4008 B

Hemodialysis Machine
Operating Instructions

Software Version 5.2

0123

Caution!
! These Operating Instructions in pdf-
format are for information only.
They are not a replacement for the
Operating Instructions supplied with
the machine/device and options.

Fresenius Medical Care

Operating Instructions 4008 B

These Operating Instructions have been updated to

16/10.03 = 16th edition, October 2003

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 16/10.03

1-1 – 1-118 16/10.03

2-1 – 2-50 16/10.03

3-1 – 3-42 16/10.03

4-1 – 4-52 16/10.03

5-1 – 5-20 16/10.03

6-1 – 6-30 16/10.03

7-1 – 7-38 16/10.03

Part No.: M34 543 1 Fresenius Medical Care 4008 B 16/10.03 (OP) 0-1
0-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
OPERATING INSTRUCTIONS
Hemodialysis Machine 4008 B
The present 4008 B Operating Instructions include the description of the profile function. 4008 B machines
are also available without profile function. Those parts of the Operating Instructions which are not
applicable for 4008 B machines without profile function have been marked as such.

These Operating Instructions are part of the machine documentation and thus an integral part of the
hemodialysis machine. They contain any information necessary for the use of the 4008 B hemodialysis
machine. All operators must have been thoroughly trained by the manufacturer and must have read the
entire Operating Instructions manual before using the machine.

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 the values entered
for correctness. 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 B hemodialysis machine reflects the latest state of technology and complies with the require-
ments of EN 60601 (IEC 601-1).

The 4008 B hemodialysis machine is classified as Class IIb (MDD) equipment.

Assembly, installation, adjustment, modification or repair are to be performed only by the manufacturer or
persons authorized by him.

Please address any inquiries to (see next page):

Fresenius Medical Care 4008 B 16/10.03 (OP) 0-3

Manufacturer:
Fresenius Medical Care AG
D-61346 Bad Homburg
Tel.: +49 61 72 / 6 09-0
www.fmc-ag.com

Local Service:

0-4 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 ............................................................. 1-54
1.6 Initial Start-Up ................................................................................................................. 1-60
1.7 Cleaning Programs ......................................................................................................... 1-79
1.8 Maintenance ................................................................................................................... 1-82
1.9 Disposables and Consumables ...................................................................................... 1-82
1.10 Specifications .................................................................................................................. 1-92
1.11 Definition and Terms ....................................................................................................... 1-107
1.12 Abbreviations and Symbols ............................................................................................ 1-109
1.13 Technical Safety Checks ................................................................................................ 1-111
1.14 Certificates ...................................................................................................................... 1-114
1.15 Literature ......................................................................................................................... 1-117

2 Preparation .................................................................................................................... 2-
2.1 Hemodialysis Machine .................................................................................................... 2-3
2.2 Functional Test ............................................................................................................... 2-12
2.3 Blood Pump .................................................................................................................... 2-25
2.4 Heparin Pump ................................................................................................................. 2-27
2.5 Air Detector ..................................................................................................................... 2-31
2.6 Extracorporeal Blood Circuit ........................................................................................... 2-33
2.7 Priming the Extracorporeal Blood Circuit With a Saline Bag ......................................... 2-35
2.8 Dialysate Side ................................................................................................................. 2-40

3 Treatment ....................................................................................................................... 3-
3.1 Ultrafiltration .................................................................................................................... 3-3
3.2 Double Needle Dialysis ................................................................................................... 3-11
3.3 Single Needle Dialysis .................................................................................................... 3-16
3.4 Single Needle Click-Clack .............................................................................................. 3-21
3.5 Isolated Ultrafiltration (ISO-UF) ...................................................................................... 3-24
3.6 Sodium and UF Profiles .................................................................................................. 3-31
3.7 DIASAFE ®plus (option) ..................................................................................................... 3-41

4 Alarm Processing ......................................................................................................... 4-

4.1 Management of Alarm Limits .......................................................................................... 4-3
4.2 Needle Adjustment .......................................................................................................... 4-11
4.3 Blood Alarms ................................................................................................................... 4-13
4.4 Dialysate Alarms ............................................................................................................. 4-31
4.5 Warnings ......................................................................................................................... 4-34
4.6 Emergency Operation ..................................................................................................... 4-40
4.7 Error Messages During Cleaning Programs ................................................................... 4-42
4.8 Error Messages After Turning Power On ........................................................................ 4-49
4.9 Error Messages When Using the Download Function ................................................... 4-50

Fresenius Medical Care 4008 B 16/10.03 (OP) 0-5

Chapter Page

5 Disconnection ............................................................................................................... 5-
5.1 End of Treatment ............................................................................................................ 5-3
5.2 Reinfusion ....................................................................................................................... 5-6
5.3 Stopping the Treatment .................................................................................................. 5-10
5.4 Emptying the bibag® (option) .......................................................................................... 5-17
5.5 Emptying the Dialyzer ..................................................................................................... 5-19

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 and Decalcification ...................................................................................... 6-6
6.5 Cleaning / Degreasing Program ..................................................................................... 6-13
6.6 Hot Rinse ........................................................................................................................ 6-18
6.7 Rinsing ............................................................................................................................ 6-21
6.8 Priming During Cleaning Programs ................................................................................ 6-23
6.9 Precirculation During the Cleaning Programs ................................................................. 6-27

7 Special Menu Functions ............................................................................................... 7-

7.1 Menu Structures – Overview .......................................................................................... 7-3
7.2 Settings on the Monitor ................................................................................................... 7-5
7.3 Auto-On Cleaning Program ............................................................................................ 7-8
7.4 Displaying / Clearing Treatment Parameters .................................................................. 7-10
7.5 Changing the DIASAFE®plus (option) on Machines with Basic Hydraulics ..................... 7-13
7.6 Changing the DIASAFE®plus (option) on Machines with Advanced Hydraulics .............. 7-18
7.7 bibag® (option) ................................................................................................................ 7-29
7.8 Transferring Treatment Parameters (Download) ........................................................... 7-33

0-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 including DIASAFE®plus (option) ....................... 1-22
1.3.3 Description of the Basic Hydraulics incl. DIASAFE ®plus (option) .................................... 1-24
Fig.: Flow diagram 4008 B 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.: Preparation of the dialysate (schematic)
Fig.: for 4008 dialysis machines with advanced hydraulics ........................................... 1-41
1.4.2 Description of the Variation Function .............................................................................. 1-45
Fig.: Possibilities of combining sodium and UF profiles ................................................ 1-45
1.4.3 Description of DIASAFE®plus (option) with Basic Hydraulics .......................................... 1-46
Fig.: System components ............................................................................................... 1-46
Fig.: Filter test procedure ................................................................................................ 1-47
Fig.: Schematic of dialysis .............................................................................................. 1-48
Fig.: Cleaning procedure ................................................................................................ 1-49
1.4.4 Description of DIASAFE®plus (option) with Advanced Hydraulics ................................... 1-50
Fig.: System components ............................................................................................... 1-50
Fig.: Schematic of the membrane integrity test (DIASAFE ®plus ) .................................... 1-51
Fig.: Schematic of dialysis .............................................................................................. 1-52
Fig.: Cleaning procedure ................................................................................................ 1-53

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-1

Chapter Page

1.5 Description of the Extracorporeal Blood Circuit ...................................................... 1-54

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

1.6 Initial Start-Up ............................................................................................................... 1-60

1.6.1 Relevant Instructions Before Initial Start-Up ................................................................... 1-60
1.6.2 How to Connect the Hemodialysis Machine ................................................................... 1-66
1.6.3 Inserting / Priming the DIASAFE®plus (option) on Machines with Basic Hydraulics ....... 1-69
1.6.4 Inserting / Priming the DIASAFE®plus (option) on Machines with Advanced Hydraulics 1-74

1.7 Cleaning Programs ....................................................................................................... 1-79

1.7.1 General Information on the Cleaning Programs ............................................................ 1-79
1.7.2 Disinfection and Removal of Calcium Deposits ............................................................. 1-80
Fig.: Disinfection flow chart ........................................................................................... 1-81

1.8 Maintenance .................................................................................................................. 1-82

1.9 Disposables and Consumables ................................................................................... 1-82

1.9.1 Disposables .................................................................................................................... 1-82
1.9.2 Consumables .................................................................................................................. 1-84
1.9.3 DIASAFE®plus (option) ..................................................................................................... 1-89
1.9.4 Part Numbers .................................................................................................................. 1-90

1.10 Specifications ................................................................................................................ 1-92

1.10.1 Dimensions, Weight and Housing Material ..................................................................... 1-92
1.10.2 Electrical Safety .............................................................................................................. 1-92
1.10.3 Electrical Supply ............................................................................................................. 1-93
1.10.4 Type Label ...................................................................................................................... 1-93
1.10.5 Fuses .............................................................................................................................. 1-94
1.10.6 Operating Conditions ...................................................................................................... 1-94
1.10.7 External Connection Options .......................................................................................... 1-95
1.10.8 Overriding Conditions ..................................................................................................... 1-96
1.10.9 Operating Programs ........................................................................................................ 1-97
1.10.10 Dialysate Circuit and Safety Systems ............................................................................. 1-98
1.10.11 Extracorporeal Blood Circuit and Safety Systems ......................................................... 1-102
1.10.12 Environmental Compatibility and Recycling.................................................................... 1-105

1.11 Definition and Terms .................................................................................................... 1-107

1.12 Abbreviations and Symbols ......................................................................................... 1-109

1.12.1 Abbreviations .................................................................................................................. 1-109
1.12.2 Symbols .......................................................................................................................... 1-110

1-2 Fresenius Medical Care 4008 B 16/10.03 (OP)

Chapter Page

1.13 Technical Safety Checks .............................................................................................. 1-111

1.13.1 Important Information ...................................................................................................... 1-111
1.13.2 TSC Checklist ................................................................................................................. 1-112

1.14 Certificates .................................................................................................................... 1-114

1.14.1 EC Certificate .................................................................................................................. 1-114

1.15 Literature ....................................................................................................................... 1-117

1.15.1 Hemodialysis in General ................................................................................................. 1-117
1.15.2 Dialysate Filter and ON-LINE HDF ................................................................................. 1-117
1.15.3 Blood Temperature Monitor (BTM) ................................................................................. 1-117

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-3

1-4 Fresenius Medical Care 4008 B 16/10.03 (OP)
1.1 Intended Use

1.1.1 Fields of Application

The 4008 B 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-5

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.

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 period of 12 weeks. Should the filter fail to pass the filter test, it must be replaced at an
earlier date. For the use of this option, the quality of the water and the dialysate must comply with
the applicable standards. (See Chapter 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).

1-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

The dialysate flow is adjustable (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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-7

1.1.5 Accessories

Caution
For any additional equipment connected to the analog and digital interfaces of
the machine, evicence must be provided that this equipment complies with the
applicable EN specifications (e.g. EN 60950 for data processing equipment, and
EN 60601 (IEC 601) for electro-medical equipment). In addition, all configura-
tions must comply with the system standard EN 60601-1-1 (IEC 601-1-1).
Anyone connecting additional equipment to the parts of signal input or signal
output component configurates the system and is, thus, responsible for compli-
ance 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. Traffic light
8. BTM 4008 Blood Temperature Monitor [including separate Operating Instructions]
9. BVM 4008 Blood Volume Monitor [including separate Operating Instructions]
10. Remote Control Unit 4008 [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. Water inlet filter
15. Flush (rinsing the water supply hose)

● In addition, the following accessories are available:

RO 08 (single-place reverse-osmosis system) [including separate Operating Instructions]

1-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-9

 How to overcome steps or stairs:
At least two persons are required for
overcoming steps or stairs.
Proceed as follows:
Lock the brake.
Clamp the vent tubing by means of
arterial forceps.
Tilt the machine.
Lift the machine and transport it (never
lift the machine on the IV pole or one of
the modules).
Deposit and set the machine 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
antifreeze).

1-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.2.2 Storage

The hemodialysis machine must be stored vertically in a well-aired room with low variations in
temperature.

Storage temperature:
– without antifreeze +5 °C to +70 °C
– with antifreeze –20 °C to +70 °C

Relative humidity:
30 % to 75 %, temporarily 95 %

Should the hemodialysis machine be stored with antifreeze, the antifreeze used should have the
following composition:
– 48.75 % water
– 48.75 % glycerine
– 2.5 % Teta-plus

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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-11

1.3 Structure and Function of Individual Machine Components

Fig.: Hemodialysis machine – front view

1 Fresenius Medical Care 4008 B

Best. Auswahl

I/O
Luftdetektor Arterieller Venöser TMP Ultrafiltration Leitfähigkeit
Druck Druck
UF Menge ml

Spülen Reset
Konz. Bic.
kPa mmHg kPa mmHg kPa mmHg

Heißreinigen 280 500 500

9
Blutleck 30 60 60 UF Rate ml/h 15.5
200
Desinfektion
20 50 400 50 400 15
10
100 40 300 40 300 14.5
0 0 30 30
Single 200 200 14
Needle –10
–100 20 20
UF Ziel ml
–20 10
100 10
100 13.5
Überbrücken
–200
Test
–30 0 0 0 0 13
–40 –300 mS/cm
(25°C)

Vorbereiten
UF Restzeit h:min
Variation

I/O Prog.
Dialyse Start
Tempera-
UF Fluß tur

Alarm I/O Prog. I/O Set

Ton Aus

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

1-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

Fig.: Hemodialysis machine – rear view

3 14

4
5

15
13

12

6 11
10
9
8

Legend

1 Monitor (rear) 9 Concentrate connector (red) for central

2 Sampling valve delivery system (optional)
3 Filter 10 Drain
4 Dialyzer supply line with flow indicator 11 Water connector (permeate) or connector
5 Dialyzer return line for water inlet filter
6 Disinfection port 12 DIASAFE ®plus (filter 1) option
7 Water inlet filter, optional 13 Vent tubing
8 Bicarbonate connector for central delivery 14 Power supply unit
system (blue), optional 15 Clamp for dialyzer connecting tubes

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-13

1.3.1 Monitor

Fig.: Hemodialysis machine – monitor front

20b
Fresenius Medical Care 4008 B 20c 20d
20a
Confirm Select
19 20
19a 19b 19c

1 1a I/O 10 12 13 14 15 16
Air Detector Arterial Venous Transmembrane Ultrafiltration Conductivity
1b Pressure Pressure Pressure
UF Volume ml
15b 16a
10a 12a 13a 14a Reset
2 2a Rinse 15a Volume Conc Bic
2b kPa mmHg kPa mmHg kPa mmHg
16c 16d
3 3a Hotrinse 11 280 500 500 15d
Blood Leak 30 UF Rate ml/h 15.5
3b 200 60 60

20 400 400 15c 15

4 4a Disinfection
11a 100
50 50

4b 10 40 300 40 300 14.5

0 0 30 30 16b
5 5a Single 200 200 15f 14
Needle 11b –10
–100 20 20
UF Goal ml
5b –20 10
100 10
100 13.5
Override
–200 15e
–30 0 0 0 0 13
6 6a Test
–40 –300 mS/cm
6b 11c 12b 13b 14b (25°C)
15h
7 7a Prime
Time Left h:min
Variation
16e
7b
Dialysis Start 15g 16f I/O Prog. 16g
8 8a Reset Alarm
8b 15i UF 17b Flow Tempera-
ture

Alarm Tone I/O Prog. I/O Set

9 9a Mute
9b 15k 15l 17c 18b
17 18

Fig.: Hemodialysis machine – monitor front (4008 B without profiles)

20b
Fresenius Medical Care 4008 B 20c 20d
20a
Confirm Select
19 20
19a 19b 19c

1 1a I/O 10 12 13 14 15 16
Air Detector Arterial Venous Transmembrane Ultrafiltration Conductivity
1b Pressure Pressure Pressure
UF Volume ml
15b 16a
10a 12a 13a 14a Reset
2 2a Rinse 15a Volume
2b kPa mmHg kPa mmHg kPa mmHg
mS/cm
(25°C)

3 3a Hotrinse 11 280 500 500 15d

Blood Leak 30 UF Rate ml/h 15.5
3b 200 60 60

20 400 400 15c 15

4 4a Disinfection
11a 100
50 50

4b 10 40 300 40 300 14.5

0 0 30 30 16b
5 5a Single 200 200 15f 14
Needle 11b –10
–100 20 20
UF Goal ml
5b –20 10
100 10
100 13.5
Override
–200 15e
–30 0 0 0 0 13
6 6a Test
–40 –300
6b 11c 12b 13b 14b 15h
7 7a Prime
Time Left h:min
Conc Bic
7b
Dialysis Start 15g 16c 16d
8 8a Reset Alarm
8b 15i UF 17b Flow Tempera-
ture

Alarm Tone I/O I/O Set

9 9a Mute
9b 15k 17c 18b
17 18
1-14 Fresenius Medical Care 4008 B 16/10.03 (OP)
 ● 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 explained in detail.

Function keys (pos. 1 – 9) Ultrafiltration monitor (pos. 15)

1a I/O key 15a UF Volume indicator
1b I/O LED 15b Reset Volume key
15c UF Rate indicator
2a Rinse key
15d ▲ and ▼ keys (UF Rate)
2b Rinse LED
15e UF Goal indicator
3a Hotrinse key 15f ▲ and ▼ keys (UF Goal)
3b Hotrinse LED 15g Time Left indicator
15h ▲ and ▼ keys (Time Left)
4a Disinfection key
15i UF LED
4b Disinfection LED
15k UF I/O key
5a Single Needle key 15l UF Prog. key
5b Single Needle LED (not applicable for 4008 B without profiles)
6a Test key
6b Test LED Dialysate monitor (pos. 16 – 18)
7a Prime key 16a Conductivity alarm indicator
7b Prime LED 16b Conductivity bargraph display
16c Conc key
8a Dialysis Start key
16d Bic key
8b Dialysis Start LED
16e Variation LED
9a Alarm Tone Mute key (not applicable for 4008 B without profiles)
9b Alarm Tone Mute LED 16f Variation I/O key
(not applicable for 4008 B without profiles)
16g Variation Prog. key
Blood monitor (Pos. 10 – 14)
(not applicable for 4008 B without profiles)
10a Air Detector alarm indicator
17b Flow LED
11a Blood Leak alarm indicator 17c Flow I/O key
11b Override LED
18b Set key
11c Override key
12a Arterial Pressure alarm indicator
Status Indicators (pos. 19)
12b Arterial Pressure bargraph display
19a Green status indicator (operation)
13a Venous Pressure alarm indicator
19b Yellow status indicator (warning/info)
13b Venous Pressure bargraph display
19c Red status indicator (alarm)
14a TMP alarm indicator
14b TMP bargraph display
Text display / Enter keys (pos. 20)
20a Text display
20b ▲ and ▼ keys
20c Confirm key
20d Select key

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-15

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

1-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Description of monitor rear 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), or if their
applicability with regard to technical safety has been proven by a specific
certificate issued by a testing agency authorized to test the ready-for-use
machine.

1 Fan
2 Service switch
3 Alarm tone volume control
4 Connection socket for traffic light / status indicator (optional)
5 RS232 interface (galvanically decoupled by optocoupler) (optional)
6 Input / output port (for external equipment)
7 Connection socket for screen
8 Operating hours indicator
9 ALARM IN port (can be used to connect an external pushbutton. This pushbutton can be
used to initiate a machine stop.)
10 ALARM OUT port (can be used to connect 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 (to supply, the hemodialysis machine with line voltage, 230 V AC; 50 – 60 Hz)
15 Loudspeaker for audible alarm
16 Port for connection of the 4008 Remote Control (optional)
17 Key interface (patient identification in conjunction with FINESSE) (optional)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-17

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 lines installed; the rotor
can be removed for cleaning)
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 line diameter)
11 ▲ key (to increase the delivery rate or the line diameter)

1-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

 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 toggle 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)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-19

 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

1-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-21

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

1-22 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 130 bibag ® drain valve
66 Heater block 131 bibag ® block
66a Water inflow chamber 131a bibag ® air sep. chamber
66b Heater rod chamber 131b bibag ® mixing chamber
66c Float chamber 132 bibag ® conductivity cell
68 Balancing chamber 133 bibag ® temperature sensor
71 Filter/concentrate 134 bibag ® pressure transducer
72 Filter/bicarbonate 135 bibag ® level sensor
73 Filter/dialysate ext. 136 bibag ® connector
74 Filter/UF 137 bibag ® microswitch 1
75 External flow indicator 138 bibag ® microswitch 2
76 Filter/fill valve 148 Filter/rinse valve 100
77 Heat exchanger 149 Filter/rinse valve 99
78 Relief valve 150 Filter
84 Disinfectant valve 151 Orifice
85 Disinfectant connector 210 Filter (degassing orifice)
86 Recirculation valve

Hydraulics measuring points

A Reduced water inlet pressure

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-23

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 at the inverse sequence). 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 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. From there, it is directed to the heater block (66) via the
loading pressure valve (65) and 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 by the flow pump (21) into the balancing chamber (68). This ensures
that the dialysate that is expelled is always replaced by the same amount of fresh dialysate.

The pressure transducer (9) is located below the secondary air separator (88b) of the multifunc-
tion 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 is removed as ultrafiltrate
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).

1-24 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 DIASAFE®plus option (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 having to separate lines and tubings. 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) is 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 presence or absence of disinfectant.

Flush, rinsing the water supply hose (option):

The water supply hose, which comes with the machine, is rinsed up to the water inlet valve (41)
during the test phase (initialization) 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-25

Fig.: Flow diagram 4008 B with advanced hydraulics

1-26 Fresenius Medical Care 4008 B 16/10.03 (OP)

Legend

2 Temperature sensor 91 Rinse valve

3 Temperature sensor 92 Vent valve
5 Float switch 94 Concentrate suction tube
6 Level sensor 95 Bicarbonate suction tube
7 Conductivity cell 97 Air separation pump
8 Blood leak detector 99 Rinse valve
9 Pressure transducer 100 Rinse valve
10 Reed contact for concentrate 102 Central concentrate delivery valve
12 Reed contact for bicarbonate 104 Central bicarbonate delivery valve
21 Flow pump 109 Temperature sensor
22 UF pump 111 Hydrophobic filter
23 Concentrate pump 112 Vent valve
24 Dialyzer valve 1 114 Dialysate filter
24b Dialyzer valve 2 115 Sensor disinfection valve
25 Bicarbonate pump 116 Sampling valve
26 Bypass valve 117 Check valve (concentrate)
29 Degassing pump 118 Check valve (bicarbonate)
30 Outlet valve 119 Filter (concentrate)
31 Balancing chamber valve 1 120 Filter (bicarbonate)
32 Balancing chamber valve 2 121 Central concentrate delivery connector
33 Balancing chamber valve 3 122 Central bicarbonate delivery connector
34 Balancing chamber valve 4 123 Pressure switch for V102
35 Balancing chamber valve 5 124 Pressure switch for V104
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 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 182 Pressure transducer 2
72 Filter/bicarbonate 183 Test valve
73 Filter dialysate external 184 Test valve filter
74 Filter/UF 185 Compressor
75 External flow indicator 188 Evacuation valve
76 Filter/fill valve 189 Retentate valve
77 Heat exchanger 201 Concentrate air separator
78 Relief valve 202 Concentrate level sensor
84 Disinfectant valve 203 Bicarbonate air separator
85 Disinfectant connector 204 Bicarbonate level sensor
86 Recirculation valve 205 Concentrate / bicarbonate mixing point
87 Drain valve 206 Buffer volume chamber
88 Multifunction block 210 Filter (degassing orifice)
88a Degassing chamber
88b Secondary air separator Hydraulics measuring points
88c Primary air separator A Reduced water inlet pressure
89 Degassing orifice B Balancing chamber loading pressure valve
90a Rinse chamber concentrate C Flow pump pressure
90b Rinse chamber bicarbonate D Degassing pump pressure

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-27

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 and the used dialysate 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.

The 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 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 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).

1-28 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 by the flow pump (21) into the balancing chamber (68). This ensures
that the dialysate that is expelled is always replaced by the same amount of fresh dialysate.

The pressure transducer (9) is located below the secondary air separator (88b) of the multifunc-
tion 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 is removed as
ultrafilatrate 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).

The heat exchanger (77) transmits part of the heat of the outflowing dialysate to the cold inflowing
water.

Larger amounts of air entering the system, as a result of major deaeration or during priming, are
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 with 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 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) is 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 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).

Flush, rinsing the water supply hose (option):

The water supply hose, which comes with the machine, is rinsed up to the water inlet valve (41)
during the test phase (initialization) 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-29

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 possibilities are available:
1. No central delivery system (factory setting)
2. Central bicarbonate delivery
3. Central acid delivery
4. Central bicarbonate delivery and central acid delivery
5. Central acetate delivery

When selecting a type of central delivery, the user is not bound to the centrally supplied
concentrate. Other concentrates can also be connected by pulling or inserting 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 activates the
concentrate or the bicarbonate pump, as appropriate.

☞ Note
Aspiration of concentrates from containers has priority (see graphical represen-
tations 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 emptied 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 correct installation and function of the CDS.

The following illustrations show the possible combinations of connection with regard to the CDS.
(The bibag ® option can be used as an alternative to bicarbonate from containers.)

1-30 Fresenius Medical Care 4008 B 16/10.03 (OP)

1. No central concentrate supply

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-31

2. Central bicarbonate supply

1-32 Fresenius Medical Care 4008 B 16/10.03 (OP)

3. Central acid supply

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-33

4. Central bicarbonate and acid supply

1-34 Fresenius Medical Care 4008 B 16/10.03 (OP)

5. Central acetate supply

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-35

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.

1-36 Fresenius Medical Care 4008 B 16/10.03 (OP)

● 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-37

 ● 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.

This produces dialysate which has the following ion composition during the basic setting
of the pumps for:

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)

1-38 Fresenius Medical Care 4008 B 16/10.03 (OP)

● 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 (option).

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-39

Fig.: Preparation of the dialysate (schematic)
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)

Concentrate container coding

1-40 Fresenius Medical Care 4008 B 16/10.03 (OP)

Fig.: Preparation of the dialysate (schematic)
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)

Concentrate container coding

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-41

 ● Safety system

Measurement of the conductivity and the bypass function prevent that dialysate of the wrong con-
centration will enter the dialyzer.

Monitoring of the desired 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 theoretical 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

1-42 Fresenius Medical Care 4008 B 16/10.03 (OP)

● 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-43

 ● Change in conductivity

Based on a basic sodium value of e.g. 140 mmol, the sodium value changes by 5 %, if the
prescribed 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 prescribed sodium value constant. This may result in a minor CD alteration.

Example:
A prescribed 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 prescribed sodium value of 102 + 38 = 140 mmol/l is preserved.

1-44 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.4.2 Description of the Variation Function (not applicable for 4008 B without profiles)

In order to improve the individual tolerance towards dialysis treatments, ultrafiltration profiles and
sodium profiles can be combined, either depending upon each other (e.g. high ultrafiltration with
high sodium concentration) or independently of each other.
Separate documentation is available from the manufacturer on request.

Fig.: Possibilities of combining sodium and UF profiles

Sodium
1 2 3 4 5 6

1
Ultrafiltration

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-45

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

1-46 Fresenius Medical Care 4008 B 16/10.03 (OP)

 ● 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
Balancing Cond./Temp.
chamber monitoring Vent valve

DIASAFE® plus

Dialyzer
valve 1

V24
UF Flow
pump pump Interlock shunt

V24b
V26 Bypass
valve

Dialyzer
valve 2

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-47

 ● 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.: Schematic of dialysis

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

1-48 Fresenius Medical Care 4008 B 16/10.03 (OP)

 ● 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
Balancing Cond./Temp.
chamber monitoring Vent valve

DIASAFE® plus

Dialyzer
valve 1

V24
UF Flow
pump pump Interlock shunt

V24b
V26 Bypass
valve

Dialyzer
valve 2

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-49

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

1-50 Fresenius Medical Care 4008 B 16/10.03 (OP)

 ● 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.: Schematic of membrane integrity test (DIASAFE®plus)

Balancing Hydrophobic filter (111)

chamber
(68) Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)

Drain Pressure
valve DIASAFE® P transducer 2
plus Cond./Temp. (182)
(87) monitoring
(114)
(3/7/109)

Retentate Bypass
valve valve
(189) (26)

Fill UF Flow Dialyzer

valve pump pump valve 1 Interlock shunt
(43) (22) (21) (24)

Pressure
transducer Dialyzer
(9) valve 2
P (24b)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-51

 ● 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.: Schematic of dialysis

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) monitoring P for venous
(114) 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

1-52 Fresenius Medical Care 4008 B 16/10.03 (OP)

 ● 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

Balancing Hydrophobic filter (111)

chamber
(68) Vent valve (112) Filter/test valve (184)
Compressor (185)
Test valve (183)

Drain Pressure
valve DIASAFE® P transducer 2
plus Cond./Temp. (182)
(87) monitoring
(114)
(3/7/109)

Retentate Bypass
valve valve
(189) (26)

Fill UF Flow Dialyzer

valve pump pump valve 1 Interlock shunt
(43) (22) (21) (24)

Pressure
transducer Dialyzer
(9) valve 2
P (24b)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-53

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

1-54 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.5.1 Double Needle Dialysis

The arterial blood pump delivers blood from the patient’s vascular access to the dialyzer. The
pressure on the suction side of the pump is measured and monitored by means of the arterial
pressure monitor, which is separated by a hydrophobic filter. If the pressure is outside the set limits,
a blood alarm will be released: the arterial blood pump stops, the venous line clamp is closed, a
visual and audible alarm is initiated. Ultrafiltration is stopped.

Heparin doses can be added to the blood at an adjustable rate via the heparin pump.

After the dialyzer, the blood enters the venous bubble catcher. Here, the venous back pressure is
measured and monitored within tight limits. The monitor for the venous back pressure is separated
by two hydrophobic filters. The venous bubble catcher is located in the level detector, which serves
as a protection 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 senses non-opaque fluid (saline or air in the tubing system) or
– OD senses opaque fluid (blood in the line tubing system).

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 volume may 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 tubing system, 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 lines, the blood
pump stops and the venous line clamp opens. The pressure, which has developed in the tubing
system, 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-55

 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 back pressure 18 SN blood pump
10 Ventilation pump

1-56 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 (Q SN) 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 delivers blood into the external compliance chamber. The blood volume
is dependent on 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 running and delivers 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 starts again.

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. The TMP stability is also improved.

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 recognition of both blood pumps is activated. Should one of the pumps stop longer than
for the set time (factory setting: 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-57

1.5.4 Effective Blood Flow and Cumulated Blood Volume

The delivery rate display on the blood pump indicates the theoretical blood flow. This value is
computed from the rotating speed of the rotor 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. By means of the menu option 4. Bloodflow.calc., the value
can be indicated on the text display of the monitor. (See Chapter 7.4.1 Displaying the Effective
Blood Flow.)

Using the actual blood flow and the elapsed treatment time, the monitor computes the accumu-
lated blood volume. This information can also be displayed under menu option 4.

1-58 Fresenius Medical Care 4008 B 16/10.03 (OP)

 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 lines installed. The rotor
can be removed for cleaning.)
8 Sensor (blood pump cover open or closed)
9 Start/Stop key (to toggle 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)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-59

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 DIN VDE 0100-710) are to be
observed when connecting the machine to the local power supply system.

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

– If the power 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 DIN VDE 0100-710 in rooms of
application group 2).

1-60 Fresenius Medical Care 4008 B 16/10.03 (OP)

Caution
When using central venous catheters the following precautions must be ob-
served:
1. The dialysis machine must be connected to a potential equalization.
2. If additional electro-medical devices are connected to the patient or they are
positioned within the reachable area of the patient, it must be ensured that all
leakage currents of these devices (device leakage currents, housing leakage
currents, earth leakage currents and patient leakage currents) are below the
respective limit for CF applied parts.
This means:
10 µA maximum in normal conditions, and 50 µA in “single fault conditions”.
This also applies to patient positioning devices (e.g. patient chairs).
Devices with leakage currents within these limits, but with an application
current exceeding the specified leakage currents (e.g. on electro stimulators)
must not be used. This concerns to defibrillators, which have no applied part
type CF, too.
If all requirements have been fulfilled, these devices may be operated on the
patient or within the reachable area of the patient, provided they are, like the
dialysis machine, integrated into the potential equalization.
If these conditions are not fulfilled, no other additional electro-medical device
must be connected to the patient or positioned within the reachable area of
the patient.
In case of doubt, ask your local technician.

Leakage currents of additional

electro-medical devices may be
led to the earth via the
central venous catheter
Catheter

Dialysis Additional
machine electromedical
device

all types!
(B / BF / CF)

Via the blood Housing leakage

and the dialysate, currents
the patient is of all types
electrically 10 times higher than
connected to the “CF” patient
earth potential leakage current!

3. When determining the room design, a group 1 room is sufficient, i.e., the
mains may be turned off in case of a single fault condition, and the treatment
may be aborted or repeated.
Additionally, the room must comprise a potential equalization.
For further information refer to the national regulations.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-61

 – 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.

1-62 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Water supply

– Only water, which is suitable for hemodialysis, should be used for operating the hemodialysis
machine. The quality of the water should comply with the local regulations (e.g. European
Pharmacopoeia - 4th Edition, ANSI/AAMI - RD5 - 1992 - Part 3.2).

– The ranges of the following parameters are specified in Chapter 1.10 Specifications: 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 1.10 Specifications.

● 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 following
table.

General notes
The microbiologic purity of dialysate prepared in the dialysis center is of critical importance.

Product water quality

The European Pharmacopoeia - 4th Edition lists maximum limits for chemical and microbiological
quality.
Modern reverse osmosis units and the appropriate design of water storage and delivery systems
(e.g. short distribution loops avoiding stagnant flow zones) enable compliance with this standard.

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 require regular inspection.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-63

 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

1-64 Fresenius Medical Care 4008 B 16/10.03 (OP)

● 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 procedure by which the effectiveness of sterilization or disinfection has been verified.
– Comments, concerning the expected recirculation of the blood flow in the extracorporeal
circuit in single needle treatments, if the recommended administration sets, dialyzers,
fistula needles and catheters are used.

☞ 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-65

1.6.2 How to Connect the Hemodialysis Machine

Initial start-up of the machine should be performed by the technical service of the Fresenius
Medical Care or a person authorized by them.

– If the machine is transported from a cooler into a warmer room, allow the hemodialysis
machine to reach room temperature for approx. 2 hours, before turning power on.

– Prior to putting the machine into operation for the first time, the DIP switch positions must be
checked and, if necessary, the switches set correctly. The setup settings must also be
checked.
(See the Technical Manual)
The selected DIP switch settings must then be entered in the Medical Device Register.

– Connection to the water supply.

Accessories include a fabric-enforced PVC tubing (red), 10 x 16 mm in size, with 3/4" screw
cap and tube clips.

– Connection to the drain.

Accessories include a fabric-enforced PVC tubing (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 supply.

– When using the central delivery system (CDS) option:

Use the enclosed connection lines to connect the machine 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 1.10.

Turn the water supply on.

Press the power switch (main switch).

☛

1-66 Fresenius Medical Care 4008 B 16/10.03 (OP)

Fresenius Medical Care 4008 B Press the I/O key.
Turn the hemodialysis machine on!

The I/O LED is illuminated.

I/O
Luftdetektor Arterieller Ve
Druck D
☛
Confirm Select Display message
Rinse required !
Connect the dialysate connecting tubes
to the interlock shunt; close the interlock
shunt.
Insert the red concentrate suction tube
into the rinse chamber.
Insert the blue bicarbonate suction tube
into the rinse chamber.

☞ 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.

Rinse Press the Rinse key.

kPa mmHg kPa
The Rinse LED is illuminated.
☛

Hotrinse 280
Blood Leak 30 60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-67

 Confirm Select Display message
>M< : 0 h 20

Confirm Select The program is terminated automatically

Mandatory rinse end after the rinse program has been com-
pleted.

The Rinse LED stops lighting.

If no DIASAFE®plus (option) is used, the

user can now perform the technical safe-
ty checks (TSC). (See Chapter 1.13
Technical Safety Checks.)

1-68 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 dialyzer lines are in the interlock shunt.
– The shunt door is closed.
– The concentrate suction tubes must be locked in the rinse chamber.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-69

 ● Operator steps

Fresenius Medical Care 4008 B Press the I/O key.

Turn the hemodialysis machine off!

The I/O LED stops lighting.

I/O
Luftdetektor Arterieller Ve
Druck D
☛

➀ Open the locking levers.

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

1-70 Fresenius Medical Care 4008 B 16/10.03 (OP)

 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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-71

 Fresenius Medical Care 4008 B Press the I/O key.
Turn the hemodialysis machine on!

The I/O LED is illuminated.

☛ I/O
Luftdetektor

Override
Arterieller
Druck
Ve
D

–30
–200
0
Test
–40 –300
The Test LED is flashing.
If the Test LED is not flashing, one of
Prime the conditions for the test to start is not
fulfilled.
Dialysis Start
Reset Alarm

Alarm Tone
Mute

1-72 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Override

☛
–30
–200
0
Test
–40 –300
Press the Test key.
Prime The Test LED is illuminated.
Dialysis Start
Reset Alarm

Alarm Tone
Mute

☞ 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 1.13 Technical
Safety Checks.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-73

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

– The optical detector senses clear fluid.

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

1-74 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Operating procedure

Confirm Select Press the Select key.

** 4008 B / VX.X **
☛
Confirm Select Use the ▲ and ▼ key to select
5. System Parameter
☛ 5. System Parameter.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ key to select

5.5 Filter change
☛ 5.5 Filter change.
Press the Confirm key.

Confirm Select Display message in the status line while

Empty filter the filter is being emptied.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-75

 Confirm Select Display message
Filter changed ?

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.

1-76 Fresenius Medical Care 4008 B 16/10.03 (OP)

 ➀ ➀ Slide the new filter from the top into
the guide slot.
➁ Close the locking levers.
➁

Confirm Select Press the Confirm key to confirm the fil-

Filter changed ? ter change.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-77

 Confirm Select Display message in the status line while
Filling filter priming the filter.

When the filter is filled, the disinfection

program defined in the SETUP will be
started automatically.

Caution
The machine must be disinfected
prior to initating the first treatment.

Perform the technical safety checks

(TSC). (See Chapter 1.13 Technical
Safety Checks.)

1-78 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.7 Cleaning Programs

1.7.1 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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-79

1.7.2 Disinfection and Removal of Calcium Deposits

Caution
It is imperative to 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 (using 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.

1-80 Fresenius Medical Care 4008 B 16/10.03 (OP)

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
Flow: 600 ml/min Flow: 450 ml/min Flow: 600 ml/min Flow: 450 ml/min Flow: 600 ml/min
Time: adjustable from Time: adjustable from Time: adjustable from Time: adjustable from Time: adjustable from
10 to 20 min in the 10 to 20 min in the 10 to 20 min in the 10 to 20 min in the 10 to 20 min in the
SETUP menu SETUP menu SETUP menu SETUP menu SETUP menu
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
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
15 to 30 min in the 10 to 25 min in the 15 to 30 min in the 10 to 25 min in the 15 to 30 min in the
SETUP menu SETUP menu SETUP menu SETUP menu SETUP menu

–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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-81

1.8 Maintenance

Perform the maintenance procedures specified in the Technical Manual. The technical safety
checks (TSC) are included in the maintenance intervals.

1.9 Disposables and Consumables

The items listed in this chapter are an extract from our extensive product range. Further
products on request.

1.9.1 Disposables

Caution
The dialyzers, blood lines and syringes listed in this chapter are disposables,
identified by the symbol: 2 = do not re-use.

The 4008 B hemodialysis system has been approved for use with the disposables listed below
within the scope of the EC design certification.

● Dialyzers

Fresenius Polysulfon® hollow-fibre dialyzers (INLINE steam-sterilization) (low-flux)

F 4 HPS, F 5 HPS, F 6 HPS, F 7 HPS, F 8 HPS, F 10 HPS

Fresenius Polysulfon® hollow-fibre dialyzers (ETO-sterilized) (low-flux)

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

Fresenius FX-Class hollow-fibre dialyzers (INLINE steam-sterilization) (high-flux)

FX 40, FX 50, FX 60, FX 80, FX 100

Fresenius Polysulfon® hollow-fibre dialyzers (INLINE steam-sterilization) (high-flux)

F 40S, F 50S, F 60S, HF 80S

Fresenius Polysulfon® hollow-fibre dialyzers (ETO-sterilized) (high-flux)

F 40, F 50, F 60, HF 80

1-82 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Blood lines

Caution
These blood lines 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 only achieved by using the original tubing
systems.
During continuous operation, the blood lines must be exchanged after 24 hours
at the latest.

Double-Needle dialysis:

Description Venous bubble catcher Sterilisation

AV-Set FMC (FA 204B / FV 204B) 22 mm ETO
AV-Set FMC (FA 204B / FV 234B) 30 mm ETO
AV-Set FMC (FA 204B / FV 204B) S 22 mm Steam
AV-Set FMC (FA 204B / FV 234B) S 30 mm Steam
AV-Set FMC (FA 204B / FV 204B) G 22 mm Gamma
AV-Set FMC (FA 204C / FV 234B) G 30 mm Gamma

Single-Needle dialysis:

Description Venous bubble catcher Sterilisation

AV-SN-Set FMC (FA 514 SN B / FV 204B) 22 mm ETO
AV-SN-Set FMC (FA 514 SN B / FV 234B) 30 mm ETO
Arterial – FA 514 SN B S – Steam
Venous – FV 204 B S 22 mm Steam
Venous – FV 234 B S 30 mm Steam
AV-SN-Set FMC (FA 514 SN B / FV 204B) G 22 mm Gamma

● 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-83

1.9.2 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

500 ml/min approx. 6 hours approx. 9 hours
800 ml/min approx. 4 hours approx. 6 hours

● Saline solution

Isotonic saline solution available in various bag sizes:

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

1-84 Fresenius Medical Care 4008 B 16/10.03 (OP)

● 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 hereafter, 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).

Caution
The following must be observed when using Puristeril®plus:
In case of treatments with High-Flux membranes, we additionally recommend to
perform a regular alkaline cleaning with Sporotal® 100.
Puristeril®plus must not be used on machines with the DIASAFE (old) and ON-
LINE-HDF options.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-85

 Disinfection

Dilution: Container concentrate is diluted with product water in the

hemodialysis machine at a ratio of 1+24 (cleaning pro-
grams 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 Puristeril®plus:
(Water temperature in the cleaning program: 37 °C)
Active substance base: peracetic acid
Active substance concentration: < 0.1 % (diluted)

3. Fresenius Sporotal® 100:

(Water temperature in the cleaning program: 37 °C)
Active substance base: sodium hypochlorite
Active substance concentration: approx. 0.1% (diluted) (cleaning program 5 only)

☞ Note
Applicable for DIASAFE®plus (option) only:
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.

4. Fresenius Citrosteril®:
(Water temperature in the cleaning program: 84 °C)
Active substance base: citric acid hydrate
Active substance concentration: approx. 0.8% (diluted)

5. Fresenius Diasteril®:
(Water temperature in the cleaning program: 84 °C)
Active substance base: hydroxyacetic acid
Active substance concentration: approx. 0.8% (diluted)

1-86 Fresenius Medical Care 4008 B 16/10.03 (OP)

Removal of calcium deposits

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 Puristeril®plus :
(Water temperature in the cleaning program: 37 °C)
Active substance base: peracetic acid
Active substance concentration: < 0.1 % (diluted)

3. Fresenius Citrosteril®:
(Water temperature in the cleaning program: 37 °C)
Active substance base: citric acid hydrate
Active substance concentration: approx. 0.8% (diluted)

4. Fresenius Diasteril®:
(Water temperature in the cleaning program: 37 °C)
Active substance base: hydroxyacetic acid
Active substance concentration: approx. 0.8% (diluted)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-87

 Indicator for disinfectants

Caution
It is recommended to perform the check for residual disinfectants at the drain of
the hemodialysis machine.
In case other test methods are applied, the requesting person bears the respon-
sibility for this decision.

Potassium-iodide-starch paper:

Detection of residual Puristeril or Sporotal

(violet coloring – iodine precipitation).

Caution
Always use fresh (white) indicator paper.

Determination of the pH:

Checking for Diasteril® (pH test strips).

Caution
Test for approx. 10 to 15 sec. In the event of a positive pH reaction (yellow color
≤ 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

Fresenius ClearSurf™:
Type of disinfection: scouring/wiping disinfection
Active substance base: cationic tensides
Use concentration: see product description
0.5 % – 1 hour
1.0 % – 15 minutes

1-88 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.9.3 DIASAFE ®plus (option)

Caution
Use only the original DIASAFE®plus specified herein.

Observe the “use by” date printed on the packaging.

“Use by” symbol:

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-89

1.9.4 Part Numbers

Part Part number Information

Dialyzers

Fresenius Polysulfon® F4 HPS 500 704 1 Low-flux

hollow-fibre dialyzers F5 HPS 500 705 1 Low-flux
(INLINE steam-sterilisation) F6 HPS 500 706 1 Low-flux
F7 HPS 500 707 1 Low-flux
F8 HPS 500 708 1 Low-flux
F10 HPS 500 720 1 Low-flux

Fresenius Polysulfon® F4 500 161 1 Low-flux

hollow-fibre dialyzers F5 500 162 1 Low-flux
(ETO-sterilized) F6 500 145 1 Low-flux
F7 500 163 1 Low-flux
F8 500 164 1 Low-flux

Fresenius FX-Class FX 40 500 884 1 High-flux

hollow-fibre dialyzers FX 50 500 885 1 High-flux
(INLINE steam-sterilisation) FX 60 500 886 1 High-flux
FX 80 500 888 1 High-flux
FX 100 500 890 1 High-flux
Fresenius Polysulfon ® F40S 500 714 1 High-flux
hollow-fibre dialyzers F50S 500 715 1 High-flux
(INLINE steam-sterilisation) F60S 500 716 1 High-flux
HF80S 500 718 1 High-flux

Fresenius Polysulfon® F40 500 141 1 High-flux

hollow-fibre dialyzers F50 500 135 1 High-flux
(ETO-sterilized) F60 500 136 1 High-flux
HF80 500 160 1 High-flux

Blood lines
Double-Needle dialysis
AV-Set FMC (FA 204B / FV 204B) 500 056 1 22 mm ETO
AV-Set FMC (FA 204B / FV 234B) 500 057 1 30 mm ETO
AV-Set FMC (FA 204B / FV 204B) S 601 421 1 22 mm Steam
AV-Set FMC (FA 204B / FV 234B) S 601 431 1 30 mm Steam
AV-Set FMC (FA 204B / FV 204B) G 501 721 1 22 mm Gamma
AV-Set FMC (FA 204C / FV 234B) G 501 706 1 30 mm Gamma
Single-Needle dialysis
AV-SN-Set FMC (FA 514 SN B / FV 204B) 501 741 1 22 mm ETO
AV-SN-Set FMC (FA 514 SN B / FV 234B) 501 742 1 30 mm ETO
Arterial – FA 514 SN B S 605 014 1 – Steam
Venous – FV 204 B S 604 804 1 22 mm Steam
Venous – FV 234 B S 604 834 1 30 mm Steam
AV-SN-Set FMC (FA 514 SN B / FV 204B) G 501 703 1 22 mm Gamma

1-90 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 508 992 1 GB, D, F, NL, E, P, I
Sodium bicarbonate 700 g 508 510 1 S, SF, DK, N
Sodium bicarbonate 950 g 508 991 1 GB, D, F, NL, E, P, I
Sodium bicarbonate 950 g 508 732 1 S, SF, DK, N

Desinfection and decalcification

Fresenius Puristeril® 340 508 551 1 5-kg container
Fresenius Puristeril® 340 508 550 1 10-kg container
Fresenius Puristeril®plus 5-kg container
508 570 1 D, NL, F, GB,
S, DK
508 571 1 E, P, I, H, HR, GR
508 572 1 RUS, SK, RO, PL,
SLO, GB
Fresenius Sporotal® 100 508 542 1 5-kg container
Fresenius Citrosteril® 508 535 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
pH test strips 628 816 1

Solutions for disinfecting

and cleaning the machine outside
Fresenius ClearSurf™ 6 x 2 liters
508 569 1 D, F, NL, I
508 573 1 GB, E, P, SLO
508 579 1 RUS, PL, RO, BG
508 577 1 S, DK, CZ, SK
508 578 1 GR, H, HR, TK

Measuring vessel 50 ml 603 062 1

Controlled volume pump 20 ml 603 063 1

DIASAFE ®plus (option)

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-91

1.10 Specifications

1.10.1 Dimensions, Weight and Housing Material

Dimensions: Height: approx. 133 cm (without IV pole)

Width: approx. 49.5 cm
Depth: approx. 34 cm (without housing footing)
Floor space: approx. 48 x 63 cm2

Weight: Approx. 80 kg (without options)

Housing material: Rigid polyurethane foam

1.10.2 Electrical Safety (classifications according to EN 60601-1, IEC 601-1)

Type of protection Safety classification I

against electrical shock:

Degree of protection Type B Symbol:

against electrical shock:

Protection against Drip-proof Symbol: IPX1

ingress of liquids:

Leakage currents: According to TSCs

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

1-92 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.10.3 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 rinsing: Approx. 9 A, hot rinsing temperature: 84 °C

hot rinsing 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 storage battery (maintenance-free)

18 V (= 3 x 6 V)/3 Ah

1.10.4 Type Label

4008 B
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 shock: type B
liquids: drip-proof 7 CE mark

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-93

1.10.5 Fuses

Mains switch: 2 x G 16 A Circuit-breaker Rear of power supply unit

Power transformer: 2 x T 2,5 A Fusible cut-out Power supply unit, LP 639/SI1, SI2
External voltage supply: 2 x T 2,5 A Fusible cut-out Power supply unit, LP 639/SI3, SI4
+5 V, +12 V: 1 x T 2,5 A Fusible cut-out Power supply unit, LP 638/SI2
+24-V regulator: 1 x T 12,5 A Fusible cut-out Power supply unit, LP 638/SI1
Standby function: 1 x T 0,2 A Fusible cut-out Power supply unit, LP 639/SI6
Battery: 1 x T 3,15 A Fusible cut-out Power supply unit, LP 639/SI5

1.10.6 Operating Conditions

Water inflow pressure: 1.5 up to 6.0 bar

Water inflow temperature: 5 °C up to 30 °C

with „Integrated Hotrinse“: 85 °C up to 95 °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:

Atmospheric pressure: 700 hPa up to1060 hPa

Relative humidity: 30 % up to 75 %, 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

1-94 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.10.7 External Connection Options

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).

Condition indicator: Can be used for the connection of a condition indicator (optional).

Input/output: Can be used for the connection of external auxiliary equipment

(no more than 24 V/24 W).

Screen: Can be used for the connection of a screen (optional) to represent

UF and sodium profiles.

Alarm in: External make contact.

(Alarm input)
Can be used for the connection of an external pushbutton switch, serving to re-
lease an alarm.

Alarm out: Potential-free alarm outlet. Alternating contact

(Alarm output) (no more than 24 V/24 W).
Can be used to connect an external alarm indicator (lamp) (nurse call).
Connection by means of a 5-pin diode plug (stereo 180°) via a shielded line.
Shield earthed on either side.

Diagnosis: Can be used for inhouse computer diagnosis.

HDF: Can be used for the connection of an ON-LINE HDF system

(optional).

ACDA: Currently not used.

4008 Remote control: For connection of a remote control (option)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-95

1.10.8 Overriding Conditions

Suppression of Alarm-tone-mute time: adjustable in the SETUP menu from 1 to 2

audible alarm: minutes (factory setting: 1 minute).
Any new alarm reactivates the silenced audible alarm.

Blood leak override: Override time: 2 minutes

Alarm override: The Dialysis Start 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.

1-96 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.10.9 Operating Programs

Functional test: Automatic test for checking the protective systems.

Must be initiated prior to each hemodialysis procedure.
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
opaque fluid in the blood line.

Priming the blood lines: Automatic priming of the blood lines when 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 (procedure according

to Bergström method).

Single needle With use being made of the arterial blood pump and the venous line
click-clack dialysis: clamp; pressure-pressure-controlled with adjustable pressure re-
verse 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 / integrated hot rinse:
Time adjustable in the SETUP menu, temperature: approx. 84 °C,
flow: 450 ml/min
Cleaning program time stops at upper temperature alarm.
Applicable to 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.

Flush, rinsing the water With a water inflow rate of 1.3 l/min and an inlet pressure of 1.5 bar,
supply hose (option) the water supply hose will be rinsed with a volume of 260 ml.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-97

1.10.10 Dialysate Circuit and Safety Systems

Blood leak detector: Threshold of response lower than and equal to 0.5 ml blood loss per
minute into 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 on the fluid volume in the hydraulic compartment
between dialyzer and blood leak detector (approx. 110 ml total fluid volume) and
on the size of the membrane rupture in the dialyzer. In addition, the response of a
blood leak alarm is, dependent on the set ultrafiltration rate.

Transmembrane pressure:Range of indication: –60 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 to maximum rate

Resolution: 1 ml/h
Pump volume accuracy: ±1 %
Maximum rate internally adjustable to 1, 2, 3, or 4 l/h.
Safe state: pressure equalization via the dialyzer membrane, ultrafiltration = 0

Cyclic pressure V24 and V24b closed; bypass operation

holding test: Activation on the outlet side of the dialyzer for 8 seconds every
12.5 minutes.

Balancing: Accuracy: ±0.1 % related to the total dialysate volume

1-98 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 = F UF + 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)
Procedure: 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 measuring equipment with
adjustable alarm window.

– Acetate: Standard setting 1+34 (further mixing ratios can be adjusted via
the SETUP menu). Range of adjustment: 125 to 150 mmol/l, de-
pending on the concentrate used.
Volumetric proportional mixing system. The rated concentration is achieved after
10 minutes at the latest.

– 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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-99

 Temperature:
– Dialysate temperature Display range: 33.5 °C up to 41.0 °C
as well as rinse and Range of adjustment: Dialysis (Rated temperature):
chemical disinfection 35.0 °C up to 39.0 °C
temperature: Cleaning programs: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.5 °C
Alarm window width: Dialysis: 33.5 °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 up to 99 °C

temperature: (Text indication)
Rated temperature: 84 °C
Resolution: 1 °C
During the hot rinsing program, timing is started as soon as 80 °C are exceeded.
In the event of a malfunction, the heater is turned off at 90 °C.

Flow: Display range: 100 up to 1000 ml/min

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

– Rinse and chemical Rated value: 600 ml/min

disinfection flow:

– Hot rinsing flow: Rated value: 450 ml/min

– Flow alarm: The dialysate flow is below 180 ml/min.

– With water deficiency: Visual alarm, heater turn-off,

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

1-100 Fresenius Medical Care 4008 B 16/10.03 (OP)

DIASAFE ®plus (option): Filter service life: Maximum of 12 weeks.
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).

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-101

1.10.11 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 clear fluid:
Alarm window width: –300 to +280 mmHg
The OD in the LD senses dark fluid:
Alarm window width: 120 mmHg, adjustable over the entire
display range
With single needle dialysis and single needle click-clack dialysis:
the OD in the LD senses either dark or clear fluid; upper limit fixed
to 280 mmHg; lower limit adjustable from 0 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 tubing systems).
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 as specified for the arterial blood pump.
Pressure transducer for single needle operation: pressure reversal.

1-102 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 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.
An alarm will be initiated when 5 ml of air over a rate of
600 ml/min are detected.
The indication of the air volume here refers to microbubbles with a
diameter <10 µm when using the tubing systems approved for the
machine.
Procedure: ultrasonic transmission

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-103

 Heparin pump: Delivery rate: 0.1 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, to
1.2 bar back pressure
(calibrated for Fresenius 30-ml
heparin syringes)
With delivery rates <1.0 ml/h the indi-
cated tolerance of ±5% may be ex-
ceeded.
Stopwatch time: 1 min to 9 h 59 min
Resolution: 1 minute
Bolus administration: 0.1 to 5.0 ml
Resolution: 0.1 ml
Maximum accumulating 1 x syringe contents
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:

1-104 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.10.12 Environmental Compatibility and Recycling

Only environmentally compatible and recyclable materials are used for the manufacture of hemo-
dialysis 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 accompanied by an asterisk come into contact with water, dialysate and dialysate con-
centrate.)

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-105

 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

1-106 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.11 Definition 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 in the blood line 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. in the
single needle mode.

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.

Occlusion clamp Device for automatically clamping the blood lines, 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 tubing system to the pressure monitoring
unit.

Product water Water suitable for hemodialysis (e.g. water purified by reverse
osmosis).

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-107

 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 back pressure Pressure in the extracorporeal circuit before the venous cannula
(e.g. in the venous bubble catcher).

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

1-108 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.12 Abbreviations and Symbols

1.12.1 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

LD = level detector

LED = light emitting diode

OD = optical detector

SI = shunt interlock

SN = single needle

SV = solenoid valve

TMP = transmembrane pressure

UF = ultrafiltration

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-109

1.12.2 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 conductor terminal

Earth terminal

Equipotentiality

I/O ON / OFF

Start of a specific procedure

Dangerous electrical voltage

1-110 Fresenius Medical Care 4008 B 16/10.03 (OP)

1.13 Technical Safety Checks

1.13.1 Important Information

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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-111

1.13.2 TSC Checklist

TSC checklist
4008 for the Technical Safety Checks
to be performed annually (every 12 months) Fresenius Medical Care

Page 1/2

Name of technician: Service report no.:

Customer/Customer no.:

Inventory no.: Serial no.: Operating hours:

System type:
With option(s):

No. Description Measured ✓

value
1 Visual inspections
1.1 Fuses accessible from the outside comply with the indicated values – ❏
1.2 Labels and identifications are present and legible – ❏
1.3 Mechanical condition permits further safe use – ❏
1.4 No damage or contaminations detectable – ❏
1.5 Power cord not damaged – ❏
2 General checks
2.1 Power failure alarm – continuous sound – text displayed: Emergency operation – ❏
2.2 Air separation by air separation pump activated; text displayed – ❏
if more air must be separated and OD senses opaque fluid: Fill program
2.3 V91, V99, V100 are operational and do not leak.
(Check will not be applicable if CDS or hydraulics test activated.) – ❏
4 Ultrafiltration system and membrane pumps
4.1 UF pump, 1 stroke = 1 ml, 60 strokes = 60 ml ± 0.5 ml ………… ❏
5 Dialysis mode
5.5 Conductivity display checked using a reference meter CD system/CD ref. …… / …… ❏
(If the bibag® option is used, connect a bibag ®.)
6 Extracorporeal components
6.3 Blood pumps: check the blood pump rate (calibration program: BP-Rate CHECK) – ❏
6.4 SN switching pressure checked according to table in TM – ❏
6.5 Blood pump stop alarm checked – ❏
6.6 Venous line clamp closes after blood alarm – ❏
6.7 Pressure of approx. 2 bar in the venous bubble catcher.
Pressure must not drop by more than 0.1 bar within 3 minutes. – ❏
7 Options
7.4 4008 HDF
7.4.1 Volume delivered by the 2nd UF pump checked: 60 strokes = 60 ml ± 0.5 ml ………… ❏
7.5 Online-HDF
7.5.6 ❏ Substituate pump (part no. 672 521 1) with DC motor:
check volume delivered by the pump desired/actual …… / …… ❏
or
❏ Substituate pump (part no. 674 982 1) with stepper motor: check the pump rate – ❏
(calibration program:BP-Rate CHECK)
7.5.7 Substituate pump stop:
– after blood alarm – ❏
– after triggering the bypass function – ❏
– after opening the blood pump door – ❏
7.5.8 Check substituate pump for proper function:
– Rinse program, delivery rate: 400 ml/min – ❏
– Hot rinse program, delivery rate: 150 ml/min – ❏
– Disinfection program, delivery rate: 400 ml/min – ❏
7.6 ONLINEplus™
7.6.4 Line in the line pinch valve 193 (ONL1) replaced – ❏
7.6.5 Valve V39 checked – ❏
(Not applicable if DIP switch array 2, P.C.B. LP 632, switch 5 set to OFF)

1-112 Fresenius Medical Care 4008 B 16/10.03 (OP)

 TSC checklist
4008 for the Technical Safety Checks
to be performed annually (every 12 months) Fresenius Medical Care

Page 2/2
No. Description Measured ✓
value
8 Checking the electrical safety
In Germany according to DIN VDE 0751 standard –1st Edition 10/2001.
In other countries, observe the local regulations!
8.1 Visual inspection performed according to item 1. ❏
8.2 Protective earth resistance maximum 0.3 ohms (with power cord) ………… Ω ❏
8.3 Measurement of the leakage current (device leakage current) ❏
❏ Differential current measurement according to fig. C.6
or
❏ Direct measurement according to fig. C.5

Nominal voltage of power supply: ………… V

Device leakage current mains polarity 1 ………… µA

for line voltage ………… V
scaled to nominal voltage (maximum 500 µA, see also Additional conditions) ………… µA

Device leakage current mains polarity 2 ………… µA

for line voltage ………… V
scaled to nominal voltage (maximum 500 µA, see also Additional conditions) ………… µA

Test equipment used ……………………………………………………………

9 Functional test
9.1 T1 test performed – ❏

Date: Signature: Stamp:

The system has been released for further use ❏ Yes ❏ No

Remarks:

Date: Signature: Stamp:

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-113

1.14 Certificates

1.14.1 EC Certificate

1-114 Fresenius Medical Care 4008 B 16/10.03 (OP)

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-115
1-116 Fresenius Medical Care 4008 B 16/10.03 (OP)
1.15 Literature

1.15.1 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

1.15.2 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

1.15.3 Blood Temperature Monitor (BTM)

– “Fresenius Publikation” (EDTNA-Journal 1992) with further literature.

Fresenius Medical Care 4008 B 16/10.03 (OP) 1-117

1-118 Fresenius Medical Care 4008 B 16/10.03 (OP)
Table of Contents 2 Preparation

Chapter Page

2.1 Hemodialysis 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 Test ............................................................................................................. 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 End of Test ...................................................................................................................... 2-20
2.2.6 Malfunctions .................................................................................................................... 2-21
2.2.7 Interruptions in the Test Sequence ................................................................................. 2-24
2.2.8 Premature Termination of the Test ................................................................................. 2-24

2.3 Blood Pump ................................................................................................................... 2-25

2.3.1 Installing the Arterial Lines .............................................................................................. 2-25
2.3.2 Selecting the Line Size ................................................................................................... 2-26

2.4 Heparin Pump ................................................................................................................ 2-27

2.4.1 Positioning the Slide Carriage ........................................................................................ 2-27
2.4.2 Setting the Delivery Rate ................................................................................................ 2-29
2.4.3 Setting the Delivery Time ................................................................................................ 2-30

2.5 Air Detector ................................................................................................................... 2-31

2.5.1 Installing the Venous Lines ............................................................................................. 2-31

2.6 Extracorporeal Blood Circuit ....................................................................................... 2-33

Fig.: Blood lines for double needle dialysis .................................................................. 2-34
Fig.: Blood lines for single needle dialysis .................................................................... 2-34

2.7 Priming the Extracorporeal Blood Circuit With a Saline Bag .................................. 2-35
2.7.1 Priming ............................................................................................................................ 2-35
2.7.2 Setting the Delivery Rate of the Blood Pump ................................................................. 2-36
2.7.3 Stopping Delivery ............................................................................................................ 2-37
2.7.4 Interrupting the Priming Program .................................................................................... 2-39
2.7.5 Premature Termination ................................................................................................... 2-39

2.8 Dialysate Side ................................................................................................................ 2-40

2.8.1 Functional Checks Prior to Each Dialysis Treatment ..................................................... 2-40
2.8.2 Setting the Acetate / Acid Pump ..................................................................................... 2-41
2.8.3 Setting the Bicarbonate Pump ........................................................................................ 2-43
2.8.4 Setting the CD Window ................................................................................................... 2-44
2.8.5 Collecting a Fluid Sample ............................................................................................... 2-46
2.8.6 Connecting the Dialyzer .................................................................................................. 2-46
2.8.7 Changing the Dialysate Flow .......................................................................................... 2-48
2.8.8 Changing the Dialysate Temperature ............................................................................. 2-48
2.8.9 Rinsing the Dialyzer ........................................................................................................ 2-49

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-1

2-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
2.1 Hemodialysis Machine

2.1.1 Turning Power on

Turn the water supply on.

Fresenius Medical Care 4008 B Press the I/O key.

Turn the hemodialysis machine on!

The I/O LED is illuminated.

☛ I/O
Luftdetektor Arterieller
Druck
Ve
D

al Care 4008 B
Indication of the machine type and the
** 4008 B / VX.X ** current software version.

Arterial Venous Transmembrane

The yellow (warning/info) status
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml
indicator is illuminated.
R Internal RAM test
CRC test
Test of the 24-V safety cutoff circuit
(watch dog)
SCANNING CAN-BUS

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-3

2.1.2 Blood Pump Self-Test

Rate: ml/min
The LED segments, the alarm (red) LED
(Ø: mm)
and the operation (green) LED light for
1 second.

Start
Stop

Rate: ml/min
Indication of the line diameter for approx.
(Ø: mm)
2 seconds.

Start
Stop

Rate: ml/min
Indication of the delivery rate.
(Ø: mm)

Start
Stop

2-4 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 LED light for 1 second.
Bolus

Rate

Start
Stop

Rate: ml/h
(Bolus: ml)
Indication of the syringe size.

( :h.min)

Bolus

Rate

Start
Stop

Rate: ml/h
(Bolus: ml)
Indication of the delivery rate.

( :h.min)

Bolus

Rate

Start
Stop

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-5

2.1.4 Concentrate Supply

● Acetate Dialysis

Rate: ml/h
(Bolus: ml)

Bolus

Rate
( :h.min)

Place the combined concentrate suction

Start
Stop
tube for acid and acetate (red) in the
acetate container.
Leave the bicarbonate suction tube
(blue) in the rinse port or place it in the
rinse port if it is not already there.
Acetate
concentrate

● Bicarbonate Dialysis

Rate: ml/h
(Bolus: ml)

Bolus

Rate
( :h.min)

Place the combined concentrate suction

Start
Stop
tube for acid and acetate (red) in the
acid container.
Place the bicarbonate suction tube (blue)
in the bicarbonate container.

Bicarbonate Acid
concentrate concentrate

Caution
Assure that the containers contain
sufficient concentrate and bicarbo-
nate to complete the treatment.

2-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

● bibag® (Option)

General Notes

Close the interlock plate when no bibag®

is used.
☛

☛
Caution
Wait until the cooling rinse program
following a hot rinse (or heat desin-
fection) has been completed before
connecting the bibag ®.

☞ Note
During treatment with the bibag®, the
bicarbonate suction tube must be in-
serted in the rinse port.
Removing the suction tube may
cause a rinse chamber overflow.

☞ Note
The bibag® will be filled when the
bibag ® and the bicarbonate suction
tube have been connected.
The bibag® has priority over bicarbo-
nate supplied by the CDS.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-7

 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°.

2-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

 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®.
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-9

 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

2-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

● 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 bicarbonate and acid being de-
livered via the CDS, the CDS must
be turned off in the user menu when
performing acetate dialysis with con-
tainers.

Confirm Select Press the Select key.

** 4008 B / VX.X **
☛ Press the ▲ and ▼ keys to select
5. System parameter.

Confirm Select Press the Confirm key.

5. System parameter
☛ Press the ▲ and ▼ keys to select
Status CDS.

Confirm Select Press the Confirm key.

5.4 Status CDS
☛ Press the ▲ and ▼ keys to set the de-
sired mode.

Confirm Select Press the Confirm key.

CDS off
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-11

2.2 Functional Test

2.2.1 General Notes

– The functional test is requested by the hemodialysis machine:

– after a start with external power (not power failure),
– after one of the cleaning programs.

– The functional test can be performed with or without previously installing the tubing system.
If the tubing system was filled during the cleaning program, the dialyzer must be deaerated
before starting the functional test. This is done by briefly opening and then closing the upper
screw cap of the dialyzer.

– Depending on the setting selected in the SETUP, the functional test will either start automat-
ically or must be started manually with the Test key.

– DIASAFE ®plus (option):

The filter test is integrated in the functional test.

– Starting conditions:
– The dialysate connectors (red/blue) are in the interlock shunt.
– The interlock shunt is closed.
– The optical detector in the air detector module senses clear fluid.
– The concentrate suction tubes are inserted in the appropriate container, or they are in-
serted according to the type of supply with CDS.

2.2.2 Start of the Test

Caution
If the XX not calibrated message is
displayed on starting the functional
test, the system must not be used to
perform a treatment.

2-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Automatic start

Override
–30
–200
0
Test
–40 –300
The Test LED is flashing.
Internal tests.
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

al Care 4008 B The yellow (warning/info) status

indicator is illuminated.

Air Detector Arterial Venous Transmembrane

Override
–30
–200
0
Test
–40 –300
The functional test is started automatic-
ally.
Prime
The Test LED is illuminated.
Dialysis Start If one of the starting conditions is not
Reset Alarm
fulfilled, an audible alarm will be
sounded.
Alarm Tone
Mute Use the Alarm Tone Mute key to ac-
knowledge 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-13

 ● Manual start

Override
–30
–200
0
Test
–40 –300
The Test LED is flashing.
Should the Test LED not be flashing,
Prime one of the conditions required for the
test to start is not fulfilled.
Dialysis Start
Reset Alarm

Alarm Tone
Mute

al Care 4008 B The yellow (warning/info) status

indicator is illuminated.

Air Detector Arterial Venous Transmembrane

Override

☛
–30
–200
0
Test
–40 –300
Press the Test key.

Prime The Test LED lights.

Dialysis Start
Reset Alarm

Alarm Tone
Mute

2-14 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.2.3 Priming During the Test

● Basic condition

Override
–30
–200
0
Test
–40 –300
The functional test has been selected.

Prime The Test LED is illuminated.

Dialysis Start
Reset Alarm

Alarm Tone
Mute

● Start

Override
–30
–200
Test
0
Press the Prime key.
–40 –300

☛ Prime The Test LED is illuminated.

Dialysis Start The Prime LED is illuminated.

Reset Alarm
Press the Dialysis Start key to start pre-
Alarm Tone circulation.
Mute
Precirculation can only be started after
completion of the display test.

al Care 4008 B The yellow (warning/info) status

indicator is illuminated.

Air Detector Arterial Venous Transmembrane

Confirm Select Temporary display message

Prime

or
Confirm Select
Prime / Circulation

Confirm Select Indication of the test steps

Test . . .

Confirm Select Display message with parallel test.

Test in Progress

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-15

 ● Setting the delivery rate of the blood pump

Rate: ml/min
The operation (green) LED is illumin-
(Ø: mm)
ated.
The blood pump is delivering.
☛ The arterial blood pump fills the tubing
Start
system up to the venous bubble catcher.
Stop A delivery rate > 180 ml/min will auto-
matically be returned to 180 ml/min.
The operator may select any delivery
rate desired.

Use the arrow keys ▲ or ▼ to select the

desired delivery rate.
(Pressing the keys longer than 3 sec-
onds will increase the change rate.)

● Delivery stops

Confirm Select Temporary display message

Prime end
The blood pump stops, as soon as the
venous bubble catcher is filled, however,
at the latest after 1 to 5 minutes.
Depending on the setting defined in
the SETUP menu

al Care 4008 B
Indication of the test steps
Test . . .
The red (alarm) status indicator is illu-
Arterial Venous Transmembrane
minated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml

Override
–30
–200
Test
0
The Test LED is illuminated.
–40 –300
Prime The Alarm Tone Mute LED is flashing.

Dialysis Start Audible alarm

Reset Alarm cleared automatically

Alarm Tone
Mute

2-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

 It may be necessary to raise the level in
the venous bubble catcher.
Pven. ☛ Press the ▲ key on the air detector mod-
ule until the desired level has been
reached.

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.
The blood pump starts running, and
Prime the venous line clamp is opened. Fluid
is recirculating.

☛
Dialysis Start
Reset Alarm
The Test LED is illuminated.
Alarm Tone
Mute The Prime LED is illuminated.
The Alarm Tone Mute is dark.

al Care 4008 B
Temporary display message
Circulation
The yellow (warning/info) status
Arterial Venous Transmembrane
indicator is illuminated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml

Confirm Select Indication of the test steps

Test . . .

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-17

 ● To interrupt priming of the tubing system

Rate: ml/min
Press the Start/Stop key.
(Ø: mm)

The operation (green) LED is dark.

Continue by pressing the key again.

Start
Stop
☛
● To stop priming

Override
–30
–200
0
Test
–40 –300
Press either the Dialysis Start or the
Prime key.

☛
Prime

Dialysis Start Continue priming by pressing the Prime

Reset Alarm
key again, or continue pre-circulation by
pressing the Dialysis Start key.
Alarm Tone
Mute

2-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.2.4 Test Steps

Confirm Select
Test Version X.X

Confirm Select
Test in Progress

Confirm Select The user must verify:

Check Status LED's Status LEDs

Confirm Select The user must verify:

Check Alarm LED's Alarm LEDs

Confirm Select In the event of a simultaneous test, the

Rinse-volume: XXXX ml rinse volume defined in the SETUP will
be displayed.

Confirm Select The user must verify:

All UF-Display Off The seven-segment displays are dark

Confirm Select The user must verify:

Check UF for 8888 – All seven-segment displays indicate
8888
– The alarm limits gradually move to
the top of the bargraph.
– Audible alarm

Confirm Select Display message

XXXXXXXXXXXXXXXXXXXX

Confirm Select
Test Display

Confirm Select Display message during serial test:

Test . . .
Bypass Bloodleak
opt. Detector Temperature
Blood system neg. Pressure
Rinse volume: XXXX ml pos. Pressure
Venous UF-Function
Air Detector Conductivity
Display DIASAFE plus
Arterial (optional)
Battery

Display message during parallel test:

Test in progress.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-19

2.2.5 End of Test

● With the tubing system not filled

Confirm Select Display message

T1 Test passed

Override
–30
–200
0
Test
–40 –300
The Test LED is dark.

Prime The Prime LED is flashing.

Dialysis Start The Dialysis Start LED is flashing.

Reset Alarm
The Alarm Tone Mute LED is flashing.
Alarm Tone
Mute Audible signal
cleared automatically

● With the tubing system filled

Confirm Select Display message

Preparation

Override
–30
–200 The Dialysis Start LED is illuminated.
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

2-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.2.6 Malfunctions

Override
–30
–200
0
Test
–40 –300
The Test LED is flashing.

Prime The Alarm Tone Mute LED is flashing.

Dialysis Start Audible signal

Reset Alarm

Alarm Tone
Mute

Confirm Select Display message

T1 Test failed

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-21

 Override

☛
–30
–200
0
Test
–40 –300
Press the Test key.
Prime
The Test LED is flashing.
Dialysis Start
Reset Alarm The Alarm Tone Mute LED is flashing.
Audible signal
Alarm Tone
Mute

Confirm Select
F.. .... Indication of the error code.

Override

☛
–30
–200
0
Test
–40 –300 Press the Test key.
Prime
The Test LED is illuminated.
Dialysis Start
Reset Alarm The Alarm Tone Mute LED is dark.

Alarm Tone
Mute

Confirm Select
Test ??? The test step which the machine failed to
pass is displayed and repeated.
If the test step is successfully passed,
the test is completed.

Confirm Select
F.. .... Should the error recur, it will be indicated
on the display together with the respect-
ive error code.

☞ Note
The following error messages can be
acknowledged by pressing the Test
key:
Skip Battery?
Skip Diasafe?

☞ Note
If the message Skip Battery? is
acknowledged by pressing the Test
key, a power failure eventually might
no longer be signalled by an audible
alarm.

2-22 Fresenius Medical Care 4008 B 16/10.03 (OP)

☛
Override
–30
–200
0
Test
–40 –300
Press the Test key.
Prime The Test LED is flashing.
Dialysis Start The Alarm Tone Mute LED is dark.
Reset Alarm

Alarm Tone
Mute

Confirm Select Display message, e.g.: Skip Battery

Skip Battery?

Override
–30
–200
0
Test
–40 –300
Press the Test key.

Prime The Test LED is flashing.

Dialysis Start The Alarm Tone Mute LED is dark.

Reset Alarm
Audible signal
Alarm Tone
Mute

Confirm Select Display message

Are you sure?

☛
Override
–30
–200
0
Test
–40 –300
Press the Test key.

Prime The Test LED is illuminated.

Dialysis Start The Alarm Tone Mute LED is dark.

Reset Alarm
If the problem persists, call the
Alarm Tone service.
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-23

2.2.7 Interruptions in the Test Sequence

– One of the starting conditions listed in Chapter 2.2.2 Start of the Test is no longer fulfilled.
– After the problem has been corrected the test continues.

2.2.8 Premature Termination of the Test

Fresenius Medical Care 4008 B Press the I/O key

Turn the hemodialysis machine off!

The I/O LED stops lighting.

☛ I/O
Luftdetektor Arterieller
Druck
Ve
D
The test can be prematurely terminated
only by turning the machine off.

2-24 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.3 Blood Pump

2.3.1 Installing the Arterial Lines

Rate: ml/min
(Ø: mm)
➀ Open the blood pump door.
➁ Press and hold the Start/Stop key
until the rotor stops.
Start
Stop

☛
➁

Rate: ml/min
(Ø: mm)
➀ Install the line segment on the left
side.
➁ Press and hold the Start/Stop key
Start until the rotor stops.
Stop
➄ ☛ ➂ Install the line segment on the right
➁ side.
➃ Close the blood pump door.
➄ Connect the pressure measuring line
to the pressure connector.

➀ ➂
➃

Connect the arterial blood line to the dia-

lyzer blood inlet.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-25

2.3.2 Selecting the Line Size

Rate: ml/min
If the rotor of the blood pump is deliver-
(Ø: mm)
ing:

Press the Start/Stop key.

Start
Stop
The operation (green) LED is dark.
☛
Rate: ml/min
Simultaneously press the ▲ and ▼ keys.
(Ø: mm)
The current line size is indicated in mm
and flashing digits.
☛
☛
Start
Stop

Rate: ml/min
Use the ▲ key or the ▼ key to select the
(Ø: mm)
desired value.
(Pressing the keys longer than 3 sec-
onds causes the changing rate to ac-

Start
☛ celerate.)
Range of adjustment:
Stop 2 to 10 mm in 0.2 mm increments

Rate: ml/min
Acknowledge the value by pressing the
(Ø: mm)
Start/Stop key.
(The value is indicated for approx.
2 seconds.)
The delivery rate of the blood pump
is set to 0.
Start
Stop
☛
Rate: ml/min
Use the ▲ key to adjust the delivery rate.
(Ø: mm)

☛
Start
Stop

2-26 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.4 Heparin Pump

2.4.1 Positioning the Slide Carriage

Rate: ml/h
(Bolus: ml)
Press the ▲ key.
The slide carriage moves to the fully
open position.
( :h.min)

Bolus

Rate
☛
☞ Note
When the slide carriage moves to the
fully open position, 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 and hold the ▼ key until the

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-27

 ☞ (
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
Make sure that the syringe wings are
in the syringe wing slot.

2-28 Fresenius Medical Care 4008 B 16/10.03 (OP)

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)
Set the desired rate by pressing the
▲ and ▼ keys.
(Pressing the keys longer than 3 sec-
( :h.min)
onds causes the changing rate to ac-
Bolus celerate.)
Range of adjustment: 0.1 to 10 ml/h in
Rate ☛ increments of 0.1 ml/h

Start
Stop

Rate: ml/h
(Bolus: ml)
Press the Rate key to acknowledge the
selected rate.
The display is flashing until the se-
( :h.min)
lected rate is acknowledged by press-
Bolus ing 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-29

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)
Select the desired time by pressing the
▲ and ▼ keys.
(Pressing the keys longer than 3 sec-
( :h.min)
onds causes the changing rate to jump
Bolus from 1-minute to 10-minute incre-
ments.)
Rate ☛ Range of adjustment: 1 minute to
9 hours 59 minutes in increments of
Start 1 minute
Stop

Rate: ml/h
(Bolus: ml)
Press the key to acknowledge the se-
lected time.
The display is flashing until the se-
( :h.min)
lected time is acknowledged by press-
Bolus
ing the key.
During this time, the previous delivery
Rate time remains active.

☛ Start The stop-watch time indicator (green)

Stop
lights after confirming the selected time.
The stop-watch time indicator (green)
is illuminated until the selected delivery
time has elapsed.

2-30 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.5 Air Detector

2.5.1 Installing the Venous Lines

Connect the venous blood line to the dia-

lyzer blood outlet.
Pven. Insert the venous bubble catcher in the
bubble catcher holder.

☞ Note
Place the clot catcher at a level
approximately 1 cm below the lower
edge of the bubble catcher holder.

Caution
Do not use ultrasound-conducting
media on the air detector.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-31

 ➃ ➀ Open the door 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 door.
➃ Connect the venous pressure meas-
uring line to the venous pressure con-
nector (Luer-lock).

➁
➀
➂

Caution
Do not remove the blood line from
the optical detector during treatment.

2-32 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 lines 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 ve-
nous alarm limit to be as close as
possible to the actual value of the ve-
nous pressure.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-33

 Fig.: Blood lines Fig.: Blood lines
for double needle dialysis for single needle dialysis

Fresenius Medical Care 4008 B Fresenius Medical Care 4008 B

Best. Auswahl Best. Auswahl

I/O I/O
Luftdetektor Arterieller Venöser TMP Ultrafiltration Leitfähigkeit Luftdetektor Arterieller Venöser TMP Ultrafiltration Leitfähigkeit
Druck Druck Druck Druck
UF Menge ml UF Menge ml

Spülen Reset Spülen Reset

Konz. Bic. Konz. Bic.
kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg kPa mmHg

Heißreinigen 280 500 500 Heißreinigen 280 500 500

Blutleck 30 60 60 UF Rate ml/h 15.5 Blutleck 30 60 60 UF Rate ml/h 15.5
200 200
Desinfektion
20 50 400 50 400 15 Desinfektion
20 50 400 50 400 15
10
100 10
100
40 300 40 300 14.5
40 300 40 300 14.5
0 0 30 30 0 0 30 30
Single 200 200 14 Single 200 200 14
Needle –10 Needle –10
–100 20 20
UF Ziel ml –100 20 20
UF Ziel ml
–20 10
100 10
100 13.5 –20 10
100 10
100 13.5
Überbrücken Überbrücken
–200 –200
Test
–30 0 0 0 0 13 Test
–30 0 0 0 0 13
–40 –300 mS/cm –40 –300 mS/cm
(25°C) (25°C)

Vorbereiten Vorbereiten
UF Restzeit h:min UF Restzeit h:min
Variation Variation

I/O Prog. I/O Prog.

Dialyse Start Dialyse Start
Tempera- Tempera-
UF Fluß tur UF Fluß tur

Alarm I/O Prog. I/O Set Alarm I/O Prog. I/O Set
Ton Aus Ton Aus

Rate: ml/min Rate: ml/min Rate: ml/min Rate: ml/min

(Ø: mm) (Ø: mm) (Ø: mm) (Ø: mm)

Pven. Pven.

Start Start Start Start

Stop Stop Stop Stop

Rate: ml/h Rate: ml/h

(Bolus: ml) (Bolus: ml)

( :h.min) ( :h.min)

Bolus Bolus

Rate Rate

Start Start
Stop Stop

2-34 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.7 Priming the Extracorporeal Blood Circuit With a Saline Bag

2.7.1 Priming

Connect the arterial connector of the tub-

ing system to the saline bag.
Break the cone of the saline bag.
Connect the venous connector of the
tubing system to the rinse bag.

Override
–30
–200
0
Test
–40 –300
Press the Prime key.

☛ Prime

Dialysis Start
Reset Alarm
The Prime LED is illuminated.

Alarm Tone
Mute

al Care 4008 B
The yellow (warning/info) status
Prime indicator is illuminated.

Arterial Venous Transmembrane

The Air Detector alarm indicator is
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml illuminated.
R
Display message

Confirm Select Temporary display message, if a rinse

Rinse-volume: XXXX ml volume has been defined in the SETUP.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-35

2.7.2 Setting the Delivery Rate of the Blood Pump

Rate: ml/min
The operation (green) LED is illumin-
(Ø: mm)
ated.
The blood pump is delivering.
☛ The arterial blood pump fills the lines up
Start
to the venous bubble catcher.
Stop A delivery rate > 180 ml/min will auto-
matically be returned to 180 ml/min.
The operator may select any delivery
rate desired.

Use the arrow keys ▲ or ▼ to select the

desired delivery rate.
(Pressing the keys longer than 3 sec-
onds will increase the change rate)

2-36 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.7.3 Stopping Delivery

Temporary display message

Confirm Select
Prime end

Display message
Confirm Select Pre-circulation will be started automat-
Preparation ically on completion of the priming pro-
cedure.

Display message when the rinse volume

Confirm Select has been reached.
Rinse volume reached

Override
–30
–200
0
Test
–40 –300
The Dialysis Start LED is flashing.

Prime The Alarm Tone Mute LED is flashing.

Dialysis Start Audible alarm (only if the venous bubble

Reset Alarm
catcher is filled)
cleared automatically
Alarm Tone
Mute

al Care 4008 B The red (alarm) status indicator is illu-

minated.
The Air Detector alarm indicator is
flashing.
Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-37

 It may be necessary to raise the level in
the venous bubble catcher.
Pven. ☛ Use the ▲ key on the air detector mod-
ule until the desired level is reached.

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.
The blood pump starts running and the
Prime venous line clamp opens.

☛
Allow fluid to recirculate until all air has
Dialysis Start been removed from the tubing system
Reset Alarm
and the dialyzer.

Alarm Tone
Mute The Dialysis Start LED is illuminated.
The Alarm Tone Mute LED is dark.

Override
–30
–200
0
Test
–40 –300
Should the venous bubble catcher not be

☛
filled after 2 minutes (depending on the
Prime
setting selected in the SETUP), proceed
Dialysis Start as follows:
Reset Alarm
Press the Prime key again.
Alarm Tone
Mute The Prime LED is illuminated.
The Dialysis Start LED is dark.

2-38 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.7.4 Interrupting the Priming Program

Rate: ml/min
Press the Start/Stop key.
(Ø: mm)

The operation (green) LED is dark.

Continue by pressing the key again.

Start
Stop
☛
2.7.5 Premature Termination

Override
–30
–200
Test
0
Press the Dialysis Start key or the
–40 –300
Prime key.

☛
Prime
Continue priming by pressing the Prime
Dialysis Start
Reset Alarm key again.

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-39

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 speci-
fications 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.

2-40 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.8.2 Setting the Acetate / Acid Pump

Press the Conc key.

Transmembrane Ultrafiltration Conductivity
Pressure
UF Volume ml

Reset
Conc Bic
kPa mmHg

☛
500 15.5

Confirm Select Mixing ratio set in the SETUP menu.

Dilution 1+XX

☞ Note
If acetate dialysis (mixing ratio 1+34)
is desired and there is an other mix-
ing ratio set, check the basic condi-
tions:
Acetate supply established. Bicarbo-
nate suction tube in rinse chamber;
bicarbonate CDS switched off;
bibag ® not connected.

Confirm Select Use the ▲ and ▼ keys to set the mixing

Dilution 1+34
☛ ratio to 1+34.

Confirm Select Press the Confirm key to confirm the

Dilution 1+XX mixing ratio.
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-41

 Confirm Select
Press the Confirm key to confirm the
Check concentrate ! safety prompt.
☛
Caution
Verify proper acetate connection and
make sure that the corresponding
mixing ratio has been selected.
In the event of inadvertant use of an
acid concentrate intended for a 1+45
mix ratio with the mix ratio set to
1+34, a conductivity will be displayed
although the dialysate will be without
physiological buffer.
Use of this dialysate presents a
hazard to the patient.

Confirm Select
Last set value.
Base Na+ xxx mmol
☛ Adjust the base Na+ by pressing the ▲
and ▼ keys.
(Range of adjustment: 125 to 150 mmol)
The base Na+ is specified on the con-
tainers and/or the package circular.

Confirm Select Press the Confirm key.

Base Na+ xxx mmol
☛
Confirm Select
Last set base value.
Prescr. Na+ xxx mmol (Depending on SETUP setting.)
☛ Set the prescribed Na + value by pressing
the ▲ and ▼ keys.
(Range of adjustment: 125 to 150 mmol)
Prescr. Na + = base Na + ±13 mmol

Confirm Select Press the Confirm key.

Prescr. Na+ xxx mmol
☛

2-42 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.8.3 Setting the Bicarbonate Pump

☞ Note
The respective sodium and bicarbo-
nate ion concentrations are specified
in the corresponding product infor-
mation.

Press the Bic key.

Transmembrane Ultrafiltration Conductivity
Pressure
UF Volume ml

Reset
Conc Bic
kPa mmHg

500 15.5
☛
Confirm Select Basic setting: ±0 (or as defined in the
Bicarbonate x mmol SETUP setting)
☛ Adjust the bicarbonate pump by pressing
the ▲ and ▼ keys.
(Range of adjustment: –8 to +8 mmol)

Confirm Select Press the Confirm key.

Bicarbonate x mmol
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-43

2.8.4 Setting the CD Window

● Repositioning the CD window

Confirm Select Press the Select key.

Preparation
☛
Confirm Select
Press the Confirm key.
1. Set cond window
☛
Confirm Select Use the ▲ and ▼ keys to shift the CD
Set Cond. Limits
☛ window.

Confirm Select Press the Confirm key.

Set Cond. Limits
☛
Caution
The alarm limits on the conductivity
display must be set around the ex-
pected value.
The actual value of 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.

2-44 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Centering the CD window around the actual value

Confirm Select Press the Select key.

Preparation
☛
Confirm Select Press the Confirm key twice.
1. Set cond window
☛ 2x

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-45

2.8.5 Collecting a Fluid Sample

➀ Place the syringe (e.g. 10-ml Luer-

➀ lock) on the Luer-lock connector of
the sampling valve.
➄ The valve is located in the dialyzer
➃
➂ feed line.
➁ Press the key and hold it.
➂ Lock the key with the holder.
➁ ➃ Draw up the syringe.
➄ Unlock the holder. The key will auto-
matically close the valve.

2.8.6 Connecting the Dialyzer

Confirm Select Open the shunt door.

Shunt Cover open
Display message

The cone does not move.

2-46 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Connect the dialyzer supply line to the
dialyzer (on the side of the venous
drain). Connect the dialyzer drain line to
the dialyzer (on the side of the arterial
feed).

Close the shunt door.

The conductivity window is set.
Observe the external flow indicator: the
cone moves up and down.
Check and, if necessary, change the dia-
lysate flow.

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-47

2.8.7 Changing the Dialysate Flow

Confirm Select
Press the Select key.
Preparation
☛
Confirm Select Use the ▲ and ▼ keys to select
7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

7.6 Set Flow
☛ 7.6 Set Flow .
Press the Confirm key.

Confirm Select Last selected flow.

Set Flow xxx ml/min
☛ Use the ▲ and ▼ keys to set the desired
flow .

Confirm Select Press the Confirm key.

Set Flow xxx ml/min Should the Confirm key not be pressed
☛ within 20 seconds, the previous dia-
lysate flow is preserved.

2.8.8 Changing the Dialysate Temperature

(25 C)

Time Left h:min

Variation Press the Set key.
I/O Prog.

Tempera-
UF Flow ture

I/O Prog. I/O Set

☛

Confirm Select Use the ▲ and ▼ keys to set the desired

Set Temp. xx.x °C
☛ temperature.

Confirm Select Press the Confirm key.

Set Temp. xx.x °C Should the Confirm key not be pressed
☛ within 20 seconds, the previous tem-
perature value is preserved.

2-48 Fresenius Medical Care 4008 B 16/10.03 (OP)

2.8.9 Rinsing the Dialyzer

Ultrafiltration If it is intended to prepare the dialyzer

UF Volume ml using a UF rate:
0000 Reset
Volume
Use the ▼ key to set the UF Goal to 0.

UF Rate ml/h
Use the ▲ key to set the UF Rate to the
desired value.
1000 ☛ Use the ▼ key to set the Time Left to 0.

UF Goal ml

0000

Time Left h:min

☛
0:00
UF

I/O Prog.
☛
☞ 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 UF parameters and
starting UF, only the values entered
are relevant.

(25 C)

Time Left h:min

Variation Press the UF I/O key.
I/O Prog.

Tempera- The UF LED is illuminated.

☛
UF Flow ture

I/O Prog. I/O Set

Fresenius Medical Care 4008 B 16/10.03 (OP) 2-49

2-50 Fresenius Medical Care 4008 B 16/10.03 (OP)
Table of Contents 3 Treatment

Chapter Page

3.1 Ultrafiltration ................................................................................................................. 3-3

3.1.1 Erasing the UF Volume ................................................................................................... 3-3
3.1.2 Erasing the UF Data ....................................................................................................... 3-4
3.1.3 Entering UF Parameters ................................................................................................. 3-5
3.1.4 Starting Ultrafiltration ...................................................................................................... 3-8
3.1.5 Stopping / Interrupting Ultrafiltration ............................................................................... 3-9
3.1.6 Continuing Ultrafiltration ................................................................................................. 3-9
3.1.7 Changing UF Data .......................................................................................................... 3-10

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 ....................................................................................... 3-15

3.3 Single Needle Dialysis .................................................................................................. 3-16

3.3.1 Preparation ..................................................................................................................... 3-16
3.3.2 Setting the Stroke Volume When Using a SN Blood Pump ........................................... 3-17
3.3.3 Connecting the Patient ................................................................................................... 3-18

3.4 Single Needle Click-Clack ............................................................................................ 3-21

3.4.1 Selecting the Treatment Mode ........................................................................................ 3-21
3.4.2 Changing the Pressure Limits / Stroke Volume ............................................................. 3-22
3.4.3 Terminating / Switching off the SN Click-Clack Mode ................................................... 3-23

3.5 Isolated Ultrafiltration (ISO-UF) ................................................................................... 3-24

3.5.1 Selecting the Treatment Mode ........................................................................................ 3-24
3.5.2 Interrupting ISO-UF ........................................................................................................ 3-27
3.5.3 Displaying ISO Data ....................................................................................................... 3-28
3.5.4 Erasing ISO Data ............................................................................................................ 3-28
3.5.5 Sequential Ultrafiltration – Manual Entry ........................................................................ 3-29

3.6 Sodium and UF Profiles ............................................................................................... 3-31

3.6.1 General Notes ................................................................................................................. 3-31
3.6.2 Entering a UF Profile With and Without Sodium Profile ................................................ 3-33
3.6.3 Entering a Sodium Profile With and Without UF Profile ................................................ 3-35
3.6.4 Starting the Program ....................................................................................................... 3-37
3.6.5 Retrieving Data ............................................................................................................... 3-37
3.6.6 Program Completed ........................................................................................................ 3-38
3.6.7 Stopping the Program ..................................................................................................... 3-39
3.6.8 Continuing the Program .................................................................................................. 3-39
3.6.9 Prematurely Terminating the Program ............................................................................ 3-40

3.7 DIASAFE ®plus (option) ................................................................................................... 3-41

3.7.1 Display During Treatment ............................................................................................... 3-41

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-1

3-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
3.1 Ultrafiltration

☞ Note
If the dialyzer has been prepared
using a UF rate, the UF volume must
be erased.

3.1.1 Erasing the UF Volume

Ultrafiltration Press the UF I/O key.

UF Volume ml
The UF LED is dark.
0000 Reset
Volume

☛ Press the UF Reset Volume key, until

UF Rate ml/h
the UF Volume display indicates 0000.
1000

UF Goal ml
Press the Flow I/O key.
0000

Time Left h:min

0:00
UF

☛ I/O Prog.

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-3

3.1.2 Erasing the UF Data

Confirm Select Press the Select key.

Preparation
☛
Confirm Select Use the ▲ and ▼ keys to select
7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Press the Confirm key.

7.1 Reset UF data
☛
Confirm Select Press the Confirm key.
Are you sure ?
☛
Confirm Select Temporary display message
value(s) cleared !

3-4 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.1.3 Entering UF Parameters

● Maximum values to be entered:

UF Rate: no more than 4000 ml/h (selectable by DIP switch)

UF Goal: 9990 ml
Time Left: 9 hours 59 minutes

● Starting position

Ultrafiltration Default values (preset in the SETUP

UF Volume ml menu).
0000 Reset
Volume Check and, if necessary, change the
indicated values.
UF Rate ml/h

0750

UF Goal ml

3000

Time Left h:min

4:00
UF

I/O Prog.

or

Ultrafiltration
UF Volume ml

0000 Reset
Volume

UF Rate ml/h

0000

UF Goal ml

0000

Time Left h:min

0:00
UF

I/O Prog.

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-5

 ● Goal function with fixed rate

Ultrafiltration Use the ▲ and ▼ keys to enter the de-

UF Volume ml sired rate.
0000 Reset
Volume
Use the ▲ and ▼ keys to enter the de-
sired goal.
UF Rate ml/h

The Time Left is automatically computed

0750
☛ and indicated.

UF Goal ml

3000
☛
Time Left h:min

4:00
UF

I/O Prog.

● Goal function with fixed time

Ultrafiltration Use the ▲ and ▼ keys to enter the de-

UF Volume ml sired time .
0000 Reset
Volume
Use the ▲ and ▼ keys to enter the de-
sired goal.
UF Rate ml/h

The UF Rate is automatically computed

0750
and indicated.

UF Goal ml

3000
☛
Time Left h:min

4:00
UF

I/O Prog.
☛

3-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

● Timer rate function

Ultrafiltration Use the ▼ key to set the UF Goal to 0.

UF Volume ml
Use the ▲ and ▼ keys to enter the de-
0000 Reset
Volume
sired rate.

UF Rate ml/h
Use the ▲ and ▼ keys to enter the de-
sired time.
0750
☛
UF Goal ml

0000

Time Left h:min

☛
4:00
UF

I/O Prog.
☛
● Rate function

Ultrafiltration Use the ▼ key to set the UF Goal to 0.

UF Volume ml
Use the ▼ key to set the Time Left to 0.
0000 Reset
Volume

Use the ▲ and ▼ keys to enter the de-

UF Rate ml/h
sired rate.
0750
☛
UF Goal ml

0000

Time Left h:min

☛
0:00
UF

I/O Prog.
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-7

 ● Timer function (no ultrafiltration)

Ultrafiltration Use the ▼ key to set the UF Goal to 0.

UF Volume ml
Use the ▼ key to set the UF Rate to 0.
0000 Reset
Volume

Use the ▲ and ▼ keys to enter the de-

UF Rate ml/h
sired time.
0000

UF Goal ml
☛
0000

Time Left h:min

☛
4:00
UF

I/O Prog.
☛
3.1.4 Starting Ultrafiltration

(25 C)

Time Left h:min

Variation Press the UF I/O key.
I/O Prog.
The UF LED is illuminated.
Tempera-

☛
UF Flow ture

I/O Prog. I/O Set

3-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.1.5 Stopping / Interrupting Ultrafiltration

Ultrafiltration Press the UF I/O key.

UF Volume ml
The UF LED is dark.
3200 Reset
Volume

The UF pump is not running.

UF Rate ml/h
Countdown of the Time Left stops.
0800

UF Goal ml

4000

Time Left h:min

1:00

☛
UF

I/O Prog.

3.1.6 Continuing Ultrafiltration

(25 C)

Time Left h:min

Variation
Press the UF I/O key.
I/O Prog.
The UF LED is illuminated.
Tempera-

☛
UF Flow ture

I/O Prog. I/O Set

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-9

3.1.7 Changing UF Data

Ultrafiltration Press the UF I/O key.

UF Volume ml
The UF LED is dark.
0000 Reset
Volume

Use the ▲ and ▼ keys to change the de-

UF Rate ml/h
sired UF data.
0750

UF Goal ml

3000

Time Left h:min

4:00

☛
UF

I/O Prog.

(25 C)

Time Left h:min

Variation Press the UF I/O key.
I/O Prog.
The UF LED is illuminated.
Tempera-

☛
UF Flow ture

I/O Prog. I/O Set

3-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.2 Double Needle Dialysis

3.2.1 Connecting the Patient

Rate: ml/min
Press the Start/Stop key on the blood
(Ø: mm)
pump module.
The operation (green) LED is dark.
The arterial blood pump has stopped.
Start
Stop
☛
Connect the arterial line to the patient.
If infusion of the saline contained in the
line is desired, connect now the venous
line.

Rate: ml/min
Set the delivery rate of the arterial blood
(Ø: mm)
pump to the desired value.

Start
☛
Stop

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-11

 Rate: ml/min
Press the Start/Stop key on the blood
(Ø: mm)
pump.
The operation (green) LED is illumin-
ated.
The blood pump starts “softly” (provi-
Start
Stop ded there is no blood alarm).
☛
al Care 4008 B
The optical detector senses dark fluid.
Preparation end
The yellow (warning/info) status indica-
Arterial Venous Transmembrane
tor is illuminated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml Display message
R The alarm windows (arterial, venous) are
set automatically.
Setting of the TMP alarm window is time-
delayed (depending on the UF coef-
ficient).
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.

Override
–30
–200 The blood pump stops.
0
Test
–40 –300 The venous line clamp closes.
Prime
Audible signal
The Dialysis Start LED is flashing.
Dialysis Start
Reset Alarm
The Alarm Tone Mute LED is flashing.
Connect the venous connector of the tu-
Alarm Tone
Mute bing system to the patient (provided this
has not been done yet).

3-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-13

3.2.2 Initiating Dialysis

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

al Care 4008 B
Display message
Dialysis
The green (operation) status indicator is
Arterial Venous Transmembrane
illuminated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml

Caution
When using high-flux dialyzers and
low UF rates are selected there is a
possibility of local backfiltration.
Backfiltration is dependent upon:
– the type of high-flux dialyzer
used,
– the difference in the flow resi-
stance on the dialysate side and
the blood side,
– the viscosity of the blood.

Rate: ml/h
(Bolus: ml)
Press the Start/Stop key on the heparin
pump.
( :h.min)
The operation (green) LED is illumin-
Bolus ated.
The heparin pump is delivering.
Rate ☛
Start
Stop

(25 C)

Time Left h:min

Variation Press the UF I/O key.
I/O Prog.
The UF LED is illuminated.
Tempera-

☛
UF Flow ture

I/O Prog. I/O Set

3-14 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.2.3 Administering a Heparin Bolus

Rate: ml/h
(Bolus: ml)
To 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
(Bolus: ml)
To administer the bolus:
Press the Bolus key and hold it for more
( :h.min)
than 2 seconds.

☛ Bolus

Rate
Indication: 0.0
The heparin pump delivers the bolus in
0.1 ml increments.
Start After the key has been released, the
Stop display still indicates the bolus volume
delivered up to that point for another
5 s.
(The bolus administration is added to
the stored bolus volume.) Then the de-
livery rate is indicated.
– Maximum bolus administration: 5 ml
– Maximum total bolus:
1x syringe capacity

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-15

3.3 Single Needle Dialysis

3.3.1 Preparation

For preparation and adjustment of the delivery rate see Chapter 2.

Rate: ml/h Rate: ml/min

➀ Attach the compliance chamber to the
(Bolus: ml) (Ø: mm)
heparin pump.
( :h.min)
➁ Connect the single needle pressure
Bolus
➁ transducer.
Start
Rate Stop

Start
Stop

☞ Note
Do not install the single needle pump
line segment!

3-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.3.2 Setting the Stroke Volume When Using a SN Blood Pump

Rate: ml/h Rate: ml/min

Simultaneously press the ▼ key and the
(Bolus: ml) (Ø: mm)
Start/Stop key on the blood pump mod-
( :h.min)
ule.
Bolus
☛ The stroke volume is indicated in ml.
Start
Rate Stop

Start
☛
Rate: ml/h Rate: ml/min
Use the ▲ or ▼ key to adjust the desired
(Bolus: ml) (Ø: mm)
stroke volume.
Range of adjustment: 10 to 50 ml in
( :h.min)
5 ml increments.
Bolus

Start
☛
Rate Stop

Start

Rate: ml/h Rate: ml/min

Press the Start/Stop key on the blood
(Bolus: ml) (Ø: mm)
pump module.
The delivery rate is indicated after
( :h.min)
approx. 2 seconds.
Bolus

Start
Rate Stop

Start
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-17

3.3.3 Connecting the Patient

Rate: ml/min
Press the Start/Stop key on the blood
(Ø: mm)
pump module.
The operation (green) LED is dark.
The arterial blood pump has stopped
running.
Start
Stop
☛
Connect the arterial line to the patient.
If infusion of the saline contained in the
line is desired, connect now the venous
line.

Rate: ml/min
Use the ▲ or ▼ key to adjust the de-
(Ø: mm)
livery rate of the arterial blood pump.

Start
☛
Stop

Rate: ml/h Rate: ml/min

Install the single needle pump line seg-
(Bolus: ml) (Ø: mm)
ment of the tubing system in the single
( :h.min)
needle blood pump.
Bolus

Start
Rate Stop

Start
Stop

3-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Rate: ml/h
Use the ▲ or ▼ key to adjust the de-
Rate: ml/min
(Bolus: ml) (Ø: mm)
livery rate of the single needle blood
pump.
( :h.min)
Recommended delivery rate of the SN
Bolus

Start
☛ pump: 10 to 15% higher than that of
the arterial blood pump.
Rate Stop

Start

Rinse
Press the Single Needle key.
kPa mmHg kPa
The Single Needle LED is illuminated.
Hotrinse 280
Blood Leak 30 60
200
20 50
Disinfection
10
100 40

☛
0 0 30
Single
Needle –10
–100 20

–20

Press the Start/Stop key on the arterial

Rate: ml/min
(Ø: mm)
blood pump module.
The operation (green) LED of the blood
pump is illuminated.
The blood pumps are delivering (provi-
Start ded there is no blood alarm).
Stop
☛
al Care 4008 B
The optical detector senses dark fluid.
Preparation end
The yellow (warning/info) status indica-
Arterial Venous Transmembrane
tor is illuminated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml Display message
R The alarm windows (arterial, venous,
TMP, and conductivity) are set automat-
Override
–200 ically.
–30
Test
0
The blood pump stops.
–40 –300
The venous line clamp closes.
Prime
Audible signal
Dialysis Start The Dialysis Start LED is flashing.
Reset Alarm
The Alarm Tone Mute LED is flashing.
Alarm Tone Connect the venous line to the patient
Mute
(unless this has already been done).

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-19

 Check and, if necessary, correct the
level in the venous bubble catcher.
Possible only if the SN pump is
Pven.
running.
☛

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start The blood pumps start running automat-

Reset Alarm
ically.
Alarm Tone
Mute

Confirm Select Display message

SN-Dialysis

☞ Note
If single needle dialysis is performed,
it is important to dialyze with the
maximum blood flow.
The effective blood flow can be dis-
played in the user menu under
option 4. Bloodflow. calc.

3-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.4 Single Needle Click-Clack

This procedure should be used in exceptional cases only, since the stroke volumes and, thus, the
respective recirculation may vary widely.
Both the arterial and the venous blood line segments are to be connected to the vascular access
by means of a Y-piece.

3.4.1 Selecting the Treatment Mode

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode
☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.3 SN-click-clack
☛ 2.3 SN-click-clack .
Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to set the lower
set lower ven. Limit value in the Venous Pressure window.
☛ Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to set the upper

set upper ven. Limit
☛ value in the Venous Pressure window.
Press the Confirm key.

Confirm Select Display message

SN-click-clack

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-21

3.4.2 Changing the Pressure Limits / Stroke Volume

Confirm Select Press the Select key.

SN-click-clack
☛
Confirm Select Use the ▲ and ▼ keys to select
3. Alarm limits
☛ 3. Alarm limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

3.2 Venous limits
☛ 3.2 Venous limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to set the lower

set lower ven. Limit
☛ value in the Venous Pressure window.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to set the upper

set upper ven. Limit
☛ value in the Venous Pressure window.
Press the Confirm key.

Confirm Select Display message

SN-click-clack

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

3-22 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.4.3 Terminating / Switching off the SN Click-Clack Mode

Confirm Select Press the Select key.

SN-click-clack
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode
☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.3 SN-click-clack
☛ 2.3 SN-click-clack.
Press the Confirm key.

Confirm Select Press the Confirm key.

SN-click-clack off ?
☛
Confirm Select Display message
Dialysis

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-23

3.5 Isolated Ultrafiltration (ISO-UF)

This treatment mode can be started at any time and can be repeated as often as necessary.

The parameters entered at the beginning of the treatment (UF Goal and Time Left) must be taken
into consideration.

In general, the total removal (UF Goal) as well as the total treatment time (Time Left) or UF Goal
and UF Rate must be programmed. The UF monitor is off.

3.5.1 Selecting the Treatment Mode

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode
☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.2 Sequ. Dialysis
☛ 2.2 Sequ. Dialysis.
Press the Confirm key.

Confirm Select
ISO-UF value

3-24 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Ultrafiltration Use the ▲ and ▼ keys on the ultra-
UF Volume ml filtration monitor to set ISO Goal and
Reset
Volume ISO Time.

UF Rate ml/h

UF Goal ml

1000
☛
Time Left h:min

0:30
UF

I/O Prog.
☛
Confirm Select
Display message
Total: V=5000 t=4.00 e.g.:
☛ 5000 total withdrawal (UF Goal)
4:00 h total time (Time Left)

Press the Confirm key.

Confirm Select
Display message
ISO-UF start ?

Ultrafiltration
Press the UF I/O key.
UF Volume ml
The UF LED is illuminated.
0000 Reset
Volume

UF Rate ml/h

UF Goal ml

5000

Time Left h:min

4:00

☛
UF

I/O Prog.

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-25

 Ultrafiltration The dialysate flow is automatically set to
UF Volume ml “off”.
0001 Reset
Volume

UF Rate ml/h

UF Goal ml

5000

Time Left h:min

3:59
UF

I/O Prog.

Transmembrane The dialysate monitor is dark.

Ultrafiltration Conductivity
Pressure
UF Volume ml

Reset
Conc Bic
kPa mmHg

500 UF Rate ml/h 15.5

60

50 400 15
40 300 14.5
30
200 14
20
UF Goal ml

10
100 13.5
0 0 13
mS/cm
(25°C)

Time Left h:min

Variation

I/O Prog.

Tempera-
UF Flow ture

I/O Prog. I/O Set

Confirm Select Display message

ISO R=2000 t=0:29 ISO rate/h and ISO time left.

☞ Note
After completion of sequential dia-
lysis, hemodialysis is automatically
continued with dialysate flow and the
computed UF parameters.
The conductivity alarm and the tem-
perature alarm are suppressed for 3
minutes.

3-26 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.5.2 Interrupting ISO-UF

● On the UF monitor

Ultrafiltration Press the UF I/O key.

UF Volume ml
The UF LED is dark.
0001 Reset
Volume

The UF pump stops.

UF Rate ml/h
The ISO time has stopped.

UF Goal ml

5000

Time Left h:min

3:29

☛
UF

I/O Prog.

● In the menu

Confirm Select Press the Select key.

ISO R=2000 t=0:29
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode
☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.2 Sequ. dialysis
☛ 2.2 Sequ. dialysis.
Press the Confirm key.

Confirm Select Press the Confirm key.

ISO-UF off ?
☛ The dialysate flow is automatically set to
“on”.
UF data is added.

Confirm Select Display message

Dialysis

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-27

3.5.3 Displaying ISO Data

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

7.2 Show ISO data 7.2 Show ISO data.
☛ Press the Confirm key.

Confirm Select Temporary display of the UF volume re-

ISO: V 1000 t=0:30 moved during ISO-UF and of the ISO UF
time.

3.5.4 Erasing ISO Data

Confirm Select The UF monitor is off.

Dialysis
☛ Press the Select key.

Confirm Select Use the ▲ and ▼ keys to select

7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

7.3 Reset ISO data
☛ 7.3 Reset ISO data.
Press the Confirm key.

Confirm Select Press the Confirm key.

Are you sure ?
☛
Confirm Select Temporary display message
value(s) cleared !

3-28 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.5.5 Sequential Ultrafiltration – Manual Entry

Ultrafiltration Use the ▲ and ▼ keys on the ultrafiltra-

UF Volume ml tion monitor to set UF Goal and Time
Reset
Volume
Left.

UF Rate ml/h

UF Goal ml

1000
☛
Time Left h:min

0:30
UF

I/O Prog.
☛
(25 C)
The Flow LED is dark.
Time Left h:min
Variation

I/O Prog. The dialysate monitor is dark.

UF Flow
Tempera-
ture
Display message
I/O Prog. I/O Set
☛

Audible signal after 30 minutes.

Flow off
Confirm Select (Adjustable in the SETUP menu:
30, 45, 60 minutes.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-29

 Ultrafiltration Press the UF I/O key.
UF Volume ml
The UF LED is illuminated.
0000 Reset
Volume

UF Rate ml/h

2000

UF Goal ml

1000

Time Left h:min

0:30

☛
UF

I/O Prog.

Confirm Select Display message after the time has

UF-Goal reached elapsed.
Acknowledge the audible signal by
pressing the Dialysis Start key.

Confirm Select Display message

Reinfusion ? Acknowledge by pressing the Dialysis
Start key.

When entering UF goal parameters, en-

ter the total fluid removal.
Example:
Total fluid removal 4000
Sequential UF goal 1000
UF Goal entry 4000

Transmembrane Ultrafiltration Conductivity Press the Flow I/O key.

Pressure
UF Volume ml
The Flow LED is illuminated.
Reset
Conc Bic
kPa mmHg The dialysate monitor is active again.
500 Temperature and conductivity are
60 UF Rate ml/h 15.5
stabilizing.
50 400 15
40 300 14.5
30
200 14
20
UF Goal ml

10
100 13.5
0 0 13
mS/cm
(25°C)

Time Left h:min

Variation

I/O Prog.

Tempera-
UF Flow ture

I/O Prog. I/O Set

☛

3-30 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.6 Sodium and UF Profiles (not applicable for 4008 B without profiles)

3.6.1 General Notes

Before selecting profiles, the following values should have been entered:
– Base Na+, prescr. Na+ and bic.
– UF Goal (minimum UF goal: 200 ml)
– Time Left (minimum UF profile time: 2 hours)
– UF Rate:
– Minimum continuous UF rate:
Profiles 1 to 6 100 ml/h
– Maximum continuous UF rate:
Profiles 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-31

 Should a UF rate be set which is higher than the maximum continuous UF rate, the following
message will be displayed upon selection of the desired UF profile:

Confirm Select
Max. UF-Rate reached

To clear the message,

– increase the Time Left,
– select a different type of profile.

When selecting a profile, the machine will prompt the operator to enter missing or to correct
incorrect data.

Profile data comprise UF and Na profile types as well as start Na+.

For possible profile combinations refer to the illustration on possible sodium and UF profile
combinations.

3-32 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.6.2 Entering a UF Profile With and Without Sodium Profile

(25 C)

Time Left h:min

Variation Press the UF Prog. key.
I/O Prog.

Tempera-
UF Flow ture

I/O Prog. I/O Set

☛
Confirm Select Use the ▲ and ▼ keys to select the
UF Profile Nr. X desired profile number (1 to 6).
☛ Press the Confirm key.

Confirm Select If no sodium profile is desired:

Na Profile Nr. X
☛ Use the ▲ and ▼ keys to select
Na Profile Off.

Confirm Select Press the Confirm key.

Na Profile Off
☛
Confirm Select Temporary display message
Profiles ready

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-33

 Confirm Select If a sodium profile is desired:
Na Profile Nr. X
☛ Accept the recommended profile by
pressing the Confirm key.

Confirm
☛ Select Use the ▲ key to set the desired value.
Start Na+ 138 mmol
The start Na+ must be higher than the
prescribed Na+ (by at least 1 mmol).

Start
Start Na+

Soll Na+
Prescribed

Base Na+
Basis
(container value)
(Kanisterwert)

Confirm Select Press the Confirm key.

Start Na+ 143 mmol
☛
Confirm Select Temporary display message
Profiles ready

3-34 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.6.3 Entering a Sodium Profile With and Without UF Profile

(25 C)

Time Left h:min

Variation Press the Variation Prog. key.
I/O Prog.

UF

I/O Prog.
Flow

I/O
Tempera-
ture

Set
☛

Confirm Select Use the ▲ and ▼ keys to select the

Na Profile Nr. X
☛ desired profile number (1 to 6).
Press the Confirm key.

☛ Confirm Select Use the ▲ key to set the desired value.

Start Na+ xxx mmol
The start Na + must be higher than the
prescribed Na+ (by at least 1 mmol).

Start
Start Na+
Na+

Soll Na+
Prescribed

Base Na+
Basis
(container value)
(Kanisterwert)

Confirm Select
Press the Confirm key.
Start Na+ xxx mmol
☛
Confirm Select If no UF profile is desired:
UF Profile Nr. X
☛ Use the ▲ and ▼ keys to select
UF Profile Off.

Confirm Select Press the Confirm key.

UF Profile Off
☛
Confirm Select Temporary display message
Profiles ready

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-35

 Confirm Select If a UF profile is desired:
UF Profile Nr. X
☛ Accept the recommended UF profile by
pressing the Confirm key.

Confirm Select Temporary display message

Profiles ready

☞ Note
Missing initial parameters are in-
quired when entering a profile.

Profile, UF and dilution parameters

cannot be reprogrammed while the
program is in progress.
The profile must be stopped and re-
started with the changed parameters.

3-36 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.6.4 Starting the Program

(25 C)

Time Left h:min

Variation Press the UF I/O key or the Variation
I/O Prog. I/O key.

☛
Tempera-
UF Flow ture The UF and Variation LEDs are illumin-
I/O Prog. I/O Set ated (depending on the preselected pro-
☛ file).
The TMP and CD limits will automat-
or ically track up.
Manual changes are still possible.

Confirm Select Display message

Dialysis Na-X UF-X
The actual Na value can be displayed by
pressing the Conc. key and is shown on
the CD display.

3.6.5 Retrieving Data

(25 C)

Time Left h:min

Variation Press the UF Prog. key or the Variation
I/O Prog. Prog. key.
Tempera-
☛

UF Flow ture

I/O Prog. I/O Set

☛

or

Confirm Select Press the Confirm key.

Na Profile Nr. X
☛
Confirm Select Press the Confirm key.
Start-Na xxx mmol/l
☛
Confirm Select Press the Confirm key.
UF-Profile Nr. X
☛
Confirm Select Display message
Dialysis Na-X UF-X

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-37

3.6.6 Program Completed

al Care 4008 B
Display message
UF-Goal reached
The yellow (warning/info) status indi-
Arterial Venous Transmembrane
cator is illuminated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml
The UF and Variation LEDs are dark
R
(depending on the preselected profile).
The UF pump is not running.
Audible signal

Override
–30
–200
0
Test
–40 –300
The Dialysis Start LED is flashing.

Prime The Alarm Tone Mute LED is flashing.

Dialysis Start The TMP limits move to the full scale
Reset Alarm
values.
Alarm Tone
Mute

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime
The Dialysis Start LED is illuminated.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute
The Alarm Tone Mute LED is dark.

Confirm Select Display message

Reinfusion ?

3-38 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.6.7 Stopping the Program

(25 C)

Time Left h:min

Variation Press the UF I/O key or the Variation
I/O Prog. I/O key.

☛
Tempera-
UF Flow ture

I/O Prog. I/O Set

The UF and/or Variation LEDs are
flashing.
☛ or
(depending on the preselected profile)

UF stop, bypass, CD value is preserved.

al Care 4008 B

Profiles paused
Display message
The yellow (warning/info) status indi-
Air Detector Arterial
Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati cator is illuminated.
UF Volume ml

R An audible signal is emitted after 10 mi-

nutes.
Override
–30
–200
0
Test
–40 –300 Press the Dialysis Start key to continue
Prime stopping the program.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

3.6.8 Continuing the Program

Profiles paused
Confirm Select
Display message
The program has been stopped.
(25 C)

Time Left h:min

Variation
Press the UF I/O key or the Variation
I/O Prog.
I/O key.
☛

Tempera-
UF Flow ture

I/O Prog. I/O Set

☛

or

Select
Stop UF-Profile ?
Confirm
Safety prompt
in case of UF and Na+ profiles or UF pro-
or file only
Confirm Select or in case of Na+ profile.
Stop Na-Profile ? (brief indication)
The stopped program is automatically
continued.

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-39

3.6.9 Prematurely Terminating the Program

(25 C)

Time Left h:min

Variation Press the UF I/O key or the Variation
I/O Prog. I/O key.

☛
Tempera-
UF Flow ture The UF and/or Variation LEDs are
I/O Prog. I/O Set flashing.
(depending on the preselected profile)
☛
or UF stop, bypass, CD value is preserved.

Profiles paused
Confirm Select Display message

(25 C)

Time Left h:min

Variation Press the UF I/O key or the Variation
I/O Prog.
I/O key.
☛

Tempera-
UF Flow ture

I/O Prog. I/O Set

☛

or

Stop UF-Profile ?
Confirm Select Safety prompt
in case of UF and Na+ profile or UF pro-
or file only
Confirm Select
or in case of Na+ profile.
Stop Na-Profile ? (brief indication)

(25 C)

Time Left h:min

Variation Press the UF I/O key or the Variation
I/O Prog.
I/O key again.
☛

Tempera-
UF Flow ture
Ultrafiltration is continued at continuous
I/O Prog. I/O Set
rate.
☛

The UF LED is illuminated.

or The Variation LED is illuminated.
The Na+ profile is active.
Stop the Na+ profile.
Repeat the procedure.

Dialysis Na-X UF-0

Confirm Select Display message, e.g.
0 indicates that the program was
stopped.

3-40 Fresenius Medical Care 4008 B 16/10.03 (OP)

3.7 DIASAFE®plus (option)

3.7.1 Display During Treatment

Confirm Select Temporary display message

Rinsing Diasafe
Retentate removed by rinsing (approx.
every 60 minutes for 5 balancing cham-
ber switching cycles)
Machine in bypass

Fresenius Medical Care 4008 B 16/10.03 (OP) 3-41

3-42 Fresenius Medical Care 4008 B 16/10.03 (OP)
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 ..................................................................................... 4-5
4.1.3 Changing the Arterial Alarm Window Size ...................................................................... 4-6
4.1.4 Changing the Venous Alarm Window Size ..................................................................... 4-7
4.1.5 Changing the TMP Alarm Limits ..................................................................................... 4-8

4.2 Needle Adjustment ....................................................................................................... 4-11

4.2.1 Start ................................................................................................................................ 4-11
4.2.2 Stop ................................................................................................................................. 4-12

4.3 Blood Alarms ................................................................................................................. 4-13

4.3.1 Indication of Alarms ........................................................................................................ 4-13
4.3.2 Arterial Pressure Alarm ................................................................................................... 4-14
4.3.3 Venous Pressure Alarm .................................................................................................. 4-16
4.3.4 TMP Pressure Alarm ....................................................................................................... 4-18
4.3.5 Blood Leak Dimness Warning ........................................................................................ 4-20
4.3.6 Blood Leak Alarm ............................................................................................................ 4-21
4.3.7 Blood Pump Alarm .......................................................................................................... 4-22
4.3.8 Heparin Pump Alarm ....................................................................................................... 4-23
4.3.9 Air Detector Alarm .......................................................................................................... 4-24
4.3.10 Blood Pump Stop Alarm .................................................................................................. 4-25
4.3.11 Blood Pump Stop Alarm With Single Needle .................................................................. 4-26
4.3.12 Cycle Alarm With Single Needle Click-Clack .................................................................. 4-30

4.4 Dialysate Alarms ........................................................................................................... 4-31

4.4.1 Indication of Alarms ........................................................................................................ 4-31
4.4.2 Conductivity Alarm .......................................................................................................... 4-31
4.4.3 Temperature Alarm ......................................................................................................... 4-32
4.4.4 Flow Alarm ...................................................................................................................... 4-33

4.5 Warnings ........................................................................................................................ 4-34

4.5.1 Indication of Warnings .................................................................................................... 4-34
4.5.2 Warning Messages / Information .................................................................................... 4-35

4.6 Emergency Operation ................................................................................................... 4-40

4.7 Error Messages During Cleaning Programs ............................................................. 4-42

4.7.1 Indication of Errors .......................................................................................................... 4-42
4.7.2 Error Messages ............................................................................................................... 4-43

4.8 Error Messages After Turning Power On ................................................................... 4-45

4.9 Error Messages When Using the Download Function ............................................. 4-50

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-1

4-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
4.1 Management of Alarm Limits

4.1.1 Centering the Arterial / Venous Alarm Limits

Arterial and/or venous alarm limits are

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure not centered.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Confirm Select Display message

Center limit?

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-3

 Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key again.
If the key is not pressed within
Prime approx. 8 seconds, the original

☛
limits will be retained.
Dialysis Start
Reset Alarm

Alarm Tone
Mute

Both the arterial and the venous alarm

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure windows are centered around the actual
value.
kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

4-4 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.1.2 Centering the TMP Alarm Limits

The TMP alarm limits are not centered.

Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

(25 C)

Time Left h:min

Variation Press the UF I/O key twice.
I/O Prog. Not possible while a profile is in
progress.
Tempera-
UF Flow ture Not applicable for 4008 B without
I/O Prog. I/O Set profiles.
☛

2x

The TMP alarm limits are set to the full

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure scale values.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

The TMP alarm limits are centered

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure around the actual value.
(Time-dependent upon the UF
coefficient.)
kPa mmHg kPa mmHg kPa mmHg

280
The position of the TMP alarm window
500 500
Blood Leak 30
200 60 60 may automatically be shifted up during
20 50 400 50 400 treatment.
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-5

4.1.3 Changing the Arterial Alarm Window Size

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
3. Alarm limits ☛ 3. Alarm limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

3.1 Arterial limit
☛ 3.1 Arterial limit.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to change the

set art. Limits
☛ Arterial Pressure alarm window size.

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select
Press the Confirm key.
set art. Limits ☛
4-6 Fresenius Medical Care 4008 B 16/10.03 (OP)
4.1.4 Changing the Venous Alarm Window Size

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select Press the Select key.

Dialysis ☛
Confirm Select Use the ▲ and ▼ keys to select
3. Alarm limits
☛ 3. Alarm limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

3.2 Venous limits
☛ 3.2 Venous limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to change the

Set ven. limits
☛ Venous Pressure alarm window size.

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select
Press the Confirm key.
Set ven. limits
☛
Fresenius Medical Care 4008 B 16/10.03 (OP) 4-7
4.1.5 Changing the TMP Alarm Limits

● Window position

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
3. Alarm limits ☛ 3. Alarm limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

3.3 TMP limits
☛ 3.3 TMP limits.
Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to select
TMP window position ☛ TMP window position.
Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to shift the po-
Set TMP Limits ☛ sition of the TMP window.

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

4-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Confirm Select
Press the Confirm key.
Set TMP Limits
☛ The position of the TMP alarm window
may automatically be shifted up during
treatment.

● Window size

Caution
Should the user change the window
size, it is important to select as small
a window size as possible to ensure
adequate safety.

Air Detector Arterial Venous Transmembrane

Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select Press the Select key.

Dialysis ☛
Confirm Select Use the ▲ and ▼ keys to select
3. Alarm limits ☛ 3. Alarm limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

3.3 TMP limits ☛ 3.3 TMP limits.
Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to select
TMP window size TMP window size.
☛ Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to change the
Set TMP Limits size of the TMP window.
☛ Double needle: ±30 to ±80 mmHg
Single needle: ±40 to ±90 mmHg
SN click-clack: ±40 to ±90 mmHg

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-9

 Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Confirm Select
Press the Confirm key.
Set TMP Limits
☛
☞ Note
Automatic adjustment of the alarm
limits is now deactivated.

Reactivate automatic alarm limits:

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
3. Alarm limits ☛ 3. Alarm limits.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

3.3 TMP limits ☛ 3.3 TMP limits .
Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to select
TMP window size TMP window size.
☛ 2x Press the Confirm key twice.

4-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.2 Needle Adjustment

This procedure allows adjustment of the needle without false alarms. Both the arterial and the
venous alarm limits are inactive for 2 minutes. The full scale values as well as the lower venous
alarm limit of 20 mmHg are still active.

4.2.1 Start

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode ☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.5 Needle-Adj-Pgm ☛ 2.5 Needle-Adj-Pgm.
Press the Confirm key.

Confirm Select Display message

Needle-Adj-Pgm

al Care 4008 B The yellow (warning/info) status

indicator is illuminated.

Air Detector Arterial Venous Transmembrane

The arterial and venous limits are

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure flashing.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-11

4.2.2 Stop

Confirm Select Press the Select key.

Needle-Adj–Pgm ☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode ☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.5 Needle-Adj–Pgm ☛ 2.5 Needle-Adj-Pgm.
Press the Confirm key.

Confirm Select Press the Confirm key.

Stop Needle-Adj–Pgm?
☛
Confirm Select Display message
Dialysis

4-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

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

Fresenius Medical Care 4008 B The red (alarm) status indicator is illu-
minated.
The Dialysis Start LED is flashing.
I/O
Air Detector Arterial V The Alarm Tone Mute LED is flashing.
Pressure Pr
The blood pump(s) stop(s).
Rinse
kPa mmHg kPa The venous line clamp closes.
Hotrinse 280
Blood Leak 30
200 60 The UF pump(s) stop(s).
20 50
Disinfection
10
100 The nurse call is active.
40

0 0 30 Audible signal
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-13

4.3.2 Arterial Pressure Alarm

The Arterial Pressure alarm indicator is

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure flashing.

Cause:
kPa mmHg kPa mmHg kPa mmHg
The arterial pressure is outside the alarm
280 500 500
Blood Leak 30 60 60
limits.
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime

☛
Dialysis Start
Reset Alarm

Alarm Tone
Mute

Display message
New art limits? The alarm limits are flashing for 8 sec-
onds.
Limits are inactive.
Arterial Venous Transmembrane Ultrafiltra
Pressure Pressure Pressure
UF Volume ml

kPa mmHg kPa mmHg kPa mmHg

280 500 500

30 60 60 UF Rate ml/h
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20
UF Goal ml
–20 10
100 10
100
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key again.
If the key is not pressed within approx.
Prime
8 seconds, the original limits will be re-

☛ Dialysis Start tained.

Reset Alarm

The Dialysis Start LED is illuminated.

Alarm Tone
Mute
The Alarm Tone Mute LED is illumin-
ated.

4-14 Fresenius Medical Care 4008 B 16/10.03 (OP)

 The arterial limits are spread briefly.
Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

The arterial limits are centering around

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure the acutal value.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-15

4.3.3 Venous Pressure Alarm

The Venous Pressure alarm indicator is

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure flashing.

Cause:
kPa mmHg kPa mmHg kPa mmHg
The venous pressure is outside the
280 500 500
Blood Leak 30 60 60
alarm limits.
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Display message
new
New ven
ven limits
limits?? The alarm limits are flashing for 8 sec-
onds.
Limits are inactive.
Arterial Venous Transmembrane Ultrafiltra
Pressure Pressure Pressure
UF Volume ml

kPa mmHg kPa mmHg kPa mmHg

280 500 500

30 60 60 UF Rate ml/h
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20
UF Goal ml
–20 10
100 10
100
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key again.
If the key is not pressed within approx.
Prime
8 seconds, the original limits will be re-

☛ Dialysis Start tained.

Reset Alarm

The Dialysis Start LED is illuminated.

Alarm Tone
Mute
The Alarm Tone Mute LED is illumin-
ated.

4-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

 The venous limits are spread briefly.
Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

The venous limits are centering around

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure the actual value.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-17

4.3.4 TMP Pressure Alarm

The TMP alarm indicator is flashing.

Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure
Cause:
The TMP is outside the alarm limits.
kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
Test
0
Press the Dialysis Start key.
–40 –300
Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Display message

New TMP
ven limits?
limits? The limits are flashing for a period deter-
mined by the calculated UFC.
Limits are inactive.
Arterial Venous Transmembrane Ultrafiltra
Pressure Pressure Pressure
UF Volume ml

kPa mmHg kPa mmHg kPa mmHg

280 500 500

30 60 60 UF Rate ml/h
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20
UF Goal ml
–20 10
100 10
100
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key again.
If the key is not pressed within approx.
Prime
8 seconds, the original limits will be re-

☛ Dialysis Start tained.

Reset Alarm

The Dialysis Start LED is illuminated.

Alarm Tone
Mute
The Alarm Tone Mute LED is illumin-
ated.

4-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

 The TMP alarm limits are spread for a
Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure time interval which is dependent upon
the determined UFK.
kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

The TMP alarm limits are centering

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure around the actual value.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Caution
Sudden TMP changes are indicative
of defect.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-19

4.3.5 Blood Leak Dimness Warning

Confirm Select Display message

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.

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.
See also Chapter 4.5 Warnings,
Prime Message Fillprogram

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

In the event of grease and/or calcium

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

4-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.3.6 Blood Leak Alarm

I/O
Air Detector Arterial V
Pressure Pr The Blood Leak alarm indicator is flash-
ing.
Rinse
kPa mmHg kPa Cause:
Hotrinse 280 Dialyzer membrane rupture.
Blood Leak 30 60
200
Disinfection
20 50 Press the Override key.
100
10 40 Override time: always 2 minutes
0 0 30
As soon as the leak closes, the alarm in-
Single
Needle –10
–100 20
dicator turns dark.
–20 10
Override If the problem persists, replace the dia-
–30
–200
0
Test
–40 –300 lyzer.
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-21

4.3.7 Blood Pump Alarm

Confirm Select Display message after 30 (15) secs.

BP-stop-alarm

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.

Start
Stop

Rate: ml/min
(Ø: mm)
Press the Start/Stop key.
E.XX

Start
Stop

☛
Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

☞ Note
If the problem persists, call the
service.

4-22 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.3.8 Heparin Pump Alarm

Confirm Select Display message

Heparin pump alarm

Rate: ml/h
(Bolus: ml)
The Alarm LED (red) on the heparin
pump is illuminated.
E.XX
( :h.min)
Error message E.XX on the heparin
Bolus pump.

Rate

Start
Stop

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

☞ Note
If the problem persists, call the
service.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-23

4.3.9 Air Detector Alarm

I/O
Air Detector Arterial V
Pressure Pr The Air Detector alarm indicator is
flashing.
Rinse
kPa mmHg kPa Cause:
Hotrinse 280 Air or frothy blood in the venous bubble
Blood Leak 30 60
200 catcher.
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300

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.

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

4-24 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.3.10 Blood Pump Stop Alarm

Confirm Select
BP-stop-alarm Display message

Rate: ml/min
The Alarm LED (red) on the blood pump
(Ø: mm)
module is illuminated.
Cause:
The rotor has stopped for more than 30
(15) seconds.
Start
Stop

Override
–30
–200
Test
0
Press the Dialysis Start key.
–40 –300
Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-25

4.3.11 Blood Pump Stop Alarm With Single Needle

Confirm Select Display message

BP-stop-alarm

Rate: ml/min
The Alarm LED (red) on the arterial
(Ø: mm)
blood pump or the SN blood pump mod-
ule is illuminated.
Cause:
Start
The rotor of one of the blood pumps is
Stop not running.
The response time is determined by
the speed.

Rinse As soon as the compliance chamber is

kPa mmHg kPa full, press the Single Needle key.
Hotrinse 280
Blood Leak 30
200 60 The Single Needle LED is dark.
20 50
Disinfection
10
100 40

☛
0 0 30
Single
Needle –10
–100 20

–20

Rate: ml/h Rate: ml/min

➀ Remove the SN pump line segment.
(Bolus: ml) (Ø: mm)

➁ Disconnect the SN pressure measur-

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

Start
Stop

4-26 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Rate: ml/min
Use the ▼ key to reduce the delivery
(Ø: mm)
rate on the arterial blood pump.

Start
Stop
☛
Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The blood pump starts running.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Rate: ml/h Rate: ml/min

Drain the fluid from the compliance
(Bolus: ml) (Ø: mm)
chamber using the syringe, with the
( :h.min)
arterial blood pump running.
Bolus

Start
Rate Stop

Start
Stop

Rate: ml/min
Stop the arterial blood pump by pressing
(Ø: mm)
the Start/Stop key.
The operation LED is dark.

Start
Stop
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-27

 Rate: ml/h
(Bolus: ml)
Rate: ml/min
➀ Clamp the SN pressure measuring
(Ø: mm)
line before the hydrophobic filter.
( :h.min)
➁ Replace the hydrophobic filter.
Bolus

Start
Rate
➁ Stop

Start
Stop
➀

Rate: ml/h Rate: ml/min

➀ Connect the SN pressure measuring
(Bolus: ml) (Ø: mm)
line and remove the clamp.
( :h.min)
➁ Install the SN pump line segment.
Bolus

Start
Rate ➀ Stop

Start
Stop

4-28 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Rinse Press the Single Needle key.
kPa mmHg kPa

Hotrinse 280 The Single Needle LED is illuminated.

Blood Leak 30 60
200
20 50
Disinfection
10
100 40

☛
0 0 30
Single
Needle –10
–100 20

–20

Rate: ml/min
Use the ▲ and ▼ keys on the arterial
(Ø: min)
blood pump to readjust the delivery rate.
Start the arterial blood pump by pressing
the Start/Stop key.
Start
Stop
The operation LED is illuminated.
☛
Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start The Alarm Tone Mute LED is dark.

Reset Alarm

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-29

4.3.12 Cycle Alarm With Single Needle Click-Clack

Confirm Select Display message

Cycle alarm

The Venous Pressure alarm indicator is

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure flashing.
Cause:
kPa mmHg kPa mmHg kPa mmHg The cycle time (approx. 15 seconds) has
280 500 500 been exceeded.
Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start The Alarm Tone Mute LED is dark.

Reset Alarm

Alarm Tone
Mute

4-30 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.4 Dialysate Alarms

4.4.1 Indication of Alarms

Fresenius Medical Care 4008 B The red (alarm) status indicator is illu-
minated.
The Alarm Tone Mute LED is flashing.

I/O The nurse call is active.

Air Detector Arterial V
Pressure Pr
Audible signal
Rinse External flow indicator: The cone does
kPa mmHg kPa
not move.
Hotrinse 280
Blood Leak 30
200 60 As soon as the alarm cause has been
Disinfection
20 50 corrected, the alarm message and the
100
10 40 alarm effect are automatically reset.
0 0 30 The audible signal can be suppressed
Single
Needle –10
–100 20 for 1 minute (factory setting) by pressing
Override
–20 10 the Alarm Tone Mute key.
–30
–200
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

4.4.2 Conductivity Alarm

Transmembrane
The Conductivity alarm indicator is illu-
Ultrafiltration Conductivity
Pressure
UF Volume ml
minated.
Reset
Bypass mode
Conc Bic
kPa mmHg
Cause:
500 UF Rate ml/h 15.5 The actual conductivity value is outside
60

50 400 15 the alarm limits.

40 300 14.5 Action required:
30
200 14 Check the concentrate side.
20
UF Goal ml
100 Correct the problem causing the alarm.
10 13.5
0 0 13
mS/cm
(25°C)

Time Left h:min

Variation

I/O Prog.

Tempera-
UF Flow ture

I/O Prog. I/O Set

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-31

4.4.3 Temperature Alarm

Confirm Select Display message

Upper temp. alarm Bypass mode
or Cause:
The actual temperature value is outside
Confirm Select
Lower temp. alarm the permissible values.
Action required:
Wait until the target temperature has
been reached, or call the service.

4-32 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.4.4 Flow Alarm

Confirm Select Display message

Flow alarm
Cause:
Dialyzer supply line, dialyzer return line
or drain line is kinked.
Hydraulics problem
Action required:
Check the lines.
Call the service.

or
Confirm Select Display message
Water alarm
Cause:
Water supply problem.
Action required:
Check the water supply.
Call the service.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-33

4.5 Warnings

4.5.1 Indication of Warnings

Fresenius Medical Care 4008 B The yellow (warning/info) status indic-

ator is illuminated.
Display message
I/O
Arterial V
The Dialysis Start LED is flashing.
Air Detector
Pressure Pr
The Alarm Tone Mute LED is flashing.
Rinse
kPa mmHg kPa
The blood system and the dialysate sys-
Hotrinse 280 tem are active.
Blood Leak 30 60
200 Audible signal
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

or

Fresenius Medical Care 4008 B Indication of malfunctions during pre-

paration / dialysis:
The red (alarm) status indicator is illu-
minated.
I/O
Air Detector Arterial V
Pressure Pr Display message
Rinse The Dialysis Start LED is flashing.
kPa mmHg kPa or
Hotrinse 280 The Prime LED is flashing.
Blood Leak 30 60
200
Disinfection
20 50 The Alarm Tone Mute is flashing.
10
100 40

0 0 30
The blood system and the dialysate sys-
Single
Needle –10 tem are inactive.
–100 20

–20
Override
–200
10
Audible signal
–30 0
Test
–40 –300
Prime
or
Dialysis Start
Reset Alarm

Alarm Tone
Mute

4-34 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.5.2 Warning Messages / Information

Message Cause Possible First Repeti-

solution warning tion

24 V Switched Off The watchdog relay Use the I/O switch to – –

has been switched toggle the machine
off. off and on again.
Call the service.

Air in system Air is present in the Switch on the flow. – –

dialysate system.

ASP failure ! The air separating Acknowledge by – –

pump is active with- pressing the
out interruption for Dialysis Start 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 Dialysis Start key.
in the dialysate sys- Perform a cleaning
tem. program.
See also Message
Fillprogram.

Connect Conc. Line Concentrate is not Check the concen- – –

connected. trate system.

CPU-II failed System error. Use the I/O switch to – –

toggle the machine
off and on again.
Call the service.

Cyclic PHT FXX Leakage in the bal- Acknowledge by Approx. Approx.

alternating with ancing system dur- pressing the Dia- 13 min 3 min
Possible balance err ing dialysis opera- lysis Start key, with
tion. a possible balancing
Bypass operation. error being taken
UF off. into consideration.
If the test fails to be
passed repeatedly,
discontinue the
treatment and call
the service.
Failure to do so
may lead to a bal-
ancing error.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-35

 Message Cause Possible First Repeti-
solution warning tion

Cyclic PHT F04 Blood alarm present Acknowledge by Approx. Approx.

alternating with for more than pressing the Dia- 15 min 6 min
Possible balance err 3 minutes. lysis Start key, with
or a possible balancing
Failure to perform error being taken
the cyclic pressure into consideration.
holding test (system If the test fails to be
error). passed repeatedly,
discontinue the
treatment and call
the service.
Failure to do so may
lead to a balancing
error.

Dialines not conn The dialysate cou- Connect the Approx. –

plings are still situat- couplings to the 9 min
ed in the interlock dialyzer.
shunt.

Error on the RCU ! Incorrect information Press the Dialysis – –

from Remote Con- Start 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
Dialysis Start 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).

4-36 Fresenius Medical Care 4008 B 16/10.03 (OP)

Message Cause Possible First Repeti-
solution warning tion

Flow - off warning The dialysate flow Press the Dialysis 30 min 30 min
has been switched Start key (unless flow 45 min 45 min
off. is desired at the mo- 60 min 60 min
ment), or switch on (SETUP) (SETUP)
the dialysate flow.

Funct. not allowed Will be displayed Observe correct – –

any time a function operating sequence.
is not available.

FXXX UF-failure UF pump or activa- Press the Dialysis – –

tion defective. Start key.
Call the service.

Hep.-Modul error E0X Communication Press the Dialysis – –

problem between Start key.
heparin pump and
monitor.

Heparin pump alarm The heparin syringe Press the Dialysis – –

has reached its end Start 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 Dialysis Approx. –
module is not Start key (no 11 min
switched on. heparinization), or
switch on the
heparin pump.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-37

 Message Cause Possible First Repeti-
solution warning tion

MODULE error Hydraulic processor Call the service. – –

malfunction.

NO – UF Ultrafiltration is off. Press the Dialysis 0 min 10 min

Start key (unless UF or or
is desired at the 30 min 30 min
moment), or switch (SETUP) (SETUP)
on ultrafiltration by
pressing the UF I/O
key.

Profiles paused Profiles have been Restart the profiles, 10 min 10 min
(not applicable for stopped. or continue to stop
4008 B machines with- them by pressing
out profiles) the Dialysis Start
key.

Profile time diff. Difference between Press the Dialysis – –

(not applicable for UF time and profile Start key, or stop
4008 B machines with- time. the profiles.
out profiles) Call the service.

RCU Keyboard Error Incorrect information Press the Dialysis – –

from Remote Con- Start key.
trol Unit. Call the service.

Relation BPR/UFR ? As compared with Press the Dialysis 2 min 30 min

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

4-38 Fresenius Medical Care 4008 B 16/10.03 (OP)

Message Cause Possible First Repeti-
solution 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 interlock shunt Close the interlock 1 min –
has been opened. shunt.

Timer ‘Alarm’ The timer time has Press the Dialysis – –

elapsed. Start key.

Timer stops UF-Rate The UF time has Press the Dialysis – –

elapsed. Start key.
The UF pump is not
running.

UF-Goal reached The UF time has Press the Dialysis – –

elapsed, and the UF Start key.
goal has been
reached. The UF
pump is not running.

V84 faultiness ! Malfunction of valve Acknowledge with – –

V84. the Dialysis Start
key.
Discontinue treat-
ment as a potential
balancing error may
have occurred.
Perform a disinfec-
tion (cleaning pro-
gram 1 to 4).
If the problem per-
sists, call the ser-
vice.

Voltage Failure One of the voltages Use the I/O switch to – –

is outside of limits toggle the machine
(+5 V, +12 V, +24 V). off and on again.
Call the service.

Wrong conc. supply Wrong concentrate Check the concen- – –

composition. trate side.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-39

4.6 Emergency Operation

al Care 4008 B
The red (alarm) status indicator is illu-
Emergency Operation minated.

Arterial Venous Transmembrane

Audible signal
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml
Nurse call active.
R

Hydraulics off.
UF pump(s) stopped.
The extracorporal blood circuit is main-
tained.

Override
–30
–200
0
Test
–40 –300
The Dialysis Start LED is illuminated.

Prime The Alarm Tone Mute LED is flashing.

Dialysis Start
Reset Alarm

Alarm Tone
Mute

4-40 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Override
–30
–200
0
Test
–40 –300
Press the Alarm Tone Mute key.
Prime The green (operation) status indicator is
illuminated.
Dialysis Start
Reset Alarm
The Dialysis Start LED is illuminated.

☛ Alarm Tone
Mute
The Alarm Tone Mute LED turns dark.
No audible signal
Emergency operation is possible for
approx. 15 minutes.
Should power supply not return, the
treatment must be stopped.
As soon as power has returned, the
program can be continued as usual.

Caution
In the event of a prolonged power
failure, use the hand crank to manu-
ally 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!

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-41

4.7 Error Messages During Cleaning Programs

4.7.1 Indication of Errors

Fresenius Medical Care 4008 B Indication of malfunctions during the

cleaning programs:
The red (alarm) status indicator is illu-
minated.
I/O
Air Detector Arterial V
Pressure Pr Display message
Rinse The Rinse LED is flashing.
or kPa mmHg kPa or
Hotrinse 280 The Hotrinse LED is flashing.
Blood Leak 30
or 200 60
or
20 50
Disinfection
10
100 40
The Disinfection LED is flashing.
Depending on the cleaning program
0 0 30
Single selected.
Needle –10
–100 20

Override
–20 10 The Alarm Tone Mute LED is flashing.
–30
–200
0
Test
–40 –300 The dialysate system is inactive.
Prime Audible signal

Dialysis Start
Reset Alarm

Alarm Tone
Mute

4-42 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.7.2 Error Messages

Message Cause Possible solution

Arterial pressure Arterial pressure outside the Check the tubing system.
(only while priming/ alarm limits. Connect the tubing system.
precirculation is in Purge the hydrophobic filter.
progress during the Increase the blood pump
cleaning programs) speed (>100 ml/min).
Call the service.

Bic line not conn The bicarbonate connector is Insert the bicarbonate connec-
not inserted in the rinse cham- tor in the rinse chamber.
ber.

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 The air detector detects blood Can be acknowledged by
at the start of a cleaning pro- pressing the respective clean-
gram. 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 inserted in the rinse cham- tor in the rinse chamber.
ber.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-43

 Message Cause Possible solution

Connect Disinfectant has not been con- Connect disinfectant.

Disinfectant nected. Message:
Press CONFIRM Key.
Press the Confirm key.

CPU-II failed System error. Press the I/O switch to toggle

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 ? Disinfection valve sensor 115 Check the disinfectant con-
does not sense any conductiv- tainer.
ity. Can be acknowledged by
Concentrate level sensor does pressing the Disinfection key.
not detect fluid. Call the service.

Disinf-Temp. to high After the rinsing clear cycle, The rinse-clear cycle con-
the temperature is higher than tinues until the temperature
40 °C. has dropped below 40 °C.
Automatically clearing.
Call the service.

Filter change ! Error detected during function- Select a different cleaning

al test. program or change the filter.
(Pressure holding test failed.) (See Chapter 7.5 or 7.6
Maximum number of treat- Changing the DIASAFE® plus.)
ments reached (after 100 If the filter is not changed,
treatments). treatment cannot be initiated.
Maximum filter service life ex-
ceeded.
Maximum number of disinfec-
tions with Sporotal reached.

4-44 Fresenius Medical Care 4008 B 16/10.03 (OP)

Message Cause Possible solution

Float-Switch Failure The lower switching point can- Can be acknowledged by

not be reached. pressing
the respective cleaning pro-
gram key.
Call the service.

Flow alarm Dialyzer lines are kinked. Check the lines.

Message is cleared automatic-
ally.
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 (precirculation impossible).
progress during the After cleaning: perform a func-
cleaning programs) tional test.
Call the service.

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

during hot rinsing:
temperature >90 °C.

Internal Error XXX Run time error in the program. Press the I/O switch to toggle
the machine off and on again.
Call the service.

Level Detect. failed Air detector test failed. Problem cannot be corrected
(only while priming/ in the cleaning program
precirculation is in (precirculation impossible).
progress during the After cleaning: perform a func-
cleaning programs) tional test.
Call the service.

Low temperature Temperature <33 °C; Call the service.

during hot rinsing:
temperature <78.5 °C.

opt. Detector failed Optical detector test failed. Problem cannot be corrected
(only while priming/ in the cleaning program
precirculation is in (precirculation impossible).
progress during the After cleaning: perform a func-
cleaning programs) tional test.
Call the service.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-45

 Message Cause Possible solution

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 being sucked Message is cleared automat-

in via the concentrate pump. ically.

Power Failure Power failure during operation. After power has returned, the
resp. program can be con-
tinued as usual.

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

ing the Rinse key.
Call the service.

Rinse Failure F02 V84 error. Press the I/O switch to toggle
the machine off and on again.
Call the service.
In disinfection program In disinfection program
(PGM 5): Concentrate level (PGM 5): Connect disinfectant.
sensor does not detect fluid.

Rinse Failure F03 V84 error. Can be acknowledged by press-

ing the Disinfection key.
Call the service.

Rinse Failure F04 The float switch does not Press the I/O switch to toggle
recognize any 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 ring line (no more than
500 mbar).

Rinse Failure F06 PSW 123 does not open. Call the service. Observe the
pressure exerted on the ring
line (no more than 500 mbar).

Rinse Failure F07* Pressure loss on PSW 124. Call the service.

Rinse Failure F08* Pressure loss on PSW 123. Call the service.

* This error message may be indicated alternately with the message DO NOT SWITCH OFF !!
Turn the machine off after 1 min only!

4-46 Fresenius Medical Care 4008 B 16/10.03 (OP)

Message on the Cause Possible solution

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 Mandatory rinse 3 min before Call the service.
end. PSW 123 has not opened
after pressure reduction.

Rinse Failure F12 It was impossible to open Call the service.

PSW 123/124.

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 press-

pump does not agree with the ing the respective cleaning pro-
specified rate. gram 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.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-47

 Message Cause Possible solution

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.

V39 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. V102 electrically opened.

V104 Failure V104 electrically opened. V104 electrically opened.

V130 Failure V130 malfunction V130 malfunction

V188 Failure V188 malfunction Call the service.

Venous pressure? Venous pressure outside the Check the tubing system.
(only while priming/ alarm limits. Connect the tubing system.
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 respect-
of limits (+12 V, +24 V). ive cleaning program key.
Press the I/O switch to toggle
the machine off and on again.
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.

4-48 Fresenius Medical Care 4008 B 16/10.03 (OP)

4.8 Error Messages After Turning Power On

Message Cause Possible solution

BRAM_#_XXXX_ System error. Use the I/O key to turn the

machine off and on.
Call the service.

EPROM-Error System error. Use the I/O key to turn the

machine off and on.
Call the service.

FXX Configuration Incorrect machine Call the service.

configuration

HPU Error Malfunction in hydraulic Use the I/O key to turn the
processing unit. machine off and on.
Call the service.

Keyboard Error The key on the monitor is Use the I/O key to turn the
pressed upon power up. machine off and on.
Short-circuit on the keyboard. Call the service.

NOVRAM-Error System error. Use the I/O key to turn the

machine off and on.
Call the service.

RAM-Error System error. Use the I/O key to turn the

machine off and on.
Call the service.

Watchdog Error This error message will only Use the I/O key to turn the
be displayed immediately machine off and on.
after turning power on. Call the service.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-49

4.9 Error Messages When Using the Download Function

Message Cause Possible solution

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.
Restart data transfer.

Download Error F012 Unacceptable dialysate flow. Check external data.

Restart data transfer.

4-50 Fresenius Medical Care 4008 B 16/10.03 (OP)

Message Cause Possible solution

Download Error F013 Value range for Base Na + or Check external data.
prescribed Na+ 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.

Restart data transfer.

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.
Restart data transfer.

Download Error F020 Block check UF rate, UF goal, Check external data.
UF time, UF profile. Restart data transfer.
Na+ profile, Base Na+,
prescribed Na+ , start Na+.

Download Error F021 UF profile data plausibility. Check external data.

Restart data transfer.

Download Error F022 Na+ profile data plausibility. Check external data.
Restart data transfer.

Download Error F023 Invalid CRC of the patient key. Check patient key.
Restart data transfer.

Fresenius Medical Care 4008 B 16/10.03 (OP) 4-51

4-52 Fresenius Medical Care 4008 B 16/10.03 (OP)
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 Repeating Reinfusion ..................................................................................................... 5-8
5.2.3 Skipping Reinfusion ........................................................................................................ 5-9
5.2.4 Premature Termination ................................................................................................... 5-9

5.3 Stopping the Treatment ................................................................................................ 5-10

5.3.1 Without Reinfusion .......................................................................................................... 5-10
5.3.2 Stopping the Treatment With Reinfusion Program ........................................................ 5-13

5.4 Emptying the bibag® (option) ....................................................................................... 5-17

5.5 Emptying the Dialyzer .................................................................................................. 5-19

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-1

5-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
5.1 End of Treatment

5.1.1 Double Needle Dialysis

al Care 4008 B
The yellow (warning/info) status indi-
UF-Goal reached cator is illuminated.

Arterial Venous Transmembrane

Display message, e.g.:
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml UF-Goal reached.
R

The TMP alarm limits are spread fully

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure open.
The UF LED is off.
kPa mmHg kPa mmHg kPa mmHg
The UF pump stops.
280 500 500
Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
The Dialysis Start LED is flashing.

Prime The Alarm Tone Mute LED is flashing.

Dialysis Start Audible signal

Reset Alarm

Alarm Tone
Mute

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start If necessary, switch the heparin pump

Reset Alarm
off.
Alarm Tone
Mute

Confirm Select Display message

Reinfusion ?

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-3

5.1.2 Single Needle Dialysis

Rate: ml/h Rate: ml/min

Stop the arterial and/or single needle
(Bolus: ml) (Ø: mm)
blood pump.
( :h.min)

Bolus

Start
Rate Stop

Start
☛
Rate: ml/h
(Bolus: ml)
Rate: ml/min
(Ø: mm)
➀ Open the cover.
( :h.min) ➁ Press the Start/Stop key, until the ro-
Bolus tor stops.
Start
Rate Stop

Start
Stop
☛
➁

Rate: ml/h
(Bolus: ml)
Rate: ml/min
(Ø: mm)
➀ Remove the line segment on the left
side.
( :h.min)

Bolus ➁ Press the Start/Stop key, until the

Start tubing system has been completely
Rate Stop
☛ removed.
Start
Stop
➁ ➂ Remove the line segment on the right
side.
➃ Close the cover.

➀ ➂

5-4 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Rinse Press the Single Needle key.
kPa mmHg kPa

Hotrinse 280 The Single Needle LED turns dark.

Blood Leak 30 60
200
20 50
Disinfection
10
100 40

☛
0 0 30
Single
Needle –10
–100 20

–20

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-5

5.2 Reinfusion

5.2.1 Performing Reinfusion

Confirm Select
Press the Confirm key.
Reinfusion ?
☛
al Care 4008 B The yellow (warning/info) status indica-
tor is illuminated.
The blood pump stops.

Arterial Venous Transmembrane The venous line clamp is closed.

The arterial, venous and TMP limits are

Arterial Venous Transmembrane
Air Detector
Pressure Pressure Pressure spread fully open for 5 minutes.

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Disconnect the arterial patient connector

and connect the line to the return solu-
tion.
Break the cone.

Rate: ml/min
Use the ▼ key to reduce the delivery
(Ø: mm)
rate of the blood pump.

Start
Stop
☛

5-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime Reinfusion starts (for a maximum of

5 minutes).

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute
The Dialysis Start LED is illuminated.

Confirm Select The optical detector senses clear

Dialysis end fluid.
The blood pump is not running.
The venous line clamp is closed.
Audible signal

Override
–30
–200
0
Test
–40 –300 Press the Dialysis Start key.
Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Confirm Select Display message

Preparation
The blood pump starts.
Reinfuse the remaining patient blood,
until an air detector alarm occurs.
(Audible signals are suppressed.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-7

 Fresenius Medical Care 4008 B The red (alarm) status indicator is illumi-
nated.
The Prime LED is flashing.
I/O
Air Detector Arterial V The Dialysis Start LED is flashing.
Pressure Pr
The Alarm Tone Mute LED is flashing.
Rinse
kPa mmHg kPa The Air Detector LED is flashing.
Hotrinse 280
Blood Leak 30
200 60 The blood pump is not running.
20 50
Disinfection
10
100 40
The venous line clamp closes.
0 0 30
Disconnect the patient on the venous
Single
Needle –10
–100 20
side.
–20 10
Override
–30
–200
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

5.2.2 Repeating Reinfusion

Confirm Select The reinfusion time has elapsed, before

Reinfusion ?
☛ the optical detector senses clear fluid.
Acknowledge by pressing the Confirm
key.

Confirm Select
Reinfusion

Override
–30
–200
0
Test
–40 –300
Restart reinfusion by pressing the
Dialysis Start key.
Prime
The Dialysis Start LED is illuminated.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

5-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

5.2.3 Skipping Reinfusion

Confirm Select Display message

Reinfusion ?

Override
–30
–200
Test
0
Press the Dialysis Start key.
–40 –300
Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Confirm Select Display message

Dialysis

5.2.4 Premature Termination

Confirm Select Press the Select key.

Reinfusion
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode
☛ 2. Treatment mode.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.4 Reinfusion ☛ 2.4 Reinfusion.
Press the Confirm key.

Confirm Select Press the Confirm key.

Stop Reinfusion ? ☛
Confirm Select Display message
Dialysis

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-9

5.3 Stopping the Treatment

5.3.1 Without Reinfusion

(25 C)

Time Left h:min

Variation Switch off ultrafiltration by pressing the
I/O Prog. UF I/O key.
Tempera-
UF Flow ture The UF LED turns dark.
I/O Prog. I/O Set
☛

Rate: ml/min
Switch off the blood pump.
(Ø: mm)

The operation LED is dark.

Reduce the delivery rate of the blood
pump.
Start
Stop
Remove the arterial patient access and
☛ connect the line to the return solution.
Break the cone.

Rate: ml/h
(Bolus: ml)
Switch off the heparin pump.
The operation LED is dark.
( :h.min)

Bolus

Rate

Start
Stop
☛
Rate: ml/min
Switch on the blood pump with reduced
(Ø: mm)
blood flow.
The operation LED is illuminated.

Start
Stop
☛

5-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

al Care 4008 B
The optical detector senses clear fluid.
Dialysis end
The yellow (warning/info) status indi-
Arterial Venous Transmembrane
cator is illuminated.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml

R
Display message
The blood pump is not running.
The venous line clamp closes.
Audible signal
Empty the bibag® (option).
See Chapter 5.4 Emptying the bibag®
(option).

The alarm limits are spread fully open.

Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–200
Test
–30 0 The Dialysis Start and the Alarm Tone
–40 –300 Mute LEDs are flashing.
Prime
Press the Dialysis Start key.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Confirm Select
Display message
Preparation
Audible signals are suppressed.
Reinfuse the remaining patient blood,
until an air detector alarm occurs.

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-11

 Fresenius Medical Care 4008 B The red (alarm) status indicator is illumi-
nated.
The Prime LED is flashing.
I/O
Arterial V
The Dialysis Start LED is flashing.
Air Detector
Pressure Pr
The Alarm Tone Mute LED is flashing.
Rinse
kPa mmHg kPa
The Air Detector LED is flashing.
Hotrinse 280
Blood Leak 30 60
The blood pump is not running.
200
20
Disinfection
100
50
The venous line clamp closes.
10 40

0 0 30 Disconnect the patient on the venous

Single
Needle –10
–100 20 side.
–20 10
Override
–30
–200
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

5-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

5.3.2 Stopping the Treatment With Reinfusion Program

(25 C)

Time Left h:min

Variation Switch off ultrafiltration by pressing the
I/O Prog. UF I/O key.
Tempera-
UF Flow ture The UF LED is dark.
I/O Prog. I/O Set

☛
● Via reset volume key

Ultrafiltration Press the Reset Volume key, until the

UF Volume ml UF Volume display indicates 0000.
3200 Reset
Volume

UF Rate ml/h
☛
0800

UF Goal ml

4000

Time Left h:min

1:00
UF

I/O Prog.

Confirm Select Display message

Reinfusion ?
☛ Press the Confirm key.

● Via the treatment mode menu

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
2. Treatment mode
☛ 2. Treatment mode.

Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

2.4 Reinfusion 2.4 Reinfusion.
☛ Press the Confirm key.

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-13

 ● Via the treatment parameters menu

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

7.1 Reset UF data
☛ 7.1 Reset UF data.
Press the Confirm key.

Confirm Select Press the Confirm key.

Are you sure ?
☛
Confirm Select Temporary display message
Value(s) cleared !

Confirm Select Automatic return

7.1 Reset UF data

Confirm Select
Press the Confirm key.
Reinfusion ?
☛

5-14 Fresenius Medical Care 4008 B 16/10.03 (OP)

al Care 4008 B
The blood pump stops.
Reinfusion
The venous line clamp closes.
Air Detector Arterial Venous Transmembrane Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml

The alarm limits are spread fully open.

Air Detector Arterial Venous Transmembrane
Pressure Pressure Pressure

kPa mmHg kPa mmHg kPa mmHg

280 500 500

Blood Leak 30 60 60
200
20 50 400 50 400
10
100 40 300 40 300
0 0 30 30
200 200
–10
–100 20 20

–20 10
100 10
100
Override
–200
–30 0 0 0 0
–40 –300

Override
–30
–200
0
Test
–40 –300
The Dialysis Start LED is illuminated.

Prime Remove the arterial patient access and

connect the line to the return solution.
Dialysis Start
Reset Alarm
Break the cone.
Alarm Tone Reduce the delivery rate of the blood
Mute
pump.

Rate: ml/h
(Bolus: ml)
Switch off the heparin pump.
The operation LED is dark.
( :h.min)

Bolus

Rate

Start
Stop
☛
Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-15

 Confirm Select The optical detector senses clear fluid.
Dialysis end
The blood pump is not running.
The venous line clamp is closed.
Audible signal
Empty the bibag® (option).
See Chapter 5.4 Emptying the bibag®
(option).

Override
–30
–200
0
Test
–40 –300
Press the Dialysis Start key.

Prime The Dialysis Start LED is illuminated.

☛
Dialysis Start
Reset Alarm

Alarm Tone
Mute

Confirm Select Display message

Preparation
The blood pump starts.
Reinfuse the remaining patient blood,
until an air detector alarm occurs.
(Audible signals are suppressed.)

Fresenius Medical Care 4008 B The red (alarm) status indicator is illu-
minated.
The Prime LED is flashing.
I/O
Air Detector Arterial V The Dialysis Start LED is flashing.
Pressure Pr
The Alarm Tone Mute LED is flashing.
Rinse
kPa mmHg kPa The Air Detector LED is flashing.
Hotrinse 280
Blood Leak 30
200 60 The blood pump is not running.
20 50
Disinfection
10
100 The venous line clamp closes.
40

0 0 30
Disconnect the patient on the venous
Single
Needle –10
–100 20
side.
–20 10
Override
–30
–200
0
Test
–40 –300
Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

5-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

5.4 Emptying the bibag® (option)

Confirm Select Display message

Dialysis end

Override
–30
–200
Test
0
Press the Dialysis Start key.
–40 –300
Prime The Dialysis Start LED lights.

☛
Dialysis Start
Reset Alarm

Alarm Tone
Mute

Confirm Select Display message

Empty BIBAG ?
☛ Press the Confirm key.

Confirm Select Display message

Emptying BIBAG
Drain program in progress.

Override
–30
–200
Test
0
The drain program can be skipped by
–40 –300
pressing the Dialysis Start key a sec-
Prime ond time.

☛
Dialysis Start
Reset Alarm

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-17

 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.

Turn the interlock plate 180°.

Close the interlock plate.

☛

5-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

5.5 Emptying the Dialyzer

Turn the dialyzer, the dialysate inlet is at

the upper end.
Open the interlock shunt.
Place the dialysate supply line on the red
color-coded connection.
Close the interlock shunt.

Confirm Select Display message

Emptying-program

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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 5-19

 Remove the tubing system from the ma-
chine.

Caution
It is imperative to disinfect the ma-
chine 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 ini-
tiating the next treatment.

5-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

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 and Decalcification ................................................................................. 6-6

6.4.1 Start ................................................................................................................................ 6-7
6.4.2 Sequence ........................................................................................................................ 6-8
6.4.3 Program Selection .......................................................................................................... 6-10
6.4.4 Program Termination ...................................................................................................... 6-11

6.5 Cleaning / Degreasing Program .................................................................................. 6-12

6.5.1 Start ................................................................................................................................ 6-13
6.5.2 Sequence ........................................................................................................................ 6-16
6.5.3 Program Termination ...................................................................................................... 6-16

6.6 Hot Rinse ....................................................................................................................... 6-18

6.6.1 Start ................................................................................................................................ 6-18
6.6.2 Sequence ........................................................................................................................ 6-19
6.6.3 Program Termination ...................................................................................................... 6-20

6.7 Rinsing ........................................................................................................................... 6-21

6.7.1 Start ................................................................................................................................ 6-21
6.7.2 Sequence ........................................................................................................................ 6-21
6.7.3 Program Termination ...................................................................................................... 6-22

6.8 Priming During Cleaning Programs ............................................................................ 6-23

6.8.1 Basic Conditions ............................................................................................................. 6-23
6.8.2 Start ................................................................................................................................ 6-23
6.8.3 Setting the Delivery Rate of the Blood Pump ................................................................. 6-24
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
6.9.4 Setting the Delivery Rate of the Blood Pump ................................................................. 6-29
6.9.5 Delivery Stops ................................................................................................................. 6-29
6.9.6 Interrupting Precirculation ............................................................................................... 6-30
6.9.7 Premature Termination ................................................................................................... 6-30

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-1

6-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
6.1 General Overview

Ende
End der Dialyse
of dialysis

Spülen
Rinse Heißreinigen
Hot rinsing Desinfektion
Disinfection (Reinigung)
(cleaning)

–R–
PGM 1: –S– –F–HR–C–
PGM 1: –F–HR–A– PGM 1: –F–D–Z–
–F–D–M–
–R–endl.
PGM 2: –S– endless –F–HR–
PGM 2: –F–HR– PGM 2: –F–HDES–Z–
–F–HDIS–M–
PGM 3: –IHR– PGM 3: –F–D–Z–HR–
–F–D–M–HR–
PGM 4: –IHR–C– PGM 4: –F–HDES–Z–HR–
–F–HDIS–M–HR–
PGM 5: –F–R(V)–Z–
–F–D(F)–M–

Dialyse
Dialysis

Explanation of the abbreviations used

PGM Program
R Rinse
R endless Endless rinse
F Rinsing clean
HR Hot rinsing
C Cooling rinse
D Disinfection
D(F) Cleaning
Disinfectant is drawn in from the front (concentrate suction tube).
HDIS Hot disinfection
M Mandatory rinse
IHR Integrated hot rinsing

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-3

6.1.1 General Notes

☞ Note
The remaining time indicated during
the cleaning programs are calculated
values.
Different environmental conditions
may result in correction of the calcu-
lated time.

☞ Note
Applicable for machines with
DIASAFE®plus (option) and advanced
hydraulics only:
When selecting a cleaning program,
a display message will inform the op-
erator when the filter needs to be
changed.
(See Chapter 7.6.1 Indication of a
Filter Change.)

6-4 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.2 External Cleaning

After the treatment, the exterior of the hemodialysis machine must be cleaned with a cleaning and
disinfecting agent. The active substance concentration of the cleaning and disinfecting agents
must not exceed <5 % for amphoteric surfactants and <48 % for alcohol.
(See also Chapter 1.9 Disposables and Consumables.)

6.3 Basic Conditions for Cleaning Programs

– The dialysate lines are connected to the shunt.

– The shunt door is closed.
– 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
Applicable for DIASAFE®plus (option)
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.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-5

6.4 Disinfection and Decalcification

Factory setting: Citrosteril® and Diasteril ® respectively. This setting must be changed by the
technician if a different agent is used.

Caution
During the hot disinfection cycle
scalding water or steam may be
emitted via the vent tubing.

Caution
Applicable for DIASAFE®plus (option)
only:
High surface temperatures on the
DIASAFE ®plus during heat disinfec-
tion.

6-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.4.1 Start

Rinse Press the Disinfection key.

kPa mmHg kPa

Hotrinse 280 The Disinfection LED is illuminated.

Blood Leak 30

☛
60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

al Care 4008 B
The yellow (warning/info) status indi-
PGM 2: –F–HDIS–M– cator is illuminated.
The text display indicates the program
Air Detector Arterial
Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati preset in the SETUP menu,
UF Volume ml

R
e.g. PGM 2: —F—HDIS—M—
The program starts automatically after
approx. 5 seconds.

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-7

6.4.2 Sequence

Confirm Select Display message

Rinsing clean

Confirm Select Rinsing clear

>F<HDIS—M— : 0 h 30
The Disinfection LED and the Rinse
LED are illuminated.

Confirm Select Hot disinfection

—F>HDIS<M— : x h xx
The Disinfection LED is illuminated.
The current temperature can be dis-
played by pressing the ▲ and ▼ keys.

Confirm Select Mandatory rinse

—F—HDIS>M< : x h xx
The Rinse LED is illuminated.

6-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Confirm Select Program end, optionally accompanied by
Mandatory rinse end an audible signal.
The red (alarm) status indicator is illu-
minated.
The Alarm Tone Mute LED is flashing.
The audible signal can be selected in
the SETUP menu.

Caution
It is recommended to perform the
check for residual disinfectants at the
drain of the hemodialysis machine.
In case other test methods are app-
lied, the requesting person bears the
responsibility for this decision.

Caution
After disinfection with Puristeril® 340
or Puristeril®plus, the machine must
be checked for residual disinfectant
after the mandatory rinse has been
completed (e.g. potassium iodide pa-
per).
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
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 strips.
If the pH is too high (yellow color
pH ≤ 4.1), run an rinse program for a
minimum of 5 min., then re-deter-
mine the pH.

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-9

6.4.3 Program Selection

Rinse Press the Disinfection key.

kPa mmHg kPa

Hotrinse 280 The Disinfection LED is illuminated.

Blood Leak 30

☛
60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select Use the ▲ and ▼ keys to select the de-

PGM 1: –F–D–M sired disinfection program.
☛ The program starts automatically after
Confirm Select
5 seconds.
PGM 2: –F–HDIS–M

Confirm Select
PGM 3: –F–D–M–HR

Confirm Select
PGM 4: –F–HDIS–M–HR

Confirm Select
PGM 5: –F–D(F)–M

6-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.4.4 Program Termination

Caution
Do not stop a disinfection program
before its completion, as premature
termination will compromise the effi-
cacy of the disinfection.

Confirm Select Press the key of the program step

>F<HDIS–M– : 0 h 29 currently in progress, e.g. Rinse, for
approx. 2 seconds.

☛ Rinse

Hotrinse
Blood Leak
kPa

30
mmHg

280
200
kPa

60

20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-11

 Confirm Select Message displayed for 2 seconds.
End cleaning pgm ?

Confirm Select Alternating display messages

Rinsing clean end
The red (alarm) status indicator is illu-
minated.

>F<HDIS—M— : 0 h 29
Confirm Select The Alarm Tone Mute LED is flashing.
Audible signal

☞ Note
If the mandatory rinse is stopped, the
mandatory rinse time will restart from
the beginning.

Disinfection programs can also be

switched off by turning the concentrate
or bicarbonate suction tube.

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

6-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.5 Cleaning / Degreasing Program

Cleaning program with the cleaning agent (Sporotal® 100) being drawn in from the front through
the concentration suction tube.

The use of cleaning agents with another composition may cause the message Disinfectant
empty ?, although the container may be full.

☞ 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 7.6.1 Indication of a Filter Change.)

6.5.1 Start

Rinse Press the Disinfection key.

kPa mmHg kPa

Hotrinse 280 The Disinfection LED is illuminated.

Blood Leak

☛
30 60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

al Care 4008 B The yellow (warning/info) status indic-

PGM 2: –F–HDIS–M– ator is illuminated.
The text display indicates the program
Air Detector Arterial
Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati preset in the SETUP menu,
UF Volume ml
e.g.: PGM 2: —F—HDIS—M—
R

Confirm Select Use the ▲ and ▼ keys to select pro-

PGM 5: –F–D(F)–M–
☛ gram 5 .
The program starts automatically after
5 seconds.

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-13

 Confirm Select Rinsing clear
>F<D(F)—M— : x h xx
The Rinse LED and the Disinfection
LED are illuminated.

Confirm Select Display message

Connect Disinfectant
The red (alarm) status indicator is illu-
minated.
The Alarm Tone Mute LED is flashing.
Audible signal

Rate: ml/h

Insert the red concentrate suction tube in

(Bolus: ml)

( :h.min)

Bolus

Rate

Start
Stop
the cleaning agent container
(Sporotal® 100).

Cleaning
agent

Caution
Assure that the container used con-
tains sufficient cleaning agent to
complete the rinse program.
Avoid aspiration of air.

6-14 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Confirm Select Display message
Press CONFIRM key
☛ Press the Confirm key.

Confirm Select
Display message
Please Wait
The yellow (warning/info) status indi-
cator is illuminated.
Cleaning agent is being drawn in.

Confirm Select
Display message
Conc line not conn
The red (alarm) status indicator is illu-
minated.
The Alarm Tone Mute LED is flashing.
Audible signal
Insert the red concentrate suction tube in
the rinse chamber.

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-15

6.5.2 Sequence

Confirm Select Cleaning

—F>D(F)<M— : x h xx
The Disinfection LED is illuminated.

Confirm Select Automatic mandatory rinse

—F—D(F)>M< : x h xx
The Rinse LED is illuminated.

Confirm Select End of program, optionally accompanied

Mandatory rinse end by an audible signal.
The red (alarm) status indicator is illu-
minated.
The Alarm Tone Mute LED is flashing.

Caution
It is recommended to perform the
check for residual disinfectants at the
drain of the hemodialysis machine.
In case other test methods are app-
lied, the requesting person bears the
responsibility for this decision.

Caution
Check the machine for residual disin-
fectant (e.g. with potassium iodide
paper)
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.)

6-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.5.3 Stopping the Program

(See Chapter 6.4.3 Stopping the Program.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-17

6.6 Hot Rinse

Available hot rinse programs:

PGM 1 with cooling rinse
PGM 2 without cooling rinse
PGM 3 integrated hot rinse
PGM 4 integrated hot rinse with cooling rinse

Caution
During the hot disinfection cycle
scalding water or steam may be
emitted via the vent tubing.

Caution
Applicable for DIASAFE®plus (option)
only:
High surface temperatures on the
DIASAFE®plus during hot rinse pro-
grams!

6.6.1 Start

Rinse Press the Hotrinse key.

☛
kPa mmHg kPa

Hotrinse 280 The Hotrinse LED is illuminated.

Blood Leak 30 60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

al Care 4008 B
The yellow (warning/info) status indi-
PGM 1: –F–HR–C– cator is illuminated.

Arterial Venous Transmembrane

The text display indicates the program
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml preset in the SETUP menu,
R e.g.: PGM 1: —F—HR—C—
The program starts automatically after
approx. 5 seconds.

6-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.6.2 Sequence

Confirm Select
PGM 1: —F—HR—C—

Confirm Select Rinsing clear

>F<HR—C— : x h xx
The Rinse LED is illuminated.
The Hotrinse LED is illuminated.

Confirm Select Hot rinsing

—F>HR<C— : x h xx
The Hotrinse LED is illuminated.
The current temperature can be dis-
played by pressing the ▲ and ▼ keys.

Confirm Select Cooling rinse

—F—HR>C< : x h xx
The Rinse LED is illuminated.

Confirm Select The Alarm Tone Mute LED is flashing.

Cooling rinse end
Audible signal
Selectable in the SETUP menu.

The red (alarm) status indicator is illu-

minated.

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-19

6.6.3 Program Termination

Confirm Select Press the respective key of the program

>F<HR—C— : 0 h 29 step currently in progress, e.g. Rinse, for
approx. 2 seconds.

☛ Rinse

Hotrinse
Blood Leak
kPa

30
mmHg

280
200
kPa

60

20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select Message displayed for approx. 2 sec-

End cleaning pgm ? onds.

Confirm Select Alternating display messages

Rinsing clean end
The red (alarm) status indicator is illu-
minated.

>F<HR—C— : 0 h 29
Confirm Select The Alarm Tone Mute LED is flashing.
Audible signal

The cleaning programs can also be

stopped by turning the concentrate or
bicarbonate suction tube.

☞ 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.

6-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.7 Rinsing

There are two rinse options:

PGM 1: rinse
PGM 2: endless rinse

6.7.1 Start

☛ Rinse

Hotrinse
Blood Leak
kPa

30
mmHg

280
200
kPa

60
Press the Rinse key.
The Rinse LED is illuminated.

20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

al Care 4008 B
The yellow (warning/info) status indi-
PGM 1: –R– cator is illuminated.

Air Detector Arterial

Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati The text display indicates the program
UF Volume ml

R
preset in the SETUP menu,
e.g. PGM 1: —R—

The program starts automatically after

approx. 5 seconds.

6.7.2 Sequence

Confirm Select
>R< : x h xx

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-21

6.7.3 Program Termination

Confirm Select Press the Rinse key for approximately

>R< : 0 h 13 2 seconds.

☛ Rinse

Hotrinse
Blood Leak
kPa

30
mmHg

280
200
kPa

60

20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select Message displayed for approximately

End cleaning pgm ? 2 seconds.

Confirm Select Alternating display messages

Please wait for approximately 20 seconds

Confirm Select
>R< : 0 h 13

Confirm Select Alternating display messages

Rinse end
The red (alarm) status indicator is illu-
minated.

>R< : 0 h 13
Confirm Select The Alarm Tone Mute LED is flashing.
Audible signal

The rinsing programs can also be

stopped by turning the concentrate or
bicarbonate suction tube.

☞ 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.

6-22 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.8 Priming During the Cleaning Programs

6.8.1 Basic Conditions

☛ Rinse

Hotrinse
Blood Leak
kPa

30
mmHg

280
200
kPa

60
Select a cleaning program, e.g. Rinse.
Press the Rinse key.

20 50
The Rinse LED is illuminated.
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

6.8.2 Start

Rinse Press the Prime key for 1 second.

kPa mmHg kPa

Hotrinse 280 The Prime LED is illuminated.

Blood Leak 30 60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300

☛ Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

al Care 4008 B
The yellow (warning/info) status indi-
Prime cator is illuminated.

Air Detector Arterial Venous Transmembrane Ultrafiltrati

Temporary display message
Pressure Pressure Pressure
UF Volume ml

Confirm Select Temporary display message if a rinse

Rinse-volume XXXX ml volume was selected in the SETUP.

Confirm Select Display message, e.g.: >R< : 0 h 15

>R< : 0 h 15

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-23

6.8.3 Setting the Delivery Rate of the Blood Pump

Rate: ml/min
The operation (green) LED is illu-
(Ø: mm)
minated.
The blood pump is delivering.
☛ The arterial blood pump fills the tubing
Start
system up to the venous bubble catcher.
Stop A delivery rate > 180 ml/min will auto-
matically be reset to 180 ml/min. The
delivery rate can be changed by the
user as desired.

Use the ▲ or ▼ key to select the desired

delivery rate.
(Pressing the key for more than 3 sec-
onds accelerates the changing rate.)

6.8.4 Stopping Delivery

The blood pump stops as soon as the

venous bubble catcher is filled, however,
after 1 to 5 minutes at the latest,
depending on the setting in the
SETUP menu
or
if the rinse volume has been reached,
depending on the setting in the
SETUP menu.

al Care 4008 B
Display message
>R< : 0 h 14
The red (alarm) status indicator lights for
Arterial Venous Transmembrane
1 - 5 seconds.
Air Detector Ultrafiltrati
Pressure Pressure Pressure
UF Volume ml

Rinse The Rinse LED is illuminated.

kPa mmHg kPa

Hotrinse 280 Audible signal

Blood Leak 30 60 cleared automatically after 2 seconds
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

6-24 Fresenius Medical Care 4008 B 16/10.03 (OP)

 It may be necessary to raise the level in
the venous bubble catcher.
Pven. ☛ Press the ▲ key on the air detector mod-
ule, until the desired level has been
reached.

6.8.5 Interrupting the Priming Program

Rate: ml/min
Press the Start/Stop key.
(Ø: mm)

The operation (green) LED turns dark.

Continue by pressing the key again.

Start
Stop
☛
6.8.6 Premature Termination

Rinse Press the Prime key for 1 second.

kPa mmHg kPa

Hotrinse 280 Continue the priming procedure by

Blood Leak 30
200 60 pressing the Prime key again.
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300

☛ Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-25

6.8.7 Malfunctions

Rinse The Prime LED is flashing.

kPa mmHg kPa

Hotrinse 280 Press the Prime key.

Blood Leak 30 60
200 An error message displays in the status
20 50
Disinfection
10
100 40
line.
0 0 30 (See Chapter 4.7 Error Messages During
Single
Needle –10
–100 20 Cleaning Programs.)
–20 10
Override
–30
–200
0
Test
–40 –300

☛ Prime

Dialysis Start
Reset Alarm

Alarm Tone
Mute

6-26 Fresenius Medical Care 4008 B 16/10.03 (OP)

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

Rinse Press the Dialysis Start key for 1 sec-

kPa mmHg kPa
ond.
Hotrinse 280
Blood Leak 30
200 60
The Prime LED is illuminated.
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300
Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

al Care 4008 B
The yellow status indicator (warning/
Prime/Circulation
info) is illuminated.

Air Detector Arterial

Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati
Temporary display message
UF Volume ml

R Precirculation will be started automat-

ically after priming has been com-
pleted.

Confirm Select Display message e.g.: >R< :0 h 15

>R< : 0 h 15

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-27

6.9.3 Start

Priming has been completed.

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

Rinse Press the Dialysis Start for 1 second.

kPa mmHg kPa

Hotrinse 280 The Prime LED is illuminated.

Blood Leak 30 60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300
Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

al Care 4008 B
The yellow status indicator (warning/
Circulation
info) is illuminated.

Air Detector Arterial

Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati
Temporary display message
UF Volume ml

Confirm Select Display message e.g.: >R< :0 h 15

>R< : 0 h 15

6-28 Fresenius Medical Care 4008 B 16/10.03 (OP)

6.9.4 Setting the Delivery Rate of the Blood Pump

Rate: ml/min
The operation (green) LED is illumin-
(Ø: mm)
ated.
The blood pump is delivering.
☛ Use the ▲ or ▼ key to select the desired
Start
delivery rate.
Stop (Pressing the key for more than 3 sec-
onds accelerates the changing rate.)

6.9.5 Delivery Stops

When the rinse volume has been

reached.

al Care 4008 B
Display message
>R< : 0 h 14
The red (alarm) status indicator lights for
Air Detector Arterial
Pressure
Venous
Pressure
Transmembrane
Pressure
Ultrafiltrati
2 seconds.
UF Volume ml

Rinse The Rinse LED is illuminated.

kPa mmHg kPa

Hotrinse 280 Audible signal

Blood Leak 30 60 cleared automatically after 2 seconds
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Fresenius Medical Care 4008 B 16/10.03 (OP) 6-29

 It may be necessary to raise the level in
the venous bubble catcher.
Pven. ☛ Use the ▲ key on the air detector mod-
ule until the desired level has been
reached.

6.9.6 Interrupting Precirculation

Rate: ml/min
Press the Start/Stop key.
(Ø: mm)

The operation (green) LED turns dark.

Continue by pressing the key again.

Start
Stop
☛
6.9.7 Premature Termination

Rinse Press the Dialysis Start key for 1 sec-

kPa mmHg kPa
ond.
Hotrinse 280
Blood Leak 30
200 60
Continue precirculation by pressing the
20
Disinfection
100
50
Dialysis Start key again.
10 40

0 0 30
Single
Needle –10
–100 20

–20 10
Override
–30
–200
0
Test
–40 –300
Prime

☛ Dialysis Start
Reset Alarm

Alarm Tone
Mute

6-30 Fresenius Medical Care 4008 B 16/10.03 (OP)

Table of Contents 7 Special Menu Functions

Chapter Page

7.1 Menu Structures Overview ........................................................................................... 7-3

7.2 Settings on the Monitor ................................................................................................ 7-5

7.2.1 Adjusting the Illuminated Segments ............................................................................... 7-5
7.2.2 Key Click ......................................................................................................................... 7-6
7.2.3 Adjusting the System Clock ............................................................................................ 7-7

7.3 Auto-On Cleaning Program .......................................................................................... 7-8

7.3.1 Selecting a Cleaning Program ........................................................................................ 7-8
7.3.2 Automatic On .................................................................................................................. 7-9

7.4 Displaying / Clearing Treatment Parameters ............................................................ 7-10

7.4.1 Displaying the Effective Blood Flow ................................................................................ 7-10
7.4.2 Displaying the Accumulating Blood Volume ................................................................... 7-10
7.4.3 Clearing the Accumulating Blood Volume ...................................................................... 7-11
7.4.4 Displaying the Effective Time ......................................................................................... 7-11
7.4.5 Clearing the Effective Time ............................................................................................. 7-12

7.5 Changing the DIASAFE ®plus (option) on Machines with Basic Hydraulics ............ 7-13
7.5.1 Filter Change Criteria ...................................................................................................... 7-13
7.5.2 Changing the Filter ......................................................................................................... 7-13

7.6 Changing the DIASAFE ®plus (option) on Machines with Advanced Hydraulics ...... 7-18
7.5.1 Filter Change Criteria ...................................................................................................... 7-18
7.6.2 Indication of a Filter Change ........................................................................................... 7-18
7.6.3 Overriding a Filter Change .............................................................................................. 7-23
7.6.4 Changing the Filter ......................................................................................................... 7-24

7.7 bibag® (option) .............................................................................................................. 7-29

7.7.1 Emptying the bibag® (during treatment) .......................................................................... 7-29
7.7.2 Connecting the bibag® .................................................................................................... 7-31

7.8 Transferring Treatment Parameters (Download) ...................................................... 7-33

7.8.1 Description ...................................................................................................................... 7-33
7.8.2 Basic Requirements ........................................................................................................ 7-33
7.8.3 Important Notes .............................................................................................................. 7-34
7.8.4 Procedure ....................................................................................................................... 7-35
7.8.5 Aborting the Data Transfer ............................................................................................. 7-38

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-1

7-2 Fresenius Medical Care 4008 B 16/10.03 (OP)
 Confirm Select
7.1
Dialysis
☛
*
1. Set cond 2. Treatment 3. Alarm 4. Blood- 5. System 6. Clock 7. Treatment 8. Empty 9. Return
window mode limits flow.calc. parameter settings param. BIBAG ? to mainprg
Confirm Confirm Confirm Confirm Confirm Confirm Confirm Confirm

*
CumBd. 3.1 Arterial 4.1 Eff. 5.1 Brightness 6.1 System 7.1 Reset Emptying Dialysis
XX0ml Start? limit bloodflow clock UF data BIBAG

2.2 Sequ. 3.2 Venous 4.2 Total 5.2 Auto–On 6.2 Auto- 7.2 Show
dialysis limits bld.volume program matic on ISO data

2.3 SN– 3.3 TMP 4.3 Clear 5.3 Key- 6.3 Ret. to 7.3 Reset
click–clack limits total vol. click mainprg ISO data
Menu Structures Overview

2.4 3.4 Ret. to 4.4 Ret. to 5.4 Status 7.4 Show

Reinfusion mainprg mainprg CDS eff. time

*
2.5 Needle- 5.5 Filter 7.5 Clear
Adj-Pgm change eff. time

*
2.6 4008 HDF 5.6 Ret. to 7.6 Dialysate
mainprg flow

2.7 Ret. to 7.7 Ret. to

mainprg mainprg

Fresenius Medical Care 4008 B 16/10.03 (OP)

* Items marked with an asterisk are active only if the option is available.

7-3
7-4 Fresenius Medical Care 4008 B 16/10.03 (OP)
7.2 Settings on the Monitor

The user can adjust or change the following settings on the hemodialysis machine via the
operator menu.

7.2.1 Adjusting the Illuminated Segments

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
5. System parameter
☛ 5. System parameter.
Press the Confirm key.

Confirm Select Press the Confirm key.

5.1 Brightness
☛
Confirm Select Use the ▲ and ▼ keys to change the
set Brightness
☛ brightness of the display.
Press the Confirm key.
The setting is effective for the treatment
in progress.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-5

7.2.2 Key Click

The key click menu can be used to accompany each key actuation by an audible tone.

Press the Select key.

Confirm Select
Dialysis
☛
Use the ▲ and ▼ keys to select
Confirm Select
5. System parameter 5. System parameter.
☛ Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

5.3 Key-click
☛ 5.3 Key-click.
Press the Confirm key.

Use the ▲ and ▼ keys to set the desired

Key-click is on
Confirm Select
mode (on/off) .
☛ Press the Confirm key.

7-6 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.2.3 Adjusting the System Clock

The system clock should be checked before using the menu option Automatic on. Observe
summer time and winter time.

Confirm
☛
Select Press the Select key.
Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
6. Clock settings 6. Clock settings.
☛ Press the Confirm key.

Confirm Select Press the Confirm key.

6.1 System clock
☛
Confirm Select Use the ▲ and ▼ keys to adjust the
09 : 11 11.11.11
☛ value of the flashing digits (hours).
Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

09 : 14 11.11.11 value of the flashing digits (minutes).
☛ Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

09 : 14 04.11.11
☛ value of the flashing digits (day).
Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

09 : 14 04.02.11
☛ value of the flashing digits (month).
Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

09 : 14 04.02.94
☛ value of the flashing digits (year).
Press the Confirm key.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-7

7.3 Auto-On Cleaning Program

7.3.1 Selecting a Cleaning Program

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
5. System parameter
☛ 5. System parameter.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

5.2 Auto-On program
☛ 5.2 Auto-On program.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select one of

5.2.1 —R— the following cleaning programs, which
will start at the time defined in the menu
option 6.2 Automatic On.
Confirm Select
5.2.2 —R— endless
Press the Confirm key.

Confirm Select
5.2.3 —F—D—M—

Confirm Select
5.2.4 —F—HDIS—M—

Confirm Select
5.2.5 –F–D–M–HR–

Confirm Select
5.2.6 –F–HDIS–M–HR–

Confirm Select
5.2.7 —F—HR—C—

Confirm Select
5.2.8 —F—HR—

Confirm Select
5.2.9 —IHR—

Confirm Select
5.2.10 —M—

Confirm Select Temporary display message

Program stored

7-8 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.3.2 Automatic On

Entry of the time when the cleaning program selected in the 5.2 Auto-On program menu is to
start.

Confirm ☛
Select Press the Select key.
Dialysis ☛
Confirm Select Use the ▲ and ▼ keys to select
6. Clock settings
☛ 6. Clock settings.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

6.2 Automatic on 6.2 Automatic on.
☛ Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to adjust the

19 : 11 11.11
☛ value of the flashing digits (hours).
Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

19 : 30 11.11
☛ value of the flashing digits (minutes).
Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

19 : 30 04.11
☛ value of the flashing digits (day).
Press the Select key.

Confirm Select Use the ▲ and ▼ keys to adjust the

19 : 30 04.12 value of the flashing digits (month).
☛ Press the Confirm key.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-9

7.4 Displaying / Clearing Treatment Parameters

7.4.1 Displaying the Effective Blood Flow

The current delivery rate is computed in relation with the arterial pressure.

Confirm Select Press the Select key.

Dialysis ☛
Confirm Select Use the ▲ and ▼ keys to select
4. Bloodflow.calc. 4. Bloodflow.calc..
☛ Press the Confirm key.

Confirm Select Press the Confirm key.

4.1 Eff. bloodflow
☛
Confirm Select Temporary display message, e.g.
Eff.BPR. 196 ml/min

7.4.2 Displaying the Accumulating Blood Volume

Indication of the blood volume actually delivered.

Confirm Select
Press the Select key.
Dialysis
☛
Confirm Select
Use the ▲ and ▼ keys to select
4. Bloodflow.calc. 4. Bloodflow.calc..
☛ Press the Confirm key.

Confirm Select
Use the ▲ and ▼ keys to select
4.2 Total bld.volume 4.2 Total bld.volume.
☛ Press the Confirm key.

Confirm Select Temporary display message, e.g.

Cum.bloodvol. 9.5 l

7-10 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.4.3 Clearing the Accumulating Blood Volume

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
4. Bloodflow.calc.
☛ 4. Bloodflow.calc..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

4.3 Clear total vol.
☛ 4.3 Clear total vol..
Press the Confirm key.

Confirm Select Press the Confirm key.

Are you sure ?
☛
Confirm Select Temporary display message
value(s) cleared !

7.4.4 Displaying the Effective Time

Depending on the presetting defined in the SETUP menu, the user can display the effective
dialysis time or the effective UF time by selecting the 7.4 Show eff. time menu.

The effective dialysis time does not include Preparation and Alarm times.

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

7.4 Show eff. time
☛ 7.4 Show eff. time.
Press the Confirm key.

Confirm Select Temporary display message, e.g.

Eff. time 0:35h

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-11

7.4.5 Clearing the Effective Time

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
7. Treatment param.
☛ 7. Treatment param..
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

7.5 Clear eff. time
☛ 7.5 Clear eff. time.
Press the Confirm key.

Confirm Select Press the Confirm key.

Are you sure ?
☛
Confirm Select Temporary display message
value(s) cleared !

7-12 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.5 Changing the DIASAFE®plus (option)
on Machines with Basic Hydraulics

7.5.1 Filter Change Criteria

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

7.5.2 Changing the Filter

☞ 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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-13

 Fresenius Medical Care 4008 B Press the I/O key.
Turn the hemodialysis machine off!

The I/O LED stops lighting.

☛ I/O
Luftdetektor Arterieller
Druck
Ve
D

➀ Open the locking levers.

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

7-14 Fresenius Medical Care 4008 B 16/10.03 (OP)

 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

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-15

 For priming the filter, proceed as descri-
bed hereafter.

The hemodialysis machine has been

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

Fresenius Medical Care 4008 B Press the I/O key.

Turn the hemodialysis machine on!

The I/O LED is illuminated.

☛ I/O
Luftdetektor Arterieller
Druck
Ve
D

Override
–30
–200
0
Test
–40 –300
The Test LED is flashing.
If the Test LED is not flashing, one of
Prime the conditions for the test to start is not
fulfilled.
Dialysis Start
Reset Alarm

Alarm Tone
Mute

7-16 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Override
–200

☛
–30 0
Test
–40 –300
Press the Test key.
Prime The Test LED is illuminated.
Dialysis Start
Reset Alarm

Alarm Tone
Mute

☞ 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 dis-
played after the functional test, this
test step has to be skipped. Then run
a heat disinfection program or a dis-
infection program followed by a hot
rinse.

Caution
Run a disinfection program after
each filter change.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-17

7.6 Changing the DIASAFE®plus (option)
on Machines with Advanced Hydraulics

7.6.1 Filter Change Criteria

– The maximum service life of the filter (12 weeks) has been reached.
– The filter is defective (T1 test failed).
– The maximum admissible number of treatments (100) has been reached.
(Applicable for the ONLINE plus™ option only.)

7.6.2 Indication of a Filter Change

● In the rinse program (front supplied)

Rinse Press the Disinfection key.

kPa mmHg kPa

Hotrinse 280 The Disinfection LED is illuminated.

Blood Leak 30

☛
60
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select Use the ▲ and ▼ keys to select

PGM 1: –F–D–M
☛ FILTER max. Cle.:.
In the Rinse program (front supplied) it
Confirm Select
will be indicated how many times the fil-
PGM 2: –F–HDIS–M ter can still be cleaned with
Sporotal ® 100.
The number of rinse procedures with
PGM 3: –F–D–M–HR
Confirm Select
Sporotal ® 100 is restricted to a maximum
of 11.
(Numbers displayed: 11 to 01).

Confirm Select
Press the Confirm key to select the
PGM 4: –F–HDIS–M–HR cleaning program.

Confirm Select
FILTER max. Cle.:

7-18 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Confirm Select If a rinse procedure (front supplied) is no
PGM 1: –F–D–M longer possible, the message Filter
change will be displayed.

Confirm Select
The DIASAFE®plus can then still be
PGM 2: –F–HDIS–M rinsed with the available cleaning pro-
grams until the end of its service life or
until the maximum number of treatments
Confirm Select
has been reached.
PGM 3: –F–D–M–HR
Press the Confirm key to change the fil-
ter (see Chapter 7.6.3 Changing the Fil-
ter)
PGM 4: –F–HDIS–M–HR
Confirm Select
or
press the ▲ or ▼ key to select a dif-
ferent cleaning program.

Confirm Select
Filter change !

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-19

 ● When exceeding the number of treatments
Applicable for ONLINE plus™ (option) only

Rinse Select a cleaning program

e.g. Hot rinse

☛
kPa mmHg kPa

Hotrinse 280
Blood Leak 30 60 Press the Hot rinse key.
200
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select The message displayed indicates how

FILTER max. Tre.: many treatments can still be performed
with the filter.
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)
The message Filter max. Tre.: may
also alternate with the message
Filter max. days:.

Press the Hot rinse key to select the

cleaning program.
The Hot rinse indicator is illuminated.

Confirm Select When the maximum number of treat-

>Treatments< ments has been reached, the message
displayed will alternate between
>Treatments< and Filter change !.

Filter change !
Confirm Select
Press the Confirm key to change the fil-
ter (see Chapter 7.6.3 Changing the Fil-
ter)
or
select the desired cleaning program to
override the filter change. (See Chapter
7.6.2 Overriding a Filter Change.)

7-20 Fresenius Medical Care 4008 B 16/10.03 (OP)

● When exceeding the service life

Rinse Select a cleaning program

☛
kPa mmHg kPa e.g. Hot rinse
Hotrinse 280
Blood Leak 30
200 60 Press the Hot rinse key.
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select The message displayed indicates for

FILTER max. days: X how many treatment days the filter can
still be used.
The filter can be used for a maximum of
12 weeks.
Only the last 7 days will be shown.
(Numbers displayed: 7 to 1)
The message Filter max. days: may
also alternate with the message
Filter max. Tre:.

Press the Hot rinse key to select the

cleaning program.
The Hot rinse indicator is illuminated.

Confirm Select When the maximum number of treatment

>Time< days has been reached, the message
displayed will alternate between >Time<
and Filter change !.

Filter change !
Confirm Select
Press the Confirm key to change the fil-
ter (see Chapter 7.6.3 Changing the Fil-
ter)
or
select the desired cleaning program to
override the filter change. (See Chapter
7.6.2 Overriding a Filter Change.)

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-21

 ● In the event of a failure to pass the T1 test

Rinse Select a cleaning program

☛
kPa mmHg kPa e.g. Hot rinse
Hotrinse 280
Blood Leak 30
200 60 Press the Hot rinse key.
20 50
Disinfection
10
100 40

0 0 30
Single
Needle –10
–100 20

–20

Confirm Select Alternating display messages

T1-Test failed
Press the Confirm key to change the fil-
ter (see Chapter 7.6.3 Changing the Fil-
ter)
Filter change !
Confirm Select
or
select the desired cleaning program to
override the filter change. (See Chapter
7.6.2 Overriding a Filter Change.)

7-22 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.6.3 Overrding a Filter Change

Select the desired cleaning program to

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

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-23

7.6.4 Changing the Filter

☞ Note
Replacement of the DIASAFE®plus
must be entered in the Medical De-
vice Register (date, batch number).

Make sure that the patient is disconnect-

ed from the machine.

Basic conditions
– The optical detector senses clear flu-
id.
– Both dialyzer lines are in the interlock
shunt.
– The shunt door is closed.
– The concentrate suction tubes are
locked in the rinse chamber.

7-24 Fresenius Medical Care 4008 B 16/10.03 (OP)

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

Confirm Select Press the Select key.

** 4008 B / VX.X **
☛
Confirm Select Use the ▲ and ▼ keys to select
5. System parameter
☛ 5. System parameter.
Press the Confirm key.

Confirm Select Use the ▲ and ▼ keys to select

5.5 Filter change
☛ 5.5 Filter change.
Press the Confirm key.

Confirm Select Display message

Empty filter

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-25

 Confirm Select Display message after the filter has been
Filter changed ? emptied.

➀ Open the locking levers.

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

Remove the protective straps ➀ and ➁

from the new filter by pulling the lug.

7-26 Fresenius Medical Care 4008 B 16/10.03 (OP)

 ➀ ➀ Slide the new filter from the top into
the guide slot.
➁ Close the locking levers.
➁

Confirm Select Press the Confirm key to confirm the

Filter changed ?
☛ filter change.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-27

 Confirm Select Message displayed while the filter is be-
Filling filter ing filled.

When the filter has been filled, the disin-

fection program defined in the SETUP
will be started automatically.

Caution
Disinfect after each filter change.

7-28 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.7 bibag® (option)

7.7.1 Emptying the bibag® (during treatment)

Confirm Select Press the Select key.

Dialysis
☛
Confirm Select Use the ▲ and ▼ keys to select
8. Empty BIBAG ?
☛ 8. Empty BIBAG ?.
Press the Confirm key.

Confirm Select Display message

Emptying BIBAG

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.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-29

 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.

Turn the interlock plate 180°.

Close the interlock plate.

☛

7-30 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.7.2 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.

Turn the interlock plate 180°.

Remove the foil from the bibag ®.

☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-31

 Assemble the bibag® onto the interlock
plate.

Push on both sides of the interlock plate

to connect the bibag®.
☛

After the biBag® has been connected, an

automatic program will be started (last-
ing approx. 35 secs).
This program will first remove all air from
the biBag ® and will then fill the bag with
water.

7-32 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.8 Transferring Treatment Parameters (Download)

7.8.1 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. Prescribed Na+
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.

7.8.2 Basic Requirements

The T1 test must have been successfully completed.

The UF unit must have been switched 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 switched off.
the UF volume has been set to 0000.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-33

7.8.3 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.

☞ Note
If parameters are changed before the data are accepted, other parameters may
also change.
(e.g.: A change of the UF time will cause a change of the UF rate).

7-34 Fresenius Medical Care 4008 B 16/10.03 (OP)

7.8.4 Procedure

Data transfer to the dialysis machine.

Confirm Select Display message

Harold Sample
If the data transfer was successful, the
patient name will be displayed.

Confirm Select Press the Conf. key.

Harold Sample
☛
Confirm Select Display message
UF parameters OK?

Ultrafiltration Check the transferred UF parameters on

UF Volume ml the ultrafiltration monitor.
0000 Reset
Volume

UF Rate ml/h

0750

UF Goal ml

3000

Time Left h:min

4:00
UF

I/O Prog.

Confirm Select Press the Conf. key.

UF parameters OK?
☛

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-35

 Confirm Select Display message
Dilution 1+XX

Confirm Select The following downloaded data are dis-

Base Na+ xxx mmol played consecutively.

Confirm Select Each data displayed must be checked

Prescr. Na+ xxx mmol and then confirmed with the Conf. key.

Confirm Select
Bicarbonate: x mmol

Confirm Select
Dialysate flow xxx ml/min

Confirm Select
set Temp. xx,x oC

Confirm Select (Displayed only if a UF profile was se-

UF Profile Nr. X lected)

Confirm Select (Displayed only if a Na+ profile was se-

Na Profile Nr. X lected)

Confirm Select (Displayed only if a Na+ profile was se-

Start Na+ xxx mmol lected)

Confirm Select Display message

UF profile Off Displayed only if no UF profile was se-
☛ lected.

Press the Conf. key.

Confirm Select Display message

Na+ Profile Off Displayed only if no Na+ profile was se-
☛ lected.

Press the Conf. key.

7-36 Fresenius Medical Care 4008 B 16/10.03 (OP)

 Confirm Select Temporary display message
Profiles ready Displayed only if UF profiles and/or
Na+ profiles were selected.

Confirm Select Display message

Preparation Displayed when all downloaded data
have been saved.

Fresenius Medical Care 4008 B 16/10.03 (OP) 7-37

7.8.5 Aborting the Data Transfer

Confirm Select Display message

Prescr. Na+ xxx mmol e.g. Prescr. Na+ xxx mmol

Confirm Select Press the Select key.

Prescr. Na+ xxx mmol ☛
Confirm Select Display message
Are you sure ?

Confirm Select Press the Conf. key.

Are you sure ? All downloaded treatment parameters
☛ will be erased.

7-38 Fresenius Medical Care 4008 B 16/10.03 (OP)