User Manual DBB-05

Manual No.
770E R0
Operating Instruction
DBB-05
0123
11.2001
DBB-05
The CE mark was given in accordance with EC Cabinet

Directive (93 42 EWG) dated 14 June 1993 relating to
medical devices.
The object of testing was the DBB-05 ; artificial dialyser
applied-for consumable materials and disposable
articles were not the subject of testing.
This manual is applicable to the equipment with

software version 1.0X.
During the start-up test, the software version is

displayed on the screen.
Importer
KIMAL plc
Arundel Road
Uxbridge
Middlesex
UB8 2SA
Tel. +44 (0) 1895 270951
Fax. +44 (0) 1895 274 035
E-Mail Kimal
Kimal Web Site
Manufacture
MEDICAL EQUIPMENT UNIT

OVERSEAS BUSINESS DIVISION
43-2, Ebisu 3-chome, Shibuya-ku, Tokyo 150-8677,
Japan
Telefon : +81-3-3443-3727
Telefax : +81-3-3470-0681
Table of contents
DBB-05
Section Page
1. General description 1
1.1. How to use this instruction manual 1-3
1.2. Introduction 1-4
1.3. Precautions before trial run 1-6
1.4. Set-up instructions (Trial run) 1-9
1.5. Storage and transportation 1-10
1.6. Configurations and functions of mechanical 1-12
components
1.7. Description of bicarbonate dialysis 1-26
1.8. Description of extracorporeal blood circuit 1-32
1.9. Setting procedure 1-36
1.10. Maintenance and checks 1-53
1.11. Consumables 1-57
1.12. Technical data 1-60
1.13. Abbreviations and symbols 1-74
1.14. Environmental issues 1-76
1.15. Maintenance with Technical Safety Inspection 1-77
2. Preparation 2
2.1. Start-up 2-2
2.2. Extracorporeal blood circuit 2-8
2.3. Priming of blood circuit 2-12
2.4. Priming of dialysate side 2-20
2.5. Start-up test 2-24
DBB-05
Table of contents
Section Page
3. Treatment conditions 3
3.1. Entering treatment data 3-2
3.2. Treatment method and treatment data 3-2
3.3. Single-needle treatment 3-4
3.4. UF data and treatment time 3-6
3.5. Setting the dialysate parameters 3-10
3.6. Setting of heparin pump 3-13
3.7. UF profile/Conductivity profile 3-15
3.8. Isolated UF (sequential treatment) 3-37
4. Treatment 4
4.1. Patient connection 4-2
4.2. Treatment start 4-7
5. Disconnection 5
5.1. Completion of treatment 5-2
5.2. Blood return 5-3
5.3. Draining of dialyser and cartridge 5-5
5.4. Draining the tube set 5-7
6. Cleaning 6
6.1. General information 6-2
6.2. Cleaning program 6-3
6.3. Priming of blood tube set and dialyser during 6-9
the cleaning program cycle
6.4. Cleaning of the DBB-05 (exterior) 6-10
DBB-05
Table of contents
Section Page
7. Troubleshooting 7
7.1. Alarms 7-2
7.2. Emergency battery operation 7-3
7.3. Message/Information 7-4
8. Replacement of dialysate filter 8

8.1. Basic conditions 8-2
8.2. Replacing the filter 8-3
8.3. Filling and disinfection 8-4
8.4. Reset of the operating hours (filter) 8-5
8.5. Protocol for filter replacement (dialysate filter) 8-6
DBB-05
DBB-05
Table of contents 1. General description

Section Page
1.1. How to use this instruction manual 1-3

1.2. Introduction 1-4
1.2.1. Scope of application 1-4
1.2.2. Side effects 1-4
1.2.3. Contraindications 1-4
1.2.4. General description 1-4
1.3. Precautions before trial run 1-6

1.4. Set-up instructions (Trial run) 1-9
1.4.1. Connection 1-9
1.4.2. Trial run 1-9
1.5. Storage and transportation 1-10

1.5.1. Storage 1-10
1.5.2. Transportation 1-11
1.6. Configurations and functions of mechanical

components 1-12
Fig. 1-1: Front/Left side view 1-12
Fig. 1-2: Rear/Right side view 1-13
Fig. 1-3: Monitor 1-14
Fig. 1-4: Power unit (1/2) 1-15
Fig. 1-5: Power unit (2/2) 1-16
1.6.1. Blood monitor 1-17
Fig. 1-6: Front view 1-17
Fig. 1-7: Blood pump 1-18
Fig. 1-8: Heparin pump 1-19
1.6.2. Dialysate monitor 1-20
Fig. 1-9: Concentrate connectors and Rinse ports 1-20
Fig. 1-10: Water supply/drain part 1-21
1.6.3. Piping 1-22
Fig. 1-11: Flow block diagram 1-22
Fig. 1-12: Flow sheet diagram (including all options) 1-24
1.7. Description of bicarbonate dialysis 1-26

Fig. 1-13: Mixing of the dialysate 1-28
Fig. 1-14: Mixing of the dialysate with central concentrate supply (Option) 1-30
1.8. Description of extracorporeal blood circuit 1-32

Fig. 1-15: Extracorporeal blood circuit-Double needle dialysis 1-32
1.8.1. Double needle dialysis 1-33
1.8.2. Single needle dialysis (click-clack method) 1-33
1.8.3. Single needle dialysis - double pump (double pump option) 1-34
Fig. 1-16: Extracorporeal blood circuit - Single needle dialysis 1-34
1-1 Operating Instruction

DBB-05
Section Page
1.9. Setting procedure 1-36

1.9.1. Data input 1-36
1.9.2. Changing the operating modes 1-43
1.9.3. Setting the alarm points 1-44
1.9.4. Description of keys 1-47
1.9.5. Functional description of menu bar 1-51
1.10. Maintenance and checks 1-53

1.10.1. Cleaning and disinfection 1-53
1.10.2. Maintenance after each dialysis 1-55
1.10.3. Daily inspection 1-56
1.10.4. Inspection and maintenance of system 1-56
1.10.5. Setting of basic values 1-56
1.11. Consumables 1-57

1.11.1. Dialyser 1-57
1.11.2. Blood tube sets 1-57
1.11.3. Heparin syringe 1-57
1.11.4. Concentrate for hemodialysis 1-58
1.11.5. Disinfectant 1-59
1.12. Technical data 1-60

1.12.1. Dimensions and weight 1-60
1.12.2. Electric safety (Classified according to EN60601-1) 1-60
1.12.3. Electric power supply 1-61
1.12.4. Fuses (Power unit) 1-61
1.12.5. Operating status 1-62
1.12.6. Water and dialysate used 1-63
1.12.7. Environmental conditions 1-64
1.12.8. Options for external connections 1-65
1.12.9. Hydraulic unit 1-66
1.12.10. Pressure monitoring (extracorporeal blood circuit) 1-69
1.12.11. Single needle dialysis (Option) 1-72
1.12.12. Utilized materials for piping 1-73
1.13. Abbreviations and symbols 1-74

1.13.1. Abbreviations 1-74
1.13.2. Symbols 1-75
1.14. Environmental issues 1-76

1.15. Maintenance with Technical Safety Inspection 1-77
Operating Instruction 1-2

DBB-05
1.1. How to use this instruction manual

l Scope of this instruction manual
This instruction manual is intended to safely operate the DBB-05, but not to treat patients.
Details of operating procedure are described on the right and respective illustrations are put on the left
side of the page as follows.
The individual operating steps are described with their respective illustrations.
Instruction for operation

WARNING Operator must always confirm entered parameters. That is,
operator must confirm that entered values are correct every
time they are entered. If the input values do not conform with
the desired values, treatment must not be started under any
circumstances.
l Warning labels
The following cautions point out special cautionary measures that are to be taken before starting
operations and treatment. They indicate possible hazards to ensure operational safety and should therefore
be read carefully before starting the operation.
This denotes immediate hazards which may result in SEVERE

DANGER PERSONAL INJURY.
This denotes hazards which may result in SEVERE PERSONAL

WARNING INJURY.
This denotes hazards which COULD result in product damage or

CAUTION improper treatment, if not avoided.
NOTE This denotes notice for operational safety.

DBB-05
1.2. Introduction
1.2.1. Scope of application
DBB-05 applies to hemodialysis for patients having acute or chronic renal failure.
1.2.2 Side effects

NAUSEA, VOMITING, HYPOTENSION and SPASMS have been observed during hemodialysis
treatments. And ALKALOSIS, ACIDOSIS, THIRST and HYPERTENSION have been observed during
AFBF treatment. Please take note of the package inserts enclosed with the hemodialysis concentrates,
dialysate concentrate or substitution fluid for AFBF, dialysers, etc.
1.2.3 Contraindications
Not use potassium-containing hemodialysis concentrates for HYPERKALEMIA

Not use potassium-free hemodialysis concentrates for HYPOKALEMIA
Not use the substitution fluid for AFBF with the pre-dilution (infuse this substitution fluid to the blood
circuit on the arterial side.)
UNCONTROLLABLE COAGULATION ANOMALIES
A different method of extracorporeal treatment may be indicated in HEMODYNAMICALLY

UNSTABLE PATIENTS.
1.2.4. General description
Using the DBB-05, dialysis can be performed without any additional units.
The DBB-05 is composed of a hydraulic unit for dialysate and an extracorporeal blood circuit.
The permeate is heated and deaerated in the hydraulic section. The deaerated permeate is then mixed with
concentrate and fed into the dialyser via the dialysate filter and the dialysis fluid feeder.
The closed balancing system assures that the input and output amount of the dialysate correspond to each
other.
The interior pressure of the dialyser is controlled automatically by adjustment of ultra filtration amount
and UF rate by the dialyser.
It is possible to heparinize the external blood circulation with the heparin pump, either continuously or by
one-shot injection, before it is passed on to the dialyser.
A two-channel monitoring system prevents any risks for the blood circulation.
The DBB-05 is set up for both the acetate dialysis and the bicarbonate dialysis.
Using the variation function of the DBB-05, the conductivity profile and UF profile can be programmed.
In its basic version, the DBB-05 incorporates all functions necessary for double-needle dialysis as well as
single-needle treatment (click-clack method).
The hydraulic unit of the DBB-05 is cleaned and disinfected using the selectable cleaning programs.
The DBB-05 is equipped with the necessary protective systems for patient safety and correct operation.

DBB-05
The DBB-05 complies with the following standards:

− EN 60601-1
− IEC 60601-1-2
− IEC 60601-2-16, Second edition
Before starting the patient treatment, make sure that the automatic start-up test has been completed.
The following accessories (Option) are available.

• Single needle dialysis
• HDF/HF
• On-line HDF/HF
• AFBF (Acetate free biofiltration)
• Blood pressure monitor
• Blood volume monitor (It doesn't function at the moment.)
• Clearance monitor (It doesn't function at the moment.)
• Heparin pump (Syringe type: 20 mL or 10 mL)
• Dialysate filter
• Bicarbonate cartridge holder
• Central concentrate supply
• Concentrate suction nozzles rinse
• Level adjuster pump
• External status display
• Alarm output (Staff call)
• Network
• Service interface
• RS232 interface (It doesn't function at the moment.)
• Nurse call
• Alarm input (This input can be used to stop the DBB-05.)
• Output for external equipment
Any other peripheral parts may be used only if they comply

CAUTION with the respective approval conditions.

DBB-05
1.3. Precautions before trial run

Instructions described in this section are also a part of the instruction manual for the DBB-05.
The installation and initial operation of the DBB-05 must be performed only by persons authorized by
NIKKISO.
In all cases, before the initial operation and subsequent trial run the instruction manual must be read
through completely.
The DBB-05 can only be operated under the following

CAUTION conditions.
Nikkiso shall be held responsible for safety, reliability, and
performance of the DBB-05 only if the unit is operated under
the following conditions and in compliance with the technical
conditions stated in chapter 1.12.
l Electric power facility
All the electric power supply points necessary for operation of the DBB-05 must conform with the
respective laws and regulations in the customer's region. In Germany, the DBB-05 may be connected only
to electric power supply points conforming with the VDE 0107 standard.
In the DBB-05's vicinity, never operate devices that cause electromagnetic interference, such as mobile
phones or CB wireless transmitters, while the DBB-05 is in operation.
If any device which transmits electromagnetic wave is used around the DBB-05, this may cause
the DBB-05 to malfunction.
Never connect any accessory other than those approved to the DBB-05.
If any improper accessory is connected to the DBB-05, leak current may exceed its allowable
limit, resulting in personal injury.
Never use any adaptor which breaks the green/yellow striped grounding cable.
The DBB-05 can't be used when a defibrillator is used on a

WARNING patient.
Do not touch the DBB-05 when discharging defibrillator.
And confirm on operation of the DBB-05 after the uses of the
defibrillator.

DBB-05
The DBB-05 has been tested and found to comply with the
WARNING limits for medical devices to the IEC 60601-1-2:1994, Medical
Device Directive 93/42/EEC. These limits are designed to
provide reasonable protection against harmful interference in a
typical medical installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is
no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference
to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
• Reorient or relocate the receiving device.

• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different
from that to which the other device(s) are connected.
• Consult the manufacturer or field service technician for help.
Accessory equipment connected to the analog and digital

WARNING interfaces must be certified according to the respective IEC
standards (i.e. IEC 60950 for data processing equipment and
IEC 60601-1 for medical equipment). Furthermore all
configurations shall comply with the system standard IEC
60601-1-1. Everybody who connects additional equipment to
the signal input part or signal output part cofigures a medical
system, and is therefore responsible that the system complies
with the requirements of IEC 60601-1-1. If in doubt, consult
the technical services department or your local representative.
Grounding reliability can only be achieved when the equipment

WARNING is connected to an equipment receptacle marked “Hospital
only” or “Hospital grade”.

DBB-05
l Water and dialysate used
Only water suitable for the hemodialysis must be supplied to the DBB-05.
Water quality shall conform to the AAMI standard for the hemodialysis system. Additionally, it shall
conform to the DAB 10 standard in Germany.
Water used in the DBB-05 must be one treated through the reverse osmosis system.
Always confirm that permeate and dialysate used for treatment conform to the appropriate
standards.
(See the technical data in chapter 1.12.)
l Drain
To drain water from the DBB-05, air accumulation among the reverse siphon, drain connector, and drain
port should be taken into consideration.
(See the Set-up instructions in chapter 1.4 and the technical data in chapter 1.12.)
l Functional check
Always perform the prescribed function check before starting patient treatment.
l Other important documents
Upon customer’s request, Nikkiso will deliver circuit diagrams, operation manuals, spare parts list, and
other documents. These documents may help service and maintenance personnel for the DBB-05.
Additionally, the testing procedures to certify validity of sterilization and disinfection can also be
provided upon request.
Data on the recirculation share of blood flow of the extracorporeal circuit in the single needle dialysis are
available upon request, if the recommend blood circuit, dialysers, fistula needles and catheters are used.

DBB-05
1.4. Set-up instructions (Trial run)

1.4.1. Connection
1. Connect the water supply connector of the DBB-05 to the water supply facility.
2. Connect the drain connector of the DBB-05 to the drain facility.

Pay special attention so that the height of the water drain does not exceed 50 cm. Additionally, the
length of the drain hose shall be no more than 3 m.
3. Connect the DBB-05 to the mains power supply.
When draining dialysate, air accumulation, the reversed siphon

CAUTION at the drain port, and the drain connector should be taken into
consideration.
The drain line should have the specified gradient, and the drain
port should be positioned beneath the dialyser.
1.4.2. Trial run
1. Supply water to the DBB-05.
2. Check the following items.

− Both concentrate connectors are securely connected to the respective rinse ports.
− Both dialyser couplers are securely connected to the bypass ports.
3. Switch ON the DBB-05.

The POWER ON indicator lights up and the computer test (start-up test) is started.
4. When the computer test is passed, the DM test is started automatically.
5. In the menu bar, touch the FUNCTION button and then touch the DISINFECTION key.
The cleaning programs will appear on the screen.
6. In the cleaning program, touch the Cleaning 4 key (rinsing program).

The color of the Cleaning 4 indicator changes.
7. Touch the Cleaning start key for 1.5 sec or longer.

The color of the Cleaning start indicator changes.
8. When the rinsing program is completed, the DBB-05 automatically enters the preset mode.
The color of the Preset indicator is changed.
9. Restart the DBB-05. (Press the Start up test key.)
10. Carry out a safe operation check according to check protocol and record all values.
After switching the DBB-05 on, it must be rinsed for at least 5

CAUTION min (cold).
Also, the DBB-05 must be carefully checked during this
cleaning run.

DBB-05
1.5. Storage and transportation

The following shows the environmental requirements for storage and transportation of the DBB-05.
Ambient temperature: −40 to +60 °C
Relative humidity: 10 to 95 % (No condensation allowed.)
Air pressure: 50 to 106 kPa
When storing the DBB-05 longer than 15 weeks, the

CAUTION environmental requirements stated in chapter 1.12 are to be
strictly adhered to.
1.5.1. Storage
Before storing the DBB-05 for a longer period, it must be disinfected and evacuated by NIKKISO
authorized personnel.
To store the DBB-05, always stand it up in a room where temperature fluctuation is minimized and is well
ventilated.
Charging of built-in battery

Battery used in the DBB-05 must be charged every 6 months using the following procedures.
1. Connect the power plug of the DBB-05 to the electric power facility.
2. Turn the DBB-05 on for 48 hours.
NOTE If the battery is completely discharged, you can start the

DBB-05 by pressing the switch on the power supply unit on the
rear panel.
Operating Instruction 1 - 10
DBB-05
1.5.2. Transportation
l Transportation in building
− Normal transportation
1. Release the foot brake.
2. After that, the DBB-05 can be moved or turned freely.
− Transportation over different heights (For example, entrance of elevator)

To prevent damage or falling of the DBB-05, always slowly move the DBB-05 to run over different
heights.
− Transportation over steps or stairs

To transport over steps or stairs, at least three personnel are required.
1. Release the foot brake.
2. Tilt the DBB-05.
3. Lift up the unit and transport it.
At this time, do not hold the DBB-05 by grasping the monitor, external status display or infusion
stand holder.
4. Place the DBB-05 on the floor and set it up by reversing the order of the above steps.
l Transportation outside building
− The unit must not be pushed across uneven surfaces (for example, stone paved road).
− To transport the DBB-05 on uneven road surfaces, place it upon a cart and protect it by appropriate
padding.
Before transporting the DBB-05, always evacuate it.
1 - 11 Operating Instruction
DBB-05
1.6. Configurations and functions of mechanical

components
Fig. 1-1:Front/Left side view
1
7
3 8
1 Monitor
2 Blood monitor
3 Concentrate connectors and rinse ports
4 Nozzles rinse holder (Option: Concentrate suction nozzles rinse)

Blue/white: Bicarbonate concentrate/acetate concentrate
Red: Acid concentrate
5 Concentrate suction nozzles

Blue/white: Bicarbonate concentrate/acetate concentrate
Red: Acid concentrate
6 Cartridge holder (Option: Bicarbonate powder cartridge)
7 Infusion stand
8 Dialyser holder
DBB-05
Fig. 1-2: Rear/Right side view
5
3
6
8
2
1 Water supply/drain part
2 Dialysate filter (Option)
3 Power unit part
4 External status display (Option)
5 Dialyser coupler (blue)

Connect this coupler to the dialysate inlet of the dialyser.
6 Dialyser coupler (red)

Connect this coupler to the dialysate outlet of the dialyser.
7 Bypass port (blue)

When no active treatment is to be performed (for example, for disinfection and cleaning operations),
connect the dialyser coupler (blue) to this port.
8 Bypass port (red)

When no active treatment is to be performed (for example, for disinfection and cleaning operations),
connect the dialyser coupler (red) to this port.
DBB-05
Fig. 1-3: Monitor
MODEL DBB-05 7
Operation of the DBB-05 and setting of certain operating conditions can be managed on
the monitor screen. Additionally, information, prompts and alarm status are indicated as
text.
1 Screen
Contents to be displayed on the screen may vary depending on the operation mode, the selected
program, and the status of the alarm function. The DBB-05 is operated via a touch screen (touch
sensitive foil on the monitor).
2 “POWER OFF” key

When this key is kept pressed for 3 sec. or longer, the DBB-05 is turned OFF.
NOTE When the DBB-05 is, for example, in start-up or treatment or

finishing mode, all treatment data will remain saved after
shut-down until the next disinfection or the next Start-up test.
3 “POWER ON” key with operating lamp

Press this key to switch ON the DBB-05. The operating lamp lights while the unit is ON.
4 “PUMP 1” key and indicator

Press this key to turn ON or OFF the arterial blood pump. The indicator is lit while the arterial blood
pump is being operated.
5 “PUMP 2” key and indicator

(Option: Single needle dialysis)
Press this key to turn ON or OFF the single needle blood pump.
The indicator is lit while the single needle blood pump is being operated.
6 “MUTE” key and alarm indicator

While the alarm buzzer is sounding, press this key to interrupt the buzzer for 2 minutes. If another
alarm occurs during that period, the alarm buzzer sounds again. The alarm indicator flashes while the
alarm buzzer is sounding.
7 Auto response sensor

The screen becomes on when a person stands up in front of DBB-05.
DBB-05
Fig. 1-4: Power unit (1/2)

1
8
1 Service interface socket (Option)
2 RS232 interface socket (Option) (It doesn't function at the moment.)
3 Output socket for external equipment (Option)
4 Socket for external status display (Option)
5 Alarm output socket (Staff call) (Option)

Socket for connection of a personnel paging device.
6 Alarm input socket (Option)

This input can be used to stop the DBB-05.
7 Nurse call socket (Option)
8 Network socket (Option) (This network can be used only for the data output.)
Data on the network are used as a reference of the treatment

WARNING information, and the user should not take any decision of
medical relevance without an additional verification of the
correctness of these data.
Before starting treatment further, the correctness of the data has
to be verified by the user.
The user should care near the patient even if the network
system use.

DBB-05
Fig. 1-5: Power unit (2/2)
1 Fuses
230 V AC 115 V AC (Option)
Mains input fuse (L): F1 (16AT) F1 (12.5AT)
Mains input fuse (N): F2 (16AT) F2 (12.5AT)
Heating element fuse (L): F3 (10AT) F3 (12.5AT)
Battery line: F5 (10AT) F5 (10AT)
2 “System-start” button switch

If the built-in battery is completely discharged and the DBB-05 cannot be operated, press this switch.
3 Connection terminal for potential equalization conductor

The connection terminal for potential equalization conductor is the terminal which connects to the
potential equalization busbar from the electrical installation.
DBB-05
1.6.1. Blood monitor
Fig. 1-6: Front view
3
6
2
7
1
8
Using the blood monitor, the blood circuit is set and extracorporeal blood circulation is
performed.
1 Arterial clamp (Option)
2 Heparin pump
3 Arterial pressure port
4 Arterial blood pump: PUMP 1
5 Dialyser inlet blood pressure port
6 Single needle blood pump: PUMP 2 (Option)
7 Single needle pressure port (Option)
8 Venous pressure port
9 Air detector part: Air detector, Blood detector, Tube detector, and Venous clamp
DBB-05
Fig. 1-7: Blood pump
1 Pump cover
2 Tube clamp
Fasten the pump tube with this tube clamp.
3 Rotor for PUMP 1 / PUMP 2
4 Sensor
This sensor detects whether the pump cover is open or closed.
NOTE The arterial blood pump (PUMP 1) and the venous blood pump
(PUMP 2) are of identical design.
DBB-05
Fig. 1-8: Heparin pump
1 Syringe slider
This slider moves the syringe plunger.
2 Unlock button
While the unlock button is pressed, the syringe slider is unlocked and can be moved freely.
3 Holder lever
This holder lever secures the syringe.
4 Holder
The flange of the syringe cylinder is set into the holder.
DBB-05
1.6.2. Dialysate monitor
Fig. 1-9: Concentrate connectors and Rinse ports
1 B concentrate connector (blue/white)

For the acetate dialysis, uncouple this connector by turning it to the right, then connect it to the
suction nozzle at the acetate container.
For the bicarbonate dialysis (not using cartridge), connect this connector to the bicarbonate container
(or central supply unit).
For operation with cartridge, this connector remains coupled to the rinse port.
2 B rinse ports (blue/white)

For performing disinfection or cleaning, this connector must be connected to the rinse port.
3 A concentrate connector (red)

For bicarbonate dialysis with acid concentrate, connect this connector to the suction nozzle of the
acid container (or central supply unit).
4 A rinse port (red)

To carry out a cleaning program, connect the concentrate connector A to this rinse port.
DBB-05
Fig. 1-10: Water supply/drain part
1 2 3
6
4
1 Disinfectant suction connector (yellow)

Connect this tube to the citric acid container.
2 Disinfectant suction connector (orange)

Connect this tube to the disinfectant container.
3 Dialysate filter connectors (Option)

Connect these connectors to the dialysate filter.
4 Dialysate supply connector (blue)

This is a dialysate supply port to the dialyser
5 Dialysate drain connector (red)

This is a dialysate return port from the dialyser
6 Water supply connector
7 Drain connector
8 Central concentrate supply connectors (Option)
DBB-05
1.6.3. Piping
Fig. 1-11: Flow block diagram
Water supply Water drain
Water supply control system
Heating system
Flushing
Deaeration system
Mixing system
Duplex pump UF pump
Bypass valves
Dialyser
Blood leak detector
Boost system
DBB-05
Water is fed into the DBB-05 through the water supply connector.
The water supply pressure is decreased to the operating pressure by the pressure reducing valve. This
valve is useful to keep the pressure constant.
Water is pre-heated by the heat exchanger and warmed by the heater.
Warm permeate is passed through the rinse line to clean the pistons and then passed to the two
concentrate pumps.
Negative pressure is applied to water by the sleeve and deaeration pump to separate it to gas and water.
Gas is discharged through the gas separation chamber 1.
Water is mixed with the concentrate in the mixing chamber to produce the dialysate.
(For the bicarbonate dialysis, water is first mixed with the bicarbonate concentrate and then, with the acid
concentrate.)
Fresh dialysate is supplied to the dialyser by the duplex pump which flows it at a constant flow rate.
The duplex pump replaces dialysate drain from the dialyser with fresh dialysate.
At this time, both amounts of drain and fresh dialysate are the same.
The dialysate conditions are shown on the monitor by temperature thermistors and conductivity cells. If
the temperature alarm or conductivity alarm occurs, dialysate supply to the dialyser is stopped by two
dialyser valves and bypassed by a bypass valve. Two pressure transducers are used to calculate TMP.
Used dialysate drained from the dialyser is monitored by the blood leak detector to recognize instantly
any blood leaks at the dialyser membrane.
Positive pressure is applied to the dialysate drain by the booster pump.
Dialysate drain is discharged by the duplex pump. At this time, a part of dialysate is drained at a flow rate
specified by the UF pump.
Dialysate drained from the duplex pump is discharged together with dialysate drained from the UF pump
through the drain connector.
DBB-05
Fig. 1-12: Flow sheet diagram (including all options)
DBB-05
Abbreviations used in flow sheet diagram
BLD Blood leak detector RV1 Relief valve 1
CFL Dialysate filter SL1 Sleeve 1

CL1 Conductivity cell 1 SL2 Sleeve 2
CL2 Conductivity cell 2 SPB Concentrate pump 1
CL3 Conductivity cell 3 (Bicarbonate/acetate)
CL4 Conductivity cell 4 SPA Concentrate pump 2 (Acid)
CP-1 Deaeration pump SV1 Water inlet valve
CP-2 Booster pump SV2 Drain valve
CV41 Check valve (Test) SV3 Circulation valve
CV42 Check valve (Bicarbonate powder) SV4 Dialyser valve 1
CV61 Check valve (Bicarbonate powder) SV5 Dialyser valve 2
SV6 Bypass valve
DH Heater SV7 UF liberation valve
DP Duplex pump SV8 Degassing valve
DPC1 Electrode 1 (Duplex pump) SV9 Test valve 1
DPC2 Electrode 2 (Duplex pump) SV11 O-line valve
SV21 Disinfection valve 1
FL1 Filter (Used-up dialysate) SV22 Disinfection valve 2
FL21 Filter (Disinfection 1) SV41 Test valve 2
FL22 Filter (Disinfection 2) SV42 Bicarbonate powder valve 1
FL41 Filter (Test filter) SV61 Bicarbonate powder valve 2
FL42 Filter (Test filter) SV62 Bicarbonate powder valve 3
FL43 Filter (Bicarbonate powder) SV63 Concentrate nozzles rinse valve 1
FL44 Filter (Bicarbonate powder) SV64 Concentrate nozzles rinse valve 2
FL61 Filter (Bicarbonate/acetate) SV65 Central concentrate supply valve 1
FL62 Filter (Acid) SV66 Central concentrate supply valve 2 (A1)
SV67 Central concentrate supply valve 3 (A1)
GC1 Gas separator 1 SV68 Central concentrate supply valve 4 (A2)
GC2 Gas separator 2 SV69 Central concentrate supply valve 5 (A2)
SV70 Bicarbonate concentrate valve
H1 Back pressure valve 1
H2 Back pressure valve 2 TH1 Temperature thermistor 1 (Control)
H-C1 Back pressure valve C1 TH2 Temperature thermistor 2 (Protect)
(Concentrate pump 1) TH3 Temperature thermistor 3 (Control)
H-C2 Back pressure valve C2 TH4 Temperature thermistor 4 (Protect)
(Concentrate pump 2) TH5 Temperature thermistor 5 (Control)
HEX Heater exchanger TH6 Temperature thermistor 6 (Protect)
TH11 Temperature thermistor 11 (Protect)
L Relief valve THS Thermostat
LVS Float switch
TPT1 Test port 1 (PT1)
MC1 Mixing chamber 1 TPT2 Test port 2 (PT2)
MC2 Mixing chamber 2 TPT3 Test port 3 (PT3)
TPT4 Test port 4 (H1)
PRT11 Port (On-line) TPT5 Test port 5 (H2)
PRT61 Port (Bicarbonate/acetate) TPT6 Test port 6 (L)
PRT62 Port (Acid)
PRV Pressure reducing valve UFC Electrode (UF pump)
UFP UF pump
PT1 Water pressure transducer
PT2 Dialysate pressure transducer 1
PT3 Dialysate pressure transducer 2
DBB-05
1.7. Description of bicarbonate dialysis

l Operation mode
The DBB-05 may be set up for operation of acetate dialysis or bicarbonate dialysis.
The bicarbonate dialysis requires the following two concentrates.
− Acid concentrate
− Bicarbonate concentrate
Never use solely acid concentrate during acetate dialysis. Acid

CAUTION concentrate may be used only in combination with bicarbonate
concentrate for bicarbonate dialysis. If during acetate dialysis
only acid concentrate is used, the dialysate after dilution does
not contain any buffers, resulting in extreme danger for the
patient during treatment.
Both concentrates are diluted by concentrate pumps with deionized water from the reverse osmosis
system (RO).
The concentrate connectors must remain closed at the concentrate bottles or at the central concentrate
supply up to the conclusion of the dialysis treatment.
Mixing is performed by proportioning pumps, i.e. a uniform volume of concentrate is added to water by
the concentrate pump.
The mixing ratio is adjusted by setting the target conductivity.
Insoluble calcium and magnesium salt may accumulate during bicarbonate dialysis.
Therefore, the lime deposits must be removed from the DBB-05 using the appropriate chemical or citric
acid after the bicarbonate dialysis is completed.
During the cleansing program, all connectors must remain connected to the ports.
DBB-05
l Concentrates for bicarbonate dialysis
The correct conductivity of the dialysate is achieved by using proper concentrates obtained by dilution.
Additionally, the DBB-05 always needs to use concentrates with proper quality to ensure its performance
and operational safety.
Dilution ratios of concentrates suitable for the DBB-05 are shown in the following.
− Bicarbonate concentrate : Water = 1 : 16 to 1 : 46
− Acid concentrate : Water = 1 : 16 to 1 : 46
NOTE Do not store any bicarbonate concentrate containers that have

been already opened.
Containers to be used in the DBB-05 must contain appropriate
amounts of concentrate and bicarbonate as necessary for the
bicarbonate dialysis.
DBB-05
Fig. 1-13: Mixing of the dialysate
MC2
SPA
MC1
SPB
Bicarbonate powder
cartridge
Bicarbonate concentrate Acid concentrate
deionized Water
DBB-05
l Safety during bicarbonate dialysis
To ensure safety during the bicarbonate dialysis, the following systems are used:
− Two separate mixing systems for bicarbonate and acid concentrate mixing
− Conductivity control systems with limit value monitoring
− Independent measuring and monitoring systems for bicarbonate solution conductivity
− Color coding for concentrate suction nozzles and bottle
− Mechanical coding for concentrate suction nozzles and containers
− All conductivity measuring values are temperature-corrected
Procedure
Dialysate is continuously produced from the bicarbonate concentrate, acid concentrate, and deionized
water.
First, the bicarbonate concentrate is mixed with water to produce bicarbonate dilution water. After that,
the bicarbonate dilution water is mixed with the acid concentrate to produce the dialysate.
Concentrate container coding

To prevent incorrect use of bicarbonate concentrate and acid concentrate, the caps are notched on their
insides for coding, allowing confirmation of the appropriate container type.
NOTE To increase operational safety, use only such coded concentrate

containers.
However, possibility of misuse of a container without coding
still remains even when this system is used.
l Protective system
Conductivity measurement and bypass path are designed in such a way, that incorrectly mixed dialysis
fluid bypasses the dialyser.
In case of a deviating mixing ratio, an audible and visible alarm is output (including a text message), and
the dialysis fluid bypasses the dialyser.
A DM test of the hydraulic section before each treatment assures that the correct mixing ratio for
permeate, acid concentrate, and bicarbonate is maintained.
DBB-05
Fig. 1-14: Mixing of the dialysate with central concentrate supply (Option)
Central concentrate supply:

MC2 Acid concentrate 1
SV66 & SV67
Central concentrate supply:

SPA Acid concentrate 2
SV68 & SV69
MC1
SV65
SPB
Bicarbonate powder
cartridge
Bicarbonate concentrate Acid concentrate
deionized Water
DBB-05
l Bicarbonate dialysis with central concentrate supply (Option)
Central concentrate supply can be select from three types.
The following 3 types are available:

− No central concentrate supply
− Central concentrate supply with 1 line of acid concentrate
− Central concentrate supply with 2 lines of acid concentrate
NOTE The user is responsible for the proper installation and function
of the central concentrate supply.
In case of two or more connections, you must verify without

CAUTION fail that the concentrate ordered by the physician has been
connected.
The following illustrations show the possible combinations of connection for central concentrate supply.
DBB-05
1.8. Description of extracorporeal blood circuit

Fig. 1-15: Extracorporeal blood circuit-Double needle dialysis
3 5
B
1
A
B
4
A
7
10 9
12 11
A External hydrophobic filter 6 Dialyser

B Internal hydrophobic filter 7 Venous drip chamber
1 Arterial pressure monitor 8 Venous pressure monitor
2 Arterial blood pump : PUMP 1 9 Air detector
3 Heparin pump 10 Tube detector
4 Dialyser inlet blood pressure chamber 11 Blood detector
5 Dialyser inlet blood pressure monitor 12 Venous clamp
DBB-05
1.8.1. Double needle dialysis
The arterial blood pump pumps the blood from the arterial access point of the patient to the dialyser. The
arterial blood pressure monitor measures and monitors the pressure created by the arterial blood pump at
the arterial access point.
By means of another pressure sensor, the blood input pressure before the dialyser is measured.
By means of the heparin pump it is possible to heparinize the external blood circuit.
After the blood has passed through the dialyser, it flows into the venous drip chamber. The venous blood
return is measured and monitored by means of the venous pressure monitor.
For additional monitoring, an air detector, a blood detector, the tube detector, and the venous clamp is
installed after the venous drip chamber. The blood is re-infused into the patient through the venous access
point.
1.8.2. Single needle dialysis (click-clack method)
This dialysis method should be used only in special cases. The

CAUTION stroke and recirculation volumes during this click-clack method
may influence the treatment's efficacy to a significant degree.
Example for use of single needle dialysis (click-clack method)
If during double-needle dialysis a shunt problem concerning the blood flow rate occurs, switching to
single-needle (click-clack method) will allow the treatment to be continued while the previously set up
tube set also continue to be used.
The arterial and venous blood lines are connected to the access points using a Y adapter. The start and
stop phases of the arterial blood pump (PUMP 1) as well as the switching phases of the venous clamp is
controlled automatically, dependent on the set upper venous switching pressure.
The venous clamp is closed while the arterial blood pump (PUMP 1) is supplying the blood. When the
venous pressure reaches the upper limit of the SN set pressure, the arterial blood pump (PUMP 1) is
stopped, and the venous clamp is opened. During this phase, the blood is returned to the patient by the
applied pressure. When the venous pressure reaches the lower limit of the SN set pressure, the venous
clamp is closed and the arterial blood pump (PUMP 1) starts working. These operations are periodically
repeated.
The operation of the single-needle dialysis (click-clack method) is monitored by means of the venous
pressure and a time limit per phase.
DBB-05
1.8.3. Single needle dialysis - double pump (double pump option)
Fig. 1-16: Extracorporeal blood circuit - Single needle dialysis
4 6
B
2
A
B
5
1
A
12 9
B B
A A
10
11 8
14 13
16 15
A External hydrophobic filter 8 SN expansion chamber

B Internal hydrophobic filter 9 SN pressure monitor
1 Arterial clamp 10 SN blood pump : PUMP 2
2 Arterial pressure monitor 11 Venous drip chamber
3 Arterial blood pump : PUMP 1 12 Venous pressure monitor
4 Heparin pump 13 Air detector
5 Dialyser inlet blood pressure chamber 14 Tube detector
6 Dialyser inlet blood pressure monitor 15 Blood detector
7 Dialyser 16 Venous clamp
DBB-05
During single needle dialysis, blood is collected alternately through each needle and returned to the
patient. This dialysis is achieved using an additional single needle module including the blood pump
(pressure - pressure control double pump system).
The single needle dialysis has two phases, the arterial phase and venous phase. Blood is taken from the
patient in the arterial phase and supplied to the patient in the venous phase.
In the arterial phase, the arterial clamp is opened, and the arterial blood pump (PUMP 1) pumps the blood
through the dialyser into the single-needle expansion chamber. In this phase, the SN blood pump (PUMP
2) is stopped and the venous clamp is closed. When the adjustable upper pressure switching point (SN set
pressure) is reached, the arterial phase is ended and the venous phase is started.
In the venous phase, the venous clamp is opened, and the SN blood pump (PUMP 2) pumps the blood
from the SN expansion chamber via the venous chamber to the patient (while simultaneously blood flows
from the chamber of the dialyser inlet blood pressure monitor via the dialyser into the SN expansion
chamber). In this phase, the arterial blood pump (PUMP 1) is stopped, and the arterial clamp is closed.
When the SN control pressure reaches the lower limit, the venous phase is concluded, and another arterial
phase is started.
All other functions are the same as in double-needle dialysis.
DBB-05
1.9. Setting procedure

1.9.1. Data input
l Basic method of data input
To input or change operating values, you can make

use of two methods for data input:
Treat.
1. Input of data via ten-key pad.
data
2. Direct change of data by touching the bar graph.
For example, Profile or Blood flow rate.
The basic methods for data input described below

may be used for almost all data changes. With all
Treat. time data fields or keys that are specially marked by a
remaining 4:00 green frame, a direct change can be made.
UF goal L Data input/data change by example of “UF

01.00 goal”:
UF rate L/h
setting data 0.25 1. On the “Preparation” screen, press the Treat.
data key.
2. Touch the numeric field to the right of

UF goal.
3. Touch the UF goal numeric field.

ESC
The display displays a number pad.
4. Enter the required value on the number pad by

Treat. time Complete pressing the corresponding keys. (See
remaining time illustration on next page.)
The entered value appears in the new field.
4:00 14:00 If a wrong value was entered, the value in the
new field may be deleted with the CLR key.
UF rate 5. Save the entered value by touching the SET key.

UF goal setting data The newly stored value appears in the old field.
02.00 0.50
L L/h
After entering a new value, always check that the values in the
CAUTION new and old fields are identical.
DBB-05
l Ten-key pad
When you touch a screen-displayed data field (parameter display) which you wish to change, a new
window with a ten-key pad for data input is opened.
By touching the appropriate key, the following

functions are executed:
ESC
[ESC]:
When you touch the ESC key, the window is closed
PARAMETER DISPLAY (after entering data).
[PARAMETER DISPLAY]:
The value to be changed is indicated in the
new PARAMETER DISPLAY field.
[new]:
old The newly entered value is indicated in the new
field.
max min [old]:

The active value before the change is indicated in
the old field.
7 8 9 CLR [min] and [max]:

The fields min and max indicate the data range
(limit values).
4 5 6 + [CLR]:
You can delete the entered values (for example,
after an input error) by touching the CLR key.
1 2 3 - [+] and [-]:

When changing the pressure parameter, determine
positive and negative input values with the + and -
keys.
Note:
0 SET • If no algebraic sign is entered, the unit sets
the value as positive.
• Press first the - sign to enter a negative
value.
[SET]:
To confirm newly entered data, the SET key must
be kept pressed continuously until the values in new
and old become identical. A short signal sounds to
indicate this to the user.
Before every treatment start, the "1 to 0" field for ten-key
CAUTION (numeric field) must be checked.
DBB-05
l Special procedure for entering data
600
ESC
500
Blood pump 1 flow set
new 250
400
old 250
max 600 min 0

300
7 8 9 CLR
200
4 5 6 +
1 2 3 - 100
0 SET
0
DBB-05
This special procedure for entering data may be used

to change the following:
1. Blood flow rate

2. UF profiles
3. Total conductivity profiles
4. Bicarbonate conductivity profiles
Special data input/data change by example of

“blood pump”:
Blood flow
1. Touch the display field Blood flow on the
screen.
100 A new window opens displaying a ten-key pad
and a bar graph for entering the blood flow rate
mL/min on screen.
2. Touch the bar graph for the blood flow rate and
slide your finger up or down, until the desired
flow rate appears in the new field.
At this time, the upper edge of the bar graph for

the blood flow rate moves as your finger slides.
(The flow rate changes in units of 10 mL/min.)
As the bar graph moves, the values of the flow

rate displayed in new and old; simultaneously,
the revolutions/min of the blood pump change.
The blood flow rate may also be entered

digitally on the ten-key pad appearing in the
numeric field.
NOTE In contrast to the above example of blood pump data entry, the
bar graph of the conductivity and UF profiles cannot be
changed by moving up or down but only by touching the
respective position.
UF profile <G> ESC
DBB-05
mode HD HD HD HD HD HD HD HD HD HD End NO.

UF rate 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.33 0.33
l Profile data entry
UF goal 0.41 6 0.41 0.41 0.41 0.41 0.41 0.41 0.41 0.13 0.13 10
MAX
0.97
5
Shift time
24
1 - 40
min
MIN ON
0.33 OFF
1 2 3 4 5 6 7 8 9 10
Step quantity for total treatment time 7
DBB-05
The following procedure for entering data may be

used to change:
1. UF profile
2. Total conductivity profile
3. Bicarbonate conductivity profile
Special data input/data change by example of

“UF profile”.
Before entering the profile, you must enter the UF

amount.
UF profile
1. Select the desired profile by touching the Treat.
data key and then the profile symbol.
2. In the opened window, touch to select the

desired profile. Now the selected profile appears
in graphic form.
3. Change the corresponding bar graph by touching

the desired value with your finger.
At this time, the upper edge of the bar graph (for

the UF rate) moves as your finger slides.
UF rate 0.97 0.97 Simultaneously, the changes of the UF rate and
UF goal 0.41 0.41 the UF volume per bar graph (UF sequence) are
displayed in the upper two lines of the UF
profile.
4. Furthermore, you can change the individual bar

graph by touching the corresponding key below
the bar graph. After touching the key, a numeric
field opens, allowing you to enter the desired UF
rate digitally.
1 2 3
4
DBB-05
When you select the End NO. key, the numeric

field opens, and you may select the number of
End NO. bars by entering a number between 1 and 10.
That is, the complete treatment time is divided
into the selected treatment sequences.
10 5. By pressing the HD key (>1.5 sec) above the bar
graph, each individual sequence of the profile
can be switched to ISO-UF.
6. Press the ON/OFF key (>1.5 sec) to activate the

selected profile.
ON
OFF
ON
OFF
DBB-05
1.9.2. Changing the operating modes
The following section describes how to set or

change the operating modes.
1. On the "Preparation" screen, open the window

for operating parameter set-up by pressing the
Treat. Treat. data key.
data 2. Then, touch the HD field to the right of the

treatment field in order to open a new window
for operating parameter set-up.
The active operating mode is displayed by the

color marked key.
Treatment
mode HD 3. Press the desired key for at least 1.5 seconds to
activate the operating mode for the next
SN mode
OFF treatment.
The changed color displays the new operating

mode.
ESC
HD HDF OHDF
ISO-UF
AFBF HF OHF
NOTE • The previous instructions for set-up of a new operating

mode is valid both for double-needle and for single-needle
operations.
• Further information regarding the setting and changing of
operating parameters or changing the operating mode, see
chapter 4.
DBB-05
1.9.3. Setting the alarm points

Functional description of alarm points (Overview)
(This section describes the venous pressure alarm points as an example.)
Description:
Venous pressure alarm + Fixed alarm point upper limit
Pressure
(Fixed alarm point upper limit) The alarm is given immediately

if the venous pressure exceeds
this point.
Venous pressure alarm + Auto. set. maximum alarm point

(Auto. set. maximum alarm
point)
The auto. set. alarm width is set
to this maximum alarm point.
setting range of Auto. set. alarm width
Maximum operating range and
The Auto. set. alarm point upper

and lower widths are
Venous pressure alarm + automatically set above and
(Auto. set. alarm point upper
Current pressure width)
below the current pressure level
after a certain period of setting
time has elapsed.
Venous pressure alarm -

(Auto. set. alarm point lower
The Auto. set. alarm point upper
width) and lower widths can be set
individually.
The alarm setting time may vary
depending on the basic settings
of DBB-05.

(Auto. set. maximum alarm
point)

(Fixed alarm point lower limit)
NOTE • When entering the Auto. set. alarm point lower width, put
Time
a negative sign (-) following the numeric value.
• When changing the blood flow rate or operating the
ALARM RESET key, or during alarm setting time, the
Auto. set. maximum alarm points become invalid and the
pressure is monitored only by the fixed alarm points.
• Whether or not the Auto. set. maximum alarm points are
made valid if the patient is disconnected and whether or not
the pressure is monitored only by the fixed alarm points can
be set using the basic settings of DBB-05.
Each alarm point can be set individually for different treatment modes.
Additionally, it is possible to change the alarm points within the maximum preset range even during
treatment.
DBB-05
Changing the alarm points
Two kinds of methods are provided to change the alarm points.
1. Opening the alarm window from the menu bar.

Press the OPERATOR key and touch the ALARM LIMITS key.
Monitor menu bar
TK HN FUNCTION MONITOR OPEREATOR PATIENT GRAPHIC ?

KEYS
ALARMLIMITS
2. Opening the alarm window by touching a scale on the bar graph
A press. V press. SN press.

– 60 mmHg + 163 mmHg + 150 mmHg
+300 +600 +600
+500 +500
+200
+400 +400
+100
+300 +300
Touch
0 +200 +200
–100 +100 +100
0 0
– 200
–100 –100
– 300 –200 –200
NOTE When touching the ALARM LIMITS menu item, the list of all
pressure parameters you can change will appear. From this list,
select a desired pressure parameter you wish to change.
If you touch a scale on the bar graph, the setup screen for the
parameter you wish to change will appear directly.
DBB-05
Selecting a desired parameter
2. Alarm point
2.1. Venous pressure alarm
2.2. Arterial pressure alarm
2.3. Dialysate pressure alarm
2.4. TMP alarm
2.5. Pressure loss alarm
2.6. Dialyser inlet press. alarm
Next Group
Alarm point (set/change)
2.1. Venous pressure alarm mmHg
HD
SPSN DPSN
ISO-UF
Fixed alarm point
upper limit 300 400 400

Auto. set.
maximum alarm point 300 300
    
Auto. set. alarm
point upper width 60 70
    
Auto. set. alarm
point lower width - 40 -70

Auto. set.
minimum alarm point 10 10
Fixed alarm point
lower limit - 50 10 - 50
Next Group
Touch a desired alarm point field.

Input an alarm limit value to change the alarm point.
DBB-05
1.9.4. Description of keys
Key list:
Alarm Bypass UF rate Override Substitu Reset of

reset select down t. fluid test NG
HP rapid Continu. Cal. curv

feed heparin setting
1.0 mL/h
Gaspurge Start Dis- CF Timer Dialysa.

connect exchange withdra.
B powder B pow. Treat. TMP-zero Micro-

B powder
w. prim. drain cart. set data -cal. switch
OFF Bicart.
DBB-05
Description of key function
Alarm reset
When this key is pressed, almost all alarms are executed or reset.
Bypass select
When this key is pressed, the bypass selection becomes valid. Basically, if a fault occurs, the bypass
selection becomes valid automatically.
Normally, you must press the Bypass select key manually only when the blood leak alarm is given. At
this time, press the Gas purge key to prime and rinse the new dialyser.
UF rate down
When this key is pressed, the UF rate is decreased to the preset minimum UF rate or 0 L/h. (This may
vary depending on the settings of DBB-05.)
When the UF rate down key is valid, the buzzer starts sounding after a period of time set as basic value
has elapsed.
Override
When this key is kept pressed, the remaining blood and saline are re-infused during disconnection. At
this time, however, the RPM of the blood pump is limited.
Substitut. fluid
To improve the needle sticking position if an alarm is given on the blood side, press Substitut. fluid key
to partially widen the Auto. set. alarm width for a period of time set as basic value.
Reset of test NG
According to the basic settings of DBB-05, the filter leak test failure can be reset using this key.
After resetting the failure, you can continue the HD treatment, but cannot continue the OHDF
treatment.
HP rapid feed
When this key is pressed, the heparin pump is operated at a rapid feed rate to remove the air from the
heparin line during preparation.
Continu. heparin
When this key is pressed, the heparin setting input window will be opened. In this window, the current
status of the heparin pump (ON/OFF) and the current feed rate are displayed.
DBB-05
Cal. curv setting

This key is used to newly perform the calibration after the concentrate has been exchanged. This
calibration must be carried out before storing the newly connected concentrate.
(By performing the calibration, it is checked that the selected concentrate is matched with the
connected concentrate.)
Gaspurge
This key is used to fill the dialyser with dialysate during preparation.
CAUTION: If it is required to fill the dialyser during treatment, always touch the
Bypass select key before operating the Gas purge key.
Start
When this key is pressed, the dialysis treatment is started and the alarm points become valid during
treatment.
Disconnect
When this key is pressed, the completion phase to disconnect the patient is started. Depending on the
operating status, the Auto. set. alarm points on the blood side become invalid. (This may vary
depending on the basic settings of DBB-05.)
CF exchange
When the sterilization filter reaches its maximum operating hours, the exchange instruction is given
automatically. After the filter has been exchanged, you can open the dialog window using this key and
reset the current operating hours to zero (0).
CAUTION: Always put the exchange date on the newly set filter.
Timer
You can open the dialog window using this key and input the timer time. (For example, this timer can
be used as medication instruction sound.)
DBB-05
Dialysa. withdra.
When this key is pressed, DBB-05 is changed to the series connection for sampling during preparation.
B powder w. prim.
When this key is pressed if the micro switch of the cartridge holder is invalid (cartridge is not
recognized automatically), the manual bicarbonate powder cartridge priming process is started.
CAUTION: Prime the cartridge manually if the set cartridge is not recognized automatically. (For
example, the cartridge is too short.)
B powder drain
If the micro switch is invalid, press this key to manually make the bicarbonate powder cartridge empty.
B pow. Cart. set

This key is displayed only when the [Bicarbonate powder cartridge] switch is invalid.
After the cartridge has been set, press this key to check that the cartridge is set completely.
That is, it is necessary to press this key after setting the cartridge and turn off this key after removing
the cartridge.
Treat. data
This key is used to display the table for entering of the treatment parameters.
The table also shows the important treatment data.
TMP-zero-cal. OFF
This key is used to make the TMP zero calibration invalid if the TMP calibration alarm is given.
Note that the TMP/UF factor display has a slight error if the TMP zero calibration is not executed.
Micro-switch Bicart.
This key is used to make the micro switch of the bicarbonate powder cartridge holder invalid. (For
example, the cartridge is too short and DBB-05 cannot recognize it automatically.)
When the micro switch is invalid, first check the current status of the cartridge holder (whether or not
the cartridge is set) using the B pow. cart. set key.
Next, press the B powder w. prim. and B powder drain keys to manually prime and drain the cartridge,
respectively.
DBB-05
1.9.5. Functional description of menu bar
Basically, only menu items necessary for operators are displayed to ensure easy view.
Touch the TK (technician) or HN (nurse) key and enter the password to call up the following
functions.
When touching the TK key quickly, it is possible to display the following menu without entry of
the password.
Standard menu bar
Extended menu bar

PREPARATION MONITOR KEYS PAT.-SELSCTION All
TREATMENT ALARM LIMITS ALARMLIMITS Arterial
DISINFECTION Venous
Pressure loss
Dialy. press.
TMP
UFR
Bic. cond.
Total cond.
FLOW DIAGRAM
Description of menu bar
FUNCTION
When touching the FUNCTION key, three basic screen menus, PREPARATION, TREATMENT, and
DISINFECTION, are displayed.
To open each screen, touch relevant menu item.
Each screen can be seen at any time. Therefore, the execution of each operation may depend on the
operating status of DBB-05 when the menu item is touched. Therefore, the menu item may become
inactive depending on the operating status.
MONITOR
When selecting MONITOR and ALARM LIMITS of the MONITOR menu, the treatment parameters
and current alarm point list are displayed, respectively.
OPEREATOR
From the OPERATOR menu, the key screen or screen to change the pressure alarm points can be
selected.
DBB-05
PATIENT
From this menu, all patient names (if they are saved) and individually saved treatment parameters can
be called up.
The patient treatment data can be used only for treatment preparation.
GRAPHIC
The GRAPHIC menu is used to display the graph of the important treatment parameters.
It is also possible to display each parameter in detail and overlap the multiple values for comparison
display.
MONITOR
The list of all treatment parameters is displayed. Additionally, almost all treatment parameters can be
changed from the MONITOR menu.
ALARM LIMITS
The list of all current alarm points is displayed.
KEYS
All operation keys are displayed in the key field. Press relevant key to continue the operation.
ALARMLIMITS
Each alarm point and alarm width can be changed for the treatment in progress.
Extended menu bar with HN password entry (nurse)

(Fig. is not provided.)
From the extended menu bar (displayed only when entering the password), it is possible to open other
menu items.
HISTORY
The HISTORY menu is used to save all dialyser operations, such as alarm displays, parameter changes,
and basic value settings for several days, and display them when necessary.
SETTING 1 / SETTING 2
The SETTING 1 / SETTING 2 menus are used to set the treatment parameters and
DBB-05 specific parameters as basic values.
PAT.-ADJUST.
Individual treatment data of multiple patients can be saved into the patient memory. When selecting a
desired patient (name), the parameters saved in this memory become the basic treatment values at start
of each treatment.
DBB-05
1.10. Maintenance and checks

1.10.1. Cleaning and disinfection
l Information on cleaning and disinfection
To carry out correct cleaning and disinfection, any processes may be combined and changed operating
times programmed as initial values.
NOTE If an alarm is output during the cleaning program, the cleaning

process time is extended by the alarm retention time.
l Removal of calcium deposit and disinfection
Removal of calcium deposit and disinfection are performed by the following cleaning programs.
− Heat disinfection/Decalcification (citric acid 50% is used.)
− Chemical disinfection
Disinfectant is sucked in via the suction tube on the rear of the unit.
Always use only citric acid for the disinfection/decalcification.

CAUTION Under no circumstances may any other disinfectant be sucked
in through the suction nozzle for citric acid.
When connecting any other disinfectant (for example, when
changing the disinfectant) to the unit via the second
disinfectant suction tube, do not fail to thoroughly clean and
rinse the suction tube beforehand.
DBB-05
l Basic process of cleaning program
− Cleaning program 1
Heat disinfection/Decalcification
[Rinsing]
ê
[Disinfectant suction]
ê
[Hot water circulation]
ê
[Forced rinsing and cooling]
Chemical disinfection
[Rinsing]
ê
ê
[Chemical circulation]
ê
[Forced rinsing]
Heat disinfection
[Rinsing]
ê
[Hot water circulation]
ê
[Cooling]
Rinse
[Rinsing]
Chemical disinfection
[Rinsing]
ê
ê
[Chemical circulation]
ê
[Forced rinsing]
DBB-05
1.10.2. Maintenance after each dialysis
The operating life of the DBB-05 and its optimum operating

CAUTION conditions depend much upon regular care, maintenance, and
periodic performance of safety-related inspections as
scheduled.
l Cleaning of casing
Care of the unit's exterior should be performed with a MOIST cloth. For surface disinfection, the cloth
may be moistened with a diluted sodium hypochlorite solution (max. concentration of 0.5%).
Never use undiluted sodium hypochlorite concentrate solution (bleaching agent). Use of agent containing
up to 70% of alcohol is allowed.
Never use any organic solvent, such as a paint thinner for

CAUTION cleaning of the DBB-05.
l Cleaning of the hydraulic unit
Always clean the inside of the dialysate line after the dialysis has been completed.
If the power to the DBB-05 is turned OFF without cleaning of the dialysate line, dialysate remains in the
dialysate line and deposits carbonate.
Carbonate deposits in the dialysate circuit may cause malfunctions.
DBB-05
1.10.3. Daily inspection
− Check that the power cable is not damaged.

− Check that the water supply and drain hoses are not bent and damaged.
− Check that the dialysate supply and drain hoses are not bent and damaged.
− Check that the concentrate line hoses are not bent and damaged.
− Check that the proper blood pressure, conductivity, and temperature are displayed.
− Check that no liquid leaks from the inside of the DBB-05.
Leakages in the system may result in ultrafiltration calculation

CAUTION errors.
1.10.4. Inspection and maintenance of system
Safety-related inspection and maintenance of the DBB-05 must be carried out only by personnel
authorized by NIKKISO.
For details of information on safety-related inspections and maintenance, see the DBB-05 service manual.
1.10.5. Setting of basic values
Basic values may be set only by persons authorized by NIKKISO.

For further information regarding the setting of basic values, see the DBB-05 service manual.
DBB-05
1.11. Consumables
Only use consumables that are approved. Disposables (for

CAUTION example, blood tube sets, dialysers, syringes etc.) are to be
disposed of according to applicable laws and regulations.
1.11.1. Dialyser
ex. AL-series dialyser

BL-series dialyser
FL-series dialyser
1.11.2. Blood tube sets
A/V tube sets
ex. Double needle dialysis: AV 03-E/B

Single needle dialysis: AV 03-SN-E/B
1. The listed blood tube sets are suitable for the pressure
CAUTION limitation system of the blood pump.
2. For contamination prevention, hydrophobic filters are to be
used at the pressure release lines. Hydrophobic filters
wetted with sodium chloride solution or blood are to be
replaced.
3. Optimum single-needle operation is ensured only when
using the original blood tube sets.
4. Assure the sterility of all blood and dialysis side connection
materials.
1.11.3. Heparin syringe
Heparin syringe 30mL (lure lock) or 20mL (lure lock)

Heparin syringe 20mL (lure lock) or 10mL (lure lock) (Option)
DBB-05
1.11.4. Concentrate for hemodialysis
l Acetate dialysis
Acetate concentrate suitable for the following proportion of concentrate and water may be used.
1L of acetate concentrate and 34L of water
l Bicarbonate dialysis
Bicarbonate concentrate and acid concentrate suitable for the following proportion of concentrate and
water may be used.
1L of acid concentrate, 32.775L of water, and 1.225L of bicarbonate concentrate 8.4%
1L of acid concentrate, 42.225L of water, and 1.775L of bicarbonate concentrate 8.4%
1L of acid concentrate, 34L of water, and 1.83L of bicarbonate concentrate with electrolytic additive
DBB-05
1.11.5. Disinfectant
l Disinfection and decalcification

For removal and disinfection of calcium deposits from the hydraulic unit, the following solutions may
be used:
− Citric acid 50%

(Cleaning program: Heat disinfection/Decalcification)
− Peracetic acid (ex. Dialox ®)

(Cleaning program: Chemical disinfection)
l Disinfection
− Sodium hypochlorite solution

(maximum chlorite concentration in disinfectant 10%)
− Peracetic acid (ex. Dialox ®)

NOTE Strictly observe the following instructions of the disinfectant

manufacturer:
1. The use-by date must not be exceeded.

2. Appropriate storage of the disinfectant must be provided.
3. Manufacturer's cautions are to be heeded.
DBB-05
1.12. Technical data

1.12.1. Dimensions and weight
l Dimensions
Height: 137 cm
Width: 39 cm
Depth: 46 cm
Base: 49 cm (W) × 75 cm (D)
l Weight
Standard system: Approximately 85 kg

System with full options: Approximately 110 kg
1.12.2. Electric safety (Classified according to EN60601-1, IEC60601-1)
l Type of electric shock protection
Class I equipment
l Grade of electric shock protection
B-type equipment Symbol:
l Protection against ingress of water
Protection against dripping water Symbol: IPX1
l Type label
DIALYSIS SYSTEM
MODEL: DBB-05
POWER: 230 V ~ 50/60 Hz
2.3 kVA
DATE:
SERIAL NO.:
IMPORTER
NIKKISO Medical GmbH

Brödermannsweg 1, D-22453 Hamburg, Germany
IPX1
0123
MANUFACTURE

43-2, Ebisu 3-Chome, Shibuya-ku,
Tokyo 150-8677, Japan
DBB-05
1.12.3. Electric power supply
l Voltage
230 V AC, ±10 %, 50/60 Hz Symbol: (Alternating current)

115 V AC, ±10 %, 50/60 Hz (Option) Symbol: (Alternating current)
l Current
16 A (Option 115 V AC: 15 A)
Never use any adaptor which breaks the green/yellow striped

WARNING grounding cable.
l Power consumption
Dialysis: Max. 5A at water temperature of 5 °C

(Option 115 V AC: Max. 8 A)
At a dialysate temperature of 37
and a dialysate flow rate of 500 mL/min
Heat disinfection: Max. 9 A

(Option 115 V AC: Max. 12 A)
Temperature of heat circulation: 90 °C (at heater outlet)
Flow rate of heat circulation: 800 mL/min.
l Battery
Type: Nickel-metal hydride battery (Ni-MH battery)

Capacity: 24 V/2.1 Ah
1.12.4. Fuses (Power unit)
230 V AC: Power line: 2 × 16 AT

Heater line: 1 × 10 AT
Battery line: 1 × 10 AT
115 V AC (Option): Power line: 2 × 12.5 AT

Heater line: 1 × 12.5 AT
Battery line: 1 × 10 AT
DBB-05
1.12.5. Operating status
l Water supply
Pressure range of supply water: 1 to 7 bar

Temperature range of supply water: 5 to 30 °C
Minimum flow rate of supply water: Average 800 mL/min
l Drain
Minimum Drain capacity: Average 800 mL/min

Drain height: Maximum 50 cm
When draining dialysate, air accumulation, the reversed siphon

CAUTION at the drain port, and the drain connector should be taken into
consideration.
The drain line should have the specified gradient, and the drain
port should be positioned beneath the dialyser.
l Concentrate supply
Inlet pressure: 0 to 0.5 bar
NOTE In order to avoid conductivity fluctuations, the maximum

pressure of 0.5 bar must not be exceeded, especially in the case
of a central concentrate supply.
DBB-05
1.12.6. Water and dialysate used
Water used in a DBB-05 dialysis must have been deionized in a

WARNING reverse osmosis system and conform to the appropriate
standards (see below).
l Standards for water and dialysate quality
1 American National Standard for hemodialysis system

ANSI/AAMI RD5R-1992
2 Canadian Standard Committee
General standard No. 2
Sub standard Z364.2.1-M1986, September, 1987
3 DAB 10 VIII. 9
Water for dilution of concentrated hemodialysis dialysate, 1st edition, 1992
4 DIN VDE 0753 Part 4
l Water quality
Bacteria contamination shall be 200KBE/mL or less. ( 1 )

Normal drink water is not applicable to the hemodialysis. Water must be treated through an appropriate
process for the hemodialysis. ( 3 and 4 )
l Dialysate quality

Exothermic load shall be 0.25EU/mL or less. ( 1 , 2 and 3 )
l Inspection results
When sampling, make unfailingly sure that a high level of sterility is ensured. Before each sampling, the
sampling port must be disinfected in accordance with specifications, and the sterile syringe must be sealed
airtight immediately after taking the sample. Make absolutely certain that the specified storage conditions
during transport (cooling) and the maximum storage period of the sample are maintained.
DBB-05
1.12.7. Environmental conditions
l Operating conditions
Ambient temperature: 10 to 35 °C
Relative humidity: 30 to 85 %
l Storage and transportation (dry machine)
Ambient temperature: −40 to 60 °C

Relative humidity: 10 to 95 % (No condensation allowed.)
When storing the DBB-05 longer than 15 weeks, the

CAUTION operating conditions are to be strictly adhered to.
DBB-05
1.12.8. Options for external connections
Status display For connection of an external status monitor display (option).
Alarm output (Staff call) For connection of the external personnel-paging device.
Contact output (max. DC 24 V/120 mA)
Alarm input For connection of the external device.

This input can be used to stop the machine.
Input voltage (DC 5 V to DC 24 V)
Nurse call For connection of an external pushbutton switch.
Output For connection of external auxiliary equipment.

The equipment must be basic insulation.
Service interface Interface for data transfer to the computer.

(galvanically decoupled by optocoupler)
RS232 interface Interface for data transfer to the patient identification.

(Not used at the moment.) (galvanically decoupled by optocoupler)
Network For connection of computer network.

(This network can be used only for the data output.)
(galvanically decoupled by optocoupler)
Data on the network are used as a reference of the treatment

WARNING information, and the user should not take any decision of
medical relevance without an additional verification of the
correctness of these data.
Before starting treatment further, the correctness of the data has
to be verified by the user.
The user should care near the patient even if the network
system use.

DBB-05
1.12.9. Hydraulic unit
NOTE Alarm settings marked * are changeable.

For information regarding the setting of limits, see the service
manual.
l Blood leak detector
Method: Optical
Sensitivity: 0.5mL* Blood / 1L Dialysate
(Blood: Hematocrit 20% calibrated at 37 °C)
NOTE 0.40mL blood/min

(Maximum flow rate: 800mL/min)
Alarm response: To remove disturbances, the response from the blood detector is
delayed.
The delayed response may depend on the volume between the
dialyser and the blood leak detector as well as on the
ultrafiltration rate. (ISO-UF)
In case of ISO-UF, the sensitivity of the blood leak detector is

CAUTION changed to reduce. This reduction of sensitivity is effective
only for ISO-UF.
(The filtrate of ISO-UF is more yellowish than dialysate of
HD.)
l TMP
Measurement range: −100 to +500 mmHg

Measurement accuracy: ±10 mmHg
Auto set alarm range: Upper limit: +70 mmHg*
Lower limit: −70 mmHg*
Auto forecast alarm range: Upper limit: +20 mmHg*
In case of SN treatment, these values are changed as follows:
Upper limit: +50 mmHg*
NOTE The alarm limits depend on the set monitoring method and the
selected treatment type.
If necessary, alarm limits can be modified!
Fixed alarm points: Upper limit: +500 mmHg*

DBB-05
Definition
PBi + PBo PDi + PDo

TMP = − − Offset
2 2
PDi = dialysate pressure on the inlet side of the dialyser

PDo = dialysate pressure on the outlet side of the dialyser
PBi = blood pressure on the inlet side of the dialyser
PBo = blood pressure on the outlet side of the dialyser
Offset = flow-dependent pressure variations
l Dialysate pressure

l Water pressure
Measurement range: 0 to 1 bar

Measurement accuracy: ±0.02 bar
l Ultrafiltration
Ultrafiltration rate: 0.00; 0.10 to 4.00* L/h

Ultrafiltration accuracy: ±30 mL/h
(At dialysate flow rate 300 to 500 mL/min)
±0.1% of the dialysate flow rate
(At dialysate flow rate 501 to 800 mL/min)
Protection system: Monitoring of UF pump (stroke)
Monitoring of UF pump (valve)
Monitoring of UF pump (Flow rate)
Monitoring of TMP
UF profile: UF profile with step change
Continuous UF profile without step change
l UFR
Measurement range: 0 to +300 mL/h/mmHg

Measurement accuracy: ±10 %
DBB-05
l Acetate dialysis
− Total conductivity
Setting range: 12.5 to 15.5 mS/cm
Total conductivity profile: Conductivity profile with step change up
continuous conductivity profile without step change
Measurement range: 10.0 to 20.0 mS/cm (100 to 200 mmol/L)
Measurement accuracy: ±0.2 mS/cm (±2 mmol/L)
Alarm range: Upper limit: Set value +5 %*
Lower limit: Set value −5 %*
− Bicarbonate conductivity
Bicarbonate Conductivity profile with step change up
conductivity profile: continuous conductivity profile without step change
Measurement range: 2.00 to 8.00 mS/cm
Measurement accuracy: ±0.1 mS/cm
Alarm delay time: maximum 20 seconds
− Total conductivity
Total conductivity profile: Conductivity profile with step change up
continuous conductivity profile without step change
Measurement range: 10.0 to 20.0 mS/cm (100 to 200 mmol/L)
Measurement accuracy: ±0.2 mS/cm (±2 mmol/L)
l Dialysate temperature
Setting range: 34.0* to 40.0* °C

Measurement range: 10.0 to 45.0 °C
Measurement accuracy: Measurement value ±0.8 °C
Flow rate of dialysate: 500 mL/min
at a constant ambient temperature
Alarm range: Upper limit: Set value +1 °C*
Lower limit: Set value −1 °C*
l Dialysate flow rate (= Duplex pump rate)
Setting range: 300 to 800 mL/min

Flow rate accuracy: Set value ±10 %
Protection system: Monitoring of duplex pump (valve)
Monitoring of duplex pump (Flow rate)
DBB-05
1.12.10. Pressure monitoring (extracorporeal blood circuit)

manual.
l Arterial pressure

NOTE The alarm limits depend on the selected treatment type.


l Venous pressure

In case of SN treatment, these values are changed as follows:
Upper limit: +70 mmHg*


DBB-05
l Dialyser inlet blood pressure



l Pressure loss
Measurement range: −300 to +500mmHg

Measurement accuracy: ±10mmHg
DBB-05
l Air detector
Method: Ultrasonic wave

Sensitivity: 0.02 mL (Air bubble)
Blood flow rate: 250 mL/min
0.0003 mL (microfroth: blood/air mixture)
Blood flow rate: 250 mL/min
l Arterial blood pump (PUMP 1)

When using the approved blood tube sets.

Inflow pressure: minimum −150 mmHg
maximum +150 mmHg
Outlet pressure: maximum +500 mmHg
Protection system: The blood pump is monitored for stoppage.
The blood pump is monitored for rotation (reverse rotation).
Display method: Blood flow rate = Rotation of blood pump
l Blood flow volume
Measurement range: 0 to 999.9 mL

l Heparin pump
Setting range: 0.0 to 10.0 mL/h

Output rate accuracy: Set value ±5 %
Back pressure: +500 mmHg
Syringe type: 30 mL (lure lock), 20 mL (lure lock),
or 10 mL (lure lock) (Option)
Bolus process: 0.1 to 5.0 mL
Max. bolus accumulation
capacity/time: 1 × syringe capacity (30 mL, 20 mL, or 10 mL)
l Heparin pump total flow

The heparin pump is used only for infusion of heparin solution.

CAUTION Do not use this pump under any circumstances for infusion of
any other chemicals.
DBB-05
1.12.11. Single needle dialysis (Option)
l SN pressure

l Control
SN control pressure: Upper limit: +200 mmHg*

Lower limit: +100 mmHg*
l SN blood pump (PUMP 2)
The SN blood pump (PUMP 2) has the same contents of the technical data as those of the arterial blood
pump (PUMP 1).
l Protection
SN pressure alarm points: Upper limit: +50 mmHg*

SN running time alarm point: Arterial phase: 18 sec.*
Venous phase: 18 sec.*
l Average blood flow
Measurement range: 0 to 999 mL/min

The average blood flow rate refers to the average of the blood flowing through the dialyser in a particular
period.
The average blood flow rate is obtained from the equation 1 below.
Qba × Qsn
Qm = Equation 1
Qba − Qsn
Qm = mean blood flow (mL/min)
Qba = flow rate of arterial blood pump (mL/min)
Qsn = flow rate of SN blood pump (mL/min)
The average blood flow rate depends upon needle and setting of the SN switching pressure as well as on
the patient's blood vessel conditions.
l Stroke volume

The stroke volume here refers to the amount of blood sent to the dialyser by the arterial blood pump
(PUMP 1) or the amount of blood drawn from the dialyser by the SN blood pump (PUMP 2).
The stroke volume is obtained from the equation 2 below.
Ct
Sv = Qm × Equation 2
60
Sv = stroke volume (mL)
Ct = cycle time (Sec) = ta + tsn
ta = arterial period (Sec)
tsn = venous period (Sec)
DBB-05
1.12.12. Utilized materials for piping
Materials which are in contact with water, concentrates, and dialysate are listed below.
− Stainless steel
− Fluoro rubber
− Silicon (SI)
− Ceramic
− Carbon
− Polysulfone (PSU)
− Polyimido (PI)
− Pyrex
− Polypropylene (PP)
− Polyphenylene ether (PPE)
− Methylpentene polymer (TPX)
− Titanium
− Polytetrafluoroethylene (PTFE)
− Polyethersulfone (PES)
− Ethylene-tetrafluoroethylene plastic (ETFE)
DBB-05
1.13. Abbreviations and symbols

1.13.1. Abbreviations
AC : Alternating current
AFBF : Acetate free biofiltration
BIC : Bicarbonate
BP : Blood pump
BPM : Blood pressure monitor
LF : Conductivity
DC : Direct current
HD : Hemodialysis
HDF : Hemodiafiltration
HF : Hemofiltration
OHDF : On-line hemodiafiltration
OHF : On-line hemofiltration
SN-KK : Single needle dialysis (click-clack method)
SN-DP : Single needle dialysis (double pump)
SV : Solenoid valve
TMP : Transmembrane pressure
UF : Ultrafiltration
DBB-05
1.13.2. Symbols
Strictly observe the instructions on the equipment.
IPX1 Protection against dripping water
Grade of electric shock protection: Type B
Grade of electric shock protection: Type BF
Alternating current
Protective earth terminal (Grounding)
OFF (Turn off power to DBB-05)
ON (Turn on power to DBB-05)
Do not handle used batteries as general waste.

Cd
Recycle battery
Ni-MH
Potential equalization conductor
DBB-05
1.14. Environmental issues

Materials used
Metals
− Stainless steel
− Aluminum
− Titanium
− Copper
− Iron
− Brass
Plastics
− Silicone (SI)
− Fluoro rubber
− Acrylonitrile-butadiene-styrene (ABS)
− Polyoxymethylene (POM)
− Polycarbonate (PC)
− Polyimide(PI)
− Polyvinyl chloride (PVC)
− Polyethylene terephthalate (PET)
− Acrylonitrile-styrene-acrylate (ASA)
− Polydicyclopentadiene (UP)
Electronic component, such as LCD and P.C.B

Pyrex, Ceramic, Carbon
Nickel-metal hydride battery (Ni-MH battery)
Contact for part disposal: NIKKISO Medical GmbH,

NIKKISO CO., LTD.,
or your local representative
DBB-05
1.15. Maintenance with Technical Safety Inspection

This inspection must be performed 12 months.
Serial No. Invent.-No.: Option:

Software version Operation place o Double-pump
Operation hours Operator o Bicarbonate powder
1. Visual inspection and Maintenance measures:

1.1. All safety labels and symbols are put on the unit and must be readable. q
1.2. Mechanical condition must not hinder safe operation. q
1.3. Exchange of the maintenance part which follows the operation time of the machine. q
1.4. Inspection of the valves (H1, H2, L) by the instruction for the inspection. q
1.5. Inspection of the blood leak detector (BLD) by the instruction for the inspection. q
1.6. Fuses must conform to their ratings designated by the manufacturer. q
2. Function inspection:
2.1. Monitor ⇒ Function q Image display q Alarm signal display q
2.2. Venous clamp/Arterial clamp Function q
2.3. Air detector Alarm function q
2.4. Arterial blood pump Delivery rate (200 mL/min ±20 mL/min) Alarm cover switch q
2.5. SN pump Delivery rate (200 mL/min ±20 mL/min) Alarm cover switch q
3. Pressure measurement:
Arterial pressure Comparison -200 mmHg q
3.1.
(Permissible tolerance ±10 mmHg) measurement at 0 mmHg q
Venous pressure Comparison 0 mmHg q
3.2.
(Permissible tolerance ±10 mmHg) measurement at +200 mmHg q
Inlet blood pressure Comparison 0 mmHg q
3.3.
SN pressure Comparison 0 mmHg q
3.4.
Inlet dialysate pressure Comparison -200 mmHg q
3.5.
Outlet dialysate pressure Comparison -200 mmHg q
3.6.
Supply water pressure Comparison 0 mmHg q
3.7.
4. Conductivity: Reference value
Comparison measurement at
4.1. Bicarbonate conductivity mS/cm
(3.0 mS/cm ±0.1 mS/cm)
Comparison measurement at
4.2. Total conductivity mS/cm
(14.0 mS/cm ±0.2 mS/cm)
4.3. Conductivity inspection must be carried out. q
5. Temperature: Comparison measurement at (37 °C +0.5 °C; −1.5 °C) q
6. UF system: Balance test: Max. defference ± 5 mL / 10 min q
7. Electrical part:
7.1. Resistance of protective ground cable (Max. 0,2 Ω) Ω
7.2. Earth leakage current (Max. 0,5 mA) mA
7.3. Patient leakage current (Max. 0,1 mA) mA
7.4. Power failure alarm (Buzzer must sound) q
8. DM test + BM test must be carried out. q
9. Disinfection must be carried out. q
Observation:
Place: Date: Signature:
DBB-05
DBB-05
Table of contents 2. Preparation

Section Page
2.1. Start-up 2-2

2.1.1. Switching on the DBB-05 2-2
2.1.2. Concentrate supply 2-3
2.1.3. Confirmation or change of concentrate 2-6
2.2. Extracorporeal blood circuit 2-8

2.2.1. Set the arterial blood line 2-8
2.2.2. Set the venous blood line 2-8
2.2.3. Pressure ports 2-9
2.2.4. Heparin pump 2-10
2.3. Priming of blood circuit 2-12

2.3.1. Manual priming of blood circuit and dialyser 2-13
2.3.2. Priming function for blood circuit and dialyser 2-14
2.4. Priming of dialysate side 2-20

2.4.1. After completion of the DM test 2-20
2.4.2. Sampling 2-21
2.4.3. Dialyser [Filling] 2-22
2.4.4. BM test and dialyser [Rinsing] 2-23
2.5. Start-up test 2-24

DBB-05
2.1. Start-up
2.1.1. Switching on the DBB-05
1. Check to see that the water supply is properly

connected.
2. Switch on the unit.
The DBB-05 starts its computer test run (start-up

test) automatically.
Buzzer test:
After you press the [POWER ON] key, an alarm
signal sounds to confirm the working condition
of the acoustic alarm.
During the test run, unit status, unit type, and

current software version are displayed.
If no alarm signal is to be heard, there will also be no acoustical

CAUTION alarm signal during treatment, either.
In this case, starting any treatment is strictly forbidden.
Before every new treatment you must verify that the DBB-05
CAUTION does not contain any disinfectants.
To verify this, take a sample from the drain tube and test this
sample according to the corresponding test method, depending
on the utilized disinfectant.

DBB-05
2.1.2. Concentrate supply
• Never conduct an acetate dialysis with acid concentrate.

CAUTION • Never conduct a bicarbonate dialysis with acetate
concentrate.
• Never conduct a bicarbonate dialysis without bicarbonate
concentrate.
• Never conduct an acetate dialysis with AFBF concentrate.
Any selection mistake would endanger the patient.
If there are two acid concentrate ports available at the central

supply system, the operator must make positively sure that the
appropriate acid concentrate for the next treatment is selected.
NOTE To remove the concentrate connector from the rinse port turn
the concentrate connector to the right (clockwise) while
simultaneously pulling.
l Acetate dialysis
1. Prepare the acetate concentrate for the acetate

dialysis.
2. Insert the concentrate suction nozzle

(blue/white) to the acetate concentrate container
and connect the concentrate connector
(blue/white) to the concentrate suction nozzle
(blue/white).

DBB-05
1. Prepare the bicarbonate concentrate and acid
concentrate necessary for the bicarbonate
dialysis.

(blue/white) into the bicarbonate concentrate
container and connect the concentrate connector
(blue/white) to the concentrate suction nozzle
(blue/white).
3. Insert the concentrate suction nozzle (red) into

the acid concentrate container and connect the
concentrate connector (red) to the concentrate
suction nozzle (red).
A concentrate container to be used must contain a sufficient

CAUTION amount of concentrate and bicarbonate necessary for dialysis
treatment.
NOTE For central supply system, conect the concentarte connector

(red) with the rinse port (red).

DBB-05
l Bicarbonate dialysis with bicarbonate powder cartridge (Option)
NOTE Always attach the bicarbonate powder cartridge so that the

filter in the bicarbonate powder cartridge faces downward.
After the bicarbonate powder cartridge has been attached, do
not turn the cartridge. Doing so may cause small plastic parts of
the cartridge to break. As a result, these broken parts may
remain inside the cartridge holder.
1. Raise the upper arm for insertion (removal) of

the cartridge while keeping the unlock button of
the upper arm at the cartridge holder pressed.
2. Set the bicarbonate cartridge into the lower

cartridge arm in such a way that the cartridge is
opened by the lower opener spike. Now lower
the upper arm onto the cartridge and lock it by
pushing lightly on the cartridge arm. The upper
opener spike is thereby pushed into the cartridge.
3. Check that the upper arm is locked.

DBB-05
2.1.3. Confirmation or change of concentrate

A concentrate B concentrate
name name
A ex. Acid 1 ex. Bicarbonate 8.4%
B Conduct. set
ESC
A concentrate Total
name conduct.
ex. Acid 1 14.0

mS/cm
B concentrate Bicarbonate
name conduct.
ex. Bicarbonate 8.4% 3.00

mS/cm
C Concentrate set
ESC
A name
Concent-
rate 1
B name
A name ex. Acid 1

Concent-
rate 2
B name ex. Bicarbonate 8.4%
Concent- A name ex. Acid 2

rate 3
B name ex Bicarbonate 8.4%
A name
Concent-
rate 4
B name
A name
Concent-
rate 5
B name

DBB-05
Process steps:
1. After the start-up test has been successfully

completed, the DM test is started.
(DM test: Self test ⇒ dialysate monitor;
hydraulic unit).
2. Check that the connected concentrate

corresponds to the concentrate menu on the
screen.
If they do not correspond, the correct dialysis
menu must be selected as follows:
A. Touch the Concentrate name area on the screen.
The Conduct. set area will appear on the screen.
B. Touch the field of the Concentrate name to open

the new Concentrate set area.
C. Touch the desired concentrate menu until the

color of the activated field changes. (By this
color change, the activation of the new
concentrate is indicated.)
NOTE The setting of the desired conductivity values and conductivity

profiles is described in detail in chapter 3.

DBB-05
2.2. Extracorporeal blood circuit

2.2.1. Set the arterial blood line
1. Open the cover.
2. Set the inlet of the pump segment to the left.
3. Set the pump segment to the right side and close

the cover.
4. Connect the arterial tube set according to the

tube layout (red lines) into the tube holder.
NOTE For single-needle dialysis, the arterial tube set must be inserted
into the arterial clamp, both for double-pump operation and for
click-clack operation.
2.2.2. Set the venous blood line
1. Insert the venous tube set according to the tube

layout (blue lines) into the tube holder.
2. The venous tube must be inserted into the air

detector, the blood and tube detector, and the
venous clamp.
3. Take care of correct seating and close both

detector covers.
NOTE For single-needle dialysis, the venous pump segment is inserted

only after connecting the patient.
(See chapter 4.)

DBB-05
2.2.3. Pressure ports
Connecting pressure lines of the blood tube

2
sets
1 4 1. Connect the pressure line of the arterial tube set
to the arterial pressure port.
2. Connect the pressure line for the dialyser inlet

3
pressure to the corresponding pressure port of
the DBB-05.
3. Connect the venous pressure line of the venous

drip chamber to the venous pressure port.
4. When performing single-needle dialysis, connect

the pressure line of the SN expansion chamber
to the SN pressure port.
To avoid any infection, the pressure lines are equipped with a

CAUTION hydrophobic filter.
If a hydrophobic filter is wetted, first push the liquid back by
using a syringe.
If the filter continues to be impermeable, replace this filter or
the tube set.

DBB-05
2.2.4. Heparin pump
Set a heparin syringe.
NOTE Always use a 30mL (20mL or 10 mL) syringe with the lure
lock connector.
The type of syringe is set up by a technician.
The syringe of 10mL is option.

CAUTION
DBB-05
1. Prime the syringe with heparin solution

prescribed based on the instructions given by the
doctor.
2. Lower the slider while keeping the unlock

button of the slider pressed.
3. Connect the heparin line of the blood tube set to

the Luer-lock connector of the syringe.
4. Place the syringe plunger plate into the slider of

the heparin pump.
5. Place the flange of the syringe cylinder in the

holder of the heparin pump while
simultaneously pressing the unlock button of the
heparin slider.
6. Pull the holder lever forward and position it

across the heparin pump by turning it.
7. To bleed the heparin line touch the

HP rapid feed key in the KEYS menu of the
screen “Preparation”.
NOTE For the HP rapid feed key, the heparin pump works only while
keeping it touched.
A single brief touching of the HP bolus sw key activates only a
single bolus infusion.
DBB-05
2.3. Priming of blood circuit
NOTE Priming and rinsing may be performed during the disinfection

phase or during the DM test, manually or by means of the
automatic priming program.
• For manual priming, the operator has to switch the arterial

blood pump (PUMP 1) by hand, using the [PUMP 1] key.
• When using the "priming program", priming volume and

flow rate of the priming phase are preset as default values
but may be changed according to individual requirements.
Max. suspension weight of the infusion pole:4kg

CAUTION
Do not connect any blood tube connector to the substitution

WARNING port for on-line HDF/HF directly on the DBB-05.
NOTE During priming, check that no saline solution is leaking from

the tube set or the dialyser.
NOTE The time for priming of the dialyser depends upon the
dialyser's manufacturer specifications.
The “hemofilter” with CE marking and designed to fit to the

CAUTION interface connector should be used for the hemofiltration
treatment.
DBB-05
2.3.1. Manual priming of blood circuit and dialyser
1. Turn on the arterial blood pump (PUMP 1) by

pressing the [PUMP 1] key ON or OFF.
2. Change the blood flow rate, if necessary, via the

touch-screen function. (See chapter 1.9 Setting
procedure.)
The connection method for the blood tube set is

the same as described in the automatic priming
program.
3. Prime and rinse the blood circuit using the

priming and rinsing volumes usually applied at
your institution as well as using the appropriate
flow rate.
NOTE Make absolutely sure to stop the arterial blood pump (PUMP 1)
manually after the rinse process.
DBB-05
2.3.2. Priming function for blood circuit and dialyser
Function description of the automatic priming

program:
• Priming of the arterial blood tube set

Priming • Priming of the venous blood tube set and
arterial dialyser
• Circulation
When you touch the Priming arterial key, the

arterial tube set is primed with saline solution.
When you touch the Priming venous key, the total

tube set and the dialyser are rinsed with a preset
rinse volume.
Rinse volume and arterial blood pump (PUMP 1)
Priming rate can be set as basic values.
venous
When you touch the Circ. key, the arterial blood
pump (PUMP 1) runs at the flow rate set as basic
value.
The above processes may be interrupted at any time

by pressing the [PUMP 1] or the appropriate key.
Circ.
DBB-05
l Priming both blood tube sets with dialyser simultaneously.
1. Connect the arterial tube set (patient connector

red) to the saline bag.
2. Turn the blood outlet port of the dialyser

upwards.
3. Connect the arterial connector of the blood tube

set (dialyser connector red) to the blood inlet
port of the dialyser.
4. Connect the venous connector of the blood tube

set (patient connector blue) to the empty bag and
the other end of the tube set to the dialyser outlet.
5. Check once again all tube and pressure

connections of the pressure lines for correct
connection.
6. Open the port of the saline bag (breaking seal).
DBB-05
7. Start priming the tube set by touching the

Priming venous key.
The arterial blood pump (PUMP 1) starts at the

flow rate set as basic value.
8. Set the level in the blood inlet pressure chamber

and in the venous drip chamber.
If you intend to perform a single-needle

treatment, set the level of the SN expansion
chamber.
9. The arterial blood pump (PUMP 1) stops as soon

as the total volume set as basic value for
Priming venous is reached.
10. Remove the venous connector of the blood tube

set from the empty bag, connect it to the saline
bag, and open the second cone (breaking seal) of
the saline bag.
11. To start the „tube circulation“ process, touch the

[PUMP 1] key to restart the arterial blood pump
(PUMP 1).
The arterial blood pump (PUMP 1) starts at a

preset blood flow rate (basic value).
DBB-05
l Separate priming of the arterial and venous tube sets with dialyser
1. Connect the arterial tube set (patient connector

red) to the saline bag.
2. Turn the blood inlet port of the dialyser upwards.
At this point, do not yet connect the arterial and

venous tube set to the dialyser, in order to allow
air to be bled off when priming the arterial tube
set.
3. Check once again all tube and pressure

connections of the pressure lines for correct
connection.
4. Open the port of the saline bag (breaking seal).
DBB-05
6. Start priming the arterial tube set by touching

the Priming arterial key.

flow rate set as basic value. (The total value is
additionally set as basic value.)
7. Set the level in the blood inlet pressure chamber.
8. The arterial blood pump (PUMP 1) stops

automatically as soon as the supply volume set
as the basic value is reached.
9. Now connect the arterial tube set to the dialyser

and turn the blood inlet port of the dialyser
downwards..
10. Connect the venous connector (patient

connector, blue) of the blood tube set to an
empty bag, and the other end of the tube set to
the outlet connector of the dialyser.
11. Start the blood pump using the [PUMP 1] key

(or manually start the
Priming arterial key) to perform the tube
priming process.
The priming of the dialyser and venous tube set
is then started.
The arterial blood pump (PUMP 1) runs at a

preset blood flow rate (basic value) until the
preset priming volume is reached.
12. Set the level in the blood inlet chamber and in

the venous drip chamber.
If you intend to carry out a single-needle

treatment, set the level of the SN expansion
chamber.
DBB-05
13. The arterial blood pump (PUMP 1) stops

automatically as soon as the preset swept
volume is reached.
14. Remove the venous connector of the blood tube

set from the empty bag, connect it to the saline
bag, and open the second cone (breaking seal) of
the saline bag.
15. Touch the [PUMP 1] key to start the circulation

process..
The arterial blood pump (PUMP 1) starts at a

preset blood flow rate.
DBB-05
2.4. Priming of dialysate side

2.4.1. After completion of the DM test
After completion of the DM test, the follwoing

message is displayed on screen:
Connect the coupler to the dialyser.

Press Filling in dial. key.
Before starting any treatment, confirm that the correct

CAUTION composition of dialysate has been prepared.
DBB-05
2.4.2. Sampling
1. Touch the Dialysa. withdra. key in the KEYS

menu.
2. Connect a syringe without Lure-Lock connector

to the sampling valve.
The sampling valve is situated at the dialyser

inlet tube.
Do not use a hollow needle!

CAUTION
3. With the syringe, draw a dialysate sample.

After the syringe is removed, the valve closes
automatically.
4. Examine the dialysate sample for correct

composition.
DBB-05
2.4.3. Dialyser [Filling]
1. Turn the blood inlet port of the dialyser upwards.
2. Connect the red coupler to the dialysate outlet

3. Connect the blue coupler to the dialysate inlet

4. Press the Filling in dial. key to fill the dialyser

Filling with dialysate.
in dial. After pressing the Filling in dial. key, the

dialysate section of the dialyser is filled for 2
minutes.
BM test
DBB-05
2.4.4. BM test and dialyser [Rinsing]
After completion of the dialyser priming process,

the BM test run starts.
Depending on the basic setting, the BM test is

performed automatically after priming of the
dialyser, or manually by pressing the
Filling BM test key.
in dial. BM test ⇒ Blood monitor test
After successful completion of the BM test, the

rinsing process of the dialyser begins automatically,
using dialysate.
The following parameters can be configured as
basic values, depending upon requirements:
BM test
⇒ Flow rate of the arterial blood pump (PUMP
1)
⇒ Rinsing time
⇒ UF volume for the rinsing time
⇒ Dialysate flow during the rinsing time
After successful completion of all tests, the screen

Rinsing displays the following message:
of dial.
Start up test passed
NOTE During the BM test, all processes run automatically. The

operator can not perform such actions as stopping the blood
pump or changing the speed.
DBB-05
2.5. Start-up test

The following test processes must have been
completed successfully without fail before the
connection to the patient be carried out:
1. Computer test (CPU test)

2. DM test (Dialysate monitor test)
3. BM test (Blood monitor test)
NOTE Conditions for starting of start up test

The start-up test depends upon the basic configuration of the
DBB-05. It starts
• automatically after power ON; or
• after pressing the Start up test key.
Starting conditions for DM tests

Automatic start after completion of Computer test.
Starting conditions for BM tests

• Blood circuit must be filled.
• Priming process of the dialysate side must have been
completed.
The BM test is started, depending on the basic setting, either
automatically or manually after “Filling in dialyser”.
Do not connect any connector of the blood tube set to the

WARNING substitution line of the DBB-05.
Before every treatment you must verify that the DBB-05 does
WARNING not contain any disinfectants.
DBB-05
Table of contents 3. Treatment conditions

Section Page
3.1. Entering treatment data 3-2

3.2. Treatment method and treatment data 3-2
3.2.1. Checking and changing treatment parameters 3-2
3.3. Single-needle treatment 3-4

3.3.1. Selection of treatment method 3-4
3.3.2. SN control pressure 3-5
3.4. UF data and treatment time 3-6

3.4.1. Setting of ultrafiltration data 3-6
3.4.2. Inputting of ultrafiltration data 3-7
3.5. Setting the dialysate parameters 3-10

3.5.1. Setting the dialysate temperature 3-10
3.5.2. Setting the dialysate flow rate 3-10
3.5.3. Setting the conductivity 3-11
3.6. Setting of heparin pump 3-13

3.7. UF profile/Conductivity profile 3-15
3.7.1. General information 3-15
3.7.2. Setting of UF profile by changing step (with step change) 3-22
3.7.3. Setting the UF profile (without step change) 3-25
3.7.4. Setting of conductivity profile (with step change) 3-29
3.7.5. Setting of conductivity profile (without step change) 3-33
3.8. Isolated UF (sequential treatment) 3-37

3.8.1. General 3-37
3.8.2. Isolated UF integrated in an UF profile (sequential UF) 3-37
3.8.3. Setting of sequential UF 3-38
3.8.4. Manual start "Isolated UF" 3-39

DBB-05
3.1. Entering treatment data

NOTE Before every treatment starts, the various treatment parameters
for the individual patient must be checked.
These parameters are confirmed by the opening of the set-up
table for the treatment data.
NOTE At the time of resetting (start up test) any treatment or during

the disinfection, all the treatment data stored in the data
memory are set to their basic values according to the default
setting.
3.2. Treatment method and treatment data

3.2.1. Checking and changing treatment parameters
1. To enter the desired treatment data and the

operating mode, press the Treat. data key on the
Treat. „Preparation“ screen:
data The screen displays a new set-up window for

entering the individual treatment data.
2. By touching the numeric value, operating mode

or profile symbol, you can open the
corresponding window for checking or changing
individual parameters.
(For a description of individual settings, see the

following pages.)
After changing or checking the individual treatment data and the setting of the
Return operating mode, you may press the Return key to return to the "Preparation"
screen.
Or press the Connect key for connecting the patient.
Connect Note!
The Connect key is also found on the "Preparation" screen.

DBB-05
ex. Single-needle treatment
UF profile Treat. time Treatment

remaining 4:00 mode HD
UF goal L SN mode
01.00 SN-DP
UF rate L/h SN change mmHg
setting data 0.25 upper press. 200
Conduct. profile
SN change mmHg
lower press. 100
Dialysate C°
temperature 37.0
Dialysate mL/min
flow rate 500
Total mS/cm
conductivity 14.0
Heparin pump mL/h Bicarbonate mS/cm
setting data 1.5 (30 mL) conductivity 3.00
HP bolus mL
volume 1.5
Blood flow HP power au min
-to OFF time 20
Return Connect
0
mL/min

DBB-05
3.3. Single-needle treatment

3.3.1. Selection of treatment method
"Single-needle" treatment may be performed as SN

double-pump or as SN click-clack process. For
setting the desired operating mode, perform the
following steps:
1. Touch the OFF field to the right of

Treatment
mode HD SN mode.
SN mode 2. On the screen, a new window for setting the SN

OFF parameter opens.
3. To activate the desired SN method, touch the

corresponding key for 1.5 seconds or more.
SN-KK ⇒ single-needle as click-clack

process
SN-DP ⇒ SN method as double-pump
ESC
process
The activation of the selected SN method is

indicated by a color change of the pressed key.
OFF SN-KK SN-DP
4. When you touch the keys
⇒ Blood flow
Average
Blood flow SN pump blood flow ⇒ SN pump
a bar graph with numeric field opens, allowing
you to change the desired flow rate of each
000 000 000 pump for SN operation.
mL/min mL/min mL/min The auto adjustment of the flow rate can be set
corresponding to the basic settings of DBB-05.
SN change SN change Volume
upper press. lower press. /stroke (Corresponding to the arterial blood flow rate,
for example, flow rate of blood pump 1 + 50
mL/min.)
000 000 000
mmHg mmHg mL 5. After entering or changing the flow rate, store
the new value by pressing the SET key.
Information window
6. To close each window, press the ESC key.

DBB-05
3.3.2. SN control pressure
1. Touch the numeric field to the right of

SN change pressure.
Treatment
mode HD On the screen, a new window for setting the SN
parameter opens.
SN mode
SN-DP 2. By pressing the keys
⇒ SN change upper pressure
SN change mmHg
upper press. 200 or
⇒ SN change lower pressure
SN change mmHg
lower press. 100 a numeric field is opened, allowing you to
change the switching point of the corresponding
SN cycle.
Note that the stroke volume is also changed as

the change point is changed.
3. After entering the new value, store it by

pressing the SET key.
ESC
4. Press the ESC key to close each window.
OFF SN-KK SN-DP The above method for setting the switching
pressures is applicable for
⇒ single-needle click-clack process
Average
Blood flow SN pump blood flow ⇒ SN method as double-pumpe process.
000 000 000

mL/min mL/min mL/min
SN change SN change Volume
upper press. lower press. /stroke
200 100 000

mmHg mmHg mL
Information window
NOTE When connecting the patient, check to make sure that the pump
segment of the SN blood pump (PUMP 2) is placed into the
pump only after connecting the venous patient connector.
All settings for SN operation may also be entered beforehand.
When the Treatment start key is pressed, the SN pump starts
running.

DBB-05
3.4. UF data and treatment time

3.4.1. Setting of ultrafiltration data
1. Touch the data to the right of the fields

Treat. time
4:00 ⇒ Treatment time remaining
remaining
⇒ UF goal
UF goal L ⇒ UF rate setting data
01.00
to change them as applicable.
UF rate L/h
setting data 0.25
On screen, a new window for changing the UF
data and the treatment time opens.
2. Check the UF data and change, if required, UF

data and/or treatment time etc.
ESC
Treat. time Complete

remaining time
4:00 14:00
UF rate
UF volume UF goal setting data
00.00 02.00 0.50

L L L/h

DBB-05
3.4.2. Inputting of ultrafiltration data
Input of UF data and treatment time can be performed by three different methods.
Depending on the selected UF data, certain limitations apply.

This means that among the following three set parameters, only two values may be freely adjusted. From
these two set values, the DBB-05 automatically calculates the third value.
Values that can be set:

1. Treatment time remaining
2. UF goal
3. UF rate setting data
l Input of UF goal reduction if treatment time is preset
1. Touch the UF goal field.
Treat. time Complete A numeric field is displayed on the screen.

remaining time
2. Enter the desired UF goal (⇒ total weight
4:00 14:00 reduction) in the numeric field.
3. Confirm this input by touching the SET key,

UF rate then close the numeric field by touching the
UF goal setting data ESC key.
02.00 0.50 By entering the UF goal when the

Treat. time remaining is preset, the DBB-05
L L/h
calculates the UF rate setting data reduction
automatically.
02.00L è 03.00L Example:

When changing the UF goal from 02.00 L to
03.00 L (while Treat. time remaining
unchanged), the DBB-05 automatically
calculates a new UF rate setting data of 0.75
L/h.
remaining time
4:00 14:00
UF rate
UF goal setting data
03.00 0.75
L L/h

DBB-05
l Inputting of UF rate for fixed treatment time
1. Activate the UF rate setting data field.
The ten-key pad will appear on the screen.

remaining time
2. Enter the desired UF rate setting data in the
numeric field.
4:00 14:00
then close the numeric field by touching the
UF rate
ESC key.
By entering the UF goal when the

02.00 0.50 Treat. time remaining is preset, the DBB-05
L L/h calculates the UF rate setting data reduction
automatically.
Example:
0.50L/h è 0.60L/h When changing the
UF rate setting remaining from 0.50 L/h to 0.60
L/h (while Treat. time remaining unchanged),
the DBB-05 automatically calculates a new UF
goal of 02.40 L.

remaining time
4:00 14:00
UF rate
02.40 0.60
L L/h

DBB-05
l Input of treatment time when the UF goal is preset
1. Activate the Treat. time remaining field.

remaining time
2. Enter the desired Treat. time remaining in the
numeric field.
4:00 14:00
UF rate
ESC key.
By entering the Treat. time remaining when the

02.00 0.50 UF goal is preset, the DBB-05 calculates the UF
L L/h rate setting data reduction automatically.
Example:
When changing the
4:00 è 5:00 Treat. time remaining remaining from 4:00 to
5:00 (while UF goal unchanged), the DBB-05
automatically calculates a new UF rate setting of
0.40 L/h.

remaining time
5:00 15:00
UF rate
02.00 0.40
L L/h

DBB-05
3.5. Setting the dialysate parameters

3.5.1. Setting the dialysate temperature
1. Activate the field to the right of

Dialysate temperature.
Dialysate C°
temperature 37.0 A numeric field opens on the screen.
Dialysate mL/min 2. Enter the desired dialysate temperature in the

flow rate 500 number pad.

ESC key.
3.5.2. Setting the dialysate flow rate

Dialysate flow rate.
Dialysate C°


ESC key.
NOTE In the basic setting, the DBB-05 can be set in such a way that
upon completion of the rinsing process for the dialyser until
connecting the patient, a reduced dialysate flow is achieved.
DBB-05
3.5.3. Setting the conductivity
l Total conductivity
1. In the [Treatment data] table, activate one of the

numeric fields to the right of
Total mS/cm Total conductivity or
conductivity 14.0 Bicarbonate conductivity
Bicarbonate mS/cm
conductivity 3.00
A concentrate B concentrate or touch the Concentrate name area on the

name name „Preparation“ screen.
ex. Acid 1 ex. Bicarbonate 8.4%
On the screen, a new window for

Conduct. set opens.
2. Touch the numeric field below

Total conduct..
Conduct. set
ESC
A ten-key pad opens on screen.
A concentrate Total
name conduct.
3. Enter the value of the desired total conductivity
in the numeric field.
ex. Acid 1
14.0 4. Confirm this input by touching the SET key,
mS/cm
B concentrate Bicarbonate ESC key.
name conduct.
ex. Bicarbonate 8.4%

3.00
mS/cm
DBB-05
l Bicarbonate conductivity
1. In the [Treatment data] table, activate one of the

Total conductivity or
Total mS/cm
conductivity 14.0 Bicarbonate conductivity
Bicarbonate mS/cm
conductivity 3.00
or touch the Concentrate name area on the

A concentrate B concentrate
name name
„Preparation“ screen.
ex. Acid 1 ex. Bicarbonate 8.4%

Conduct. set opens.

Bicarbonate conduct..
Conduct. set
ESC
A concentrate Total 3. Enter the value of the desired total conductivity

name conduct. in the numeric field.
ex. Acid 1
14.0 4. Confirm this input by touching the SET key,
mS/cm ESC key.
name conduct.
ex. Bicarbonate 8.4%

3.00
mS/cm
DBB-05
3.6. Setting of heparin pump

1. Touch a field to the right of
Heparin pump setting data to open the new
Heparin pump mL/min window Setting of HP for changing the heparin
setting data 1.5 (30 mL) parameters.
HP bolus mL
volume 1.5
HP power au min
-to OFF time 20
2. By touching the corresponding numeric value to

Setting of HP ESC the right of
⇒ HP rate
HP rapid HP
feed HP
bolus sw
⇒ HP power auto OFF time
(30 mL) 1.5 mL/h
1.5 mL
⇒ HP bolus volume
HP rate 1.5 mL/h
HP power auto OFF time 20 min a numeric field opens where you can input the
desired change of the selected parameter.
HP bolus volume 1.5 mL
Heparin bolus start Automatic
By pressing the Automatic key, you can switch

from automatic start of the heparin bolus in the
access connecting phase to manual bolus
Automatic Manual infusion.
DBB-05
Description of heparin key functions:
HP rapid ⇐ By touching this key, you can fix the general operation of the continuous
feed heparinisation.
(30 mL)
And, a select type of syringe is indicated.
⇐ With this key, you can start or stop the continuous heparinisation. You
HP
1.5 mL/h
may preset an automatic start at blood detection as a basic value.
HP
⇐ By touching this key, you can trigger the infusion of a heparin bolus.
bolus sw The bolus volume may be freely preset as a basic value.
1.5 mL
NOTE The activation of the HP key for continuous heparinisation at

blood detection and for HP bolus sw may be set up as a basic
value as an automatic function.
If an automatic start was fixed, the key indicates this by
flashing. As soon as the corresponding function has been
triggered automatically, the key color changes from flashing to
continuos lighting. The corresponding functions can be
deactivated at any time.
DBB-05
3.7. UF profile/Conductivity profile

3.7.1. General information
The default UF and conductivity profiles exist as 8 basically different profiles with step change (time
sequences) and one continuous profile without step change.
UF profile and conductivity profile can be combined or separated.
When combining both profiles, the cycle steps (time sequences) are switched synchronously; here, the UF
profile provides the basis. When a combination of both profiles is to be executed, you have to set up the
UF profile before you activate the conductivity profile.
Additionally, before setting the UF and conductivity profiles you should set
− Treatment time
− UF goal
Combination patterns for UF profile and conductivity profile
UF profile
UF rate
Conductivity profile
Conductivity
Step 1 2 3 4 5 6 7 8 9 10
Treatment time
Start End
DBB-05
l UF profile with step change
For inputting an UF profile with step change, you can choose among 8 (A to H) preset profile patterns
(individually variable). These 8 profiles can be changed as "basic profiles" but also adjusted individually
before any treatment.
Each profile may be subdivided into a maximum of 10 steps.
When changing the UF rate of any step, the UF rate of the remaining steps in the case of a predetermined
[UF goal] is changed automatically in order to keep the set target reduction constant.
UF rate
Step 1 2 3 4 5 6 7 8 9 10
Treatment time
Start End
DBB-05
l Continuous UF profile without step change
For the continuous UF profile without step change, a starting UF rate and an end UF rate is set by the
operator.
Additionally, a progressive, degressive, or linear curve can be set individually by pressing the Profile
course key. Then, the UF rate change almost continuously follows the pattern displayed in the profile
curve.
Fixing the starting and end UF rates plus entering the course yields the following profile patterns.
Patterns of UF profiles
l Starting UF profile higher than end UF profile
Start
Digressively falling
(Course<1)
á
UF rate Linear falling
(Course=1)
End
à
Time Progressively falling
(Course>1)
l End UF profile higher than starting UF profile
End
Digressively rising
á (Course>1)
UF rate
Linear rising
(Course=1)
Start
à
Time Progressively rising
(Course<1)
DBB-05
l Conductivity profile
With the conductivity profile, you can set and activate the bicarbonate conductivity and the total
conductivity separately.
l Conductivity with step change
For inputting a conductivity profile with step change, you can choose among 8 preset profile patterns
(individually variable). These 8 profiles (A to H) can be changed as "basic profiles" but can also be
adjusted individually before any treatment.
Each profile may be subdivided into a maximum of 10 steps.
When combining with a UF profile, you must first select the UF profile.
Each separate step of the conductivity profile can be varied individually within the preset limit value
range.
Conductivity
Step 1 2 3 4 5 6 7 8 9 10
Treatment time
Start End
DBB-05
Conductivity profile start
A manual start of the conductivity profile during treatment is executed by pressing the ON/OFF key.
⇐ Touch the ON/OFF key to turn on the conductivity profile.
⇐ Treatment start
Conductivity
Step 1 2 3 4 5 6 7 8 9 10
Start Treatment time End

Conductivity
Step 1 2 3 4 5 6 7 8 9 10
Start Treatment time End
DBB-05
l Continuous conductivity profile without sequential steps
With the continuous conductivity profile without step change, a starting and an end conductivity are set by
the operator.
Additionally, a progressive, degressive, or linear curve can be set individually by pressing the Profile
course key. Then, the conductivity rate change almost continuously follows the pattern displayed in the
profile curve.
Fixing the starting and end UF rates plus entering the course yields the following profile patterns.
Examples of conductivity profile patterns
l Start conductivity is higher than end conductivity
Start
Digressively falling
(Course<1)
á
Conductivity Linear falling
(Course=1)
End
à
Time Progressively falling
(Course>1)
l End conductivity is higher than start conductivity
End
Digressively rising
á (Course>1)
Conductivity
Linear rising
(Course=1)
Start
à
Time Progressively rising
(Course<1)
DBB-05
Conductivity profile start
A manual start of the conductivity profile during treatment is executed by pressing the ON/OFF key.
⇐ Touch the ON/OFF key to turn on the conductivity profile.
⇐ Treatment start
Conductivity
Treatment time
Start End
Conductivity
Treatment time
Start End
DBB-05
3.7.2. Setting of UF profile by changing step (with step change)
l Setting the profile
1. In the [Treatment data] screen, touch the UF

profile field.
UF profile
The screen displays profiles A to H.
2. Touch the desired profile.
The screen displays the selected profile as a

large graph.
l Setting of end step
1. Touch the End NO. key.
End NO. The screen displays a numeric field for inputting

the bar number.
10 2. Enter the number of desired steps (time

sequences).
3. Confirm your entry by touching the SET key.
4. Now press the ESC key to leave the numeric

field.
The number of steps for the complete treatment

process is displayed.
Shift time 5. In addition to above, the time sequence by step

is also displayed.
24
min
UF profile <G> ESC
mode HD HD HD HD HD HD HD HD HD HD End NO.

UF rate 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.97 0.33 0.33
UF goal 0.41 0.41 0.41 0.41 0.41 0.41 0.41 0.41 0.13 0.13 10
MAX
0.97
Shift time
3 - 23
24
min
MIN ON
0.33 OFF
1 2 3 4 5 6 7 8 9 10
DBB-05
DBB-05
l Setting of UF rate per each step
To enter the UF rate for each step, you can choose

UF rate 0.97 0.97 among two setting methods.
UF goal 0.41 0.41
A. Direct change in the bar graph:
Touch the position of the bar graph to pull the

A upper edge of the colored bar up or down.
The corresponding change of UF rate caused by
this action is indicated in the upper line of the
bar graph.
Repeat this action until the desired UF rate is
displayed.
B. Input via numeric field:
1. Press the number below the bar graph to be

changed.
The screen displays a numeric field.
2. Enter a value between 0 and 200 to change the

UF rate for the selected bar graph.
3. Confirm the input value by pressing the SET

key.
4. Touch the ESC key to leave the numeric field.

Corresponding to the entered UF rate change for
a bar graph, the UF rate of the remaining steps
1 2 3 changes automatically, ensuring the UF goal for
the patient.
B 5. Touch the ON/OFF key to turn on the UF
profile.
Note:
The maximum UF rate (per unit time) setting is
set based on the preset basic value [Setting 2].
ON
OFF
ON
OFF
DBB-05
3.7.3. Setting the UF profile (without step change)
l Profile selection

profile field.
UF profile
The screen displays the profiles A to H and the
symbol for continuous UF profile.
2. Touch the profile symbol for continuous UF

profile.
3. The screen displays the selected profile as a

large graph.
UF profile <I> ESC
DBB-05
mode HD HD HD HD HD HD HD HD HD HD UF profile
course
UF rate
1.08 0.99 0.92 0.86 0.82 0.79 0.76 0.74 0.74 0.72
UF goal 0.45 0.41 0.38 0.36 0.34 0.33 0.32 0.31 0.31 0.30
MAX
1.08 2.0
3 - 26
MIN
0.72
ON
Start End OFF
150 100
DBB-05
l Setting the starting and end rate
1. Touch the Start key to change the start UF rate.

Start
150 The screen displays a numeric field.

UF rate for the treatment start.

key.
After pressing the SET key, a new start UF rate

is displayed in the upper line of the graph.
5. Touch the End key to change the end UF rate.

UF rate for the treatment end.
End
100 7. Confirm the input value by pressing the SET
key.
After pressing the SET key, a new end UF rate

is displayed in the graph.
The pattern and the UF rate of the individual

time sections change according to the newly set
values.
DBB-05
l Setting of the curve
1. Touch the UF profile course key.

UF profile
course The screen displays a ten-key pad.
2. To fix the pattern, enter a value between 0 - 2 in
2.0 the numeric field.
The following change can be entered depending

on the Start and End values.
Number 1 – 2 = progressive pattern

Number 1 = linear pattern
Number 0 – 1 = degressive pattern
3. Touch the SET key to set the data.
The pattern changes according to the newly set

value.
5. Touch the ON/OFF key to turn ON the UF

profile.
ON
OFF
ON
OFF
DBB-05
3.7.4. Setting of conductivity profile (with step change)
The bicarbonate conductivity profile and total conductivity profile are set using the same procedure.
l Selection of the profile
1. In the [Treatment data] screen, touch the

Conduct. profile field.
UF profile
The screen displays profiles A to H.

large graph.
Conduct. profile
Cond. profile <G> ESC
DBB-05
Total cond. (mS/cm)

End NO.
15.5
15.0 10
14.5
14.0
13.5
13.0
12.5
3 - 30
1 2 3 4 5 6 7 8 9 10
Bicarbo cond. (mS/cm)
7.00
6.00
5.00
4.00
3.00 ON
2.30 OFF
1 2 3 4 5 6 7 8 9 10
DBB-05
l Setting the number of steps
NOTE The number of steps can be changed only if no UF profile is

activated!
If an UF profile has been activated before, the number of steps
is applied automatically in the conductivity profile.
1. Touch the End NO. field.

End NO.
The screen displays the numeric field.
10 2. Enter the number of desired steps.
3. Confirm the input by touching the SET key.
4. Press the ESC key to close the numeric field

window.
In the profile, the number of input steps is

displayed.
NOTE The number of UF profile staps must be the same as that of LF

profile staps (time sequence).
DBB-05
l Setting of conductivity for each step
To enter the conductivity for each step, you can

choose among two setting methods.
A. Direct change in the bar graph:
Touch the position of the bar graph to pull the

upper edge of the colored bar up or down.
The corresponding change of conductivity
caused by this action is indicated at the left edge
of the conductivity profile.
15.0 To read the precise conductivity value for the
selected bar graph in digital form, it is
14.5 recommended to select the following setting
method.
14.0 A
13.5 B. Input via numeric field:
1. Press the number below the bar graph to be

13.0 changed.
12.5 The screen displays a numeric field.
1 2 3 2. Enter the desired value for the selected bar graph

in the numeric field.
B 3. Confirm the input value by pressing the SET
key.
Select the required profile by touching the Total

cond. (mS/cm) key and/or the Bicarbo. cond.
(mS/cm) key.
5. Touch the ON/OFF key to turn on the

conductivity profile.
ON
OFF
ON
OFF
DBB-05
3.7.5. Setting of conductivity profile (without step change)
l Selection of the profile
1. In the [Treatment data] screen, touch the

Conduct. profile field.
UF profile
The profiles A to H and the symbol for the
continuous LF profile are displayed.
2. Touch the profile symbol for the continuous

conductivity profile.

Conduct. profile large graph.
Conduct. profile <I> ESC
DBB-05
Total cond.
Total cond. (mS/cm)
15.5 course
15.0
14.5
2.0
14.0
13.5
B cond.
13.0 course
12.5
3 - 34
Start End
13.5 15.0 2.0
Bicarbo cond. (mS/cm)
7.00
6.00
5.00
4.00
3.00
2.30 ON
Start End OFF
2.50 3.00
DBB-05
l Setting of the starting and end conductivity
1. Touch the Start key to change the

Start Start-conductivity.
13.5
2. Enter the desired starting conductivity in the

numeric field.

key.
After pressing the SET key, the new

Start-conductivity is displayed.
5. Touch the End key to change the

End-conductivity.
End The screen displays a numeric field.

15.0
6. Enter the desired end conductivity for the
treatment end in the numeric field.

key.
After pressing the SET key, a new

End-conductivity is displayed in the graph.
The pattern changes according to the newly set

start and end values.
9. Select the required Total conductivity and/or

Bicarbonate conductivity profiles by touching
the Total cond. (mS/cm) key and/or the Bicarbo
cond. (mS/cm) key.
DBB-05
l Setting of the curve
1. Touch the Total conduct. course key.

Total cond.
course The screen displays a ten-key pad.
2. To fix the pattern, enter a value between 0 and 2
2.0 in the numeric field.
The following change can be entered depending

on the Start and End values.
Number 1 – 2 = progressive pattern

Number 1 = linear pattern
Number 0 – 1 = degressive pattern
B cond.
3. Confirm this input by touching the SET key.
course
2.0 The pattern changes according to the newly set

value.
5. Touch the ON/OFF key to turn on the LF

profile.
ON
OFF
ON
OFF
6. To select the bicarbonate profile, touch the
Bicarbo cond. mS/cm bar to individually make
the bicarbonate profile active.
At this time, set the profile in the same manner
as described in previous section, Setting of
Bicarbo cond. mS/cm conductivity profile.
DBB-05
3.8. Isolated UF (sequential treatment)

3.8.1. General
In "isolated ultrafiltration", no dialysate flows through the dialyser; instead, only ultrafiltration (fluid
removal) is carried out.
The DBB-05 provides two ways to perform isolated ultrafiltration.
The "isolated UF" can be

• selected as an integrated time segment in an UF profile (sequential therapy), i.e. "isolated UF" is
included in the treatment duration
• or started and stopped by manually switching the ISO-UF Start End key ON and OFF.
The calculation for "isolated UF" (included in the treatment duration or NOT included in the
treatment duration) can be set as basic value.
In "sequential UF" as an integrated sequence of an UF profile, "isolated UF" and "hemodialysis" are
combined and the switch-over between ISO UF and HD mode occurs automatically.
NOTE When the ISO-UF (profile or individual) is valid, the set UF

volume is basically included in the set target volume.
3.8.2. Isolated UF integrated in an UF profile (sequential UF)
UF rate
ISO-UF
Hemodialysis [HD]
Step 1 2 3 4 5 6 7 8 9 10
Treatment time
Start End
DBB-05
3.8.3. Setting of sequential UF

profile field.
UF profile
The screen displays the profiles A to H.
The screen displays the selected profile.
3. To switch a sequence (one step) of the complete

UF profile <G> profile to isolated UF, press the HD key above
the corresponding bar for at least 1.5 seconds.
The activation of ISO-UF for the selected

mode HD HD HD sequence is indicated by a color change and a
new ISO-UF text field of the pressed key.
UF rate 0.97 0.97 0.97
UF goal
UF profile <G>
mode ISO-UF HD HD
UF rate 0.97 0.97 0.97

UF goal
4. To switch ON the selected profile after setting it,
press the ON/OFF key.
ON
OFF
DBB-05
3.8.4. Manual start "Isolated UF"
NOTE When ISO-UF is activated as a sequence of an UF profile,

manual start of ISO-UF is not possible.
A manual start of ISO-UF for starting or during

treatment is executed by pressing the ISO-UF Start
End key.
1. First, touch the ISO-UF key in the window for

ESC treatment mode selection.
The screen displays the new window

ISO-UF setting.
HD
ISO-UF
2. To set the treatment parameters, you may enter

the desired data to the right of the fields
ISO-UF setting ESC
ISO-UF total volume 0.50 L

⇒ ISO-UF remaining time
⇒ ISO-UF target volume
ISO-UF remaining time 00:30
⇒ ISO-UF rate
ISO-UF target volume 1.00 L
ISO-UF rate 2.00 L/h 3. To do this, touch the field to be changed and
input the desired value in the numeric field of
ISO-UF
the newly opened window.
Start
End
DBB-05
4. Confirm your input by pressing the SET key.
Depending upon the priority of your input, the

ISO-UF setting ESC DBB-05 calculates the third parameter
automatically.
ISO-UF remaining time 00:30 If you input

and
ISO-UF rate 2.00 L/h ⇒ ISO-UF target volume
the ISO-UF rate is calculated.
ISO-UF
Start
End If you input
and
⇒ ISO-UF rate
the ISO-UF target volume is calculated.
5. To switch ON the ISO-UF, press the

ISO-UF Start End key accordingly.
The line ISO-UF total volume serves merely as

an indicator of the expired ultrafiltration.
NOTE The ISO-UF currently running can be stopped at any time using
the ISO-UF Start/End key.
DBB-05
Table of contents 4. Treatment

Section Page
4.1. Patient connection 4-2

4.1.1. Double-needle treatment 4-3
4.1.2. SN treatment 4-4
4.1.3. Manual start "Isolated UF" 4-5
4.1.4. Setting the heparin pump 4-6
4.2. Treatment start 4-7

DBB-05
4.1. Patient connection
Use of high flux dialyser and selection of low ultrafiltration rate

CAUTION may cause partial back filtration.
Causes of the back filtration are shown below.
1. High flux dialyser is used.

2. Difference in pressure due to resistance between dialysate and
blood pass
3. Blood viscosity
NOTE To avoid the risk of backfiltration, the lower limit of a TMP

alarm should be set at 0mmHg.
With this setting, a TMP alarm is likely to occur at a low UF rate.
To avoid the TMP alarm, increase the UF rate after consulting a
physician for the correct setting, or carefully change the lower
limit for the TMP fixed alarm.

DBB-05
4.1.1. Double-needle treatment
1. As soon as you touch the Connect key, the

arterial blood pump (PUMP 1) stops and the
Connect patient can be connected.
2. Remove the arterial tube connector from the

saline bag (or 3 way valve in the case of "On-line
priming") and connect it to the arterial patient
access.
3. Start the arterial blood pump (PUMP 1).

blood flow rate set as basic value.
4. When the blood detector detects blood, the

arterial blood pump (PUMP 1) stops
automatically and a short acoustic signal sounds.
5. Remove the venous blood tube connector from

the saline or empty bag and connect it to the
venous patient access.
6. Check once again all levels of air or expansion

chambers and set the levels as required.

DBB-05
4.1.2. SN treatment
NOTE Make sure that the SN double-pump mode is activated and that
during the access connecting phase the pump segment of the SN
blood pump (PUMP 2) is not yet placed in the SN blood pump
(PUMP 2).
In the SN method, the patient access connection is

executed in the same manner as in the double-needle
method.
As soon as you touch the Connect key, the arterial

blood pump (PUMP 1) stops and the patient can be
Connect connected in the same manner as for double-needle
treatment.
After connecting the patient, install the pump

segment in the SN blood pump (PUMP 2) while the
blood pumps stand still.
Set the pump segment of the venous blood line to the

SN blood pump (PUMP 2):
1. Open the pump cover.
2. Set the inlet of the pump segment to the left.
3. Set the pump segment while turning the rotor

handle clockwise.
4. Finally, set the outlet of the pump segment to the

right.
NOTE The SN blood pump (PUMP 2) is started automatically after you

press the Start key for treatment start.

DBB-05
4.1.3. Manual start "Isolated UF"
NOTE When an UF profile is activated, a manual start of the ISO-UF is

not possible.
You can trigger a manual start of ISO UF for starting

or during treatment is executed by pressing the
ISO-UF Start End key.
1. First, touch the Treatment mode HD field.

Treatment mode HD
2. Then, touch the ISO-UF key to open another
window (for setting the ISO-UF parameters).
The screen displays the new window
ISO-UF setting.
1. To set the treatment parameters, you may enter

the desired data to the right of the fields
ESC
⇒ ISO-UF target volume
⇒ ISO-UF rate
HD
2. To do this, touch the field to be changed and input
ISO-UF the desired value in the numeric field of the
newly opened window.
3. Confirm your input by pressing the SET key.
6. To switch ON the ISO-UF, press the

ISO-UF Start End key accordingly.
The line ISO-UF total volume serves merely as

an indicator of the expired ultrafiltration.
ISO-UF setting ESC The UF volume during ISO-UF is included in the
total weight.
You can stop the started ISO-UF at any time by
ISO-UF remaining time 00:30
pressing the ISO-UF Start End key once again.
ISO-UF rate 2.00 L/h
ISO-UF
Start
End

DBB-05
4.1.4. Setting the heparin pump
By pressing the Continu. heparin key, you can open

Continu. the setting window for heparin.
heparin
1.0 mL
Press the numeric value to the right of
⇒ HP rate
Setting of HP ESC ⇒ HP power auto OFF time
HP rapid HP
⇒ HP bolus volume
feed HP
bolus sw
(30 mL) 1.5 mL/h
1.5 mL
in order to set the corresponding parameters as
described in chapter 4.
HP rate 1.5 mL/h
HP power auto OFF time 20 min
HP bolus volume 1.5 mL
Heparin bolus start Automatic
By pressing the Automatic key, you can switch from

automatic start of the heparin bolus in the access
Automatic Manual
connecting phase to manual bolus infusion.
Description of heparin key functions:
HP rapid
⇐ By touching this key, you can fix the general operation of the continuous
feed heparinisation.
(30 mL) And, a select type of syringe is indicated.
⇐ With this key, you can start or stop the continuous heparinisation. You may
HP preset an automatic start at blood detection as a basic value.
1.5 mL/h
⇐ By touching this key, you can trigger the infusion of a heparin bolus.
The bolus volume may be freely preset as a basic value.
HP
bolus sw
1.5 mL
NOTE The activation of the HP key for continuous heparinisation at

blood detection and for HP bolus sw may be set up as a basic
value as an automatic function.
If an automatic start was fixed, the key indicates this by flashing.
As soon as the corresponding function has been triggered
automatically, the key color changes from flashing to continuos
lighting. The corresponding functions can be deactivated at any
time.

DBB-05
4.2. Treatment start

1. To start the treatment, press the Start key.
The DBB-05 switches to the "Treatment" screen

and the arterial blood pump starts automatically
Start at the flow rate set as basic value.
Depending on the selected treatment mode
• SN double-pump
the 2nd pump (PUMP 2) starts automatically.
NOTE For a description of changes of individual parameters or of the

operating mode, see chapter 3 in the operating instruction.
Monitor messages and text instructions in the information

CAUTION window of the screen !
Immediately after treatment start or during treatment, the

CAUTION following locations should be examined for leakages:
*Extracorporeal blood circuit

*Dialysate filter
Leakages in the system may result un ultrafiltration calculation

errors.

DBB-05

DBB-05
Table of contents 5. Disconnection

Section Page
5.1. Completion of treatment 5-2

5.1.1. Treatment end (double-needle mode) 5-2
5.1.2. Treatment end (single-needle mode) 5-2
5.2. Blood return 5-3

5.2.1. Blood return with saline bag 5-3
5.2.2. Blood return (Repetition) 5-4
5.3. Draining of dialyser and cartridge 5-5

5.3.1. Draining of dialyser 5-5
5.3.2. Draining of the bicarbonate cartridge 5-6
5.4. Draining the tube set 5-7

5.4.1. Removal of the pump segments 5-7
5.4.2. Removal of the heparin syringe 5-7
5.4.3. Removal of the pressure ports 5-8
5.4.4. Removal of the concentrate connectors 5-8

DBB-05
5.1. Completion of treatment
NOTE You can abort the treatment at any time by pressing the
Dis-connect key. The patient is to be disconnected from the
system according to the detaching phase described in the next
section.
5.1.1. Treatment end (double-needle mode)
When the treatment time has expired, the DBB-05

sounds an acoustic signal.
Dis- To prolong the treatment, you can increase the
connect treatment time as desired.
To end the treatment, press the Dis-connect key.
The DBB-05 switches automatically to the bypass

mode and the arterial blood pump (PUMP 1) stops.
5.1.2. Treatment end (single-needle mode)
NOTE If a single-needle treatment was performed, SN blood pump

(PUMP 2) and arterial blood pump (PUMP 1) stop automatically
after the Dis-connect key is pressed.
After the blood pumps have stopped, remove the

pump segment of the SN blood pump (PUMP 2).
¬ Open the cover.
- Remove the pump segment on the pump's left

side.
® Turn the rotor lever clockwise to the right to

remove the pump segment.
¯ Remove the pump segment on the right side

and close the cover.

DBB-05
5.2. Blood return

5.2.1. Blood return with saline bag
1. Remove the arterial patient connector and

connect it to the saline bag.
2. Open the cone of the saline bag.
3. Press the [PUMP 1] key to start the blood pump.
The arterial blood pump (PUMP 1) runs at the

blood flow rate set as basic value to reinfuse the
blood and to rinse the tube set with dialyser.
4. If the air detector detects air, the arterial blood

pump (PUMP 1) stops and an acoustic alarm
signal sounds.
5. Cancel the alarm and disconnect the venous

patient connector.
Since during the "detaching phase" the alarm limits are partially
WARNING spread, the pressure during the blood return must be monitored
visually without fail.

WARNING substitution solution port of the DBB-05.

DBB-05
5.2.2. Blood return (Repetition)
In order to perform a further blood return, the arterial

blood pump (PUMP 1) can be started manually even
if an air bubble alarm was triggered.
If the blood return is performed manually, the arterial blood

CAUTION pump (PUMP 1) can be started despite any triggered air bubble
alarm.
Therefore make absolutely sure that at restart the arterial blood
pump(PUMP 1) is arrested in time.
After the air detector has detected air bubbles, you

can cause a further return of the remaining blood by
keeping the Override key pressed continuously.
During this phase, an intermittent alarm signal

sounds.
The arterial blood pump (PUMP 1) operates only as

long as the Override key is being pressed.
The basic setting of the arterial blood pump's (PUMP

1) running time may be configured to a maximum of
7 revolutions.
After completing the blood return, disconnect the

patient connector.

DBB-05
5.3. Draining of dialyser and cartridge

5.3.1. Draining of dialyser
1. Disconnect the venous blood tube from the air

and blood detector.
2. Turn the dialyser in such a way that the dialysate

inlet faces up.
3. Connect the blue dialyser coupler to the bypass

port.
The draining process for dialyser and bicarbonate

cartridge (When it is being set.) starts
automatically when
• no tube set is inserted

• no blood is detected by the blood detector.
4. After completion of the draining process, connect

the red dialyser coupler to the bypass port.

DBB-05
5.3.2. Draining of the bicarbonate cartridge
1. It is required to manually drain the bicarbonate

powder cartridge (for example, when replacing
B powder the cartridge), press the
B powder drain key to drarin the cartridge.
drain
2. After the cartridge draining phase is completed,
press the unlock button of the upper cartridge arm
in order to shift it to the upper
removal/installation position.
3. Detach the bicarbonate cartridge from the

cartridge holder.
4. Press the unlock button of the upper cartridge

arm and shift the upper arm down to the cleaning
position.
5. Check that the cartridge arm is completely

locked.

DBB-05
5.4 Draining the tube set

5.4.1. Removal of the pump segments
1. Open the pump cover.
2. Remove the pump segment on the left side.
3. Turn the rotor lever clockwise to the right while

pulling out the pump segment.
4. Finally, disconnect the outlet of the pump

segment from the right.
5.4.2. Removal of the heparin syringe
1. Turn the holder lever of the heparin pump to

remove the syringe.
2. Turn the unlock button of the syringe slider to

move the syringe slider to the original position.

DBB-05
5.4.3. Removal of the pressure ports
Remove the pressure ports from the DBB-05

(location 1-4).
2
1
4
5.4.4. Removal of the concentrate connectors
1. Remove the concentrate connectors from the

container and connect the connectors to the rinse
port of the DBB-05.
2. Attach the concentrate suction nozzles (if

container is used) to the holder of the DBB-05.
Every time a treatment is completed, the system must be

CAUTION disinfected without fail.
After each bicarbonate treatment the system must be decalcified.

DBB-05
Table of contents 6. Cleaning

Section Page
6.1. General information 6-2

6.2. Cleaning program 6-3
6.2.1. Conditions for starting of cleaning program 6-3
6.2.2. Selection of cleaning program 6-4
6.2.3. Aborting the cleaning process 6-5
6.2.4. Description of cleaning program 6-6
6.3. Priming of blood tube set and dialyser during 6-7

the cleaning program cycle
6.4. Cleaning of the DBB-05 (exterior) 6-8

DBB-05
6.1. General information

There are 5 cleaning programs available.
The process and corresponding time interval for cleaning/disinfection and rinsing can be adjusted
individually within fixed lower limits to the routine process of the center.
The following diagram indicates the cleaning process between two treatments.
l Flow chart
Completion of treatment
Program 1 (Heat disinfection/Decalcification)
Program 2 (Disinfection/cleaning)
Program 3 (Heat disinfection)
Program 4 (Rinse)
Program 5 (Disinfection/cleaning)
Preset
DBB-05 switches OFF

if no tube set is inserted.
Start-up test

DBB-05
6.2. Cleaning program

6.2.1. Conditions for starting of cleaning program
Before starting the cleaning program, make sure that

the following conditions are met:
1. The concentrate connector is securely connected

to the rinse port.
2. The dialyser coupler is securely connected to the

bypass port.
3. The blood detector detects no blood.
4. The pressure lines of the tube sets must not be

connected to the pressure inlet port.
5. There must be no tube set inserted in the tube

detector.
6. The upper arm of the bicarbonate cartridge holder

must be locked.
(Cleaning position: down)
If the above starting conditions are not fully met, a

corresponding message is displayed on screen.

DBB-05
6.2.2. Selection of cleaning program
1. Press the key of the desired program until the key

color changes.
Cleaning
1 2. Press the Cleaning start key to activate the
selected program.
Depending on the basic configuration, the

DBB-05 switches OFF after completion of the
Cleaning cleaning process (if no blood tube set is inserted)
2 or switches automatically to the
„Preset“ operating mode or to the start-up test
(self-test).
If 2 cleaning programs are executed in direct

Cleaning Cleaning succession (for example, evening and next
start 3 morning), the 2nd cleaning process skips the
pre-rinsing phase automatically.
Cleaning
4
Cleaning
5
HINWEIS The cleaning programs can be set up as a weekly program, i.e.

the ON and OFF times may be programmed for the operation of
a whole week.

DBB-05
6.2.3. Aborting the cleaning process
A cleaning phase that has been activated already can

be aborted at any time.
1. To abort an already started cleaning program,

press the [Preset] key for at least 1.5 seconds.
Preset 2. Subsequently, the follwing dialog window will

appear. Repeat th eoperation described in step 1
again.
This interrupts the cleaning process and triggers

the following message in the message window:
Cleaning not finished
If the DBB-05 has sucked in disinfectant already,

a forced rinse is performed after abortion of the
cleaning.
The remaining forced rinsing time is indicated as
a red number in the cleaning time field.
Only after the forced rinsing is completed, the DBB-05 switches

CAUTION to the „Preset“ mode.
NOTE If in a forced rinsing phase a new disinfection program is started,

the free rinsing time is reduced by the forced rinsing time. In the
case of "citric thermal" cleaning, the forced rinsing time is at
least 8 minutes, in the case of chemical disinfection it is 15
minutes.
NOTE To make the weekly timer valid, it is absolutely necessary that

the Weekly timer key is lit in green.
Normally, the Weekly timer key becomes valid automatically
when the operation mode of the DBB-03 is changed from the
treatment mode to the disinfection mode. However, if other
disinfection program is already started, the Weekly timer key
does not become valid automatically. In this case, to start the
automatic disinfection on the next day, you must make the
Weekly timer key valid manually after the cleaning has been
completed.

DBB-05
6.2.4 Description of cleaning program
1. Other settings in auto cleaning program frame

The operation status after completion of the disinfection can be set as individual basic value for each
cleaning program (1 to 5). The following operation status can be set.
a) The Start up test key is lit.
b) The DBB-03 is turned OFF automatically (if the blood tube set is not connected) or the start up test
is started automatically (if the blood tube set is connected).
c) The DBB-03 starts the start up test automatically.
For example, if this operation status has been set for program 5 and the start up test needs to be
performed automatically after completion of the cleaning program, this operation status also applies
to the auto cleaning program.
2. Start value of cleaning program

The item, “Start value of cleaning program”, sets what cleaning program (1 to 5) is selected when the
screen is changed to the cleaning screen automatically after completion of the treatment.
However, this selection becomes invalid automatically if the user inputs the schedule of the cleaning
program using item 7 of basic value 2. In this case, the program 5, in which the auto cleaning program
has been set, is always shown after completion of the treatment.
3. Cautions for disinfection after not operated for an extended period of time
Basic value 2; Item 12, by technician password
When the preset period of time (standard value: 72 h) elapses after the DBB-03 has started the operation,
the warning message will appear, showing that the set standby time has elapsed and the disinfection
needs to be performed.

DBB-05
6.3. Priming of blood tube set and dialyser during the

cleaning program cycle
During the cleaning program cycle, you can already
prime the blood tube set and the dialyser with saline
solution.
1. After selecting the desired program, touch the

Cleaning start key.
2. After the cleaning start, you may already install

the tube set and the dialyser on the DBB-05 and
prime it.
(See chapter 2.)
To start the cleaning process, the connectors of the pressure inlet

CAUTION port must not be connected and the tubes must not be inserted
into the tube detector.

DBB-05
6.4. Cleaning of the DBB-05 (exterior)

The DBB-05 surface can be cleaned using the usual
cleaning agents or disinfectants.
Do not use any thinner, undiluted sodium hypochlorite solution,

CAUTION or other organic solvents to clean the DBB-05.
Thinners with an alcohol content of no more than 70% may be
used.
NOTE Screen maintenance

Care of the unit's exterior should be performed with a MOIST
cloth. For surface disinfection, the cloth may be moistened with
a diluted sodium hypochlorite solution (max. concentration of
0.5%). Make sure that no liquid enters the unit.
Press the [MUTE] key to deactivate the touch screen for the
duration of the cleaning.

DBB-05
Table of contents 7. Troubleshooting

Section Page
7.1. Alarms 7-2

7.1.1. Blood alarm 7-2
7.1.2. Dialysate system alarm 7-2
7.1.3. Blood and dialysate system alarm 7-2
7.1.4. Override function 7-3
7.2. Emergency battery operation 7-3

7.3. Message/Information 7-4
7.3.1. General information 7-4
lA 7-4
lB 7-5
lC 7-7
lD 7-8
l E, F, G 7-10
l H, I, J, K, L 7-11
l M, N, O 7-12
l P, Q, R, S 7-13
lS 7-14
lT 7-15
lU 7-17
l V, W, X, Y, Z 7-18
7.3.2. Test messages and technical messages 7-19
l TFB 7-19
l TFC 7-23
l TFD 7-26
l TFE 7-35

DBB-05
7.1. Alarms
Press the [MUTE] key to override the alarm signal for 2
NOTE minutes. The volume of the alarm signal may be changed as a
basic value.
(Setting range: 22.75 dB to 70 dB)
7.1.1. Blood alarm
At the time of a blood alarm, the following actions are triggered:
§ The [MUTE] lamp flashes.

§ The blood pump is stopped.
§ The UF pump is stopped.
§ The personnel pager socket is activated.
§ The alarm signal sounds.
§ An alarm message is displayed on screen.
§ The venous tube clamp closes (only for certain alarms).
NOTE The venous tube clamp closes only when the lower venous
alarm limit is triggered and in case of air bubble or micro-foam
detection.
7.1.2. Dialysate system alarm

§ The dialysate runs via bypass circuit.
7.1.3. Blood and dialysate system alarm

§ The blood pump is stopped.
§ The UF pump is stopped.
§ The venous tube clamp closes.
§ The dialysate runs via bypass circuit.
Blood alarms may be cancelled by pressing the Alarm reset key.

Dialysate alarms should be merely confirmed by pressing the [MUTE] key until the cause of the alarm
has been eliminated.
Conductivity alarms are reset automatically as soon as the actual conductivity value returns to within the
alarm limit range.
If a conductivity alarm is triggered several times, the

CAUTION treatment should be interrupted to protect the patient.

DBB-05
7.1.4. Override function
l Normal override
The Override key can disable the following alarm function for up to 2 minutes.
− Arterial pressure alarm

− Venous pressure alarm
− Dialyser inlet blood pressure alarm
− Blood leak alarm
The user must always monitor the relevant protection system

CAUTION (alarm) while the override function is being enabled.
l Special override
During the [End] operating mode, the air bubble trap alarm can be deactivated temporarily by keeping the
Override key pressed continuously.
During treatment, the key remains without function.
See the Blood return (Repetition) in chapter 5.2.2.
While the Override function is active, the operator must

CAUTION unfailingly monitor all alarms visually.
7.2. Emergency battery operation

If a power failure occurs during treatment, the machine is automatically switched to the emergency
battery operation.
The "battery selection switch" must select the "Automatic".

CAUTION
The dialysate flow and monitoring are stopped.

Operation and monitoring of the blood monitor are continued.
The buzzer is activated for 2 seconds.

The ultrafiltration is stopped.
During battery operation, the screen displays the message [In battery operation (auto.)].
If it is predicted that the power failure cannot be recovered, stop the treatment.
When the power supply has been restored, the treatment may be continued at any time.
After completing the BM test, an emergency operation by

CAUTION battery is continued for about 10 to 30 minutes (depending on
battery capacity).

DBB-05
7.3. Message/Information
7.3.1. General information
lA
Air alarm (Micro bubble)

Cause
Ø The air bubble detector has detected micro foam.
Possible error elimination
ü Reduce the blood pump speed. Open the air trap and set the venous blood chamber slightly
upwards.
ü Close the air trap and confirm by pressing the Alarm reset key.
ü If necessary, change the level value.
Air alarm (Normal bubble)

Cause
Ø The air bubbles detector has detected any air bubbles.
ü Check the blood circuit.
ü Check the dialyser.
ü When the level has decreased:
ü Set a clamp between venous blood chamber and dialyser.
ü Using a 30 mL syringe, establish a pressure of -100 to -150 mmHg in the venous blood chamber.
ü Open the venous blood tube clamp. By means of the negative pressure the venous blood
chamber is filled with blood from the patient side.
ü Close the tube clamp and remove the clamp between venous blood chamber and dialyser.
ü Press the Alarm reset key.
Arterial press. alarm (Full range upper)

Arterial press. alarm (Full range lower)
Arterial press. alarm (Fixed range upper)
Arterial press. alarm (Fixed range lower)
Arterial press. alarm (Auto. set. upper)
Arterial press. alarm (Auto. set. lower)
Cause
Ø The arterial pressure has exceeded the alarm point.
ü Check the shunt of the patient.
ü Check the blood flow rate.
ü Check the alarm points.
ü Touch the Alarm reset key.
NOTE:
Is the hydrophobic filter of the pressure measuring line wetted?
Press out the hydrophobic filter using a syringe or replace it.

DBB-05
lB
Bicarbo. conductivity alarm (Full range upper)

Bicarbo. conductivity alarm (Full range lower)
Bicarbo. conductivity alarm (Upper)
Bicarbo. conductivity alarm (Lower)
Cause
Ø The bicarbonate conductivity is out of range.
ü Check the canister.
ü Check the cartridge.
ü Press the [MUTE] key until conductivity has built up once again.
Bicarbonate calibration curve (Upper)

Bicarbonate calibration curve (Lower)
Cause
Ø The analytic curve of the bicarbonate conductivity has exceeded the alarm limit.
ü Check the concentrate selection.
ü Check if the correct concentrate is connected.
ü Are the concentrate suction tubes connected correctly to the central supply?
(Please wait for stabilization time for build-up of conductivity.)
ü If the alarm is triggered once again, contact the technical service.
Bicarbonate powder cartridge full up abnormal

Cause
Ø The filling operation of the bicarbonate cartridge is faulty.
ü Check the bicarbonate powder cartridge.
ü Proceed as for error Mode mismatch alarm(B powder cartridge upper).
If the same alarm occurs again, contact a technician.
Blood flow rate is too slow

Cause
Ø Blood flow rate exceeds the lower limit of setting range.
ü Increase the blood flow rate.
Blood leak alarm

Cause
Ø The blood leak detector has detected blood in the dialysate.
ü Check dialyser liquid tube (drain) for blood leak with test strip.
ü In case of blood leak, press the bypass key. This restarts the blood pump.
Prepare the dialyser as usual for exchange.
ü Connect the dialyser couplers to the dialyser.
ü Select KEYS, and press Gaspurge key.
ü Press the Gaspurge key once again after the dialyser has been filled with dialysate.
ü Switch over to the treatment screen and press Bypass select.
The dialysis treatment will be continued.

DBB-05
BP 1 cover open
Cause
Ø The cover of blood pump 1 is open.
ü Close the cover of blood pump 1.
BP 1 flow set. 0
Cause
Ø The blood flow rate was not input.
ü Enter the blood flow rate.
BP 1 OFF
Cause
Ø The [PUMP 1] key is OFF.
ü Press the [PUMP 1] key.
BP 2 cover open
Cause
Ø The cover of blood pump 2 is open.
ü Close the cover of blood pump 2.
BP 2 flow set. 0
Cause
Ø The blood flow rate was not input.
ü Enter the blood flow rate.
BP 2 OFF
Cause
Ø The [PUMP 2] key is OFF.
Bypass alarm
Cause
Ø The dialyser coupler is not connected to the rinse bridge.
ü Connect the dialyser coupler to the bypass port.
Bypass ON
Cause
Ø The Bypass select key has been activated.
ü Press the Bypass select key if you wish to leave the bypass operation.

DBB-05
lC
Can't select SN-DP

Cause
Ø Wrong blood circuit inserted.
Ø Blood circuit inserted in the wrong way.
ü Insert correct blood circuit, or connect existing blood circuit properly.
Citric acid lower

Cause
Ø The disinfectant has not built up sufficient conductivity.
ü Check whether the correct disinfectant is connected or whether the container is empty.
Citric acid upper

Cause
Ø The disinfectant's conductivity has reached an excessive value.
ü Check whether the correct disinfectant has been connected.
Cleaning key isn't being pushed

Cause
Ø Reminder alarm indicating that the cleaning should be started with the Cleaning start key as the
unit has been ready in stop for a long time.
ü Touch the Cleaning start key.
Cleaning not finished

Cause
Ø The cleansing procedure has been aborted.
ü Confirm the message by pressing the Alarm reset key.
ü After confirming this message by pressing the Alarm reset key, this message is not output any
more.
Complete time of cleaning was be delayed

Cause
Ø The cleansing period was extended.
ü This message is not confirmed by pressing Alarm reset key.
ü For indication purpose only.

DBB-05
lD
Detect of blood
Cause
Ø The blood detector has identified the presence of blood.
ü If blood is detected in the [Preparation] screen while the patient is already being connected,
press the Connect key.
If the Connect key cannot be activated, first check the Treatment data.
ü Start the treatment with Start.
ü Make sure that the detector is clean.
ü If this alarm message is output although the blood tube system contains no blood call the
technician to solve the problem.
Detect of saline
Cause
Ø The blood detector has detected any saline.
ü Insert the tube system properly into the blood detector.
ü The operator has pressed the Start key although there is no blood in the system.
ü If blood is detected the alarm will reset by itself.
Dialyser coupler is still connected to bypass port

Cause
ü The dialyser couplers are still connected to the bypass port.
ü Connect the dialyser coupler to the dialyser.
Dialyser inlet press. alarm (Full range upper)

Dialyser inlet press. alarm (Full range lower)
Dialyser inlet press. alarm (Fixed range upper)
Dialyser inlet press. alarm (Fixed range lower)
Dialyser inlet press. alarm (Auto. set. upper)
Dialyser inlet press. alarm (Auto. set. lower)
Cause
Ø The input blood pressure exceeded the alarm limit.
ü Check the blood tube system and the dialyser.
ü Check the alarm points.
ü Start to rinse the dialyser with 100 mL of NaCl. If the input pressure does not fall, replace the
dialyser or abort the treatment.

DBB-05
Dialysate press. alarm (Full range upper)

Dialysate press. alarm (Full range lower)
Dialysate press. alarm (Fixed range upper)
Dialysate press. alarm (Fixed range lower)
Dialysate press. alarm (Auto. set. upper)
Dialysate press. alarm (Auto. set. lower)
Cause
Ø The dialysate pressure has exceeded the alarm point.
ü Has the UF volume been set too high?
ü Is the dialyser's UF factor too small?
ü Is there air present on the dialysate side?
ü If air is detected, press the Bypass select key and then the Gaspurge key of the key pad.
ü As soon as the air has been removed from the dialysate tubes, press once more the Gaspurge
key and then the Bypass select and Alarm reset keys in order to continue the treatment.
Disinfectant canister empty?

Cause
Ø The disinfectant canister is empty.
ü After exchanging the disinfectant canister, reset the alarm by pressing the
Alarm reset key.
Doesn't a device contain any disinfectants?

Cause
Ø Inquiry after completion of cleansing.
ü After a disinfection, the operator is prompted to verify that the unit contains no disinfectant.

DBB-05
lE
Empty syringe (Heparin complete)

Cause
Ø The heparin syringe is in the stopper position.
ü Switch off the heparin pump and insert a new syringe if necessary.
End of connect time

Cause
Ø Reminder alarm indicating that the treatment should be started with the Start key as the unit has
been ready in connection mode for a long time.
ü Press [MUTE] key if the patient is yet to be connected.
ü If required, go back to Preset screen.
(only possible with saline solution detection).
ü Press Start key if patient has been connected already.
End of infusion time (Heparin complete)

Cause
Ø After the heparin stop time was entered the heparin pump switched off.
ü Check the heparin stop time if the error message is output too early.
l F, G
DBB-05
lH
Heater outlet temperature abnormal

Cause
Ø The temperature at the heater outlet is too high.
ü Contact the service technician if the alarm is triggered once again.
HP bolus volume set. 0

Cause
Ø A bolus is to be administered but no volume has been entered.
ü Enter a bolus volume.
ü Or deactivate the automatic heparin bolus.
HP OFF
Cause
Ø The HP key was switched off.
ü Press the HP key.
HP rate set. 0
Cause
Ø No heparin infusion rate has been entered.
ü Enter the heparin infusion rate, or set the heparin pump to HP No use if you do not wish to use
heparinization.
lI
Initial UF factor alarm (Upper)

Initial UF factor alarm (Lower)
Cause
Ø The UF factor has exceeded the alarm limit.
ü Check the dialyser for coagulation. Start-rinse with saline solution.
ü Increase the blood flow.
ü Check the heparin supply.
l J, K, L
DBB-05
lM
Mode mismatch alarm (Acid concentrate port)

Cause
Ø The acid concentrate connector is removed from the rinse port.
ü Connect the acid concentrate connector to the rinse port.
Mode mismatch alarm (A/B concentrate port)

Cause
Ø The bicarbonate acetate concentrate connector is removed from the rinse port.
ü Connect the bicarbonate acetate concentrate connector to the rinse port.
Mode mismatch alarm (B powder cartridge lower)

Cause
Ø The movable arm of the bicarbonate cartridge holder is not correctly fastened at the bottom.
ü Check the position at the movable arm of the bicarbonate cartridge holder.
Mode mismatch alarm (B powder cartridge upper)

Cause
Ø The upper arm of the bicarbonate cartridge holder is not latched securely, or the micro switch
does not recognize the cartridge.
ü Check the position at the upper arm of the bicarbonate cartridge holder.
ü If the position is OK select menu item [On treatment 1]. Select treatment data, select treatment 2,
set micro switch to not-active.
ü In the [Preparation] screen, press the B powder w. prim. key.
lN
No blood circuit
Cause
Ø The tube detector has not detected a tube system.
ü Visual check whether blood tube system has been set.
ü Check if the blood tube system in the tube detector is properly seated.
ü Is the blood pump switched on?
ü Check whether the detector cover is properly closed.
No HP syringe
Cause
Ø No heparin syringe inserted.
ü Insert a heparin syringe, or press the HP No use key.
lO
DBB-05
lP
Pressure loss alarm (Fixed range upper)

Pressure loss alarm (Fixed range lower)
Cause
Ø The difference between the inlet and outlet pressure levels of the dialyser has exceeded the
alarm point.
ü Check the blood tube system.
ü Check the dialyser. Check the alarm points.
ü Start to rinse the dialyser with 100 mL of NaCl.
If the input pressure does not fall, replace the dialyser or abort the treatment.
Pump segment was not inserted into BP2

Cause
Ø The pump segment was not inserted into the BP2.
ü Insert the pump segment.
ü This message text may appear also during an infusion or injection into the venous blood
chamber.
Recommendation: Increase the air cushion by lowering the level of the venous blood chamber
by 2 cm.
ü After this, cancel by pressing the Alarm reset key.
lQ
lR
Replace time of Dialysate filter

Cause
Ø The dialysate filter's maximum operating time of [750 hours] has been reached.
ü Replace the dialysate filter (see chapter 8).
DBB-05
lS
Saline bag empty

Cause
Ø The saline solution bag is empty.
ü Replace the saline solution bag.
ü Conduct circulation with a new saline bag.
Selected concentrate does not accord with port (Check A/B concentrate connector)
Selected concentrate does not accord with port (Check Acid concentrate connector)
Selected concentrate does not accord with port (Check B powder cartridge upper)
Selected concentrate does not accord with port (B Check powder cartridge lower)
Cause
Ø The connection of the concentrate connector does not accord with the selected concentrate or
the operating mode.
ü Connect the concentrate connector according to the operating mode, or select the appropriate
concentrate in the concentrate selection menu.
Shortage of heat disinfection

Cause
Ø The hot disinfection was not conducted correctly or was aborted.
ü Conduct the hot disinfection procedure.
SN control time alarm (Arterial phase)

SN control time alarm (Venous phase)
Cause
Ø The SN control time has exceeded the alarm limit.
ü Inspect the blood tube system.
ü Inspect the dialyser.
ü Check the blood flow rate; if necessary, change switching points.
ü If necessary, set the SN level slightly higher.
SN press. alarm (Fixed range upper)

SN press. alarm (Fixed range lower)
Cause
Ø The single needle pressure has exceeded the alarm point.
ü Check the blood flow rate; if necessary, change switching points.
Sodium hypochlorite lower

Cause
Ø The disinfectant has built up insufficient conductivity.
ü Check whether the correct disinfectant is connected or whether the container is empty.
DBB-05
Sodium hypochlorite upper

Cause
Ø The disinfectant's conductivity has reached an excessive value.
ü Check whether the correct disinfectant has been connected.
lT
Temperature alarm (Full range upper)

Temperature alarm (Auto. set. upper)
Cause
Ø The temperature is too high.
Temperature alarm (Full range lower)

Temperature alarm (Auto. set. lower)
Cause
Ø The temperature is too low.
TMP alarm (Full range upper)

TMP alarm (Full range lower)
TMP alarm (Fixed range upper)
TMP alarm (Fixed range lower)
TMP alarm (Auto. set. upper)
TMP alarm (Auto. set. lower)
TMP alarm (Auto. forecast upper)
TMP alarm (Auto. forecast lower)
Cause
Ø The TMP has exceeded the alarm point.
ü Is the pressure transducer at blood inlet pressure filled with blood?
TMP zero calibration alarm (Upper)

TMP zero calibration alarm (Lower)
Cause
Ø The TMP zero compensation value has exceeded the alarm point.
ü Check the installation position of the dialyser.
ü Check whether the tube system has been inserted correctly into the blood detector.
ü In case of plate dialysers, monitor the time for TMP zero calibration.
NOTE:
If the hydrophobic filter of the pressure measuring line is wetted, press out the hydrophobic
filter using a syringe or replace it.
If the alarm is triggered during a SN treatment, the cause may be an upper SN switching point
that was set too high. Set the switching point to a lower value for the duration of the TMP zero
calibration.
DBB-05
Total calibration curve can't be measured

Total calibration curve (Upper)
Total calibration curve (Lower)
Cause
Ø The analytical curve of total conductivity has exceeded the alarm limit.
ü Check the concentrate selection.
ü Check the concentrate.
ü Are the concentrate suction tubes connected properly to the central supply?
Total conductivity alarm (Full range upper)

Total conductivity alarm (Full range lower)
Total conductivity alarm (Upper)
Total conductivity alarm (Lower)
Cause
Ø The total conductivity has exceeded the alarm limit.
ü Press the [MUTE] key.
ü Check the concentrate and concentrate line.
ü The alarm is automatically reset as soon as the total conductivity returns to the preset range.
DBB-05
lU
UF control system OFF

Cause
Ø The UFC OFF key has been activated.
ü Press the UFC OFF key about lift.
Enter the UF rate.
UF factor drop alarm

Cause
Ø The UF factor has exceeded the alarm limit.
ü Check the entered weight and time.
UF goal set. 0
Cause
Ø The weight was not input.
ü Enter the weight decrease volume.
UF rate down ON
Cause
Ø The UF pause key has been activated.
ü Press the UF pause key about lift.
Enter the UF rate.
UF rate exceeds limited range

Cause
Ø The UF rate exceeds the limited range.
ü Extend the treatment time or reduce the ultrafiltration volume.
UF rate exceeds operation range

Cause
Ø The UF rate exceeds the operation range.
ü Extend the treatment time or reduce the ultrafiltration volume.
UF rate set. 0
Cause
Ø The UF rate is not set.
ü Set the UF rate.
UF rate too much

Cause
Ø The UF rate in relation to the blood flow rate is too high.
ü Increase the blood flow rate or lower the UF rate.
DBB-05
lV
Venous press. alarm (Full range upper)

Venous press. alarm (Full range lower)
Venous press. alarm (Fixed range upper)
Venous press. alarm (Fixed range lower)
Venous press. alarm (Auto. set. upper)
Venous press. alarm (Auto. set. lower)
Cause
Ø The venous pressure has exceeded the alarm point.
ü Check the shunt of the patient.
ü Check the blood flow rate.
ü Check the alarm items.
NOTE:
If the hydrophobic filter of the pressure measuring line is wetted, press out the hydrophobic
filter using a syringe or replace it.
lW
Water pressure alarm (Upper)

Water pressure alarm (Lower)
Cause
Ø The water pressure is out of range.
ü Check the water supply, coupling, osmosis, water inlet tube.
ü Contact the service technician if the alarm cannot be cancelled.
l X, Y, Z
DBB-05
7.3.2. Test messages and technical messages
l TFB
TFB101 BP1 flow rate alarm (Upper)

TFB102 BP1 flow rate alarm (Lower)
Cause
Ø The speed of the blood pump 1 has exceeded the alarm point.
ü Check the setting of the pump segment.
TFB103 BP1 control error

Cause
Ø The speed of the blood pump 1 cannot be controlled.
TFB104 BP1 over load alarm

Cause
Ø The blood pump 1 has been overloaded.
TFB105 BP1 reverse revolution alarm

Cause
Ø The blood pump 1 has rotated in the reverse direction.
TFB111 BP2 flow rate alarm (Upper)

TFB112 BP2 flow rate alarm (Lower)
Cause
Ø The speed of the blood pump 2 has exceeded the alarm point.
TFB113 BP2 control error

Cause
Ø The speed of the blood pump 2 cannot be controlled.
DBB-05
TFB114 BP2 over load alarm

Cause
Ø The blood pump 2 has been overloaded.
TFB115 BP2 reverse revolution alarm

Cause
Ø The blood pump 2 has rotated in the reverse direction.
TFB131 Heparin pump speed alarm (Upper)

TFB132 Heparin pump speed alarm (Lower)
Cause
Ø The speed of the heparin pump has exceeded the alarm point.
TFB133 Heparin pump reverse revolution alarm

Cause
Ø The heparin pump has rotated in the reverse direction.
TFB141 Blood detector offset error

Cause
Ø An error has occurred during operation of the blood detector.
TFB151 Air detector alarm (Test)

TFB152 Air detector alarm (Normal bubble)
TFB153 Air detector alarm (Micro bubble)
Cause
Ø An error has occurred during operation of the air detector.
DBB-05
TFB201 Arterial press. transducer compare test NG

Cause
Ø The arterial pressure transducer test has failed.
ü If necessary, place the venous tube in another position.
ü Confirm by pressing the BM test key.
TFB202 V clamp open test NG

Cause
Ø The venous clamp open test has failed.
TFB203 V clamp close test NG

Cause
Ø The venous clamp close test has failed.
ü Confirm by pressing the [BM test] key.
TFB204 BP1 stop test NG

Cause
Ø The arterial blood pump 1 stop test has failed.
TFB205 BP1 revolution test NG

Cause
Ø The arterial blood pump 1 revolution test has failed.
TFB206 Blood transducer open test NG

Cause
Ø The blood pressure transducer open test has failed.
ü Check the connection of the pressure output.
ü Has a SN system been inserted but no SN treatment selected?
ü Is the pressure transducer wetted?
TFB207 Blood transducer boosted time over

Cause
Ø The time for the blood pressure transducer test has expired.
DBB-05
TFB208 Blood transducer boosted test NG

Cause
Ø The blood pressure transducer boosted test has failed.
TFB209 A clamp open test NG

Cause
Ø The arterial clamp open test has failed.
TFB210 A clamp close test NG

Cause
Ø The arterial clamp close test has failed.
TFB211 BP2 stop test NG

Cause
Ø The blood pump 2 stop test has failed.
TFB212 BP2 revolution test NG

Cause
Ø The blood pump 2 revolution test has failed.
TFB213 Blood detector offset error

Cause
Ø An error has occurred in the blood detection voltage (offset).
TFB215 SN pressure transducer test NG

Cause
Ø The SN pressure transducer test has failed.
DBB-05
l TFC
TFC101 to TFC115 CPU failure (I)

TFC116 Task starting error (I)
TFC117 Task performance time over (I)
TFC118 EEPROM write error (I)
TFC119 Database write address error (I)
TFC120 Database check SUM error (I)
TFC121 Common database check count error (I)
TFC122 Time base error (I)
Cause
Ø An error has occurred in computer operation.
Mögliche Fehlerbeseitigung
ü Press the [POWER OFF] key to stop the machine.
ü Press the [POWER ON] key again.
TFC131 Task 2 error (I)

Cause
TFC151 3PRAM command data error (I)

TFC152 3PRAM sum error (I)
TFC153 3PRAM time out error (I)
TFC154 3PRAM answering error (I)
TFC155 3PRAM key data error (I)
TFC156 3PRAM read error (I)
TFC157 3PRAM address bus error (I)
Cause
DBB-05
TFC201 to TFC215 CPU failure (P)

TFC216 Task starting error (P)
TFC217 Task performance time over (P)
TFC218 EEPROM write error (P)
TFC219 Database write address error (P)
TFC220 Database check SUM error (P)
TFC221 Common database check count error (P)
TFC222 Time base error (P)
Cause
Ø An error has occurred in the database.
TFC231 Task 2 error (P)

Cause
TFC251 3PRAM command data error (P)

TFC252 3PRAM sum error (P)
TFC253 3PRAM time out error (P)
TFC254 3PRAM answering error (P)
TFC255 3PRAM key data error (P)
TFC256 3PRAM read error (P)
TFC257 3PRAM address bus error (P)
Cause
DBB-05
TFC301 to TFC315 CPU failure (C)

TFC316 Task starting error(C)
TFC317 Task performance time over (C)
TFC318 EEPROM write error (C)
TFC319 Database write address error (C)
TFC320 Database check SUM error (C)
TFC321 Common database check count error (C)
TFC322 Time base error (C)
Cause
TFC331 Task 2 error (C)

Cause
TFC351 3PRAM command data error (C)

TFC352 3PRAM sum error (C)
TFC353 3PRAM time out error (C)
TFC354 3PRAM answering error (C)
TFC355 3PRAM key data error (C)
TFC356 3PRAM read error (C)
TFC357 3PRAM address bus error (C)
Cause
DBB-05
l TFD
TFD101 Duplex pump flow rate alarm (Upper)

TFD102 Duplex pump flow rate alarm (Lower)
Cause
Ø The speed the duplex pump has exceeded the alarm point.
TFD103 Duplex pump control error

Cause
Ø The speed of the duplex pump cannot be controlled.
TFD104 Duplex pump over load alarm

Cause
Ø The duplex pump has been overloaded.
TFD105 Duplex pump cell1-1 leak alarm

Cause
Ø An error has occurred in the inlet valve of the duplex pump.

Cause
Ø An error has occurred in the outlet valve of the duplex pump.

Cause
Ø An error has occurred in the inlet valve of the duplex pump.

Cause
Ø An error has occurred in the outlet valve of the duplex pump.
DBB-05
TFD109 Duplex pump (supply) rate alarm (Upper)

TFD110 Duplex pump (supply) rate alarm (Lower)
Cause
TFD121 UF pump speed error (Upper)

TFD122 UF pump speed error (Lower)
Cause
Ø The throughput rate of the UF pump has exceeded the alarm limit.
TFD123 UF pump cell1 error

Cause
Ø An error has occurred in the inlet cell of the UF pump.
TFD124 UF pump cell1 leak alarm

Cause
Ø An error has occurred in the inlet valve of the UF pump.
TFD125 UF pump cell2 error

Cause
Ø An error has occurred in the outlet cell of the UF pump.
TFD126 UF pump cell2 leak alarm

Cause
Ø An error has occurred in the outlet cell of the UF pump.
TFD131 Blood leak detector voltage alarm (G upper)

TFD132 Blood leak detector voltage alarm (G lower)
Cause
Ø The voltage of the blood leak detector (G) has exceeded the alarm point.
DBB-05
TFD133 Blood leak detector voltage alarm (R upper)

TFD134 Blood leak detector voltage alarm (R lower)
Cause
Ø The voltage of the blood leak detector (R) has exceeded the alarm point.
TFD141 Float switch of GS2 error

Cause
Ø An error has occurred in the float switch of the gas separator 2.
TFD160 Duplex pump (drain) rate alarm (Upper)

TFD161 Duplex pump (drain) rate alarm (Lower)
Cause
TFD170 Back pressure valve (H1) alarm (Supply)

TFD171 Back pressure valve (H2) alarm (Drain)
Cause
Ø An error has occurred in the back pressure valve.
TFD181 Deaeration pump rev. alarm (Upper)

TFD182 Deaeration pump rev. alarm (Lower)
Cause
Ø The throughput rate of the deaeration pump has exceeded the alarm limit.
TFD183 Deaeration pump control error

Cause
Ø The throughput rate of the deaeration pump cannot be regulated.
DBB-05
TFD184 Deaeration pump over load alarm

Cause
Ø The deaeration pump is overloaded.
TFD185 Deaeration pump lock alarm

Cause
Ø The operation of the deaeration pump has been interrupted.
TFD191 Booster pump rev. alarm (Upper)

TFD192 Booster pump rev. alarm (Lower)
Cause
Ø The throughput rate of the booster pump has exceeded the alarm limit.
TFD193 Booster pump control error

Cause
Ø The throughput rate of the booster pump cannot be regulated.
TFD194 Booster pump over load alarm

Cause
Ø The booster pump is overloaded.
TFD195 Booster pump lock alarm

Cause
Ø The operation of the booster pump has been interrupted.
TFD201 Heater shut down relay test NG

Cause
Ø Failure of the heating relays switch-off test.
DBB-05
TFD202 Blood leak detector (G) contamination test NG

Cause
Ø The blood leak detector (green) contaminate test has failed.
TFD203 Blood leak detector (R) contamination test NG

Cause
Ø The blood leak detector (red) contaminate test has failed.
TFD204 Blood leak detector test NG

Cause
Ø The blood leak detector test has failed.
TFD205 Dialysate pressure transducer test NG

Cause
Ø The dialysate pressure transducer test has failed.
TFD206 Bypass SV relay test NG

Cause
Ø The bypass solenoid valve test has failed.
TFD207 Piping leak test (negative type) NG

Cause
Ø The piping leak test has failed.
TFD208 Water pressure transducer test NG

Cause
Ø The water pressure transducer test has failed.
DBB-05
TFD209 Heat exchanger leak test NG

Cause
Ø The heat exchanger leak test has failed.
TFD210 UF pump test NG

Cause
Ø The UF pump test has failed.
TFD211 Temperature control test NG

Cause
Ø The temperature control test has failed.
TFD212 Duplex pump balance test (–) NG

Cause
Ø The duplex pump balance test (−) has failed.
ü In case of problems, set the dialysate flow rate to 500 mL.
ü After the balance test, set the flow rate again.
TFD213 Duplex pump balance test (+) NG

Cause
Ø The duplex pump balance test (+) has failed.
ü In case of problems, set the dialysate flow rate to 500 mL.
ü After the balance test, set the flow rate again.
TFD214 Dialysate filter leak test NG

Cause
Ø The dialysate filter leak test has failed.
ü Check the dialysate couplers and confirm that the rinse bridge is correctly seated.
ü The buzzer is stopped by touching the Reset of test NG key inside the menu.
The OHDF/OHF operation can't be continued.
ü Contact the service technician.
DBB-05
TFD215 Float switch test NG

Cause
Ø The float switch test has failed.
TFD216 SV41 test NG

Cause
Ø The solenoid valve 41 test has failed.
TFD217 UF pump relay test NG

Cause
Ø The UF pump relay test has failed.
TFD220 SV5 test NG

Cause
Ø The solenoid valve 5 test has failed.
TFD221 SV4, 6 test NG

Cause
Ø The solenoid valve 4 and 6 test has failed.
TFD222 Piping leak test (positive press. type) NG

Cause
Ø The piping leak test has failed.
DBB-05
TFD223 SV4 leak test NG

Cause
Ø The solenoid valve leak test has failed.
TFD251 TH1=TH2 compare test (zero) NG

TFD253 TH1=TH2 compare test (span) NG
TFD255 TH1=TH2 compare test (high) NG
Cause
Ø The thermistor comparison test has failed.
TFD261 Cell1=Cell2 compare test NG

Cause
Ø The cell (Cell 1 and Cell 2) comparison test has failed.
TFD262 Cell3=Cell4 compare test NG

Cause
Ø The cell (Cell 3 and Cell 4) comparison test has failed.
DBB-05
TFD300 SV4 leak alarm (Small)

Cause
Ø An error has occurred in the solenoid valve.
TFD308 SV4 open alarm

Cause
Ø The solenoid valve isn’t open.
TFD320 SV4 leak alarm (Quantity)

Cause
Ø An error has occurred in the solenoid valve.
TFD330 SV test NG (Central concentrate supply A1)

TFD331 SV leak alarm (Central concentrate supply A1)(P)
TFD332 SV66 leak alarm (Central concentrate supply A1)(C)
TFD334 SV test NG (Central concentrate supply A2)
TFD335 SV leak alarm (Central concentrate supply A2)(P)
Cause
Ø An error has occurred in the central concentrate supply line.
DBB-05
l TFE
TFE101 Touch key failure

Cause
Ø The touch screen detects a permanent key pressure (possibly malfunction).
TFE110 Pump1 switch failure

Cause
Ø The [PUMP 1] key is ON.
TFE111 Pump 2 switch failure

Cause
Ø The [PUMP 2] key is ON.
TFE112 Mute switch failure

Cause
Ø The [MUTE] key is ON.
TFE121 5V line failure (C)

Cause
Ø An error has occurred in the 5 V line.
TFE122 12V line failure (C)

Cause
DBB-05
TFE123 5V line failure (P)

Cause
TFE124 12V line failure (P)

Cause
TFE201 Battery no connect

Cause
Ø No battery is connected.
ü Touch the BM test key.
TFE202 Battery voltage lower

Cause
Ø The battery capacity is insufficient.
ü Touch the BM test key.
Manual No. 774E R0
DBB-05
AFBF
(Option)
0123
11.2001
DBB-05

medical devices.


EC-representative

Telefon : +49-40-414629-19
Telefax : +49-40-414629-49
Manufacture

Japan
Telefon : +81-3-3443-3727
Telefax : +81-3-3470-0681
Operating Instruction -2- AFBF

DBB-05
Table of contents AFBF

Section Page
1.1. How to use this instruction manual 4
1.2. Outline 5
1.3. Part names and function 6
Fig. 1: Front/Left side view 6
Fig. 2: Substitution fluid pump 7
1.4. Description of extracorporeal blood circuit - AFBF 8
1.5. Description of keys 10
1.6. Consumables 11
1.7. Technical data 12
1.7.1. Hydraulic unit 12
1.7.2. AFBF 12
1.8. Abbreviations and symbols 13
1.8.1. Abbreviations 13
1.8.2. Symbols 14
1.9. Environmental issues 15
2. Preparation 16
2.1. Concentrat supply 16
2.1. Preparation and priming of the substitution fluid circuit
for AFBF treatment 17
2.2. Start-up test 20
3.1. Entering treatment data 21
3.2. Setting of the treatment data for AFBF 22
3.2.1. Selection of data 22
3.2.2. Setting the substitution fluid rate 23
3.2.3. Setting the conductivity 25
4. Treatment 26
4.1. Patient connection 26
4.2. AFBF treatment 27
4.3. Treatment start 28
5.1. General information 29
5.2. Test messages and technical messages 30
6. Maintenance with Technical Safety Inspection 31
AFBF -3- Operating Instruction

DBB-05
1. General description

circumstances.
l Warning labels

WARNING PERSONAL INJURY.

CAUTION INJURY.

ATTENTION improper treatment, if not avoided.

DBB-05
1.2. Outline
l Scope of application
AFBF system applies to AFBF treatment for patients having acute or chronic renal failure.
AFBF treatment
WARNING
Always carefully check the treatment conditions during AFBF
treatment. Additionally, monitor the balance of the acid and
base appropriately using the blood gas analyzer. If acidosis or
alkalosis is found, take appropriate actions.
In the AFBF treatment, always use the dialysate concentrate

and substitution fluid for AFBF at the same time. Do not use
the dialysate concentrate or substitution fluid for AFBF
individually.
If the dialysate concentrate and substitution fluid for AFBF are
not used at the same time, this may cause excessive acidosis or
alkalosis to occur.
Additionally, do not use any dialysate concentrate or
substitution fluid for other hemodialysis system together with
the dialysate concentrate or substitution fluid for AFBF at the
same time.
Always use the substitution fluid for AFBF with the

post-dilution (infuse this substitution fluid to the blood circuit
on the venous side.)
If the substitution fluid for AFBF is used with the pre-dilution
(infuse this substitution fluid to the blood circuit on the arterial
side), this may cause excessive acidosis to occur.
Treatment other than AFBF treatment
Do not use the dialysate concentrate or substitution fluid for

AFBF for a treatment other than the AFBF treatment
If the dialysate concentrate or substitution fluid for AFBF is
used for a treatment other than the AFBF treatment, this may
cause excessive acidosis or alkalosis to occur.

DBB-05
1.3. Part names and function
Fig. 1:Front/Left side view
1
2
1 Substitution fluid pump: PUMP 2
2 Air detector for substitution fluid
3 Scale
4 B concentrate connector (blue/white/green)

For the AFBF treatment, uncouple this connector by turning it to the right, then connect it to the
suction nozzle at the AFBF container.
5 B rinse ports (blue/white/green)

For performing disinfection or cleaning, this connector must be connected to the rinse port.

DBB-05
Fig. 2: Substitution fluid pump
1 Pump cover
2 Tube clamp
3 Rotor
4 Sensor

DBB-05
1.4. Description of extracorporeal blood circuit - AFBF
3 5 13
B A
1
A
16
B
4 14
A
15
7
10 9
12 11
A External hydrophobic filter 9 Air detector

B Internal hydrophobic filter 10 Tube detector
1 Arterial pressure monitor 11 Blood detector
2 Arterial blood pump : PUMP 1 12 Venous clamp
3 Heparin pump 13 Scale
4 Dialyser inlet blood pressure chamber 14 Substitution fluid line air detector
5 Dialyser inlet blood pressure monitor
6 Dialyser 15 Substitution fluid pump : PUMP 2
7 Venous drip chamber 16 Substitution fluid champ
8 Venous pressure monitor

DBB-05
For the AFBF treatment, an additional AFBF unit including a scale and substitution fluid pump (PUMP 2)
necessary.
The substitution fluid line and the connection of the blood circuit use a post-dilution.
For post-dilution, connect the substitution line to the venous drip chamber.

WARNING post-dilution (infuse this substitution fluid to the blood circuit
In the AFBF treatment, the dialysate is supplied and the substitution fluid is infused to DBB-05 at the
same time (except for intermittent operation of the substitution fluid pump).
That is, as the substitution fluid pump is stopped if an alarm occurs, the dialysate supply to DBB-05 is
stopped.
On the contrary, as the dialysate supply to DBB-05 is stopped if an alarm occurs, the substitution fluid
pump is stopped.
<Example: the supply stop of the dialysate to dialyser and substitution fluid pump stop>
♦ When the cover of blood pump is open.
♦ When the [PUMP 1] key is OFF.
♦ When the cover of substitution fluid pump is open.
♦ When the substitution fluid rate setting value is 0.00L/h.
♦ When an A concentrate connector isn't connected with the A rinse port.
♦ When an alarm occurs.
The setting method of substitution fluid rate select from two methods.
l The substitution fluid rate is automatically calculated, based upon the ratio.
(Ratio of blood flow rate of blood pump to substitution fluid rate)
l The substitution fluid rate is set up in the manual.
Then, the substitution fluid pump (PUMP 2) takes out substitution solution from the substitution fluid bag
hung on the scale and supplies it to the blood circuit.
The infused substitution fluid volume is independently measured and controlled by two sensors in the
scale as well as the set revolutions of the substitution fluid pump (PUMP 2). As soon as the value falls
short of the preset minimum amount (configurable) in the substitution fluid bag during treatment, the
substitution fluid pump (PUMP 2) stops, and the monitor displays a "bag empty" message for the operator.
Also, an air detector detects and indicates a level drop-off in the infusion system.
When the substitution fluid rate is less than 1.2L/h, the

CAUTION substitution fluid pump becomes intermittent operation.

DBB-05
1.5. Description of keys
Key list :
Alarm Bypass UF rate Override Reset of

reset select down test NG
HP rapid Continu. Sub. bag Cal. curv

feed heparin exchange setting
1.0 mL/h

B powder B powder B pow. Treat. TMP-zero Micro-

OFF Bicart.
Sub. bag excange

When this key is pressed after the substitution bag has been exchanged in the HDF treatment, the
measuring sensor is adjusted newly.
To make this key valid, first stop the blood pump.
Operating Instruction - 10 - AFBF

DBB-05
1.6. Consumables

l AFBF line
Infusion line: NK-H201PX
l Concentrate for AFBF
The concentrate for AFBF suitable for the following proportion of concentrate and water may be used.
1L of concentrate for AFBF and 34L of water
l Substitution solution for AFBF
The substitution solution of buffer free for AFBF may be used.

WARNING and substitution fluid for AFBF at the same time.
AFBF individually.
alkalosis to occur.

AFBF - 11 - Operating Instruction

DBB-05
1.7. Technical data

manual.
l Dialysate pressure

The TMP alarm isn't monitored in the AFBF treatment.

CAUTION
1.7.2. AFBF
l Substitution fluid pump (PUMP 2)

when using the AFBF line which has been specially built.
Setting range: 0.00; 0.10 to 4.00* L/h

NOTE In the AFBF operating mode, the second pump is operated as a

substitution fluid pump (PUMP 2); therefore SN blood pump
operation is not possible.
l Scale
Setting range
of substitution amount: 0.5 to 20 kg
Suspension weight/time: maximum 10 kg
Balance accuracy: ±25 g
Balance alarm point: Difference between calculation value and actual value
±200/600 g

DBB-05
BIC : Bicarbonate
BP : Blood pump
LF : Conductivity
DC : Direct current
HD : Hemodialysis
HF : Hemofiltration
SV : Solenoid valve

DBB-05
1.8.2. Symbols
Alternating current

Cd
Recycle battery
Ni-MH

DBB-05
Materials used
Metals
− Stainless steel
− Aluminum
− Copper
− Iron
− Brass
Plastics
− Silicone (SI)
− Fluoro rubber
− Polyimide(PI)
Electronic component, P.C.B

NIKKISO CO., LTD.,

DBB-05
2. Preparation
2.1. Concentrate supply

AFBF individually.
alkalosis to occur.

NOTE To remove the concentrate connector from the rinse port turn
the concentrate connector to the right (clockwise) while
simultaneously pulling.
1. Prepare the AFBF concentrate for the AFBF

treatment.

(blue/white/green) to the AFBF concentrate
container and connect the concentrate connector
(blue/white/green) to the concentrate suction
nozzle (blue/white/green).

DBB-05
2.2. Preparation and priming of the substitution fluid circuit for AFBF
treatment
l Selection of treatment method AFBF
1. On the "Preparation" screen, touch the Treat.

data key and then the field to the right of
Treatment mode.
2. This opens a new window for setting the desired

treatment mode.
3. Keep the key of the desired treatment method

(AFBF) pressed for at least 1.5 seconds.
Treat.
The activation of the treatment mode is
data displayed by a color change of the pressed key.
4. Select the ESC key to close the window.
(The input of such treatment parameters as

substitution fluid rate is described in chapter 3.)
Treatment
mode HD
SN mode
OFF
ESC
HD HDF OHDF
ISO-UF
AFBF HF OHF
Other mode can't be select during AFBF treatment, and AFBF

CAUTION can't be select during other treatment.
Therefore, select AFBF in the "preparation".

DBB-05
l Set the substitution fluid line
NOTE In order to perform easy air-free priming of the pump segment,

it is recommended to prime the substitution system manually
by gravity before inserting it into the substitution fluid pump
(PUMP 2).
1. Open the cover of the substitution fluid pump

(PUMP 2).
2. Set the inlet of the pump segment to the left of

the substitution fluid pump (PUMP 2).

handle clockwise.

right of the substitution fluid pump (PUMP 2).
5. Now insert the substitution fluid lines into the

tube holders.
6. Connect the supply tube of the substitution fluid

line to the substitution bag and open the
breaking seal of the bag.
7. Fasten the air detector to the substitution fluid

line below the bag.
Before priming the substitution fluid line, confirm that the

CAUTION correct composition of substitution solution has been prepared.

DBB-05
l Priming the substitution Fluid line

AFBF individually.
alkalosis to occur.

1. For priming the substitution fluid line, start the

substitution fluid pump (PUMP 2).
The substitution fluid pump (PUMP 2) stops

automatically as soon as the preset priming
volume is reached.
2. Connect the supply connector of the substitution

fluid line to the venous tube set:
3. Then open the clamp.
4. Start the substitution fluid pump (PUMP 2) once

again and set the liquid level of the substitution
fluid chamber.
5. Stop the substitution fluid pump (PUMP 2).
NOTE At treatment start, the substitution fluid pump (PUMP 2) starts

automatically after you press the treatment START key.
Do not connect any connector of the blood tube set or the

WARNING substitution fluid line (AFBF) at the on-line connector of the
DBB-05.

DBB-05
2.3. Start-up test



DBB-05. It starts

Automatic start after completion of CPU test.

completed.

WARNING substitution fluid line of the DBB-05.

DBB-05
3. Treatment conditions


setting.

remaining 4:00 mode AFBF
UF goal L
01.00
UF rate L/h
setting data 0.25
Conduct. profile
.
Substitution L/h Dialysate C°

rate 00.00 temperature 37.0
Substitution % Dialysate mL/min
Ratio Sub/BP 13.0 flow rate 500
Substitution POST Total mS/cm
Subs.-port conductivity 14.0
Heparin pump mL/h
setting data 1.5 (30mL)
HP bolus mL
volume 1.5
-to OFF time 20
Return Connect
0
mL/min

DBB-05
3.2. Setting of the treatment data for AFBF
NOTE Check that you have activated the desired treatment method as
AFBF.
3.2.1. Selection of data
Input of data can be performed by two different methods.

Depending on the selected data, certain limitations apply.

Substitution fluid rate, Substitution fluid ratio Sub/BP

Treat. time
remaining 4:00 ⇒ Substitution rate
⇒ Substitution ratio Sub/BP
to change them as applicable.
On screen, a new windows for changing the

substitution fluid data opens.
Substitution L/h
rate 00.00
Substitution % 2. To make a desired parameter valid, keep
ratio Sub/BP 13.0 relevant field pressed for 1.5 sec or longer.
ESC

remaining time
Emergent
substi. 4:00 14:00
0.00 L
UF rate
00.00 02.00 0.50

L L L/h
Substitution Substitution Substitution Substitution
ratio Sub/BP rate ratio Sub/BP rate
-- 00.00 13.0 --.--

% L/h % L/h

DBB-05
3.2.2. Setting the substitution fluid rate
l Input of substitution fluid rate
1. Activate the Substitution rate field.
Treat. time Complete The ten-key pad will appear on the screen.
remaining time
2. Enter the desired Substitution rate in the
4:00 14:00 numeric field.

ESC key.
Substitution Substitution
ratio Sub/BP rate
-- 00.00
% L/h
00.00L/h è 02.00L/h

remaining time
4:00 14:00
ratio Sub/BP rate
-- 02.00
% L/h

DBB-05
l Input of substitution fluid ratio
1. Activate the Substitution ratio Sub/BP field.

remaining time
2. Enter the desired
4:00 14:00 Substitution ratio Sub/BP in the numeric field.
(Ratio of blood flow rate of blood pump 1 to
substitution fluid volume)

ratio Sub/BP rate ESC key.
13.0 --.-- Example:

Priority ⇒ Substitution ratio Sub/BP
% L/h
When changing the
Substitution ratio Sub/BP from 13.0 % to
13.5 %, the DBB-05 automatically calculates a
13.0% è 13.5% new Substitution rate.
Substitution rate =
Substitution ratio Sub/BP
× Blood flow rate
remaining time
4:00 14:00
ratio Sub/BP rate
13.5 --.--
% L/h
NOTE When Substitution ratio SUB/BP has the priority, the
substitution fluid rate is displayed at start of AFBF treatment.

DBB-05
3.2.3. Setting the conductivity
l Total conductivity
1. In the [Treatment data] table, activate the

Total mS/cm Total conductivity.
conductivity 14.0
or touch the Concentrate name area on the

A concentrate B concentrate „Preparation“ screen.
name name
ex. AFBF concentrate

Conduct. set opens.

Total conduct..
Conduct. set
ESC A ten-key pad opens on screen.
3. Enter the value of the desired total conductivity

A concentrate Total in the numeric field.
name conduct.
ex. AFBF concentrate 4. Confirm this input by touching the SET key,
14.0 then close the numeric field by touching the
mS/cm
ESC key.
name conduct.
mS/cm

DBB-05
4. Treatment
AFBF treatment
WARNING
Always carefully check the treatment conditions during AFBF
treatment. Additionally, monitor the balance of the acid and
base appropriately using the blood gas analyzer. If acidosis or
alkalosis is found, take appropriate actions.

and substitution fluid for AFBF at the same time. Do not use
the dialysate concentrate or substitution fluid for AFBF
individually.
alkalosis to occur.
Additionally, do not use any dialysate concentrate or
substitution fluid for other hemodialysis system together with
the dialysate concentrate or substitution fluid for AFBF at the
same time.

post-dilution (infuse this substitution fluid to the blood circuit
Use of high flux dialyser and selection of low ultrafiltration

CAUTION rate may cause partial back filtration.

2. Difference in pressure due to resistance between dialysate
and blood pass
3. Blood viscosity

DBB-05
4.2. AFBF treatment
Make sure that the following conditions for

HDF/HF treatment are met:
1. The desired operating mode AFBF must be

activated.
2. The pump segment in the substitution fluid

pump (PUMP 2) must be inserted air-free.
3. The clamp in the inlet line to the blood tube set

must be opened.
4. The sensor for air detection ("bag empty"

detection) must be connected to the substitution
fluid line.
NOTE When you press the Start key, the substitution fluid pump
(PUMP 2) for treatment start turns on automatically.
Monitor all messages in the information window of the screen!

CAUTION

DBB-05
Start


*Substitution fluid line at bag AFBF

errors.

DBB-05
5. Troubleshooting
AFBF-treatment isn't - - - deviation of scale

Cause
Ø Balance indication is out of range.
Balance of substitution fluid alarm (excess)

Balance of substitution fluid alarm (shortage)
Cause
Ø The weight of the substitution bag has exceeded the alarm point.
The balance indicates a weight change of +/-200 g.
ü Check the weight of the substitution bag.
ü Clamp opened? Line not air-free? Tube kinked?
ü Check the patient's weight.
ü Is there any foreign matter attached to the bag?
ü Has the substitution bag been correctly attached to the balance?
Balance of substitution fluid alarm (+600g excess)

Balance of substitution fluid alarm (–600g shortage)
Cause
Ø The weight of the substitution bag has exceeded the limit point.
ü Check the volume of the substitution solution.
ü A 200g alarm was confirmed by pressing the Alarm reset key 3 times.
ü Touch the Sub. bag exchange key in the Keys of menu to start the blood pump 2.
ü If necessary, abort the HDF/HF treatment.
Mode mismatch alarm (Substitution port)

Cause
Ø The port for the substitution solution is open.
ü Close the port for the substitution solution or correct the treatment mode.
Substitution bag empty

Cause
Ø The substitution bag does not contain any solution any more, or the empty bag weight (adjustable by
the technician) has been reached.
ü The BP2 stops.
ü Attach a new bag to the balance.
ü If necessary, fill the substitution inlet tube again with solution.
ü Attach the air detector for the substitution fluid (air sensor) to the substitution inlet.
ü Press the Sub. bag exchange key. Then, restart the BP2.

DBB-05
Substitution fluid empty

Cause
Ø The air detector for the substitution fluid (air sensor) has not been connected to the substitution inlet
tube, or it has detected air.
ü The BP2 stops.
ü Check the air detector for the substitution fluid (air sensor).
5.2. Test messages and technical messages
TFB161 Scale abnormal

Cause
Ø An error has occurred during operation of the scale.

DBB-05
6. Maintenance with Technical Safety Inspection

Software version Operation place o AFBF
Operation hours Operator o
2.1. Air detector for substitution fluid Alarm function q
Delivery rate (1.2 L/ ±0.12 L/ ) q

2.2. Substitution fluid pump
Alarm cover switch q
3. Scale
3.1. Inspection of Zero point Comparison measurement at (0 kg ±30 g) q
3.2. Inspection of Span point Comparison measurement at (10 kg ±30 g) q

Observation:

DBB-05

Manual No. 771E R0
DBB-05
Blood pressure monitor
(Option)
0123
11.2001
DBB-05

medical devices.


EC-representative

Telefon : +49-40-414629-19
Telefax : +49-40-414629-49
Manufacture

Japan
Telefon : +81-3-3443-3727
Telefax : +81-3-3470-0681
Operating Instruction -2- Blood pressure monitor

DBB-05
Table of contents Blood pressure monitor

Section Page
1.2. Danger and warnings for instruction 5
1.3. Warnings and cautions for safe measurement 5
2. Outline 7
2.1. Features 7
2.2. Measurement principle 8
3. Part names and function 9

Fig. 1: Rear side view of DBB-05 9
4. Preparation for measurement 12

4.1. Cuff selection 12
4.2. Selecting the measurement mode 13
4.3. Cuff connection 14
4.4. Wrapping the cuff 15
4.5. Wrapping the infant dispo-cuff 19
5. Measurement 20
5.1. Manual measurement 23
5.2. Automatic measurement (Interval measurement) 24
5.3. Continuous measurement 25
6. Alarms 27
6.1. Measurement alarm 27
6.2. Blood pressure alarm 29
6.3. Blood pressure monitor alarm 30
7. Cleaning and checks 31

7.1. Cleaning of cuff/cuff hose 31
7.2. Checks 31
8. Technical data 32
8.1. Specifications 32
8.2. Accessories 33
Blood pressure monitor -3- Operating Instruction

DBB-05

circumstances.
l Warning labels

DANGER PERSONAL INJURY.

WARNING INJURY.

CAUTION improper treatment, if not avoided.

DBB-05
1.2. Danger and warnings for introduction
Do not use the DBB-05 where a highly flammable anasthetic is

DANGER used, in the presence of flammable gas, in a high pressure
oxygen room or in an oxygen tent.
This could cause an explosion.
To avoid accidents do not use any unauthorized accessories and

WARNING options, in order to avoid accidents.
Prior to use of the DBB-05, read the instruction manual for

WARNING DBB-05 carefully.
This instruction manual does not describe cautions for
DBB-05.
Pre-use inspection and preventive maintenance must be

WARNING performed for safe use.
Neglecting such operations could cause accidents.
1.3. Warnings and cautions for safe measurement
When measurement is not possible or when there are doubts

WARNING about measurement values, please check the patient’s condition
first, it could be that patient’s condition has deteriorated to the
point where measurement limits are exceeded or the cuff hose
is kinked or blocked.
(When the hose is blocked, despite the pressure display on the

device indicating 0 mmHg, there could still be air in the cuff.
Since the blood flow in the arm could be blocked by this which
could cause peripheral nerve problems, special attention is
required after body position changes.)

DBB-05
Measurements using a cuff should not be conducted in the

WARNING following cases:
n Wrapping the cuff on the same arm where the dialysis is

being conducted is dangerous. This is to be avoided.
n Don't wrap the Cuff except for the patient connected with
DBB-05 to apply.
n Cuff measurement should not be conducted on patients who
are on a heart-lung machine.
This could a cause of accidents.
Measurements are not possible in the following cases:

CAUTION
n Insufficient peripheral circulation, acute cases of low blood
pressure, low temperature (due to insufficient blood flow in
the measurement section).
n Measurements on patients with frequent arrhythmia.
n Measurements on patients using a pump oxygenator (since
there are no pulses with them).
In the following cases, proper measurements may not be

CAUTION possible:
n When heart massage is conducted. When there are

continuous external vibrations present (possibly from the
operator) or patient motion artifact is present due to spasm
and the like.
n Measurements taken with the wrong sized cuffs.
n When the heights of the cuff position and the heart are
different. (When there is a 10 cm difference in height, there
may be maximum of 7-8 mmHg difference in blood pressure
reading.)
n When the patient moves or talks during a measurement.
n When measurements are taken over a thick clothing.
n When a rolled up sleeve is adding pressure to the arm.
Measurement position should be checked from time to time. If

CAUTION any abnormality is found, measurement position should be
changed. Not doing this may lead to inflammation by sweating
or internal hemorrhaging.

DBB-05
2. Outline
2.1. Features
The blood pressure monitor is built in by DBB-05, and it is the non-invasive blood pressure method blood
pressure monitor utilizing oscillometric method.
Blood pressure monitor has the following features:
• Cuff measurement has following methods.

Manual measurement by measurement key
Automatic measurement by measurement interval setting
Continuous measurement by measurement time setting
Automatic measurement when venous pressure alarm of DBB-05 is reset
Automatic measurement when blood flow rate, UF rate or substitution fluid rate of DBB-05 is
changed
‚ The following items has the alarm point of the upper limit/lower limit independently.
Systolic blood pressure (SYS)
Diastolic blood pressure (DIA)
Mean arterial pressure (MAP)
Pulse rate (PR)
ƒ When the systolic pressure alarm occurs, DBB-05 can control the following pumps.
Blood pump
UF pump
Substitution fluid pump
At the treatment for AFBF;

CAUTION Substitution fluid pump depends on the activities of the blood
pump.
When the alarm occurs, there may be various reasons for this.
WARNING Always verify the patient’s condition by auscultation and
palpation methods.
„ The following measurement result data can be displayed on the screen.

(Maximum of 256 data can be stored.)
Pulse rate (PR)
… The following measurement result can be displayed as the graph on the screen.
Pulse rate (PR)

DBB-05
2.2. Measurement principle
Oscillometric method
This method measures the blood pressure by detecting the pulsation of the artery which is caused by the
contraction of the heart, as the pressure oscillation in the cuff.
When the cuff around the upper arm is fully inflated, blood flow stops but pulsation of the artery
continues and causes oscillation of the pressure in the cuff.
As the pressure in the cuff is decreased slowly, the magnitude of the pressure oscillation in the cuff
gradually increases and eventually reaches a peak.
Further decrease of the cuff pressure causes the oscillation to decrease.
The relationship between the changes of cuff pressure and its oscillation is stored in memory and used to
determine blood pressure.
Namely, cuff pressure when the oscillation increased rapidly is taken as the systolic pressure, and that
when the oscillation decreases rapidly is taken as the diastolic pressure.
Cuff pressure when oscillation reaches a peak is taken as the mean arterial pressure(MAP).
The oscillometric method does not determine blood pressure instantaneously unlike the auscultatory
method and microphone type automatic blood pressure monitor, but determines it from the curves of the
changes of the pressure and its oscillation as described above.
This feature gives it antinoise characteristics as it is not affected by external noise or electric surgical
units.
KOROTKOV SOUNDS
200
CUFF PRESSURE
160 157
120
83
80 mmHg
40
OSCILLATIONS IN
CUFF PRESSURE
RADIAL PULSE
5 SEC
Comparison among the auscultatory, oscillometric and

palpatory methods of measuring blood pressures.
SOURCE: MEASUREMENT OF BLOOD PRESSURE

BY L.A.GEDDES

DBB-05
3. Part names and function

Fig. 1: Rear side view of DBB-05
1 Cuff hose connection port

This is used to connect the cuff hose.
2 Socket for external measurement switch

This is used to connect the external measurement switch for manual measurement.
3 Cuff hose
Turn in clockwise direction and fasten securely.
A cuff suitable for the patient is connected at the other end.
NOTE Meaning of the symbol on the rear

DBB-05
Description of key function
Blood pressure
Action Alarm
reset reset
Time 15 : 32 Interval
SYS / DIA 125 / 90 30 min
mmHg
MAP 98 mmHg Inflation p. CUFF CONT
Pulse 83 bpm 180 mmHg Adult measure.
No. Date & Time SYS DIA MAP Pulse

AUTO
001 10 / 04 09 : 32 122 76 97 82 measure.
002 10 / 04 10 : 32 117 82 92 83
003 10 / 04 11 : 32 122 76 91 78
Setting
004 10 / 04 12 : 32 90 63 74 94
005 10 / 04 13 : 32 105 34 43 82
Manual
measure.
Alarm reset
When this key is touched, almost all alarms are executed or reset.
CONT measure.
When this key is touched, the continuous measurement is started.
AUTO measure.
When this key is touched, the automatic measurement (interval measurement) is started.
Setting
When this key is touched, the BPM setting input window will be opened.
Manual measure.
When this key is touched, the manual measurement is started.
The character changes in Stop from Manual measure. when it touches either key of three keys and
blood pressure measurement starts (Continuous, Automatic, Manual).
NOTE The blood pressure measurement can be stopped at any time

using the Stop key.
Action reset
When this key is touched, the control of following pumps is returned for the control before an systolic
pressure alarm occurs
Blood pump
UF pump
Substitution fluid pump
Operating Instruction - 10 - Blood pressure monitor

DBB-05
26/10/’01 (Fri) BPM

03 STOP
09:28
BPM STOP
The blood pressure measurement can be stopped at any time using the BPM STOP key.
NOTE When the blood pressure measurement is started, the BPM

STOP key is displayed on the screen.
Message
ESC
Hidden menu
Alarm
BPM ESC
reset
disable
BPM failure (Exxx ----------------------) Over

ride
Hidden
menu
UF
setting
BPM disable
When this key is touched, all function of the blood pressure monitor is stopped.
NOTE When an BTM error (Exx ----) occurs, the BPM disable key is
Blood pressure monitor - 11 - Operating Instruction

DBB-05
4. Preparation for measurement

4.1. Cuff selection
The cuff and cuff hose must use the COLIN’s product or the
WARNING product which specified COLIN.
They are necessary to keep patient's safety and the precision of
the measurement.
It is important to select the appropriate size of cuff for each patient to get correct measurement.
Please select a cuff to fit each patient by referring to the following table.
The cloth cuff which can be used for this blood pressure monitor has dark blue.
Arm circumference Bladder width

Name
(cm) (cm)
Regular Cloth CUFF

CUFF No.3 REF A013ZZ 23 - 33 12
(Standard accessory)
CUFF No.1 REF A011ZZ 12 – 18 7

Regular Cloth CUFF
CUFF No.2 REF A012ZZ 17 - 23 9
(Option)
CUFF No.4 REF A014ZZ 31 - 40 14
CUFF No.13 REF AL024Z 8.5 - 13 5

Infant
CUFF No.12 REF AL023Z 7.5 - 10.5 4
Dispo-CUFF
CUFF No.11 REF AL022Z 5.0 - 7.5 3
(Option)
CUFF No.10 REF AL021Z 3.5 - 6.0 2.5
In order to get correct value, select the appropriate cuff.

CAUTION If a bigger cuff is used, the measured blood pressure values
become lower than the actual values. If a smaller cuff is used,
the measured blood pressure values become higher than the
actual values.

DBB-05
4.2. Selecting the measurement mode
1. Touch the Setting key.
2. On the screen, a new window for setting the

BPM parameter opens.
Setting 3. Touch the Cuff selection field.
4. Enter the value of the desired cuff in the numeric

field.
0(Adult) ⇒ Regular Cloth CUFF
1(Infant) ⇒ Infant Dispo-CUFF

ESC key.
Do not use a infant dispo-cuff when in adult mode. High

CAUTION pressure is applied to the cuff, which is dangerous.

DBB-05
4.3. Cuff connection
Connect cuff to cuff hose.
l In case of adult cuff
After connecting turn the hose clockwise and

securely lock the hose.
Cuff hose
(Light blue)
Cuff
Colin’s brown cuff and gray cuff hose cannot be used with the
CAUTION blood pressure monitor.
The accessory cuff hose is 3.5 m long.
Since, the cuff hose should not be made more than 5 m long as
there will be effects on measurement.
l In case of infant dispo-cuff
Firm connection must be made.

Cuff hose
(Pink)
Dispo-cuff
Colin’s conventional blue-green cuff hose cannot be used.

CAUTION
Confirm that there is no looseness in the connecting section.

CAUTION If there is air leak, measurement may be faulty.

DBB-05
4.4. Wrapping the cuff
Measurements using a cuff should not be conducted in the

WARNING following cases:
n Wrapping the cuff on the same arm where the dialysis is

being conducted is dangerous. This is to be avoided.
n Don't wrap the Cuff except for the patient connected with
DBB-05 to apply.
n Cuff measurement should not be conducted on patients who
are on a heart-lung machine.
No correct measurement is possible or measurement itself
may not be possible if there is no pulse.
n Blood pressure is measured by pressing the arm. Some

CAUTION patients may experience a transient macula due to
subcutaneous bleeding. This macula will disappear in a
matter of hours. For a patient where this is a concern, try the
following:
• Wrap one layer of thin cloth beneath the cuff.
Note that wrapping a cloth thickly may cause pressing by
the cuff to be insufficient and result in higher
measurements of blood pressure.
n Ensure there is no kink or closing of cuff and/or hose.

When there is kink or closing in the cuff and/or hose, When
the hose is blocked, despite the pressure display on the
device indicating 0 mmHg, there could still be air in the cuff.
Since the blood flow in the arm could be blocked by this
which could cause peripheral nerve problems, special
attention is required after body position changes.
n Do not start the blood pressure measurement without

wrapping the cuff on the patient’s arm. It may cause the cuff
to blow out.

DBB-05
Measurement values may be faulty in the following cases:

CAUTION
n If the patient is lying down on one side and the cuff is not on
the same level as the heart, there may be error in the blood
pressure value.
If the height difference is 10 cm, there will be maximum of
7-8 mmHg difference in the blood pressure.
Caution on the use of the cloth cuff
n If there is a cut in the cloth bag, do not use the cuff.

When pressure is applied, the rubber bag could come out and
it may blow out.

DBB-05
1. Wrap the selected cuff around a bare arm or an

arm wearing thin clothing.
If the arm is wearing thick clothing or the sleeve
is rolled or bunched up as shown in the right
figure below, a large inaccurate measurement
error can result.
Center of rubber
bladder 2. When wrapping the cuff around the arm, the
center (marked with a circle) of the rubber
bladder must be located over the brachial artery.
Place the hose toward the hand so as not to kink
it.
LNDEX LINE When doing this, confirm that the “Index Line”
comes inside the “Range”.
Outside the “Range”, the error in the blood
RANGE pressure measurement will be greater. Use cuffs
of other sizes.

DBB-05
3. The cuff should be wrapped so that two fingers

can be inserted between the adult cuff and the
arm.
HEART 4. While measuring, the brachial artery around

which the cuff is wrapped should be held at the
same level as the right atrium of the patient’s
heart.
Keep it in the same position in the same way

when you measure it even if patient sit down.
Arterial

DBB-05
4.5. Wrapping the infant dispo-cuff
Select a cuff to fit the patient so that the end of the

Use an another size cuff cuff will be placed within the cuff size indicator as
shown left.
Have the hose on the hand side to prevent kink.
Cuff size indicator
Artry alignment index
Caution on the use of the infant dispo-cuff

CAUTION
n When wrapping the cuff, do not make it too tight.
This cause congestion of blood.
n Ensure that there is no inflammation or damage in the
measurement position in every eight hours even if it is the
worst.
n Don't use Dispo-cuff for other patients again to prevent
infection.
Dispo-cuff is for single-patient use only.

DBB-05
5. Measurement
n Blood pressure is measured by pressing the arm. Some

CAUTION patients may experience a transient macula due to
subcutaneous bleeding. This macula will disappear in a
matter of hours. For a patient where this is a concern, try the
following:
• Wrap one layer of thin cloth beneath the cuff.
Note that wrapping a cloth thickly may cause pressing by
the cuff to be insufficient and result in higher
measurements of blood pressure.
n Ensure there is no kink or closing of cuff and/or hose.

When there is kink or closing in the cuff and/or hose, despite
the pressure display on the device indicating 0 mmHg, there
could still be air in the cuff. Since the blood flow in the arm
could be blocked by this which could cause peripheral nerve
problems, special attention is required after body position
changes.
n Do not start the blood pressure measurement without

wrapping the cuff on the patient’s arm. It may cause the cuff
to blow out.

DBB-05
When the measurement has failed or when the measurement

WARNING value is questionable, always verify the patient’s condition by
auscultation and palpation methods.
There are cases where wrong measurement values may be

obtained.
n When heart massage is conducted or when there are

continuous external minute vibrations (due to contacts with
the operator) or when there are motion artifact from the
patient from spasm and the like.
n When the patient moves or talks during measurement.
There are cases when measurement is not possible.
n Incases of peripheral nerve disorder, severe cases of low

blood pressure or low body temperature, measurements may
be faulty or impossible due to insufficient blood flow in the
measurement locations.
n Patients with frequent arrhythmia are not suitable for
measurement.
Even though measurements can be made, the reliability of
the measurement values will be low.

DBB-05
Inflation value
First measurement: Initial inflation value
Second and subsequent measurements:
Automatic inflation or
Smart inflation
(by the selection.)
NOTE Initial inflation value:

Initial inflation value set on the setting screen.
Automatic inflation:
Inflate to the previous measurement plus the proper value.
Smart inflation:
Estimate the proper cuff pressure corresponding with the
patient’s blood pressure value and increase the cuff pressure to
that value (this is called smart inflation).
Smart inflation is effective in the following case.
• Manual measurement
• Measurement interval is more than 3 minutes in the
automatic measurement.

DBB-05
5.1. Manual measurement
1. Touch the Manual measure. key (or press the

external measurement switch), the cuff is
inflated up to initial cuff pressure.
Manual n If the measurement has failed, the measurement

is retried twice.
measure. n If the inflation pressure is not sufficient, the
pressure will increase to an adequate level
during the measurement.
n By touching the Stop key (or press the external
measurement switch), during the measurement,
the measurement is stopped.
2. When the measurement is completed, the

measurement values are displayed and the air in
the cuff is rapidly let out.

DBB-05
5.2. Automatic measurement (Interval measurement)
1. Touch the Setting key.
2. On the screen, a new window for setting the

BPM parameter opens.
Setting
3. Touch the Interval field.
4. Enter the value the desired

automatic measurement interval in the numeric
field.

ESC key.
6. Touch the AUTO measure. key, the cuff is

inflated up to initial cuff pressure.
AUTO
measure. n By touching the Stop key (or press the external
the measurement is stopped.

8. By touching the AUTO measure. key for 1.5 sec

or longer, the automatic measurement is
finished.
Caution for the measurement interval

CAUTION
When the measurement interval is short, damage may be given
to a measurement locations by the patient's condition and
wrapping the cuff and so on.
Think about need fully, and set up the measurement interval.
When the automatic measurement is not conducted, turn off the

CAUTION automatic measurement to prevent the cuff being inflated
automatically. This is to prevent cuff blow out.

DBB-05
5.3. Continuous measurement (CONT)
The measurement time of the continuous measurement has two kinds of time, and the time must set up in
advance.
5 minutes: When the current measurement completed, the next measurement is immediately
started.
12 minutes: Continuous measurement is measured for 1 minute in the interval.
Caution when selecting 5 minutes measurement time (For

CAUTION patient safety)
n After 5 minutes have elapsed, the 2.5 minutes automatic

measurement is automatically reverted to.
n When Step key is touched to stop measurement during a
measurement, continuous measurement is also stopped. And
after 5 minutes have elapsed, the 2.5 minutes automatic
measurement is automatically started.
Caution when selecting 12 minutes measurement time (For

CAUTION patient safety)
n After 12 minutes have elapsed, the 2.5 minutes automatic

measurement is automatically reverted to.
n When Stop key is touched to stop measurement during a
measurement, continuous measurement is also stopped. And
after 1 minute have elapsed, measurement is resumed.
Caution for the measurement interval

CAUTION
When continuous measurement is used, damage may be given
to a measurement locations by the patient's condition and
wrapping the cuff and so on.
Think about need fully, and do the continuous measurement.
When the continuous measurement is not conducted, turn off

CAUTION the continuous measurement to prevent the cuff being inflated
automatically. This is to prevent cuff blow out.

DBB-05
1. Touch the Continue key, the cuff is inflated up

to initial cuff pressure.
n By touching the Stop key (or press the external

CONT the measurement is stopped.
measure.
3. By touching the Continue key for 1.5 sec or

longer, the automatic measurement is finished.

DBB-05
6. Alarms
When the measurement has failed, there may be various
WARNING reasons for this. Always verify the patient’s condition by
auscultation and palpation methods.
6.1. Measurement alarm
The measurement alarm message list is on the next page.
l Re-measurement
n When a measurement has failed, a message is displayed and the measurement will be repeated.
n Re-measurement is tried twice.

When measurement fails twice, then measurement will be stopped.
However, when the “C14 Insufficient Pressure” alarm message is displayed, the measurements are
carried out three times.
l Not available
n When measurement is not possible after two re-measurements, or when re-measurement will not take
place due to alarm contents (C11), this message is displayed.
n During repeat measurements 160 seconds elapse from the first measurement before the repeat
measurement, “C17 Time-Out” is displayed and measurement is stopped.
n When measurement is stopped, “No read” is printed in the alarm data and alarm continues to sound.
The alarm sound can be stopped by pressing [MUTE] key.

DBB-05
Measurement alarm message list
Alarm message Contents Confirmation items
The preset cuff pressure was not Check connections or looseness of

reached within the specified time cuff hose, DBB-05, and cuff. (See if it
BPM alarm
after inflation started. is locked by turning clockwise.)
(C11 Check Cuff)
“Re-measurement will not be Also check that the cuff is not
conducted.” wrapped loosely.
The measurement was incomplete

BPM alarm and the cuff pressure came down to Confirm patient condition.
(C12 Check 10 mmHg in the adult mode, 5 Also, check cuff wrapping.
Cuff/Patient) mmHg in the infant mode.
BPM alarm Air dump was stopped for more than Check for motion and arrhythmia of
(C13 Motion Artifact) 15 seconds due to motions artifact. patient.
BPM alarm Cases of high blood pressure and

(C14 Insufficient Insufficient pressure motion artifact by patient can be
Pressure) suspected.
BPM alarm
Proper signal were not obtained.
(C15 Irregular Pulses) Check patient condition.
Check for motion and arrhythmia of
Measurement was not possible due to patient.
BPM alarm
motion artifact, arrhythmia, and thew
(C16 Weak Pulse)
like.
More than 160 (Infant: 80) seconds

have elapsed from the first
BPM alarm
measurement before retry.
(C17 Time-Out)
“Re-measurement will not be Check for causes that are stopping air
conducted.” dump to take place, such as patient
motion artifact, kink of cuff hose and
More than 160 pulse rate has been cuff hose and the like.
BPM alarm
detected.
(C18 Time-Out over
“There will be only one
160 Pulses)
re-measurement.”
Confirm that the patient is not bending

BPM alarm Cuff pressure reached more than 300 arm.
(C19 Pressure Failure) mmHg (Infant: 150 mmHg). Also, see if there is no kink of cuff
hose and cuff hose.
The pulse signal was too small for

BPM alarm
detection. Check patient condition.
(C20 Cannot Take
“Re-measurement will not be Also, check cuff wrapping.
Signal Properly)
conducted.
BPM alarm
Infant cuff is used in adult mode. Measurement object should be
(C21 Check Cuff
Cuff was wrapping too tight. checked.
Size)

DBB-05
6.2. Blood pressure alarm
When a patient’s measurement values goes beyond alarm points, an alarm occurs.
Systolic blood pressure alarm (Upper)

Systolic blood pressure alarm (Lower)
Mean arterial pressure alarm (Upper)
Mean arterial pressure alarm (Lower)
Diastolic blood pressure alarm (Upper)
Diastolic blood pressure alarm (Lower)
Pulse rate alarm (Upper)
Pulse rate alarm (Lower)
The setting range of setting values is shown below, the lower limit cannot exceed the higher limit.
Item Lower limit (range) Upper limit (range)

SYS [mmHg] 200 (60 to 250) 80 (60 to 250)
MAP [mmHg] 180 (45 to 235) 60 (45 to 235)
Adult
DIA [mmHg] 160 (40 to 200) 50 (40 to 200)
PR [bpm] 170 (40 to 200) 50 (40 to 200)
SYS [mmHg] 120 (40 to 120) 50 (40 to 120)
MAP [mmHg] 90 (30 to 100) 40 (30 to 100)
Infant
DIA [mmHg] 80 (20 to 90) 30 (20 to 90)
PR [bpm] 180 (40 to 240) 70 (40 to 240)

DBB-05
6.3. Blood pressure monitor alarm
This is displayed when a problem occurs with blood pressure monitor.

If the system alarm message is displayed even though touch the Alarm reset key, then the system must be
repaired.
Touch the BPM disable key, and the function of blood pressure monitor is disabled.
BPM failure (E03 Pressure Sensor)

BPM failure (E07 A/D Offset)
BPM failure (E08 Time-Out of Commu.to SUB CPU)
BPM failure (E08 Watch Dog of Main CPU)
BPM failure (E09 Cuff Pressure Monitor: Adult)
BPM failure (E09 Pressing Time Monitor: Adult)
BPM failure (E09 Zero Calibration)
BPM failure (E09 Voltage Monitor: 2.5V)
BPM failure (E09 Watch Dog)
BPM failure (E09 Inflation Pressure for Infant Monitor)
BPM failure (E09 Pressure Compare)
BPM failure (E09 Short-Measure CONT-Time Monitor)
BPM failure (E09 CONT-Measure CONT-Time Monitor)
BPM failure (E09 Security Function)
BPM failure (E09Voltage Monitor: 4.096V)
BPM failure (E09 Voltage Monitor: 3.25V)
BPM failure (E09 Cuff Pressure Monitor: Infant)
BPM failure (E09 Pressing Time Monitor: Infant)
BPM failure (E09 ROM Test)
BPM failure (E09 RAM Test)
BPM failure (E09 Release time monitor)
BPM Communication failure

DBB-05
7. Cleaning and checks

7.1. Cleaning of cuff/cuff hose
n Do not put solutions on the accessories. Do not wet the

WARNING connectors.
n When using sterilizing solution, follow the manufacturer’s
instructions.
NOTE Based on the rules set by medical institutions, cleaning and

sterilization should be conducted with see the “Directions for
Use” of COLIN.
7.2. Checks
n The person checking the cuff should put on the cuff and confirm that the blood pressure measured is
normal.
n During the measurement, bend the arm and stop the air dump by motion. Confirm that the cuff pressure
does not come down during the stoppage.

DBB-05
8. Technical data
8.1. Specifications
Measurement technology: Oscillometric
Measurement method: Linear deflation method
Pressure display range: 10 to 300 mmHg
Pressure display accuracy: Less than ±3 mmHg
Measurement range:
Adult Systolic 60 to 250 mmHg
MAP 45 to 235 mmHg
Diastolic 40 to 200 mmHg
Pulse rate 40 to 200 bpm
Infant Systolic 40 to 120 mmHg
MAP 30 to 100 mmHg
Diastolic 20 to 90 mmHg
Pulse rate 40 to 240 bpm
Pulse rate accuracy: ±2 % or ±2 beats
Usable cuff size: 2.5 to 14 cm
Defibrillator protection: Protected
Alarm range:
Adult SYS upper limit: 60 to 250 mmHg
SYS lower limit: 60 to 250 mmHg
MAP upper limit: 45 to 235 mmHg
MAP lower limit: 45 to 235 mmHg
DIA upper limit: 40 to 200 mmHg
DIA lower limit: 40 to 200 mmHg
PR upper limit: 40 to 200 bpm
PR lower limit: 40 to 200 bpm
Infant SYS upper limit: 40 to 120 mmHg
SYS lower limit: 40 to 120 mmHg
MAP upper limit: 30 to 100 mmHg
MAP lower limit: 30 to 100 mmHg
DIA upper limit: 20 to 90 mmHg
DIA lower limit: 20 to 90 mmHg
PR upper limit: 40 to 240 bpm
PR lower limit: 40 to 240 bpm
Reference standard: IEC60601-2-30 (1999)

EN1060-1 (1995)
EN1060-3 (1997)
CISPR 11 (1999) Class B

DBB-05
8.2. Accessories
l Standard accessories
CUFF No.3 (adult 12 cm) REF A013ZZ

CUFF HOSE No.1 (3.5 m) REF A015ZZ
External measurement switch
l Optional accessories
CUFF No.1 (infant 7 cm) REF A011ZZ

CUFF No.2 (infant 9 cm) REF A012ZZ
CUFF No.4 (adult 14 cm) REF A014ZZ
CUFF No.10 (infant 2.5 cm) REF AL021Z
CUFF No.11 (infant 3 cm) REF AL022Z
CUFF HOSE No.3 (infant 3.5 m) REF AL012Z
l Abbreviations
AUTO : Automatic
CONT : Continuous
DIA : Diastolic blood pressure
MAP : Mean arterial pressure
NIBP : Non-invasive blood pressure
PR : Pulse rate
SYS : Systolic blood pressure

BP : Blood pump
HD : Hemodialysis
HF : Hemofiltration

DBB-05
l Symbols
External measurement switch for manual measurement
Follow local governing ordinances and recycling plans regarding disposal and other device components.
The composed main material for each part is as follows.
Name Part Material (s)
Internal parts General electronic parts

Unit Enclosure ABS
Connector Brass
Rubber bag LATEX

CUFF
Cloth Nylon and Polyester
Hose PVC
CUFF HOSE
Connector Brass

DBB-05

This inspection must be performed 24 months and after maintenance and repair.
Software version Operation place o Blood pressure monitor
Cuff pressure 0 mmHg q

(Permissible tolerance: ±3 mmHg)
2.1. NOTE: 150 mmHg q
In the case of the measurement by the mercury manometer:
±6 mmHg 300 mmHg q
Air leakage
2.2.
(Permissible tolerance: ±6 mmHg/min)
300 mmHg q
2.3. Alarm function q
2.4. Measurement function of external measurement switch q

Observation:

DBB-05

Manual No. 772E R0
DBB-05
HDF / HF
(Option)
0123
11.2001
DBB-05

medical devices.


EC-representative

Telefon : +49-40-414629-19
Telefax : +49-40-414629-49
Manufacture

Japan
Telefon : +81-3-3443-3727
Telefax : +81-3-3470-0681
Operating Instruction -2- HDF / HF

DBB-05
Table of contents HDF / HF

Section Page
1.2. Outline 5
1.4. Description of extracorporeal blood circuit - HDF/HF 8
1.6. Consumables 11
1.7.2. Pressure monitoring (extracorporeal blood circuit) 12
1.7.3. HDF/HF 12
1.8.2. Symbols 14
2. Preparation 16
2.1. Preparation and priming of the substitution fluid circuit for HDF/HF
treatment 16
3.2. Setting of the treatment data for HDF/HF 21
3.2.2. Inputting of data 22
4. Treatment 25
4.2. HDF/HF treatment 26
4.3. Bolus substitution fluid 27
HDF / HF -3- Operating Instruction

DBB-05

circumstances.
l Warning labels


CAUTION INJURY.


DBB-05
1.2. Outline
HDF/HF system applies to HDF/HF treatment for patients having acute or chronic renal failure.

DBB-05
1
2
2 Air detector for substitution fluid
3 Scale

DBB-05
1 Pump cover
2 Tube clamp
3 Rotor
4 Sensor

DBB-05
1.4. Description of extracorporeal blood circuit - HDF/HF
3 5 13
B A
1
A
16
B
4 14
A
15
7
10 9
12 11
A External hydrophobic filter 9 Air detector

B Internal hydrophobic filter 10 Tube detector
1 Arterial pressure monitor 11 Blood detector
2 Arterial blood pump : PUMP 1 12 Venous clamp
3 Heparin pump 13 Scale
4 Dialyser inlet blood pressure chamber 14 Substitution fluid line air detector
5 Dialyser inlet blood pressure monitor
6 Dialyser 15 Substitution fluid pump : PUMP 2
7 Venous drip chamber 16 Substitution fluid champ
8 Venous pressure monitor

DBB-05
For the HDF/HF treatment, an additional HDF/HF unit including a scale and substitution fluid pump
(PUMP 2) necessary.
Either the HDF or HF method can be selected.
There are two methods to connect the substitution fluid line and blood circuit.
For pre-dilution, connect the substitution fluid line after the blood pump to the substitution fluid port for
pre-dilution.
For post-dilution, connect the substitution fluid line to the venous drip chamber.
NOTE The selection of the pre-dilution or post-dilution method is

made at the time of initial set-up.
This selection is initially set at post-dilution before shipment
from the factory.
The substitution fluid pump (PUMP 2) takes out substitution solution from the substitution fluid bag hung
on the scale and supplies it to the blood circuit.
Then, the substitution fluid rate is automatically calculated, based upon the substitution fluid volume and
treatment time.
The infused substitution fluid volume is independently measured and controlled by two sensors in the
scale as well as the set revolutions of the substitution fluid pump (PUMP 2). As soon as the value falls
short of the preset minimum amount (configurable) in the substitution fluid bag during treatment, the
substitution fluid pump (PUMP 2) stops, and the monitor displays a "bag empty" message for the operator.
Also, an air detector detects and indicates a level drop-off in the infusion system.

DBB-05
Key list :

HP rapid Continu. Sub. bag Post- Cal. curv

feed heparin exchange subs. setting
1.0 mL/h


OFF Bicart.
Sub. bag excange

When this key is pressed after the substitution bag has been exchanged in the HDF treatment, the
measuring sensor is adjusted newly.
To make this key valid, first stop the blood pump.
Post-subs. / Pre-subs.
This key is used to switch between the pre-substitution and post-substitution in the HDF, and HF
treatment modes.
CAUTION: In the pre-substitution, the SUB/BP speed rate to be monitored is fixed at 100%.
In the post-substitution, the SUB/BP speed rate to be monitored is set as each basic value.
Operating Instruction - 10 - HDF / HF

DBB-05
1.6. Consumables

l HDF/HF line
Infusion line: S-03E/B
1.7. Technical data

manual.
To remove disturbances, the response from the blood detector

CAUTION is delayed.
The delayed response may depend on the volume between the
dialyser and the blood leak detector as well as on the
ultrafiltration rate. (HF treatment)
In case of HF treatment, the sensitivity of the blood leak

CAUTION detector is changed to reduce. This reduction of sensitivity is
effective only for HF treatment.
(The filtrate of HF treatment is more yellowish than dialysate
of HDF treatment.)
l TMP (In case of HDF/HF treatment, the values are changed as follows.)

Definition (HDF)
PBi + PBo PDi + PDo

2 2

HDF / HF - 11 - Operating Instruction

DBB-05

manual.
l Venous pressure (In case of HDF/HF treatment, the values are changed as follows.)


(In case of HDF/HF treatment, the values are changed as follows.)

1.7.3. HDF/HF

when using the HDF/HF line which has been specially built.
Setting range: 0.00; 0.10 to 4.00* L/h

NOTE In the HDF/HF operating mode, the second pump is operated

as a substitution fluid pump (PUMP 2); therefore SN blood
pump operation is not possible.
l Substitution fluid volume
Measurement range: 0 to 99.99 L

l Scale
Setting range
of substitution amount: 0.5 to 20 kg
Suspension weight/time: maximum 10 kg
Balance accuracy: ±25 g
Balance alarm point: Difference between calculation value and actual value
±200/600 g
l Bolus substitution fluid
Setting range: 40 to 500 mL/min.

Bolus process: 0 to 500 mL
capacity/time: 1000 mL/per one treatment

DBB-05
BIC : Bicarbonate
BP : Blood pump
LF : Conductivity
DC : Direct current
HD : Hemodialysis
HF : Hemofiltration
SV : Solenoid valve

DBB-05
1.8.2. Symbols
Alternating current

Cd
Recycle battery
Ni-MH

DBB-05
Materials used
Metals
− Stainless steel
− Aluminum
− Copper
− Iron
− Brass
Plastics
− Silicone (SI)
− Fluoro rubber
− Polyimide(PI)

NIKKISO CO., LTD.,

DBB-05
2. Preparation
2.1. Preparation and priming of the substitution fluid circuit for HDF/HF
treatment
l Selection of treatment method HDF/HF

Treatment mode.

treatment mode.

(HDF or HF) pressed for at least 1.5 seconds.
Treat.
The activation of the treatment mode is
data displayed by a color change of the pressed key.

substitution fluid volume and substitution fluid
Treatment rate is described in chapter 3.)
mode HD
SN mode
OFF
ESC
HD HDF
ISO-UF
HF

DBB-05
l Set the substitution fluid line
NOTE In order to perform easy air-free priming of the pump segment,

it is recommended to prime the substitution system manually
by gravity before inserting it into the substitution fluid pump
(PUMP 2).

(PUMP 2).
2. Set the inlet of the pump segment to the left of

the substitution fluid pump (PUMP 2).

handle clockwise.

right of the substitution fluid pump (PUMP 2).
5. Now insert the substitution fluid lines into the

tube holders.
6. Connect the supply tube of the substitution fluid

line to the substitution bag and open the
breaking seal of the bag.
7. Fasten the air detector to the substitution fluid

line below the bag.
Before priming the substitution fluid line, confirm that the

CAUTION correct composition of substitution solution has been prepared.

DBB-05
l Priming the substitution Fluid line
1. For priming the substitution fluid line, start the

substitution fluid pump (PUMP 2).
The substitution fluid pump (PUMP 2) stops

automatically as soon as the preset priming
volume is reached.

fluid line to the blood tube set:
• for post-dilution
to the venous tube set
• For pre-dilution, connect the supply
connector to the chamber for measurement
of the inlet blood pressure (located in front
of the dialyser).
3. Then open the clamp.
4. Start the substitution fluid pump (PUMP 2) once

again and set the liquid level of the substitution
fluid chamber.
5. Stop the substitution fluid pump (PUMP 2).
NOTE At treatment start, the substitution fluid pump (PUMP 2) starts

automatically after you press the treatment START key.
Do not connect any connector of the blood tube set or the

WARNING substitution fluid line (HDF/HF) at the on-line connector of the
DBB-05.

DBB-05
2.2. Start-up test



DBB-05. It starts


completed.


DBB-05


setting.

remaining 4:00 mode HDF
UF goal L SN mode
01.00 OFF
UF rate L/h
setting data 0.25
Conduct. profile
Substitution L .
goal 00.00
Dialysate mL/min
flow rate 500
HP bolus mL
volume 1.5
-to OFF time 20
Return Connect
0
mL/min

DBB-05
3.2. Setting of the treatment data for HDF/HF
HDF/HF.

Treat. time
remaining 4:00 ⇒ Treatment time remaining
⇒ Substitution goal
⇒ Substitution rate
Substitution L to change them as applicable.

goal 00.00
On screen, a new windows for changing the
Substitution L/h
rate 00.00 substitution data opens.
2. Check the substitution data and change their

parameters.
or
ESC if required.

remaining time
Emergent
substi. 4:00 14:00
0.00 L
UF rate
00.00 02.00 0.50

L L L/h
Substitution Substitution Substitution

volume goal rate
00.00 00.00 00.00

L L L/h

DBB-05
3.2.2. Inputting of data
l Input of substitution fluid goal if treatment time is already set
1. Activate the Substitution goal field.
remaining time
2. Enter the desired Substitution goal in the

ESC key.
goal rate By entering the Substitution goal, the DBB-05
calculates the Substitution rate reduction
00.00 00.00 automatically.
L L/h Example:
When changing the
Substitution goal from 00.00 L to 08.00 L, the
DBB-05 automatically calculates a new
00.00L è 08.00L
Substitution rate of 02.00 L/h.

remaining time
4:00 14:00
goal rate
08.00 02.00
L L/h

DBB-05
l Input of substitution fluid rate if treatment time is already set
remaining time

ESC key.
goal rate By entering the Substitution rate, the DBB-05
calculates the Substitution goal reduction
00.00 00.00 automatically.
L L/h Example:
When changing the
Substitution rate from 00.00 L/h to 02.00 L/h,
the DBB-05 automatically calculates a new
00.00L/h è 02.00L/h
Substitution goal of 08.00 L.

remaining time
4:00 14:00
goal rate
08.00 02.00
L L/h

DBB-05
l Input of treatment time if substitution fluid volume is already set
remaining time

ESC key.
goal rate By entering the Treat. time remaining, the
DBB-05 calculates the
00.00 00.00 Substitution rate reduction automatically.
L L/h Example:
When changing the
Treat. time remaining from 4:00 to 5:00, the
4:00 è 5:00

remaining time
5:00 15:00
goal rate
08.00 01.60
L L/h

DBB-05
4. Treatment


and blood pass
3. Blood viscosity

With this setting, a TMP alarm is likely to occur at a low UF
rate.
To avoid the TMP alarm, increase the UF rate after consulting
a physician for the correct setting, or carefully change the
lower limit for the TMP fixed alarm.

DBB-05
4.2. HDF/HF treatment
Make sure that the following conditions for

HDF/HF treatment are met:
1. The desired operating mode HDF/HF must be

activated.
2. The pump segment in the substitution fluid

pump (PUMP 2) must be inserted air-free.
3. The clamp in the inlet line to the blood tube set

must be opened.
4. The sensor for air detection ("bag empty"

detection) must be connected to the substitution
fluid line.
Monitor all messages in the information window of the screen!

CAUTION

DBB-05
4.3. Bolus substitution fluid
1. For infusion of a substitution fluid bolus during

Emergent HDF/HF and on-line HDF/HF treatment , press
substi. the Emergent substi. key.
0.10 L The new Emergent sub. window opens on the
screen.
2. Before starting the substitution fluid bolus,

check the parameters in the Emergent sub.
Emergent sub. window.
ESC
Total subs.
volume 3. Touch the Start End key to start the substitution
fluid bolus.
0.00 The substitution fluid pump (PUMP 2) starts at
the indicated flow rate and infuses the
L substitution fluid volume which is displayed as
Substitution Substitution Substitution Substitution goal.
goal rate
volume Eiden the Auto. Set. Venous pressure alarm
width during bolus substitution fluid so that the
0 100 100 alarm is not given.
mL mL mL/min
To interrupt or abort the actual substitution fluid
bolus, you can press the
Start
End Start End key.
Confirm the Total subs. volume indication and be careful the

CAUTION patient weight when the bolus is used.
The following values are displayed in the Emergent sub. window.

Total subs. Substitution
⇐ Indicates the actual
volume ⇐ Total substitution fluid volume
substituted bolus volume of
amount during treatment
the currently running
0.00 0
substitution fluid bolus.
The following values can be changed in the Emergent sub. window:

goal ⇐ Setting of the target rate ⇐ Setting of the flow rate for
substitution fluid for a the substitution fluid bolus
100 substitution fluid bolus 100

DBB-05
Start


*Substitution fluid line at bag HDF/HF

errors.

DBB-05
5. Troubleshooting
Balance of substitution fluid alarm (excess)

Balance of substitution fluid alarm (shortage)
Cause
Ø The weight of the substitution bag has exceeded the alarm point.
The balance indicates a weight change of +/-200 g.
ü Clamp opened? Line not air-free? Tube kinked?
ü Is there any foreign matter attached to the bag?
ü Has the substitution bag been correctly attached to the balance?
Balance of substitution fluid alarm (+600g excess)

Balance of substitution fluid alarm (–600g shortage)
Cause
Ø The weight of the substitution bag has exceeded the limit point.
ü Check the volume of the substitution solution.
ü A 200g alarm was confirmed by pressing the Alarm reset key 3 times.
ü Touch the Sub. bag exchange key in the Keys of menu to start the blood pump 2.
ü If necessary, abort the HDF/HF treatment.
HDF-treatment isn't- - - deviation of scale

Cause
Ø Balance indication is out of range.
Substitution fluid rate exceeds operation range

Cause
Ø The substitution fluid rate exceeds the operation range.
ü Increase the treatment time or decrease the substitution volume. Make sure that the upper limit value
is not exceeded, for ex. 4 L/h, when setting the substitution rate.
ü Dialysis condition 2
ü Adjustment range
ü Upper limit substitution rate setting range HDF/HF.
Substitution volume is not set yet

Cause
Ø No substitution volume has been set.
ü Set the substitution volume in the treatment data.

DBB-05
Substitution fluid rate exceeds limited range

Cause
Ø The substitution fluid rate exceeds the limited range.
ü Increase the treatment time or decrease the substitution volume. Make sure that the upper limit value
is not exceeded, for ex. 4 L/h, when setting the substitution rate.
ü Dialysis condition 2
ü Adjustment range
ü Upper limit substitution rate setting range HDF/HF.
Substitution bag empty

Cause
Ø The substitution bag does not contain any solution any more, or the empty bag weight (adjustable by
the technician) has been reached.
ü The BP2 stops.
Substitution fluid empty

Cause
Ø The air detector for the substitution fluid (air sensor) has not been connected to the substitution inlet
tube, or it has detected air.
ü The BP2 stops.
ü Check the air detector for the substitution fluid (air sensor).
TFB161 Scale abnormal

Cause
Ø An error has occurred during operation of the scale.

DBB-05

Software version Operation place o HDF/HF
2.1. Air detector for substitution fluid Alarm function q

3. Scale
3.1. Inspection of Zero point Comparison measurement at (0 kg ±30 g) q
3.2. Inspection of Span point Comparison measurement at (10 kg ±30 g) q

Observation:

DBB-05

Manual No. 773E R0
DBB-05
On-line HDF / On-line HF
(Option)
0123
11.2001
DBB-05

medical devices.


EC-representative

Telefon : +49-40-414629-19
Telefax : +49-40-414629-49
Manufacture

Japan
Telefon : +81-3-3443-3727
Telefax : +81-3-3470-0681
Operating Instruction -2- On-line HDF / On-line HF

DBB-05
Table of contents On-line HDF / On-line HF

Section Page
1.2. Outline 5
1.4. Description of extracorporeal blood circuit - On-line HDF/On-line HF 8
1.6. Consumables 12
1.7.1. Water and dialysate used 12
1.7.3. Pressure monitoring (extracorporeal blood circuit) 13
1.7.4. On-line HDF/On-line HF 14
1.8.2. Symbols 16
2. Preparation 18
2.1. Preparation and priming of the substitution fluid line
for On-line HDF/On-line HF treatment 18
2.2. Priming the blood circuit with on-line solution 23
3.2. Setting of the treatment data for On-line HDF/On-line HF 26
3.2.2. Inputting of data 27
3.2.3. Setting the dialysate flow rate 32
4. Treatment 33
4.2. On-line HDF/On-line HF treatment 34
4.3. Bolus substitution fluid 35
5. Disconnection 37
5.1. Blood return with on-line solution 37
5.2. Removal of the on-line HDF/on-line HF line 38
On-line HDF / On-line HF -3- Operating Instruction

DBB-05

circumstances.
l Warning labels


CAUTION INJURY.


DBB-05
1.2. Outline
On-line HDF/On-line HF system applies to on-line HDF/on-line HF treatment for patients having acute or
chronic renal failure.

DBB-05
2 Substitution fluid port for on-line fluid

In order to perform an On-line HDF/On-line HF treatment, after completion of the DM test open this
substitution fluid port by turning the thumb screw to the left, then connect the substitution fluid line
(Lure-lock connector).

DBB-05
1 Pump cover
2 Tube clamp
3 Rotor
4 Sensor

DBB-05
1.4. Description of extracorporeal blood circuit - On-line HDF/On-line HF
3 5
A
B
1
A 14
B
4
A
13
6 15
A 16
7
10 9
12 11
A External hydrophobic filter 8 Venous pressure monitor

B Internal hydrophobic filter 9 Air detector
1 Arterial pressure monitor 10 Tube detector
2 Arterial blood pump : PUMP 1 11 Blood detector
3 Heparin pump 12 Venous clamp
4 Dialyser inlet blood pressure chamber 13 Substitution fluid pump : PUMP 2
5 Dialyser inlet blood pressure monitor 14 HDF filter
6 Dialyser 15 Substitution fluid port
7 Venous drip chamber 16 Dialysate filter

DBB-05
l System description
For the on-line HDF/on-line HF treatment, an additional on-line HDF/on-line HF unit including a
dialysate filter and substitution fluid pump (PUMP 2) necessary.
Either the on-line HDF or on-line HF method can be selected.
The on-line HDF/on-line HF treatment can be configured for two different treatment methods, which are
distinguished by the substitution fluid addition location (before or after the dialyser).
For “pre-dilution” (substitution fluid addition before the dialyser), the substitution fluid line must be
connected to the substitution fluid port after the blood pump (blood inlet side).
For “post-dilution” (substitution fluid addition after the dialyser), the substitution fluid line must be
connected to a position located after the dialyser (for example, venous drip chamber).
NOTE The set-up of the treatment method, pre- or post-dilution, may

be carried out by the user.
At the time of shipping, the module is set to post-dilution.
The substitution solution used for on-line HDF/on-line HF treatment is, contrary to conventional HDF/HF
treatment, produced from the dialysate available inside the machine. The adjusted conductivity and
temperature are continuously checked by independent monitoring systems.
At first, the prepared dialysis fluid is fed to the dialysate filter (EF-01D), in order to eliminate germs,
endotoxins and pyrogens by adsorption and filtration. After the dialysis fluid has passed the dialysis fluid
filter membrane, the substitution fluid amount set by the user is diverted by means of the substitution fluid
pump (PUMP 2) and fed to the blood circulation via an additional HDF filter (EFL-015; single-use filter).
If the physiological characteristic of the dialysis fluid is outside the preset limit values, the fluid is
diverted in the dialysate filter via a bypass before passing through the membrane. At the same time, the
substitution fluid pump (PUMP 2) stops, so that neither substitution solution can get into the blood
circulation nor freshly prepared dialysis fluid into the dialyser.
The ultrafiltration rate in the dialyser results from the substitution fluid flow rate and the set weight
removal for the patient. That means that the substitution fluid amount diverted before the dialyser is
filtrated again at the dialyser, because dialysate filter and dialyser are component of the closed hydraulic
system. The additionally required UF amount for removal from patient is assured by the UF pump.
For determination of an on-line HDF/on-line HF treatment, for clearance calculation it has to be taken in
account that contrary to conventional HDF/HF therapy the dialysis fluid flow through the dialyser is
reduced by the substitution fluid share and thus the diffuse share is reduced. The diffusion loss can be
compensated by increasing the dialysis fluid flow by the substitution fluid share. In order to assure
maximum safety, before each treatment a tightness leak test of the dialysate filter is carried out. One
objective of this test is to check the filter membrane in regard to leaks and micro leaks.
The maximum substitution fluid pump (PUMP 2) capacity is limited depending on the selected
substitution fluid procedure (pre- or post-dilution) and the set blood flow rate, in order to limit the fluid
reduction in the dialyser blood compartment caused by the filtration in the dialyser.

DBB-05
The following conditions must be met for on-line HDF/on-line

WARNING HF treatment:
1. Before each on-line HDF/on-line HF treatment, the unit

must be heat-cleaned with citric acid (50%), or a chemical
disinfection with peracetic acid or sodium hypochlorite has
to be carried out.
The maximum non-operation time of a DBB-05 filled with
osmosis water after disinfection should not exceed 12
hours.
2. The maximum operation time of the dialysate filter of 750

operation hours must not be exceeded.
(Before reaching the maximum operation time, the user is
notified about the pending requirement for filter change.)
3. The permeate or the dialysis fluid may not exceed the

following limit values:
§ Permeate (after reverse osmosis) microbiological
contamination:
max. 200 KBE/mL
§ Dialysis fluid (before dialysate filter) microbiological
contamination:
max. 2000 KBE/mL
§ Endotoxin contamination:
max. 0.25 EU/mL
Operating Instruction - 10 - On-line HDF / On-line HF

DBB-05
Key list :

Continu. OHDF
HP rapid Post- flow Cal. curv
feed heparin subs. setting
1.0 mL/h aplicat


OFF Bicart.
Post-subs. / Pre-subs.
This key is used to switch between the pre-substitution and post-substitution in the HDF, and HF
treatment modes.
CAUTION: In the pre-substitution, the SUB/BP speed rate to be monitored is fixed at 100%.
In the post-substitution, the SUB/BP speed rate to be monitored is set as each basic value.
OHDF flow aplicat

If the duplex interlock is valid in the OHDF treatment, the flow rate of the dialysate flowing through
the dialyser is not changed by the branched substitution fluid if the flow rate of the dialysate has been
preset at 500 mL/min.
Dialysate flow rate = Flow rate of dialysate flowing through dialyser
If the duplex interlock is not valid, the flow rate of the dialysate flowing though the dialyser is
decreased by the substitution fluid volume.
On-line HDF / On-line HF - 11 - Operating Instruction

DBB-05
1.6. Consumables

l On-line HDF/On-line HF system
Infusion line: EFL-015 with HDF filter

(once article)
1.7. Technical data
1.7.1. Water and dialysate used
Water used in a DBB-05 dialysis must have been deionized in a

WARNING reverse osmosis system and conform to the appropriate
standards (see below).
l Standards for water and dialysate quality
1 American National Standard for hemodialysis system

ANSI/AAMI RD5R-1992
2 Canadian Standard Committee
General standard No. 2
Sub standard Z364.2.1-M1986, September, 1987
3 DAB 10 VIII. 9
Water for dilution of concentrated hemodialysis dialysate, 1st edition, 1992
4 DIN VDE 0753 Part 4
l Water quality

Normal drink water is not applicable to the hemodialysis. Water must be treated through an appropriate
process for the hemodialysis. ( 3 and 4 )
l Dialysate quality

Exothermic load shall be 0.25EU/mL or less. ( 1 , 2 and 3 )
l Inspection results
When sampling, make unfailingly sure that a high level of sterility is ensured. Before each sampling, the
sampling port must be disinfected in accordance with specifications, and the sterile syringe must be sealed
airtight immediately after taking the sample. Make absolutely certain that the specified storage conditions
during transport (cooling) and the maximum storage period of the sample are maintained.

DBB-05

manual.
l TMP (In case of on-line HDF/on-line HF treatment, the values are changed as follows.)

Definition 1 (On-line HDF)
PBi + PBo PDi + PDo

2 2
Definition 2 (On-line HF)
PBi + PBo
TMP = − PDo − Offset
2


manual.
l Venous pressure
(In case of on-line HDF/on-line HF treatment, the values are changed as follows.)


(In case of on-line HDF/on-line HF treatment, the values are changed as follows.)


DBB-05
1.7.4. On-line HDF/On-line HF

when using the on-line HDF tube set with HDF filter which has been specially built.
Setting range: 0.00; 0.10 to 18.00* L/h (On-line HDF)

0.00; 0.10 to 30.00* L/h (On-line HF)
Flow rate accuracy: 10% of set value
NOTE In the on-line HDF/on-line HF operating mode, the second

pump is operated as a substitution fluid pump (PUMP 2);
therefore SN blood pump operation is not possible.
l Bolus substitution fluid

Bolus process: 0 to 500 mL
l Wash back

Wash back process: 0 to 500 mL
Max. wash back accumulation

DBB-05
BIC : Bicarbonate
BP : Blood pump
LF : Conductivity
DC : Direct current
HD : Hemodialysis
HF : Hemofiltration
SV : Solenoid valve

DBB-05
1.8.2. Symbols
Alternating current

Cd
Recycle battery
Ni-MH

DBB-05
Materials used
Metals
− Stainless steel
− Aluminum
− Copper
− Iron
− Brass
Plastics
− Silicone (SI)
− Fluoro rubber
− Polyimide(PI)

NIKKISO CO., LTD.,

DBB-05
2. Preparation
2.1. Preparation and priming of the substitution fluid line with HDF filter for
On-line HDF/On-line HF treatment
l Selection of treatment method On-line HDF/On-line HF

Treatment mode.

treatment mode.

(OHDF or OHF) pressed for at least 1.5
Treat. seconds.
data The activation of the treatment mode is
displayed by a color change of the pressed key.

Treatment substitution volume and substitution rate is
mode HD described in chapter 3.)
SN mode
OFF
ESC
HD HDF OHDF
ISO-UF
AFBF HF OHF

DBB-05
l Inserting the substitution fluid line with HDF filter

(PUMP 2) and insert the pump segment on the
pump's left side.
2. Turn the rotor lever clockwise to the right.
3. Insert the pump segment on the right side of the

substitution fluid pump (PUMP 2) and close the
cover.
Before priming the substitution fluid line with HDF filter,

CAUTION confirm that the correct composition of dialysate has been
prepared.

DBB-05
l Sampling
1. Touch the Dialysa. withdra. key in the KEYS

menu.
2. Connect a syringe without Lure-Lock connector

to the sampling valve.
The sampling valve is situated at the dialyser

inlet tube.
Do not use a hollow needle!

CAUTION
3. With the syringe, draw a dialysate sample.

After the syringe is removed, the valve closes
automatically.
4. Examine the dialysate sample for correct

composition.

DBB-05
l Connecting the substitution fluid line with HDF filter

fluid line with the check valve to the blood tube
set:
• for post-dilution
to the venous tube set
• For pre-dilution, connect the supply
connector to the chamber for measurement
of the inlet blood pressure (located in front
of the dialyser).
2. After completion of the DM test, the following

message is displayed on screen:
Connect substitution fluid line to port.
Connect the dialyser coupler to the dialyser after
priming and press Filling in dial. key.
3. As soon as this message is displayed, connect

the substitution fluid line to the on-line
connector of the DBB-05.
To ensure the sterility of the substitution fluid with the filter

CAUTION (EFL-015), take out the tube set from its package immediately
before priming, and then connect it to the DBB-05.
The connecting point with the on-line connector is to be

disinfected thoroughly!
The connection of the substitution fluid line to the substitution

CAUTION fluid port of the DBB-05 has to be performed with special care.
During treatment, watch for leakages.

DBB-05
l Filling the substitution fluid line
1. To air-bleed the HDF filter (one-way filter),

open the clamp at the filter's upper end.
2. Now press the [PUMP 2] key to fill the filter.
3. As soon as the filter is filled completely, close

the clamp of the HDF filter.
While closing the clamp, the substitution fluid

pump (PUMP 2) may continue to run without
interruption.
NOTE By closing the clamp at the upper end of the HDF filter,
substitution solution (on-line solution) is forced through the
filter membrane of the HDF filter whereby the connecting line
to the blood tube set is filled and rinsed.
Filling and rinsing volume are preset as basic values.
Therefore, the substitution fluid pump (PUMP 2) stops
automatically when it reaches the preset value.

DBB-05
2.2. Priming the blood circuit with on-line solution
NOTE Priming and rinsing of the blood tube set and the dialyser can
be performed with external saline solution during the DM test
or with on-line solution after completion of the DM test and
filling of the substitution fluid line with HDF filter.
Both processes can be executed manually as well as
automatically.
1. For priming the blood circuit with on-line

solution, connect the arterial tube set (patient
connector red) to the 3 way valve of the HDF
filter.
A) When using the automatic rinse program, the

substitution fluid pump (PUMP 2) starts
automatically as soon as you press the Priming
arterial or Priming venous key.
B) When priming the blood circuit manually, first

start the substitution fluid pump (PUMP 2),
then fill the blood circuit.
Make absolutely sure to stop the substitution

fluid pump (PUMP 2) manually after the rinse
process.
NOTE Before connecting the coupler of the dialyser, confirm that the
HD and blood tube sets have been completely rinsed by the
volume set as basic values.

DBB-05
2.3. Start-up test



DBB-05. It starts


completed.


DBB-05


setting.

remaining 4:00 mode OHDF
UF goal L SN mode
01.00 OFF
UF rate L/h
setting data 0.25
Conduct. profile
Substitution L .
goal 00.00
Substitution % Dialysate mL/min
ratio Sub/BP 30 flow rate 500
HP bolus mL
volume 1.5
-to OFF time 20
Return Connect
0
mL/min

DBB-05
3.2. Setting of the treatment data for On-line HDF/On-line HF
on-line HDF/HF.
Input of data can be performed by two different methods.

Depending on the selected data, certain limitations apply.

Substitution fluid goal, Substitution fluid rate, Substitution fluid ratio Sub/BP, Treatment time remaining

Treat. time
remaining 4:00 ⇒ Treatment time remaining
⇒ Substitution ratio Sub/BP
Substitution L
goal 00.00 to change them as applicable.
Substitution L/h
rate 00.00 On screen, a new windows for changing the
substitution fluid data opens.
Substitution %
ratio Sub/BP 30
2. To make a desired parameter valid, keep
relevant field pressed for 1.5 sec or longer.
ESC

remaining time
Emergent
substi. 4:00 14:00
0.00 L
UF rate
00.00 02.00 0.50

L L L/h
Substitution Substitution Substitution Substitution Substitution Substitution

ratio Sub/BP goal rate ratio Sub/BP goal rate
-- 00.00 00.00 30 --.-- --.--

% L L/h % L L/h

DBB-05
3.2.2. Inputting of data
l Input of substitution fluid goal if treatment time is already set
1. Activate the Substitution goal field.
remaining time
2. Enter the desired Substitution goal in the


ESC key.
ratio Sub/BP goal rate
By entering the Substitution goal, the DBB-05
calculates the Substitution rate reduction
-- 00.00 00.00 automatically.
% L L/h
Example:
Priority ⇒ Substitution goal
00.00L è 08.00L When changing the

Substitution goal from 00.00 L to 08.00 L, the

remaining time
4:00 14:00

-- 08.00 02.00
% L L/h

DBB-05
l Input of substitution fluid rate if treatment time is already set
remaining time

ESC key.
ratio Sub/BP goal rate By entering the Substitution rate, the DBB-05
calculates the Substitution goal reduction
-- 00.00 00.00 automatically.
% L L/h Example:
Priority ⇒ Substitution rate
When changing the

00.00L/h è 02.00L/h
Substitution rate from 00.00 L/h to 02.00 L/h,

remaining time
4:00 14:00

-- 08.00 02.00
% L L/h

DBB-05
l Input of treatment time if substitution fluid volume is already set
remaining time

ESC key.
ratio Sub/BP goal rate By entering the Treat. time remaining, the
DBB-05 calculates the
-- 08.00 02.00 Substitution rate reduction automatically.
% L L/h Example:
Priority ⇒ Substitution goal
When changing the

4:00 è 5:00

remaining time
5:00 14:00

-- 08.00 01.60
% L L/h

DBB-05
Example:
Priority ⇒ Substitution rate
remaining time
When changing the
4:00 14:00 DBB-05 automatically calculates a new

-- 08.00 02.00
% L L/h
4:00 è 5:00

remaining time
5:00 14:00

-- 10.00 02.00
% L L/h

DBB-05
l Input of substitution fluid ratio
1. Activate the Substitution ratio Sub/BP field.

remaining time
2. Enter the desired
4:00 14:00 Substitution ratio Sub/BP in the numeric field.
(Ratio of blood flow rate of blood pump 1 to
substitution fluid volume)

ratio Sub/BP goal rate ESC key.
30 --.-- --.-- Example:

Priority ⇒ Substitution ratio Sub/BP
% L L/h
When changing the
Substitution ratio Sub/BP from 30 % to 35 %,
30% è 35% Substitution rate and
Substitution goal ⇒ Total volume
Substitution rate =
Substitution ratio Sub/BP
Treat. time Complete × Blood flow rate
remaining time
4:00 14:00

35 --.-- --.--
% L L/h
NOTE When Substitution ratio SUB/BP has the priority, numeric
values of test parameters (substitution fluid rate and target
substitution fluid volume) are displayed at start of on-line
HDF/on-line HF treatment.

DBB-05
3.2.3. Setting the dialysate flow rate

Dialysate flow rate.
Dialysate C°


ESC key.
NOTE In the basic setting, the DBB-05 can be set in such a way that
upon completion of the rinsing process for the dialyser until
connecting the patient, a reduced dialysate flow is achieved.
NOTE In DBB-05, it is possible to automatically adjust the flow rate

for the on line HDF treatment.
This allows the dialysate to correctly flow through the dialyser
at a preset flow rate regardless of the on line fluid branched
previously.
(The setting is possible.)
NOTE It is possible to change DBB-05 (flow rate adjustment

ON/OFF) corresponding to the basic set values using the
OHDF flow aplicat key even during treatment.
To change the flow rate manually, it is absolutely necessary
that the OHDF flow aplicat key is invalid.
OHDF
flow
aplicat

DBB-05
4. Treatment


and blood pass
3. Blood viscosity

With this setting, a TMP alarm is likely to occur at a low UF
rate.
To avoid the TMP alarm, increase the UF rate after consulting
a physician for the correct setting, or carefully change the
lower limit for the TMP fixed alarm.

DBB-05
4.2. On-line HDF/On-line HF treatment
Make sure that the following conditions for on-line

HDF/on-line HF treatment are met:
1. The desired operating mode OHDF/OHF must

be activated.
2. The pump segment must be inserted free of air

bubbles in the substitution fluid pump (PUMP
2).
Make sure that the connectors to the blood tube set

CAUTION (pre-dilution or post-dilution) have been connected correctly
and the clamp in the inlet line is opened.
During the connection phase, watch for messages in the

CAUTION display's information window.
The “dialysate flow rate” through the dialyser in relation to the substitution fluid rate can be calculated
in 2 different methods as follows (On-line HDF):
1. OHDF flow aplicat key ⇒ OFF (passive)

By deactivation of the OHDF flow aplicat key, the DBB-05 calculates constantly a fixed dialysate
flow rate, independent of the substitution fluid rate.
That means, the flow through the dialyser is reduced by the substitution fluid rate.
Example:
Displayed Dialysate flow rate – Substitution fluid rate
= Dialysate fluid flow rate through the dialyser
[500mL/min] – [50 mL/min] = 450 mL/min
2. OHDF flow aplicat key ⇒ ON (active)

By activation of the OHDF flow aplicat key, the DBB-05 calculates the dialysate flow rate in
relation to substitution fluid rate.
That means, the dialysate flow rate through the dialyser is always the same than the displayed
dialysate flow rate. There is no flow-reduction by the substitution fluid rate.
Example of OHDF-treatment with substitution fluid-flow = 50mL/min:

Displayed Dialysate flow rate = Dialysate fluid flow through the dialyser
[500mL/min] = 500 mL/min (constant)

DBB-05
4.3. Bolus substitution fluid
1. For infusion of a substitution fluid bolus during

Emergent HDF/HF and on-line HDF/HF treatment , press
substi. the Emergent substi. key.
0.10 L The new Emergent sub. window opens on the
screen.
2. Before starting the substitution fluid bolus,

check the parameters in the Emergent sub.
Emergent sub. window.
ESC
Total subs.
volume 3. Touch the Start End key to start the substitution
fluid bolus.
0.00 The substitution fluid pump (PUMP 2) starts at
the indicated flow rate and infuses the
L substitution fluid volume which is displayed as
Substitution Substitution Substitution Substitution goal.
goal rate
volume Eiden the Auto. Set. Venous pressure alarm
width during bolus substitution fluid so that the
0 100 100 alarm is not given.
mL mL mL/min
To interrupt or abort the actual substitution fluid
bolus, you can press the
Start
End Start End key.
Confirm the Total subs. volume indication and be careful the

CAUTION patient weight when the bolus is used.
The following values are displayed in the Emergent sub. window.

Total subs. Substitution
⇐ Indicates the actual
volume ⇐ Total substitution fluid volume
substituted bolus volume of
amount during treatment
the currently running
0.00 0
substitution fluid bolus.
The following values can be changed in the Emergent sub. window:

goal ⇐ Setting of the target rate ⇐ Setting of the flow rate for
substitution fluid for a the substitution fluid bolus
100 substitution fluid bolus 100

DBB-05
Start


*Substitution line with HDF filter

*Dialysate filter

errors.

DBB-05
5. Disconnection
5.1. Blood return with on-line solution
1. Disconnect the arterial patient connector and

connect it to the 3 way valve of the on-line filter.
2. Open the 3 way valve of the on-line filter.
3. Press the [PUMP 2] key.
4. Start "arterial blood pump (PUMP 1)".
The arterial blood pump (PUMP 1) runs at the

blood flow rate set as basic value to reinfuse the
blood and to rinse the tube set with dialyser.
The flow rate of the 2nd pump [substitution

pump (PUMP 2)] adjusts automatically to the
flow rate of arterial blood pump (PUMP 1).
5. When the blood return volume reaches the level

preset as the basic value, the pump is stopped
automatically.
The blood pump can be stopped at any time
using the [PUMP 1] key. Additionally, after the
blood return is completed, press the [PUMP 1]
key to restart the pump.
6. Disconnect the venous patient connector.
• Since during the "detaching phase" the alarm limits are

CAUTION partially spread, the pressure during the blood return must be
monitored visually without fail.
• Be careful the patient weight when the wash back is used.
• Do not start draining the cartridge at the blood return phase.

DBB-05
5.2. Removal of the on-line HDF/on-line HF line
1. Close the clamp of the supply line at the on-line

HDF/on-line HF system.
2. Remove the luer-lock connector of the on-line

HDF/on-line HF line from the substitution port
of the DBB-05.
3. Disinfect the substitution port of the DBB-05.
4. Attach the screw plug to the substitution port of

the DBB-05.
NOTE Ensure aseptic conditions and make sure that the substitution
port is closed airtight.

DBB-05
6. Troubleshooting
Mode mismatch alarm (Substitution port)

Cause
Ø The port for the substitution solution is open.
ü Close the port for the substitution solution or correct the treatment mode.
Replace time of Dialysate filter

Cause
Ø The dialysate filter's maximum operating time of [750 hours] has been reached.
ü Replace the dialysate filter.
Substitution volume is not set yet

Cause
Ø No substitution volume has been set.
ü Set the substitution volume in the treatment data.
TFD214 Dialysate filter leak test NG

Cause
Ø The dialysate filter leak test has failed.
ü Check the dialysate couplers and confirm that the rinse bridge is correctly seated.
ü The buzzer is stopped by touching the Reset of test NG key inside the menu.
The OHDF/OHF operation can't be continued.

DBB-05

Software version Operation place o On-line HDF/HF


Observation:

User Manual DBB-05

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Manual No.

The CE mark was given in accordance with EC Cabinet

This manual is applicable to the equipment with

During the start-up test, the software version is

MEDICAL EQUIPMENT UNIT

8. Replacement of dialysate filter 8

Table of contents 1. General description

1.1. How to use this instruction manual 1-3

1.3. Precautions before trial run 1-6

1.5. Storage and transportation 1-10

1.6. Configurations and functions of mechanical

1.7. Description of bicarbonate dialysis 1-26

1.8. Description of extracorporeal blood circuit 1-32

1-1 Operating Instruction

1.9. Setting procedure 1-36

1.10. Maintenance and checks 1-53

1.11. Consumables 1-57

1.12. Technical data 1-60

1.13. Abbreviations and symbols 1-74

1.14. Environmental issues 1-76

Operating Instruction 1-2

1.1. How to use this instruction manual

Instruction for operation

This denotes immediate hazards which may result in SEVERE

This denotes hazards which may result in SEVERE PERSONAL

This denotes hazards which COULD result in product damage or

NOTE This denotes notice for operational safety.

1-3 Operating Instruction

1.2.2 Side effects

Not use potassium-containing hemodialysis concentrates for HYPERKALEMIA

UNCONTROLLABLE COAGULATION ANOMALIES

A different method of extracorporeal treatment may be indicated in HEMODYNAMICALLY

1.2.4. General description

Operating Instruction 1-4

The DBB-05 complies with the following standards:

The following accessories (Option) are available.

Any other peripheral parts may be used only if they comply

1-5 Operating Instruction

1.3. Precautions before trial run

The DBB-05 can only be operated under the following

l Electric power facility

The DBB-05 can't be used when a defibrillator is used on a

Operating Instruction 1-6

• Reorient or relocate the receiving device.

Accessory equipment connected to the analog and digital

Grounding reliability can only be achieved when the equipment

1-7 Operating Instruction

l Water and dialysate used

l Other important documents

Operating Instruction 1-8

1.4. Set-up instructions (Trial run)

2. Connect the drain connector of the DBB-05 to the drain facility.

3. Connect the DBB-05 to the mains power supply.

When draining dialysate, air accumulation, the reversed siphon

1.4.2. Trial run

1. Supply water to the DBB-05.

2. Check the following items.

3. Switch ON the DBB-05.