.
Cancel treatment Audible signal
The alarm limits stay centered around
the actual value.

Dialysis will be continued with the alarm
C Conf
limits centered around the actual value.
☛

3.3 Single-Needle Dialysis
3.3.1 Preparation
For priming and setting of the delivery rate, refer to Chapter 2.
Rate: ml/h Rate: ml/min

➀ Attach the compliance chamber to the
(Bolus: ml) (Ø: mm)
heparin pump module.
( :h.min)
➁ Connect the single-needle pressure
Bolus
➁ transducer.
Start
Rate Stop
Start
Stop
☞ Note
Do not install the single-needle pump
segment!

3.3.2 Setting the Stroke Volume When Using a SN Blood Pump

Simultaneously press the ▼ key and the
Start/Stop key on the blood pump mo-
( :h.min)
dule.
Bolus
☛ The stroke volume is displayed in ml.
Start
Rate Stop
☛
Use the ▼ or ▲ keys to set the desired
stroke volume.
Selectable range: 10 to 50 ml
( :h.min)
in 5 ml increments
Bolus
☛
Start
Rate Stop

pump module.
The delivery rate will display after
( :h.min)
approx. 2 seconds.
Bolus
Start
Rate Stop
☛

3.3.3 Connecting the Patient
Rate: ml/min
(Ø: mm)
pump module
The Operation LED (green) is dark.
The arterial blood pump has been
stopped.
Start
Stop
☛
Connect the arterial line set to the pa-
tient.
If infusion of the saline contained in the
line is desired, connect now the venous
line set.
Rate: ml/min
Use the ▼ or ▲ key to set the delivery
(Ø: mm)
rate for the arterial blood pump.
Start
☛
Stop

Install the single-needle pump segment
of the line set in the single-needle blood
( :h.min)
pump.
Bolus
Start
Rate Stop
Start
Stop

Rate: ml/h
(Bolus: ml)
Rate: ml/min
Use the ▼ or ▲ key to set the delivery
(Ø: mm)
rate for the single-needle blood pump.
( :h.min)
It is recommended to select a delivery
rate for the SN pump that is 10 - 15 %
Bolus
Start
☛ higher than the delivery rate selected
for the arterial blood pump
Rate Stop
Fresenius Medical Care 4008 S Press the SN key.

On/Off Air detector Blood leak The SN LED is illuminated.
Arterial Venous
280 500 500
200
400 400
SN 100
300 300
0
☛
200 200
Rate: ml/min
Press the Start/Stop key on the arterial
(Ø: mm)
blood pump module.
The Operation LED (green) of the blood
pump is illuminated.
The blood pumps are delivering (pro-
Start
Stop vided there is no blood alarm)
☛
The optical detector senses dark fluid.
Preparation end
Display message
–300 The alarm limits (arterial, venous, TMP
Test
and conductivity) are set automatically.
Conductivity
mS/cm
The blood pump stops.
Prime 15,5
Flow UF
15 On/Off On/Off The venous line clamp closes.
Start/Reset 14,5
7 8 9 Audible signal
14
13,5 Dialysate
4 5 6 The Start/Reset LED is flashing.
Tone Mute UF
13 Menu Menu 1 2 3 The Tone Mute LED is flashing.
Connect the venous line set to the pati-
ent (unless this has already been done).

Check the level in the venous bubble
catcher and adjust, if necessary.
Possible only, if the SN pump is
Pven.
running.
☛
–300
Conductivity
Prime 15,5
Flow UF The blood pumps are started automat-
15 On/Off On/Off ically.
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
SN-Dialysis
Display message
☞ Note
When performing single-needle dia-
lysis, it is important to dialyze with
maximum blood flow.

3.4 Single-Needle Click-Clack
This procedure should be used in exceptional cases only, as the stroke volumes and thus the
respective recirculation may vary widely.
The arterial and the venous blood line are connected with a Y-piece to the vascular access.
3.4.1 Selecting the Treatment Mode / Entering Treatment Data
Use the keys

to move to the Treatment mode field.
C Conf
☛
Use the keys

to move to the SN Click-Clack field.
Select On with the keys.
To change the default values:
Use the keys
to move to the fields
– Upper Limit
– Lower Limit
Enter the desired values with the keys.
C Conf
☛
SN-Click-Clack
Display message

3.4.2 Changing Treatment Data / Stopping Treatment
Use the keys

to move to the Treatment mode field.
C Conf
☛
Use the keys
– Upper Limit
– Lower Limit
To stop:
Use the keys
to move to the SN Click -Clack field.
Set SN Click-Clack to Off
with the keys.
C Conf
☛

3.5 Isolated Ultrafiltration ISO UF
Isolated ultrafiltration can be started at any time and can be repeated as often as necessary.
The parameteres entered at the beginning of the treament (UF Goal and UF Time) must be taken
into consideration.
The total volume to be removed (UF Goal), the total treatment time (UF Time Left) or the UF Goal
and the UF Rate must always be programmed.
3.5.1 Selecting the Treatment Mode
–300
Test ➀ Press the UF On/Off key to turn Ul-
Conductivity trafiltration off.
mS/cm
Prime 15,5 The Ultrafiltration LED is dark.

Flow UF
15 On/Off On/Off ➁ Press the UF Menu key to display the
☛ ☛
Start/Reset 14,5
➀ 7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Use the keys to select

first ISO Goal
and then ISO Time.
If only the ISO time is entered, the cur-
rent UF rate will be automatically cal-
culated and displayed.
Enter the desired values

7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
The calculated ISO UF Rate displays in

the ISO Rate field.
C Conf
☛
ISO-UF start?
Display message

–300
Test Press the UF On/Off key to start isolated
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off The dialysate flow is automatically set to
14,5 Off.
☛
Start/Reset
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
ISO R = XXX t = X:XX

Display message: ISO Rate and ISO
Time left
If only the ISO time is entered, only the
remaining ISO time will be shown on
the display.
☞ Note
On completion of the isolated ultrafil-
tration, dialysis will automatically be
continued with dialysate flow and the
calculated UF parameters.
Conductivity alarm and temperature
alarm are suppressed for 3 minutes.

3.5.2 Changing ISO UF Data / Stopping ISO UF
Press the UF On/Off key to turn ultrafil-

tration off.
The UF LED is dark.
Press the UF Menu key to display the

Use the keys

– ISO Goal
– ISO Time
– ISO Rate
To stop ISO UF:
Use the keys
to move to the ISO UF field.
Use the keys to set ISO UF to Off.
Press the Conf key.

3.6.3 Entering a UF Profile With Sodium Profile
–300
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys
to move to the UF Profile field.
Enter the desired profile
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
The machine will prompt the operator
in the event of missing or incorrectly
entered parameters.

The profile number is shown in the yel-
C Conf
low UF Profile circle next to the UF Pro-
file field.
☛
–300
Test Press the Dialysate Menu key to display
Conductivity the Dialysate menu.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛

–300
Test Press the Flow On/Off key to set the
Conductivity dialysate flow to Off.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Flow off
Display message
Audible signal after 30 minutes.
(adjustable in SETUP: 30, 45, 60
minutes)
–300
Test Press the UF On/Off key to turn the ul-
Conductivity trafiltration on.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

3.6 Sodium and UF Profiles
3.6.1 General Notes
The following values should have been entered before selecting profiles:
– Base Na +, concentrate and bicarbonate.
– UF Goal (minimum UF Goal: 200 ml)
– UF Time (minimum UF profile time: 2 hrs)
– UF Rate:
– minimum continuous UF rate:
Profiles 1 to 6 100 ml/h
– maximum continuous UF rate:
Profile Rate (ml/h)
1 3000
2 3000
3 2660
4 2050
5 2050
6 1250
Sodium
1 2 3 4 5 6
1
Ultrafiltration
The above table shows the profile combinations available.
The machine will prompt the operator in the event of missing or incorrectly entered data.

3.6.2 Entering a UF Profile Without Sodium Profile
–300
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys
Select the desired profile
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
entered parameters.

C Conf
file field.
☛
–300
Test Press the UF On/Off key to start the pro-
Conductivity file.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

3.6.3 Entering a UF Profile With Sodium Profile
–300
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
entered parameters.

C Conf
file field.
☛
–300
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛

Use the keys
to move to the Na Profile field.
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
entered parameters.
☞ Note
In this mode the machine automat-
ically adjusts the preset UF profile
number to match the selected Na+
profile and informs the operator.
C Conf
☛
–300
Conductivity file.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☞ Note
Missing or incorrectly entered
starting parameters are inquired
while entering the profiles.
Profiles, UF and dilution parameters
cannot be reprogrammed while the
program is in progress.
The profile must be stopped and re-
started with the altered parameters.

3.6.4 Entering a Sodium Profile Without UF Profile
In the UF menu select the UF profile

field and press the C key to reset the
profile to 0 (deselection).
–300
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys

7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
entered parameters.
C Conf
☛
–300
Conductivity file.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

3.6.5 Entering a Sodium Profile With UF Profile
–300
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Use the keys

7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
entered parameters.
C Conf
☛
–300
Conductivity UF menu.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛

Use the keys
7 8 9 0
with the 4
1
5
2
6
3
keys or the keys.
entered parameters.

The profile number is shown in the UF
C Conf
Profile circle next to the UF Profile field.
☛

3.6.6 End of Program
UF-Goal reached
Display message
The Ultrafiltration LED is dark.
The UF pump has been stopped.
Audible signal
–300
Test The Start/Reset LED is flashing.
Conductivity
Prime 15,5
Flow UF The TMP alarm limits are spread fully
15 On/Off On/Off open.
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
–300
Conductivity
Prime 15,5
Flow UF The Tone Mute is dark.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
An Info message displays.
Reinfusion?

3.6.7 Stopping the Program
–300
Conductivity
mS/cm The UF LED is flashing.
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Profiles paused Display

Continue Profile
Use the keys
Stop UF Profile
Stop both profiles to select the desired function.
C Conf
☛

3.7 DIASAFE®plus (option)
3.7.1 Display During Treatment
Rinsing Diasafe
Retentate removed by rinsing (approx.
every 60 minutes for 5 balancing cham-
ber switching cycles)
Machine in bypass

Table of Contents 4 Alarm Processing
Chapter Page
4.1 Management of Alarm Limits ....................................................................................... 4-3

4.1.1 Centering the Arterial / Venous Alarm Limits .................................................................. 4-3
4.1.2 Centering the TMP Alarm Limits ..................................................................................... 4-4
4.1.3 Changing the Arterial / Venous / TMP Alarm Limits ...................................................... 4-5
4.2 Needle Adjustment ....................................................................................................... 4-6

4.2.1 Selection ......................................................................................................................... 4-6
4.2.2 Deselection ..................................................................................................................... 4-7
4.3 Blood Alarms ................................................................................................................. 4-8

4.3.1 Indication of Alarms ........................................................................................................ 4-8
4.3.2 Arterial Pressure Alarm ................................................................................................... 4-9
4.3.3 Venous Pressure Alarm .................................................................................................. 4-11
4.3.4 Transmembrane Pressure Alarm .................................................................................... 4-13
4.3.5 Blood Leak Dimness Warning ........................................................................................ 4-15
4.3.6 Blood Leak Alarm ............................................................................................................ 4-16
4.3.7 Blood Pump Alarm .......................................................................................................... 4-17
4.3.8 Heparin Pump Alarm ....................................................................................................... 4-18
4.3.9 Air Detector Alarm .......................................................................................................... 4-19
4.3.10 Blood Pump Stop Alarm .................................................................................................. 4-20
4.3.11 Blood Pump Stop Alarm in Single Needle Mode ........................................................... 4-21
4.3.12 Cycle Alarm in Single Needle Click-Clack Mode ........................................................... 4-25
4.4 Dialysate Alarms ........................................................................................................... 4-26

4.4.1 Indication of Alarms ........................................................................................................ 4-26
4.4.2 Conductivity Alarm .......................................................................................................... 4-26
4.4.3 Temperature Alarm ......................................................................................................... 4-27
4.4.4 Flow Alarm ...................................................................................................................... 4-28
4.5 Warnings ........................................................................................................................ 4-29

4.5.1 Indication of Warnings .................................................................................................... 4-29
4.5.2 Warnings / Information .................................................................................................... 4-30
4.6 Emergency Operation ................................................................................................... 4-35
4.7 Error Messages During Cleaning Programs ............................................................. 4-37

4.7.1 Indication of Errors .......................................................................................................... 4-37
4.7.2 Error Messages ............................................................................................................... 4-38
4.8 Error Messages After Turning Power On ................................................................... 4-44
4.9 Error Messages When Using the Download Function ............................................. 4-45

4.1 Management of Alarm Limits
4.1.1 Centering the Arterial / Venous Alarm Limits
Air detector Blood leak The arterial and/or venous alarm limits
Arterial Venous are not centered.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
New Limit?
Display message
–300
Test Press the Start/Reset key a second
Conductivity time.
mS/cm
If the key is not pressed within approx.
Prime 15,5
Flow UF 8 seconds, the original alarm limits are
15 retained.
On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Air detector Blood leak The arterial and the venous alarm limits
Arterial Venous are centered around the actual value.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300

4.1.2 Centering the TMP Alarm Limits
Air detector Blood leak The TMP alarm limits are not centered.
Arterial Venous
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
–300
Test Press the UF On/Off
Conductivity key to turn Ultrafiltration off and on
Prime
mS/cm
again.
15,5
Flow UF (This function is not available when
15 On/Off On/Off running a profile)
☛
Start/Reset 14,5
14
2x 7 8 9
4 5 6
13 Menu Menu 1 2 3
Air detector Blood leak The TMP alarm limits are spread fully
Arterial Venous open.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Air detector Blood leak The TMP alarm limits are centered
Arterial Venous around the actual value.
(time delay depending on the UF
mmHg mmHg mmHg
280 coefficient)
500 500
200
400 400 The position of the TMP alarm window
100
300 300
may automatically track up during the
0 treatment.
200 200
–100
100 100
–200
0 0
–300

4.1.3 Changing the Arterial / Venous / TMP Alarm Limits
Caution
It is important that the lower venous
alarm limit is set to be as close as
possible to the actual value of the
venous pressure.
Caution
When the TMP alarm limits are ad-
justed by the operator, care must be
taken to select a window size as
small as possible to ensure appro-
priate protection.
☞ Note
Automatic adaption of the window
size is now deactivated.
Dialysis
Use the keys
to select the Alarm limits menu.
Press the Conf key.
Use the keys

to move to the Position and/or Size
field for the desired alarm limit.
Change the alarm limits with the keys.
Press the Conf key.
The position of the TMP alarm window
may automatically track up during the
treatment.

4.2 Needle Adjustment
This function permits correction of the needle without false alarms. The arterial and venous alarm
limits are deactivated for 2 minutes. The full scale values and the lower venous alarm limit of
20 mmHg are still active.
4.2.1 Selection
Dialysis
Use the keys
Press the Conf key.
Use the keys

to move to the Needle Adj. Pgm field.
Set the Needle Adjustment Program to
On with the keys.
Press the Conf key.
Needle-Adj-Pgm
Display message


Air detector Blood leak
The arterial and venous alarm limits are
Arterial
Pressure
Venous
Pressure TMP
flashing.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
4.2.2 Deselection
Needle Adj. Pgm

Use the keys
Press the Conf key.
Use the keys

to move to the Needle Adj. Pgm field.
Set the Needle Adjustment Program to
Off with the keys.
Press the Conf key.

4.3 Blood Alarms
Caution
When overriding a safety system the
responsibility for the patient’s safety
rests with the operator of the ma-
chine.
4.3.1 Indication of Alarms
The red status indicator (alarm) is illumi-

nated.
–300
Conductivity
Prime 15,5
Flow UF The blood pump(s) stop(s).
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14 The UF pump(s) stop(s).
4 5 6
Tone Mute 13,5 Dialysate UF The nurse call is active.
13 Menu Menu 1 2 3
Audible signal
Alarm An Alarm message displays
!
e.g. Upper ven. alarm
Upper ven. alarm

4.3.2 Arterial Pressure Alarm
Air detector Blood leak The Arterial Pressure alarm indicator is

Arterial Venous flashing.
mmHg mmHg mmHg
280 500 500 Cause:
200 The arterial pressure is outside the alarm
400 400
100 limits.
300 300
0
200 200
–100
100 100
–200
0 0
–300
!
e.g.: Lower art. alarm
Lower art. alarm
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
New art. limits

Display message
Air detector Blood leak The alarm limits are flashing for 8
Arterial Venous seconds.
The alarm limits are inactive
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300

–300
Test Press the Start/Reset key again.
Conductivity If the key is not pressed within approx.
Prime
mS/cm
8 seconds, the orginal alarm limits will be
15,5
Flow UF retained.
15 On/Off On/Off
The Start/Reset LED is illuminated.
Start/Reset 14,5
7 8 9
14 The Tone Mute LED is illuminated.
☛
4 5 6
13 Menu Menu 1 2 3
Air detector Blood leak The arterial alarm limits are temporarily
Arterial Venous spread.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Air detector Blood leak The arterial alarm limits are centered
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Caution
If the filter in the pressure measuring
line is wetted, disconnect the line
and use a syringe to purge the filter
or replace the filter.

4.3.3 Venous Pressure Alarm
Air detector Blood leak The Venous Pressure alarm indicator is

mmHg mmHg mmHg
280 500 500 Cause:
200 The venous pressure is outside the
400 400
100 alarm limits.
300 300
0
200 200
–100
100 100
–200
0 0
–300
!
e.g. Upper ven. alarm
Upper ven. alarm
–300
Conductivity
Prime 15,5
Flow UF The Tone Mute LED is illuminated.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
New ven. limits?

Display message
Air detector Blood leak The alarm limits are flashing for 8
Arterial Venous seconds.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300

–300
Prime
mS/cm
15,5
Flow UF retained.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Air detector Blood leak The venous alarm limits are temporarily
Arterial Venous spread.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Air detector Blood leak The venous alarm limits are centered
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300

4.3.4 Transmembrane Pressure Alarm
Air detector Blood leak The TMP alarm indicator is flashing.

Arterial Venous
mmHg mmHg mmHg
Cause:
280 500 500 The TMP is outside the alarm limits.
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
!
e.g. Upper TMP alarm
Upper TMP alarm
–300
Conductivity
Prime 15,5
Flow UF The Tone Mute LED is illuminated.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
New TMP limit?

Display message
Air detector Blood leak The alarm limits are flashing for some
Arterial Venous time depending on the calculated UFC.
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300

–300
Prime
mS/cm
15,5
Flow UF retained.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Air detector Blood leak The TMP alarm limits are spread for
Arterial Venous some time, depending on the calculated
mmHg mmHg mmHg
UFC.
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Air detector Blood leak The TMP alarm limits are centered
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Caution
Sudden changes of the TMP are in-
dicative of a defect.

4.3.5 Blood Leak Dimness Warning
Warning A Warning displays.
! BLD Dimness Warning Cause:

Dialysate side primed in dialysis mode.
High deaeration caused by high ultrafil-
tration rate.
Dialysate drain line not tightly connected.
Poor pre-deaeration – air bubbles in dia-
lysate feed line.
Grease or calcium precipitate.
–300
Conductivity See also Chapter 4.5 Warnings,
mS/cm Message Fillprogram
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
In the event of grease and/or calcium

precipitate:
Run the usual disinfection program on
completion of the treatment.

4.3.6 Blood Leak Alarm
Air detector Blood leak The Blood Leak alarm indicator is

mmHg mmHg mmHg
Cause:
Dialyzer membrane rupture.
Alarm An Alarm message displays.
! Blood leak
[Override with [Confirm] key.
C Conf
☛
Bld. leak override

Display message
Override time: 2 minutes each time the
key is pressed.
The alarm indicator will stop flashing if
the leak is closed.
If the blood leak persists, replace the
dialyzer.

4.3.7 Blood Pump Alarm
Alarm Alarm message after 30 (15) secs.
! Bloodpump-stop
Rate: ml/min
The Alarm LED (red) on the blood pump
(Ø: mm)
module is illuminated.
E.XX
Error message E.XX on the blood pump
module.
Start
Stop
Rate: ml/min
(Ø: mm)
E.XX
☛
Start
Stop
–300
Test Press the Dialysis Start key.
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
☞ Note
If the problem persists, call the
service.

4.3.8 Heparin Pump Alarm
! Heparin pump alarm
Rate: ml/h
(Bolus: ml)
The Alarm LED (red) on the heparin
Err
pump is illuminated.
( :h.min)
Message Err displays on the heparin
Bolus pump.
Rate Press the Rate key.

☛
Start
Stop
Rate: ml/h
(Bolus: ml)
Error message E.XX on the heparin
E.XX
pump.
( :h.min)
Bolus
Rate
Start
Stop
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
☞ Note
If the problem persists, call the
service.

4.3.9 Air Detector Alarm
Air detector Blood leak The Air Detector alarm indicator is

mmHg mmHg mmHg
Cause:
Air or blood foam in the venous bubble
catcher.
Press the ▲ key to raise the level in the

venous bubble catcher.
The venous line clamp is closed, the
Pven. ☛ delivery rate of the blood pump is re-
duced to 180 ml/min.
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

4.3.10 Blood Pump Stop Alarm
! Bloodpump-stop
Rate: ml/min
The Alarm LED (red) on the blood pump
(Ø: mm)
is illuminated.
Cause:
The rotor stopped for more than 30
Start
Stop
(15) seconds.
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

4.3.11 Blood Pump Stop Alarm in Single Needle Mode
! BP-stop
Rate: ml/min
The Alarm LED (red) on the arterial
(Ø: mm)
blood pump or the SN blood pump mod-
ule lights.
Cause:
Start
One of the blood pump rotors has
Stop stopped.
The response time is determined by
the speed.
Fresenius Medical Care 4008 S With the compliance chamber filled,

press the SN key.
Arterial Venous The SN LED is dark.

280 500 500
200
400 400
SN 100
300 300
0
200 200
☛

➀ Remove the SN pump segment.
➁ Disconnect the SN pressure meas-

( :h.min)
uring line and connect it to a syringe.
Bolus ➁
Start
Rate Stop
Start
Stop

Rate: ml/min
Press the ▼ key to reduce the delivery
(Ø: mm)
rate of the arterial blood pump.
Start
Stop
☛
–300
Conductivity
mS/cm
The blood pump starts running.
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Rate: ml/h
(Bolus: ml)
Rate: ml/min
Use the syringe to drain the fluid from
(Ø: mm)
the compliance chamber while the arter-
( :h.min)
ial blood pump is running.
Bolus
Start
Rate Stop
Start
Stop
Rate: ml/min
Press the Start/Stop key to stop the ar-
(Ø: mm)
terial blood pump.
The Operation LED is dark.
Start
Stop
☛
Rate: ml/h
(Bolus: ml)
Rate: ml/min
➀ Clamp the SN pressure measuring
(Ø: mm)
line before the hydrophobic filter.
( :h.min)
Bolus
➁ Replace the hydrophobic filter.
Start
Rate
➁ Stop
Start
Stop
➀

➀ Connect the SN pressure measuring
line and remove the clamp.
( :h.min)
➁ Insert the SN pump segment.
Bolus
Start
Rate ➀ Stop
Start
Stop

On/Off Air detector Blood leak The SN LED is illuminated.
Arterial Venous
280 500 500
200
400 400
SN 100
300 300
0
200 200
☛
Rate: ml/min
Use the ▲ and ▼ key to set the delivery
(Ø: min)
rate for the blood pump.
Press the Start/Stop key to start the ar-
terial blood pump.
Start
Stop
The Operation LED is illuminated.
☛
–300
Conductivity
mS/cm
Prime 15,5
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

4.3.12 Cycle Alarm in Single Needle Click-Clack Mode
! Cycle alarm
Air detector Blood leak The Venous Pressure alarm indicator is

mmHg
280
mmHg mmHg
Cause:
500 500
200
Cycle time (approx. 15 seconds) ex-
400 400 ceeded.
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
–300
Conductivity
Prime 15,5
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

4.4 Dialysate Alarms
4.4.1 Indication of Alarms
The red (alarm) status indicator is

illuminated.
–300
Test The Tone Mute LED is flashing.
Conductivity
mS/cm Nurse call active.
Prime 15,5
15 On/Off On/Off
Flow indicator (external): the cone does
Start/Reset 14,5
7 8 9 not move.
14
13,5 Dialysate
4 5 6 The alarm message and the effect of the
Tone Mute UF
alarm are automatically reset when the
13 Menu Menu 1 2 3
problem causing the alarm has been cor-
rected.
The audible alarm can be suppressed for
1 minute by pressing the Tone Mute key
(factory setting).
4.4.2 Conductivity Alarm
Conductivity
mS/cm
The conductivity alarm indicator is
15,5 illuminated.
Flow
15 On/Off The machine is in bypass mode.
14,5
Cause:
14 The actual conductivity value is outside
13,5 Dialysate the alarm limits.
13 Menu
Remedy:
Verify the concentrate side.
Correct the problem causing the alarm.

4.4.3 Temperature Alarm
! Upper temp. alarm Cause:

The actual temperature is outside the
alarm limits.
or Remedy:
Wait for the temperature to reach the
Warning desired value or call the service.
! Lower temp. alarm

4.4.4 Flow Alarm
! Flow alarm Cause:

Line to or from dialyzer, or drain line
kinked.
Defect in hydraulics.
Remedy:
Check the lines.
Call the service.
or
! Water alarm Cause:

Water supply problem.
Remedy:
Check the water supply.
Call the service.

4.5 Warnings
4.5.1 Indication of Warnings
Messages will be displayed in the text field or in a pop-up window. The messages are either
warnings or information messages.
Example:
! Wrong conc. supply Blood system and dialysate side are

active.

4.5.2 Warnings / Information
Message displayed Cause Possible solution First Repeti-

warning tion
24 V Switched Off The watchdog relay Press the On/Off key – –

has been switched to turn the machine
off. off and on again.
Call the service.
Air in system Air in the dialysate Switch flow on. – –

system.
ASP failure ! The air separating Acknowledge by – –

pump is active with- pressing the
out interruption for Start/Reset key.
more than 60 sec-
onds.
BLD dimness warning The blood leak de- Acknowledge by – –

tector is contaminat- pressing the
ed, or air is present Start/Reset key.
in the dialysate Perform a cleaning
system. program.
See also message
Fillprogram.
Connect Conc. Line No concentrate con- Check concentrate – –

nected. side.
CPU-II failed System error. Press the On/Off key – –

to turn the machine
off and on again.
Call the service.
Cyclic PHT FXX Leakage in the bal- Acknowledge by Approx. Approx.

ancing system dur- pressing the 13 min 13 min
ing dialysis. Start/Reset key,
Bypass operation. considering a
UF off. possible balancing
error.

warning tion
Cyclic PHT F04 Blood alarm present Press the Approx. Approx.
for more than Start/Reset key 15 min 15 min
3 minutes. to acknowledge.
or or
Failure to perform Acknowledge by
the cyclic pressure pressing the
holding test (system Start/Reset key,
error). considering a
possible balancing
error.
Error on the RCU! Incorrect information Press the – –

from Remote Con- Start/Reset key.
trol unit. Call the service.
Fillprogram Air is present in the Acknowledge – –

dialysate system. automatic air
The TMP limits are purging
flashing and are in- (Fillprogram end)
active. by pressing the
Start/Reset key.
If the message dis-
plays repeatedly,
discontinue the
treatment and call
the service.
Failure to do so may
lead to a balancing
error (incorrect UF
volume).
Flow off warning The dialysate flow Press the Start/ 30 min 30 min
has been switched Reset key (unless 45 min 45 min
off. flow is desired at the 60 min 60 min
moment), or switch (SETUP) (SETUP)
the dialysate flow on.

warning tion
Funct. not allowed Will be displayed Observe correct – –

any time a function operating sequence.
is not available.
FXXX UF-failure UF pump or control Press the Start/ – –

function defective Reset key.
Call the service.
Hep.-Modul error Communication Press the Start/ – –

EXX problem between Reset key.
heparin pump and
monitor.
Heparin pump alarm The heparin syringe Press the Start/ – –

has reached its end Reset key (no
position. heparinization),
or install a new
syringe.
Heparin pump (See Chapter 4.3.8
failure. Heparin Pump
Alarm.)
Heparin pump not on The heparin pump Press the Start/ Approx. –
module is not on. Reset key (no 11 min
heparinization), or
switch the heparin
pump on.

warning tion
MODULE error Hydraulic processor Call the service. – –

malfunction.
NO – UF Ultrafiltration is off. Press the Start/ 10 min 10 min

Reset key (unless or or
UF is desired at the 30 min 30 min
moment), or switch (SETUP) (SETUP)
on ultrafiltration by
pressing the Ultrafil-
tration On/Off key.
Profiles paused Profiles have been Restart profiles, or 10 min 10 min

stopped. continue to stop
them by pressing the
Start/Reset key.
Profile time diff. Difference between Press the Start/ – –

UF time and profile Reset key, or stop
time. the profiles.
Call the service.
RCU Keyboard Error Incorrect information Press the Start/ – –

from Remote Con- Reset key.
trol Unit. Call the service.
Relation BPR/UFR ? As compared with Press the Start/ 2 min 30 min

the delivery rate of Reset key. Reduce
the blood pump, the the ultrafiltration
ultrafiltration rate is rate, or increase the
too high. blood pump rate.

warning tion
Set UF rate It is impossible to Turn the UF unit off. – –

reach the UF goal Adjust the UF para-
with the remaining meters (e.g. the UF
UF time and with rate).
the programmed
UF rate.
Shunt Cover open The shunt cover has Close the shunt 1 min –
been opened. cover.
Timer ‘Alarm’ The timer time has Press the Start/ – –

elapsed. Reset key.
Timer stops UF-Rate The UF time has Press the Start/ – –

elapsed. Reset key.
The UF pump is not
running.
UF-Goal reached The UF time has Press the Start/ – –

elapsed, and the UF Reset key.
goal has been rea-
ched. The UF pump
is not running.
V84 faultiness ! Malfunction of valve Press the Start/ – –

V84. Reset key.
Start disinfection
(cleaning programs
1 to 4).
Call the service.
Voltage Failure One of the voltages Press the On/Off – –

is outside the limits key to turn the ma-
(+5 V, +12 V, +24 V). chine off and on
again.
Call the service.
Wrong conc. supply Wrong concentrate Check the concen- – –

composition. trate side.

4.6 Emergency Operation

illuminated.
Audible signal
Nurse call active.
The hydraulic is off.
UF pump(s) stop(s).
The extracorporeal blood circuit is main-
tained.
Emergency Operation
Display message
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

–300
Test Press the Tone Mute key.
Conductivity
mS/cm
The green (operation) status indicator
Prime 15,5 is illuminated.
Flow UF
15 On/Off On/Off The Start/Reset LED is illuminated.
Start/Reset 14,5
7 8 9 The Tone Mute LED stops lighting.
14
13,5 Dialysate
4 5 6 No audible signal
Tone Mute UF
13 Menu Menu 1 2 3 Emergency operation is limited to
approx. 15 minutes.
☛
In the event of a prolonged power failure,

treatment must be discontinued.
Upon power return continue the program
as usual.
Caution
In the event of a prolonged power
failure, use the pump handle to ma-
nually return the blood to the patient.
For manual reinfusion, remove the
venous patient line from the venous
line clamp. Visually check the line for
air (emergency operation)!
In Single Needle mode, also remove
the BP segment for the BP (SN) from
the blood pump!

4.7 Error Messages During Cleaning Programs
4.7.1 Indication of Errors
Indication of errors during cleaning pro-

grams:
illuminated.
Fresenius Medical Care 4008 S An Alarm message or Warning dis-

plays.
Arterial Venous The Cleaning LED is flashing.

Cleaning mmHg mmHg mmHg The Tone Mute LED is flashing.
280 500 500
200 The dialysate side is inactive.
400 400
SN 100
300 300 Audible signal
0
200 200
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

4.7.2 Error Messages
Message displayed Cause Possible solution
Arterial pressure Arterial pressure outside the Check the line system.
(only while priming/ alarm limits. Connect the line system.
precirculation is in pro- Purge the hydrophobic filter.
gress during the clean- Increase the blood pump
ing programs) speed (>100 ml/min).
Call the service.
Bic line not conn The bicarbonate connector is Insert the bicarbonate connec-
not in the rinse port. tor in the rinse port.
Blood Sensed The air detector detects blood Check the optical detector.
by OD at the start of a cleaning pro- Call the service.
gram.
Bypass Valve failed Actual state of bypass valve Can be acknowledged by

(on/off) does not match the pressing the respective clean-
desired state. ing program key.
Call the service.
Conc. detected F01 Bicarbonate level sensor (204) After Rinse/Hotrinse.

shorted. Start a disinfection program.
Call the service.
Conc. detected F02 Concentrate level sensor (202) After Rinse/Hotrinse.

shorted. Start a disinfection program.
Call the service.
Conc. detected F03 Bicarbonate level sensor (204) After Rinse/Hotrinse.

and concentrate level sensor Start a disinfection program.
(202) shorted. Call the service.
Conc line not conn The concentrate connector is Insert the concentrate connec-
not in the rinse port. tor in the rinse port.
Connect No disinfectant connected. Connect disinfectant.

Disinfectant Message:
Press CONFIRM Key.
Press the Confirm key.
CPU-II failed System error. Press the On/Off switch to turn

the machine off and on again.
Call the service.

Dial. Valve failed The actual condition of the Can be acknowledged by

dialyzer valves (on/off) does not pressing the respective clean-
agree with the rated state. ing program key.
Call the service.
Disinfectant empty ? Float switch does not detect Check the disinfectant con-
fluid. tainer.
Disinfection valve sensor 115 Can be acknowledged by
does not sense any conducti- pressing the Disinfection key.
vity. Call the service.
Concentrate float switch fails
to detect fluid.
Disinf-Temp. to high Temperature after rinsing The rinse-clear cycle con-

above 40 °C. tinues until the temperature
has dropped below 40 °C.
Cleared automatically.
Call the service.
Filter change! Error detected during Select a different cleaning pro-

functional test. gram or change the filter.
(Pressure holding test failed.) (see Chapter 7.1/7.2 Changing
Maximum number of treat- the DIASAFE®plus).
ments reached (after 100 If the filter is not changed,
treatments). treatment cannot be initiated.
Maximum filter life after in-
stallation exceeded.
Maximum number of disin-
fections with Sporotal reached.
Float-Switch Failure The lower switching point can- Can be acknowledged by

not be reached. pressing the respective
cleaning program key.
Call the service.
Flow alarm Dialyzer lines are kinked. Check lines.

Message cleared automat-
ically.
Call the service.
F. pos. Pressure Pressure transducer 9 fails to Problem cannot be corrected

(only while priming/ detect pressure built-up in the cleaning program
precirculation is in pro- (precirculation impossible).
gress during the clean- After cleaning: perform a func-
ing programs) tional test.
Call the service.

High temperature Temperature >41 °C; Call the service.

during hot rinse:
temperature >90 °C.
Internal Error XXX Run time error in the program. Press the On/Off switch to turn
Call the service.
Level Detect. failed Air detector test failed. Problem cannot be corrected
(only while priming/ in the cleaning program
Call the service.
Low temperature Temperature <33 °C; Call the service.

during hot rinse:
temperature <78.5 °C.
opt. Detect. failed Optical detector test failed. Problem cannot be corrected
(only while priming/ in the cleaning program
Call the service.
PGM 5: not possible Mandatory rinse requested. Perform a different cleaning

The maximum number of dis- program.
infections with Sporotal has Change the filter.
been reached.
Please Wait Disinfectant is drawn in via the Cleared automatically.

concentrate pump.
Power Failure Power failure during operation. After power has returned, the
resp. program can be contin-
ued as usual.

Rinse Failure F01 V84 error. Can be acknowledged by press-

ing the Cleaning key.
Call the service.
Rinse Failure F02 V84 error. Press the On/Off switch to turn
In disinfection program the machine off and on again.
(PGM 5): Call the service.
Concentrate level sensor fails In disinfection program
to detect fluid. (PGM 8): Connect disinfectant
Rinse Failure F03 V84 error. Can be acknowledged by press-

ing the Cleaning key.
Call the service.
Rinse Failure F04 The float switch does not Press the On/Off switch to turn
detect fluid. the machine off and on again.
Call the service.
Rinse Failure F05 PSW 124 does not open. Call the service.
Observe the pressure exerted
on the distribution piping (no
more than 500 mbar).
Rinse Failure F06 PSW 123 does not open. Call the service.
Observe the pressure exerted
on the distribution piping (no
more than 500 mbar).
Rinse Failure F07* Pressure drop on PSW 124. Call the service.
Rinse Failure F08* Pressure drop on PSW 123. Call the service.
* This error message may be indicated alternately with the message DO NOT SWITCH OFF !!
Wait for 1 min. before turning the machine off!

Rinse Failure F09 PSW 123/124 does not open Call the service.
after pressure reduction.
Rinse Failure F10 System error. Call the service.
Rinse Failure F11 3 min before end of mandatory Call the service.
rinse PSW 123 has not opened
after pressure reduction.
Rinse Failure F12 Failure to open PSW 123/124. Call the service.
Rinse Failure F13 No pressure build-up or Call the service.

pressure loss on PSW 123/124.
Rinse Failure F14 Flow problems in the rinsing- Call the service.
area test.
Rinse Failure F21 Maximum number of strokes Press the I/O switch to toggle
for drawing in disinfectant the machine off and on again.
exceeded. Replace the disinfectant con-
tainer.
Call the service.
Rinse required! The mandatory rinse was Select the rinse program.
stopped.
UF-Pump failed The actual rate of the UF Can be acknowledged by

pump does not agree with the pressing the respective clean-
specified rate. ing program key.
Call the service.
Shunt cover defect Dialyzer lines connected to Change the blood lines.
alternating with dialyzer although the hemo- Check the dialyzer couplings.
Change blood lines! dialysis machine is in the Check the interlock shunt.
(only with priming/ cleaning mode. (If cleaning can be started al-
precirculation is in though the two dialyzer coup-
progress during the lings are not in the interlock
cleaning programs) shunt: call the service.)
Upper Flow Alarm The cleaning flow rises above Can be acknowledged by press-
1000 ml/min. ing the respective cleaning pro-
gram key.
Call the service.

V 39 Failure V39 malfunction Call the service.
V91/V100 Failure The valve does not open. Call the service.
V99 Failure The valve does not open. Call the service.
V102 Failure V102 electrically opened. Call the service.
V104 Failure V104 electrically opened. Call the service.
V130 Failure V130 malfunction Call the service.
V188 Failure V188 malfunction Call the service.
Venous pressure? Venous pressure outside the Check the line set.
(only while priming/ alarm limits. Connect the line set.
precirculation is in Purge the hydrophobic filter.
progress during the Increase the blood pump
cleaning programs) speed (>100 ml/min).
Call the service.
Voltage Failure One of the voltages is outside Acknowledge with the respec-
the limits (+12 V, +24 V). tive cleaning program key.
Press the On/Off switch to turn
Call the service.
Water alarm Float switch for t>30 s high. Check the water supply.
Float switch for t>10 s low. Cleared automatically.
Call the service.

4.8 Error Messages After Turning Power On
Audible Signal
The red status indicator is flashing.
Cause:
Bios Test passed Dual flashing rate: EPROM error
ROM Test passed Triple flashing rate: RAM error
RAM Test passed Quadruple flashing rate: NOVRAM error
Possible solution:
Call the service.
FXX Configuration Incorrect machine Call the service.

configuration
HPU Error Malfunction in hydraulic Press the ON/Off key to turn

processing unit. the machine off and on.
Call the service.
Keyboard Error Key on the monitor pressed Press the ON/Off key to turn
upon power up. the machine off and on.
Short-circuit on the keyboard. Call the service.
Watchdog Error This error message will only Press the ON/Off key to turn
be displayed immediately the machine off and on.
after turning power on. Call the service.
XX NOVRAM error at start of test. Press the ON/Off key to turn

(not calibrated) the machine off and on.
Call the service.

4.9 Error Messages When Using the Download Function
Download Error F001 Optical detector does not sense Ensure basic requirements are
clear fluid. fulfilled. Restart data transfer.
Download Error F002 Data transfer disabled or im- Call the service.
possible.
(DIP switch 1 LP763 set to OFF)
Download Error F003 Patient key not connected. Connect the patient key.
Restart data transfer, if
necessary.
Download Error F004 CRC check for communication Call the service.
inactive.
Download Error F005 Data record received in Call the service.

incorrect format.
(comma position)
Download Error F007 Not in Preparation mode. Ensure basic requirements are
fulfilled. Restart data transfer.
Download Error F008 Illegal patient name Enter the patient name.
(19 blanks) Restart data transfer.
Download Error F009 UF parameter range exceeded. Check external data.

Restart data transfer.
Download Error F010 Non-uniform profile numbers Check external data.

(UF profile/Na+ profile). Restart data transfer.
Download Error F011 Illegal UF or Na+ profile number. Check external data.
Download Error F012 Unacceptable dialysate flow. Check external data.


Download Error F013 Value range for Base Na+ or Check external data.
concentrate exceeded or Restart data transfer.
plausibility ±13 mmol.
Download Error F014 Value range for Start Na+ Check external data.
exceeded. Restart data transfer.
Download Error F015 Value range for bicarbonate Check external data.
exceeded. Restart data transfer.
Download Error F016 Temperature not acceptable. Check external data.

Download Error F018 UF rate, UF goal, UF time Check external data.

plausibility. Restart data transfer.
Download Error F019 Start Na+ plausibility check. Check external data.
Download Error F020 Block check UF rate, UF goal, Check external data.
UF time, UF profile. Restart data transfer.
Na+ profile, Base Na+, concen-,
trate, start Na+.
Download Error F021 UF profile data plausibility. Check external data.

Download Error F022 Na+ profile data plausibility. Check external data.
Download Error F023 Invalid CRC of the patient key. Check patient key.

Table of Contents 5 Disconnection
Chapter Page
5.1 End of Treatment .......................................................................................................... 5-3

5.1.1 Double Needle Dialysis ................................................................................................... 5-3
5.1.2 Single Needle Dialysis .................................................................................................... 5-4
5.2 Reinfusion ..................................................................................................................... 5-6

5.2.1 Performing Reinfusion .................................................................................................... 5-6
5.2.2 Restarting Reinfusion ..................................................................................................... 5-9
5.2.3 Skipping Reinfusion ........................................................................................................ 5-9
5.2.4 Stopping Reinfusion ........................................................................................................ 5-10
5.3 Stopping Treatment ...................................................................................................... 5-11

5.3.1 Manually Stopping Treatment ......................................................................................... 5-11
5.3.2 Stopping Treatment With Reinfusion .............................................................................. 5-14
5.4 Emptying the bibag® (option) ....................................................................................... 5-18
5.5 Emptying the Dialyzer .................................................................................................. 5-20

5.1 End of Treatment
5.1.1 Double Needle Dialysis
The yellow status indicator is illumin-

ated. (warning/info).
UF Goal reached
Display message, e.g.: UF goal reached
Fresenius Medical Care 4008 S The TMP alarm limits are spread fully
open.
Arterial Venous The UF LED is dark.

Cleaning mmHg mmHg mmHg The UF pump stops.
280 500 500
200 The Start/Reset LED is flashing.
400 400
SN 100
300 300 The Tone Mute is flashing.
0
200 200 Audible signal
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
–300
Conductivity
Prime 15,5
Flow UF Turn the heparin pump off, if necessary.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

Reinfusion?

5.1.2 Single Needle Dialysis

Stop the arterial or the single needle
blood pump.
( :h.min)
Bolus
Start
Rate Stop
☛
Rate: ml/h
(Bolus: ml)
Rate: ml/min
(Ø: mm)
➀ Open the cover.
( :h.min)
Bolus
Start
Rate Stop
Start
Stop
☛
➁
Rate: ml/h
(Bolus: ml)
Rate: ml/min
(Ø: mm)
➀ Remove the line segment on the left.
( :h.min)
Bolus
pressed until the line set has been
Start
Rate Stop completely removed.
Start
Stop
☛
➁
➂ Remove the line segment on the
right.
➃ Close the cover.
➀ ➂

On/Off Air detector Blood leak The SN LED stops lighting.
Arterial Venous
280 500 500
200
400 400
SN 100
300 300
0
200 200
☛

5.2 Reinfusion
5.2.1 Performing Reinfusion

Reinfusion?
C Conf
☛

The venous line clamp is closed.
Reinfusion
Display message
Air detector Blood leak The arterial, venous and TMP alarm
Arterial Venous limits are spread fully open for 5
mmHg mmHg mmHg
minutes.
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Disconnect the line from the arterial pa-

tient access and connect it to the return
solution.
Break the cone.

Rate: ml/min
(Ø: mm)
rate of the blood pump.
Start
Stop
☛
–300
Conductivity
mS/cm
Reinfusion starts (max. 5 minutes).
Prime 15,5
Flow UF The Start/Reset LED is illuminated.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Dialysis end
Display message
The blood pump has stopped.
Audible signal
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Preparation
Display message
The blood pump starts.
The blood still present in the line set is
reinfused to the patient until an air detec-
tor alarm occurs.
(Audible alarms suppressed.)

illuminated.
Fresenius Medical Care 4008 S The Prime LED is flashing.

On/Off Air detector Blood leak The Start/Reset LED is flashing.
Arterial Venous
Pressure Pressure TMP The Tone Mute LED is flashing.
280 500 500
The Air Detector LED is flashing.
200
400 400 The blood pump has stopped.
SN 100
300 300
0
200 200
–100 Disconnect the line from the venous pati-
100 100
–200
ent access.
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

5.2.2 Restarting Reinfusion

Reinfusion? The reinfusion time has elapsed, before
the optical detector senses clear fluid.
C Conf
☛
Reinfusion?
Display message
–300
Test Press the Start/Reset to restart
Conductivity Reinfusion.
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
5.2.3 Skipping Reinfusion

Reinfusion?
–300
Test Press the Start/Reset to skip
Conductivity Reinfusion.
mS/cm
Prime 15,5 The Start/Reset LED is illuminated.

Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Dialysis
Display message

5.2.4 Stopping Reinfusion
Use the keys

to select the Alarm limits menu and
press the Conf key to display the
screen.
Use the keys

to move to the Reinfusion field.
Set Reinfusion to Off with the keys.
C Conf
☛
Dialysis
Display message

5.3 Stopping Treatment
5.3.1 Manually Stopping Treatment
–300
mS/cm
Prime 15,5 The UF LED is dark.

Flow UF
15 On/Off On/Off
Start/Reset 14,5
☛ 7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Rate: ml/min
Turn the blood pump off.
(Ø: mm)

Reduce the delivery rate of the blood
pump.
Start
Stop
Disconnect the line from the arterial
☛ patient access and connect it to the
return solution.
Break the cone.
Rate: ml/h
(Bolus: ml)
Turn the heparin pump off.
( :h.min)
Bolus
Rate
Start
Stop
☛
Rate: ml/min
Turn on the blood pump with reduced
(Ø: mm)
blood flow.
The Operation LED is illuminated.
Start
Stop
☛

No blood sensed by OD Menu options

Continue Treatment The blood pump is stopped.
Cancel treatment The venous line clamp closes.

Audible signal
Empty the bibag® (option).
See Chapter 5.4 Emptying the bibag®
(option).
The alarm limits stay centered around

the actual value.
–300
Conductivity
mS/cm
Prime 15,5
Flow UF Use the ▲ and ▼ keys to select
15 On/Off On/Off Cancel treatment.
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
C Conf
☛
or
–300
Test Leave the cursor bar on the highlighted
Conductivity Continue treatment option (green).
mS/cm
Prime 15,5 Press the Start/Reset key.

Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

Preparation
Display message
Audible signals suppressed.
The blood still left in the line set is rein-
fused to the patient until an air detector
alarm occurs.

illuminated.

Arterial Venous
280 500 500
200
400 400
SN 100
300 300
0 The venous line clamp closes.
200 200
–100
100 100 Disconnect the line from the venous pati-
–200
0 0
ent access.
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

5.3.2 Stopping Treatment With Reinfusion
–300
mS/cm
Prime 15,5
Flow UF
The UF LED stops lighting.
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Use the keys

to select the Alarm limits menu and
press the Conf key to display the
screen.
Use the keys

to move to the Reinfusion field.
Set Reinfusion to On with the keys.
C Conf
☛
Reinfusion
Display message

Air detector Blood leak
The alarm limits are spread fully open.
Arterial Venous
mmHg mmHg mmHg
280 500 500
200
400 400
100
300 300
0
200 200
–100
100 100
–200
0 0
–300
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
Disconnect the line from the arterial

patient access and connect it to the
return solution.
Break the cone.
Rate: ml/min
(Ø: mm)
rate of the blood pump.
Start
Stop
☛

Rate: ml/h
(Bolus: ml)
Turn the heparin pump off.
( :h.min)
Bolus
Rate
Start
Stop
☛
–300
Conductivity
mS/cm
The Start/Reset key is illuminated.
Prime 15,5
Flow UF The blood is returned to the patient.
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
Dialysis end
Display message
Audible signal
Empty the bibag® (option).
See Chapter 5.4 Emptying the bibag®
(option).
–300
Conductivity
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

Preparation
Display message
The blood pump starts.
The blood still left in the line set is rein-
fused to the patient until an air detector
alarm occurs.
(Audible signals suppressed).

illuminated.

Arterial Venous
280 500 500
200
400 400 The blood pump has stopped.
SN 100
300 300
0
200 200
–100 Disconnect the patient on the venous
100 100
–200
side.
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

5.4 Emptying the bibag® (option)
Dialysis End
Display message
–300
Conductivity
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3
C Conf
☛
Emptying BIBAG
Display message
Drain program in progress
–300
Test The bibag ® drain program can be
Conductivity skipped by pressing the Start/Reset key
Prime
mS/cm
again.
15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
☛

13 Menu Menu 1 2 3

When the bibag ® is empty, press the un-
lock pad and remove the bibag ®.
☛ If the interlock plate does not move to
the front, the bibag® can be removed by
slightly turning the bag.
☞ Note
Always clean the sealing area of the
connector after dialysis to remove
bicarbonate precipitate.
Close the interlock plate.

☛

5.5 Emptying the Dialyzer
Turn the dialyzer. The dialysate inlet port

must be at the upper end.
Open the interlock shunt.
Place the dialysate supply line on the red
color-coded connection.
Close the interlock shunt.
Emptying program
Display message
Open the interlock shunt as soon as air

bubbles are visible in the outlet line.
Place the outlet line on the blue color-
coded connection.
Close the interlock shunt.

Remove the line set from the machine.
Caution
The machine should be disinfected
after each dialysis treatment.
Caution
Applicable for DIASAFE®plus (option)
only:
It is imperative to disinfect the ma-
chine after each dialysis treatment.
☞ Note
only:
If the machine has been idle for more
than 72 hours, it is recommended to
run a disinfection program before ini-
tiating the next treatment.

Table of Contents 6 Cleaning
Chapter Page
6.1 General Overview .......................................................................................................... 6-3

6.1.1 General Notes ................................................................................................................. 6-4
6.2 External Cleaning .......................................................................................................... 6-5
6.3 Basic Conditions for Cleaning Programs ................................................................... 6-5
6.4 Disinfection, Decalcification ........................................................................................ 6-6

6.4.1 Starting the Program ....................................................................................................... 6-6
6.4.2 Sequence ........................................................................................................................ 6-7
6.5 Cleaning / Degreasing Program .................................................................................. 6-11

6.5.2 Sequence ........................................................................................................................ 6-14
6.6 Hot Rinse ....................................................................................................................... 6-15

6.6.2 Sequence ........................................................................................................................ 6-16
6.7 Rinsing ........................................................................................................................... 6-18

6.7.2 Sequence ........................................................................................................................ 6-19
6.8 Priming During Cleaning Programs ............................................................................ 6-22

6.8.1 Basic Conditions ............................................................................................................. 6-22
6.8.4 Stopping Delivery ............................................................................................................ 6-24
6.8.5 Interrupting the Priming Program .................................................................................... 6-25
6.8.6 Premature Termination ................................................................................................... 6-25
6.8.7 Malfunctions .................................................................................................................... 6-26
6.9 Precirculation During the Cleaning Programs .......................................................... 6-27

6.9.1 Basic Conditions ............................................................................................................. 6-27
6.9.2 Preselection .................................................................................................................... 6-27
6.9.3 Start ................................................................................................................................ 6-28
6.9.5 Delivery Stops ................................................................................................................. 6-29
6.9.6 Interrupting Precirculation ............................................................................................... 6-30
6.9.7 Premature Termination ................................................................................................... 6-30

6.1 General Overview
Display
(during cleaning
program)
–R–*
–F–HR–C–
–F–HR–
–IHR–
–F–D–M–
–F–HDIS–M–
–F–D–M–HR–
–F–HDIS–M–HR–
–F–D(F)–M–
Indication of the disinfections
still available
Filter change program
(applicable for advanced hydraulics only)
Indication of
date, time and program
of the last disinfection
that was fully completed (arrow)
* Select Rinse or Rinse endless with the +/– keys.
The part of the cleaning program currently in progress is displayed as follows: > < (e.g. >F<HDIS–
M–, free rinsing in progress).
Explanation of abbreviations used

R Rinse
R endless Rinse endless
F Rinse free
HR Hot rinse
C Cooling rinse
D Disinfection
D(F) Disinfection
Disinfectant is drawn in from the front (concentrate suction tube)
HDIS Heat disinfection
M Mandatory rinse
IHR Integrated hot rinse

6.1.1 General Notes
☞ Note
The count-down times shown during
the cleaning programs are calculated
values. This time may vary depend-
ing on the ambient conditions.
☞ Note
Applicable for machines with
DIASAFE®plus (option) and advanced
hydraulics only:
When pressing the Cleaning key it
will be displayed in the Cleaning
menu when the filter needs to be
changed. (See Chapter 7.2.1 Indica-
tion of a Filter Change.)

6.2 External Cleaning
After treatment, the exterior of the hemodialysis machine should be cleaned with a cleaning and
disinfecting agent with an active substance concentration <5 % for amphoteric surfactants and
<48 % for alcohol. (See also Chapter 1.10 Disposables and Consumables.)
6.3 Basic Conditions for Cleaning Programs
– The dialysate lines are connected to the shunt.

– The concentrate suction tubes are in the appropriate rinse ports.
– The interlock plate of the bibag® connector (option) is closed.
– The optical detector does not sense blood.
Any failure to comply with the basic conditions will be indicated by a message on the display.
All treatment data will be erased when selecting a cleaning program.
Caution
only:
Contact of the filter with organic sol-
vents can affect the properties of the
material of housing, seals and capil-
laries. Safe function can then no lon-
ger be ensured and the manufacturer
shall no longer have any liability.
(See DIASAFE®plus package insert.)

6.4 Disinfection, Decalcification
Factory setting: Citrosteril® and Diasteril® respectively. For use of a different disinfectant, this
setting must be changed by a technician.
Caution
During the heat disinfection cycle,
hot water or steam may be emitted
via the vent tubing.
Caution
only:
High surface temperatures on the
DIASAFE®plus during heat disinfec-
tion.
6.4.1 Starting the Program

Arterial Venous
280 500 500
200
400 400
☛
SN 100
300 300
0
200 200
Use the keys

to select the desired disinfection pro-
gram
e.g. Hot disinfection
Press the Conf key.

6.4.2 Sequence
On-line display of the cleaning program

in progress
Display message e.g.: >F<HDIS–M–
The Cleaning LED is illuminated.

Mandatory rinse end The end of the program is indicated by

an audible signal and the flashing Tone
Mute LED.
Selectable in SETUP

illuminated.
Caution
After disinfection with Puristeril®
check the machine for residual disin-
fectant after completion of the man-
datory rinse cycle (e.g. with potassi-
um iodide paper).
Caution
After a disinfection with Diasteril®,
the following must be observed:
After termination of the rinse pro-
gram, (mandatory rinse) the hemo-
dialysis machine must be checked
for residual disinfectant using the
pH test.
If the pH is too high (yellow color
pH ≤ 4.1), run a rinse program for a
minimum of 5 min., then re-deter-
mine the pH.

Caution
only:
After a disinfection with peracetic
acid, the following must be observed:
After termination of the rinse pro-
gram, (mandatory rinse) the hemo-
dialysis machine must be checked
for residual disinfectant using the
peracetic acid test.
If the test shows a residual concen-
tration of peracetic acid, the rinse
program must be restarted. (In this
case it is not necessary to run the
entire rinse program.)

Caution
only:
Do not stop a disinfection program
before its completion. Premature ter-
mination will compromise the efficacy
of the disinfection.

Arterial Venous
280 500 500
200
400 400
☛
SN 100
300 300
0
200 200

End cleaning pgm?
(Press [Confirm] to stop)
C Conf
☛
>F<HDIS–M– Alternating display messages

Audible signal
Mandatory rinse end The Tone Mute LED is flashing.
illuminated.

☞ Note
If the mandatory rinse program is
stopped, the mandatory rinse time
will restart from the beginning.
Disinfection programs can also be

stopped by turning the concentrate or
the bicarbonate suction tubes.
☞ Note
Do not remove the concentrate and
bicarbonate suction tubes from their
ports to prevent leakage of fluid
which might then enter the interior
portions of the machine.

6.5 Cleaning / Degreasing Program
In this cleaning program the cleaning agent (Sporotal®) is drawn in from the front via the
concentrate suction tube.
☞ Note
Applicable for DIASAFE®plus (option) only:
After installation, the DIASAFE®plus may be cleaned with Sporotal® 100 for a
maximum of 11 times.
In machines with basic hydraulics the cleaning procedures with Sporotal® 100
must be documented.
In machines with advanced hydraulics the cleaning procedures with Sporotal®
100 are monitored by the hemodialysis machine.
(See Chapter 7.2.1 Indication of a Filter Change.)

Arterial Venous
280 500 500
200
400 400
☛
SN 100
300 300
0
200 200
Use the keys

to select
Cleaning (front supplied) from the
cleaning menu.
Press the Conf key.

Free rinse cycle.
Warning A warning displays.
! Connect Disinfectant Audible signal

illuminated.
Rate: ml/h

(Bolus: ml)
( :h.min)
Bolus
Rate
Start
Stop
the container with the cleaning agent
(Sporotal® 100).
Press the Conf key.
Cleaning
agent
Caution
Assure that the container used con-
tains sufficient cleaning agent to
complete the rinse program.
Avoid aspiration of air.

! Please Wait The yellow status indicator (warning/

Cleaning agent is drawn in.
! Conc line not conn Audible signal

illuminated.
the rinse port.

6.5.2 Sequence
On-line display of the rinse program in

progress
Display message: –F>D(F)<M–


Mute LED.
Selectable in SETUP

illuminated.
Caution
Check the machine for residual disin-
fectant (e.g. with potassium iodide
paper)
Caution
only:
If the test shows a residual concen-
tration, the respective rinse program
must be restarted.
(In this case it is not necessary to run
the entire rinse program.)
(See Chapter 6.4.3 Stopping the Program.)

6.6 Hot Rinse
Caution
During the heat disinfection cycle,
hot water or steam may be emitted
via the vent tubing.
Caution
only:
High surface temperatures on the
DIASAFE®plus during hot rinse pro-
grams!

Arterial Venous
280 500 500
200
☛
400 400
SN 100
300 300
0
200 200
Use the keys

to select the desired hot rinse program
e.g. Hot rinse
Press the Conf key.

6.6.2 Sequence

in progress.
Display message e.g.: >F<HR–C–


Mute LED.
Selectable in SETUP

illuminated.


Arterial Venous
280 500 500
200
☛
400 400
SN 100
300 300
0
200 200

End cleaning pgm?
C Conf
☛
>F<HR–C– Alternating display messages

Audible signal
Rinsing clean end The Tone Mute LED is flashing.
illuminated.
Cleaning programs can also be stopped

by turning the concentrate or bicarbo-
nate suction tube.
☞ Note

6.7 Rinsing

Arterial Venous
280 500 500
200
400 400
☛
SN 100
300 300
0
200 200
Use the keys

to select the rinse program.
Select Rinse or Rinse endless with the
keys.
Press the Conf key.

6.7.2 Sequence

in progress.
Display message: >R<

Rinse end The end of the program is indicated by

Mute LED.
Selectable in SETUP

illuminated.


Arterial Venous
280 500 500
200
☛
400 400
SN 100
300 300
0
200 200

End cleaning pgm?
C Conf
☛
>R< Alternating display messages

for approximately 20 seconds
Please wait

>R< Alternating display messages
Audible signal
Rinse end The Tone Mute LED is flashing.
illuminated.
Rinse programs can also be

stopped by turning the concentrate or
the bicarbonate suction tube.
☞ Note

6.8 Priming During Cleaning Programs
6.8.1 Basic Conditions

280 500 500 Press the Cleaning key.
200
400 400
☛
SN 100
300 300
0
200 200
Use the keys

to select the desired program.
e.g. Rinse
Press the Conf key.

–300
Test Press the Prime key for 1 second.
Conductivity
mS/cm
The Prime LED is illuminated.
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14

Prime
Rinse-volume: xxxx ml
Temporary display message if a rinse
volume has been defined in the SETUP.
>R<
Display message, e.g.: >R<

Rate: ml/min
The Operation LED (green) is
(Ø: mm)
illuminated.
Start
matically be reset to 180 ml/min. The
delivery rate can be changed by the
operator as desired.
Use the ▲ or ▼ key to set the desired

delivery rate.
onds will accelerate the change rate.)
6.8.4 Stopping Delivery

venous bubble catcher is filled or after 1
to 5 minutes at the latest.
the SETUP
Dialysis Rinse volume reached

Display message
If a rinse volume has been defined in
the SETUP.
The red status indicator (alarm) lights for

2 seconds.
>R<
Display message
Fresenius Medical Care 4008 S The Cleaning LED is illuminated.

On/Off Air detector Blood leak Audible signal
cleared automatically after 2 seconds
Arterial Venous
280 500 500
200
400 400
SN 100
300 300
0
200 200

Pven. To raise the level, press the ▲ key on
☛ the air detector module.
6.8.5 Interrupting the Priming Program
Rate: ml/min
(Ø: mm)
The Operation LED (green) stops

lighting .
Press the Start/Stop key again to conti-
Start
Stop
nue priming.
☛
6.8.6 Premature Termination
–300
Test Press the Prime key for 1 second.
Conductivity
mS/cm
Press the Prime key again to continue
Prime 15,5
Flow UF
priming.
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

6.8.7 Malfunctions

280 500 500 The Prime LED is flashing.
200
400 400 Press the Prime key.
SN 100
300 300
0
An error message displays in the status
200 200 line.
–100
100 100 (See Chapter 4.7 Error Messages During
–200
0 0 Cleaning Programs).
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
☛
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3

6.9 Precirculation During the Cleaning Programs
6.9.1 Basic Conditions
A cleaning program has been selected.

Priming has been started with the Prime
key.
☞ Note
The dialysate couplings must be in
the interlock shunt.
6.9.2 Preselection

280 500 500 Press the Start/Reset key for 1 second.
200
400 400 The Prime LED is illuminated.
SN 100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

Prime/Circulation
Precirculation will be started automat-
ically after priming has been completed.
>R<
Display message e.g.: >R<

6.9.3 Start
Priming has been completed.

The blood pump stops, the venous
bubble catcher is filled.

200
400 400 The Prime LED is illumiated.
SN 100
300 300
0
200 200
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

Circulation
>R<
Display message e.g.: >R<

Rate: ml/min
The operation (green) LED is illumin-
(Ø: mm)
ated.
☛ Use the ▲ or ▼ key to set the desired
Start
delivery rate.
Stop (Pressing the key for more than 3 sec-
onds will accelerate the change rate.)
6.9.5 Delivery Stops
When the rinse volume has been

reached.
The red status indicator (alarm) lights for

2 seconds.
>R<
Display message
Fresenius Medical Care 4008 S The Cleaning LED is illuminated.

On/Off Air detector Blood leak Audible signal
cleared automatically after 2 seconds
Arterial Venous
280 500 500
200
400 400
SN 100
300 300
0
200 200

Pven. ☛ Press the ▲ key on the air detector mo-
dule to set the desired level.
6.9.6 Interrupting Precirculation
Rate: ml/min
(Ø: mm)
The operation (green) LED stops

lighting.
Continue by pressing the key again.
Start
Stop
☛
6.8.7 Premature Termination

200
400 400 Continue precirculation by pressing the
SN 100
300 300 Start/Reset key again.
0
200 200
–100
100 100
–200
0 0
–300
Test
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
☛
4 5 6
13 Menu Menu 1 2 3

Table of Contents 7 Special Menu Functions
Chapter Page
7.1 Changing the DIASAFE ®plus (option) on Machines with Basic Hydraulics ............. 7-3
7.1.1 General Notes ................................................................................................................. 7-3
7.1.2 Filter Change Cirteria ...................................................................................................... 7-3
7.1.3 Changing the Filter ......................................................................................................... 7-3
7.1.4 Priming a Filter ................................................................................................................ 7-5
7.2 Changing the DIASAFE ®plus (option) on Machines with Advanced Hydraulics ...... 7-7
7.2.1 Indication of a Filter Change ........................................................................................... 7-7
7.2.2 Overriding a Filter Change .............................................................................................. 7-11
7.2.3 Changing the Filter ......................................................................................................... 7-12
7.3 bibag® (option) .............................................................................................................. 7-17

7.3.1 Emptying the bibag® (during treatment) .......................................................................... 7-17
7.3.2 Connecting the bibag® .................................................................................................... 7-20
7.4 Transferring Treatment Parameters (Download) ...................................................... 7-22

7.4.1 Description ...................................................................................................................... 7-22
7.4.2 Basic Requirements ........................................................................................................ 7-22
7.4.3 Important Notes .............................................................................................................. 7-23
7.4.4 Procedure ....................................................................................................................... 7-24
7.4.5 Aborting the Data Transfer ............................................................................................. 7-26

7.1 Changing the DIASAFE®plus (option)
on Machines with Basic Hydraulics
7.1.1 General Notes
☞ Note
Replacement of the DIASAFE®plus
must be entered in the Medical De-
vice Register (date, batch number).
Ensure that the patient is disconnected

from the machine.
7.1.2 Filter Change Criteria
– The maximum number of treatments (100) has been reached.

– The maximum service life of the filter (12 weeks) has been reached.
– The filter is defective (T1 Test failed).
7.1.3 Changing the Filter

☛
Arterial Venous

➁
➁ Slide the used filter upwards and out
of the guide slot.
➀


the guide slot.
➁

7.1.4 Priming a Filter
The hemodialysis machine has been

prepared for the functional test as de-
scribed in the Operating Instructions.

☛
Arterial Venous
–300
Conductivity If the Test is not flashing, one of the
mS/cm conditions for the test to start is not ful-
Prime 15,5 filled.
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
–300
☛
Conductivity
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☞ Note
If the machine fails to pass the
functional test, repeat the test by
pressing the Test key.
If a DIASAFE®plus failure (FXX) is
displayed after the functional test,
this test step has to be skipped.
Then run a heat disinfection program
or a disinfection program followed by
a hot rinse.

Caution
Run a disinfection program after
each filter change.

7.2 Changing the DIASAFE®plus (option)
on Machines with Advanced Hydraulics
7.2.1 Indication of a Filter Change

200
☛
400 400
SN 100
300 300
0
200 200
● In the rinse program (front supplied)
The number displayed in the Cleaning

(front supplied) field indicates how many
times the filter can still be cleaned with
Sporotal.
The number of rinse procedures is re-
stricted to a maximum of 11.
(Numbers displayed: 11 to 1).
e.g. -5-
If the maximum number of cleaning

(front supplied) procedures is exceeded,
this option will no longer be displayed in
the Cleaning menu.
The DIASAFE®plus can then still be
rinsed with the available programs until
the end of its service life or until the
maximum number of treatments has
been reached.

● When exceeding the number of treatments
The number displayed in the Filter

change field indicates how many treat-
ments can still be performed with the fil-
ter.
The number of treatments is restricted to
a maximum of 100.
Only the last 9 treatments will be dis-
played.
(Numbers displayed: 9 to 1)
e.g. -6-
The Filter change field can indicate the

remaining treatments and the remaining
treatment days simultaneously.
e.g. 6-5d,
6 treatments
5 treatment days
Filter change Info message, displays only with the

only 2 treatment(s) last 3 treatments
(Continue with [Conf] key) (numbers displayed: 3 to 1)
e.g. only 2 treatment(s)
When the last 3 treatments coinciding

with the last 3 treatment days have
been reached, the following message
will be displayed:
only 1 day(s)
Filter change Info message, displays when the

maximum number of treatments
Too many treatments has been reached.
Press the Conf key to initiate a
filter change.
(See Chapter 7.2.3 Changing the Filter)
or
Press the Esc key to override a
filter change.
(See Chapter 7.2.2 Overriding a
Filter Change).

● When exceeding the service life
The number displayed in the Filter

change field indicates for how many
treatment days the filter can still be used.
The maximum is 12 weeks.
Only the last 7 treatment days will be
displayed.
(Numbers displayed: 7 to 1)
e.g. --5D-
The Filter change field can indicate the

remaining treatments and the remaining
treatment days simultaneously.
e.g. 6-5d,
6 treatments
5 treatment days
Filter change Info message, displays only with the

only 1 day(s) last 3 treatment days
(Continue with [Conf] key) (numbers displayed: 3 to 1)
e.g. only 1 day(s)
When the last 3 treatments coinciding

with the last 3 treatment days have
been reached, the following message
will be displayed:
only 1 day(s)
Filter change Info message, displays when the

maximum number of treatment days
Max. filter life exceeded has been reached.
Press the Conf key to initiate a
filter change.
(See Chapter 7.2.3 Changing the Filter)
or
Press the Esc key to override a
filter change.
(See Chapter 7.2.2 Overriding a
Filter Change).

● In the event of a failure to pass the T1 test
Filter change An Info message displays.

T1-Test failed Press the Conf key to select a filter
change.
(See Chapter 7.2.3 Changing the Filter.)
or
Press Esc to override a filter change.
(See Chapter 7.2.2 Overriding a Filter
Change.)

7.2.2 Overriding a Filter Change
Press the Esc key to override a filter

change.
If the filter is not changed, treatment can
be initiated without the advantages of the
DIASAFE®plus .

7.2.3 Changing the Filter
● General Notes
☞ Note
Replacement of the DIASAFE® plus
must be entered in the Medical De-
vice Register (date, batch number).
Make sure that the patient is discon-

nected from the machine.
● Filter Change Criteria
– The maximum number of treatments (100) has been reached.

– The maximum service life of the filter (12 weeks) has been reached.
– The filter is defective (T1 test failed).
● Basic conditions

– Both dialyzer lines are in the interlock shunt.
– The concentrate suction tubes are locked in the rinse chamber.

● Operator steps
☞ Note
A filter change may never be prema-
turely terminated, but must always
be properly completed.

200
☛
400 400
SN 100
300 300
0
200 200

Use the keys
to select the
Filter change
program.
C Conf
☛

Empty filter

Info message Info message after the filter has been
emptied.
Filter changed?

➁
➁ Slide the used filter upwards and out
of the guide slot.
➀


the guide slot.
➁
C Conf
☛
Filling filter
Cleaning menu
Disinfect as specified in the Operating
Instructions.
Caution
Run a disinfection program after
each filter change.

7.3 bibag® (option)
7.3.1 Emptying the bibag® (during treatment)
–300
Conductivity
mS/cm
Prime 15,5
Flow UF
15 On/Off On/Off
Start/Reset 14,5
7 8 9
14
4 5 6
13 Menu Menu 1 2 3
☛
Dialysis
Use the keys
to move to the Empty BIBAG? field.
Use the keys to select Yes.
C Conf
☛

Emptying BIBAG
Display message
The drain program is in progress.
The bibag ® drain program can also be

started by unlocking (for approximately 1
to 5 seconds) and then re-locking the bi-
carbonate suction tube.
Acknowledge the message
Empty BIBAG? with the Conf key.
☞ Note
Do not remove the bicarbonate suc-
tion tube from its port to prevent lea-
kage of fluid which might then enter
the interior portions of the machine.
When the bibag® is empty, press the un-

lock pad and remove the bibag®.
☛ If the interlock plate does not move to
the front, the bibag ® can be removed by
slightly turning the bag.

Close the interlock plate.
☛
☛

7.3.2 Connecting the bibag®
Caution
Wait until the cooling rinse program
following a hot rinse or a heat desin-
fection has been completed before
connecting the bibag®.
Press the unlock pad to open the inter-

☛ lock plate.
Remove the foil from the bibag®.

☛

plate.

☛
After the bibag® has been connected, an

the bibag ® and will then fill the bag with
water.

7.4 Transferring Treatment Parameters (Download)
7.4.1 Description
The function to transfer (download) treatment parameters allows transfer of patient-related treat-
ment parameters to the dialysis machine.
The following treatment parameters are eligible for transfer:
Patient data UF data Dialysate data
Patient name UF rate Dialysate flow

UF goal Dialysate temperature
UF time Base Na +
UF profile no. Concentrate
Bicarbonate value
Start Na +
Na+ profile No.
An external system (data source) can be used to transfer the treatment parameters.
The treatment parameters downloaded to the dialysis machine must be accepted in total. It is not
possible to accept individual parameters only.
7.4.2 Basic Requirements
The T1 test must have been successfully completed.

The UF unit must have been turned off.
The UF volume must have been set to 0000.
The machine must be in the Preparation mode.
(The optical detector on the air detector module does not sense blood, but clear fluid.)
A patient key must be in the key box.
☞ Note
After the treatment parameters have been transferred, the downloaded data can
only be accepted on the dialysis machine, provided:
the UF unit has been turned off.
the UF volume has been set to 0000.

7.4.3 Important Notes
Caution
The data received must be verified by the user, i.e. the user must check the data
received to ensure they are correct. Only then may the data be accepted with the
Conf key.

7.4.4 Procedure
Data transfer to the dialysis machine.
Download data for: Message
Harold Sample After successful data transfer the

patient's name will be displayed.
C Conf
☛
The Ultrafiltration menu displays.

The transferred data are shown against
a yellow background.
C Conf
☛

The Dialysate menu displays.
The transferred data are shown against
a yellow background.
C Conf
☛
Harold
Sample Preparation
Display message
The patient's name is displayed on the
left.
Displayed when all downloaded data
have been saved.

7.4.5 Aborting the Data Transfer
Menu
e.g. Ultrafiltration menu
Esc
Press the Esc key.
☛
C Conf

Cancel download [Conf/Esc] ?
(Select with [Conf] key)
C Conf
☛

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4008 S

Software Version 4.1

Fresenius Medical Care

These Operating Instructions have been updated to

11/02.01 = 11th edition, February 2001

Page(s) Current version

0-1 – 0-6 11/02.01

1-1 – 1-132 11/02.01

2-1 – 2-50 11/02.01

3-1 – 3-40 11/02.01

4-1 – 4-46 11/02.01

5-1 – 5-22 11/02.01

6-1 – 6-30 11/02.01

7-1 – 7-26 11/02.01

Explanation of symbols used in the Operating Instructions:

The 4008 S hemodialysis machine is classified as Class IIb equipment (MDD).

Please send any inquiries to (see next page):

Fresenius Medical Care 4008 S 11/02.01 (OP) 0-3

0-4 Fresenius Medical Care 4008 S 11/02.01 (OP)

0 General Notes ................................................................................................................ 0-

1 General Machine Description ...................................................................................... 1-

4 Alarm Processing ......................................................................................................... 4-

Fresenius Medical Care 4008 S 11/02.01 (OP) 0-5

7 Special Menu Functions ............................................................................................... 7-

0-6 Fresenius Medical Care 4008 S 11/02.01 (OP)

1.1 Intended Use ................................................................................................................. 1-5

1.2 Transportation and Storage ......................................................................................... 1-9

1.3 Structure and Function of Individual Machine Components ................................... 1-12

1.4 Description of the Procedure ...................................................................................... 1-36

Fresenius Medical Care 4008 S 11/02.01 (OP) 1-1

1.5 Description of the Extracorporeal Blood Circuit ...................................................... 1-53

1.6 Initial Start-Up ............................................................................................................... 1-59

1.7 Menu Description .......................................................................................................... 1-73

1.8 Cleaning Programs ....................................................................................................... 1-90

1.9 Maintenance .................................................................................................................. 1-93

1.10 Disposables and Consumables ................................................................................... 1-93

1.11 Technical Data ............................................................................................................... 1-103

1.12 Definitions and Terms .................................................................................................. 1-117

1.13 Abbreviations and Symbols ......................................................................................... 1-119

1-2 Fresenius Medical Care 4008 S 11/02.01 (OP)

1.14 Technical Safety Checks .............................................................................................. 1-121

1.15 Certificates .................................................................................................................... 1-123

1.16 Literature ....................................................................................................................... 1-132

Fresenius Medical Care 4008 S 11/02.01 (OP) 1-3

1.1.1 Fields of Application

1.1.2 Side Effects

– Hyperkalemia (for potassium-containing hemodialysis concentrates only)

A different method of extracorporeal treatment may be indicated in hemodynamically unstable

Fresenius Medical Care 4008 S 11/02.01 (OP) 1-5

The bicarbonate concentration can be readjusted within a range of ±8 mmol.

It is possible to perform ultrafiltration without dialysate flow (sequential dialysis/isolated ultrafiltration,

1-6 Fresenius Medical Care 4008 S 11/02.01 (OP)

Fresenius Medical Care 4008 S 11/02.01 (OP) 1-7

● The hemodialysis machine can be supplied with the following modules:

1. A blood pump for performing single needle dialysis.

● The following accessories (options) are available:

1. BPM 4008 Blood Pressure Monitor [including separate Operating Instructions]

● In addition, the following accessories are available: