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DBB-06 - Technical Manual - ENG - 954en-R4

Nikkiso, manual técnico
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0% found this document useful (0 votes)
1K views

DBB-06 - Technical Manual - ENG - 954en-R4

Nikkiso, manual técnico
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 294

Manual No.

954en-R4

Technical Manual
DBB-06

2016-05

Issuance
NIKKISO CO., LTD.

DBB-06 Electronic Manual Technical Manual 954en-R4


1611
This manual is applicable to DBB-06 using software version 2.0.

The software version will be displayed during the start-up test.

This manual is protected by copyright, and all rights are reserved by NIKKISO CO., LTD.
Do not copy any part of this manual in any form such as paper or electronic without written
permission of NIKKISO CO., LTD.

Manufacturer: NIKKISO CO.,LTD.


20-3, Ebisu 4-Chome, Shibuya-ku, Tokyo 150-6022, Japan
Telephone : +81-3-3443-3727
Telefax : +81-3-3470-0681

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954en-R4 Technical Manual No.954en-R4
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Table of contents
Section Page
1. General description
1.1. How to use technical manual 1-1
1.2. Abbreviation and symbols 1-3
1.3. Introduction 1-10
1.4. Configuration and function of mechanical components 1-13
1.5. Screen description 1-20
1.6. Technical data 1-24

2. Hydraulic circuit
2.1. Block diagram 2-1
2.2. Explanation of flow diagrams 2-2

3. Electrical system
3.1. Microcomputer system 3-1
3.2. Power supply system 3-4
3.3. MAIN P.C.B. voltage monitoring system 3-12

4. Installation
4.1. Unpacking and visual inspection 4-1
4.2. Precautions before installation 4-1
4.3. Installation 4-4
4.4. Installation check list 4-6

5. Maintenance
5.1. PM kit 5-1
5.2. Maintenance with technical safety inspection 5-8

6. Setting
6.1. Classification 6-1
6.2. Table of setting 6-3

7. SERVICE-MODE
7.1. General instruction 7-1
7.2. Table of SERVICE-MODE 7-4

8. Self-tests
8.1. Computer tests 8-1
8.2. Blood monitor tests 8-2
8.3. Dialysate monitor tests 8-10

9. Troubleshooting
9.1. General description 9-1
9.2. Messages(See also Operator’s manual Chapter 7) 9-1

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Appendix A Required tools

Appendix B Flow diagram

Appendix C Required action after replacement

Appendix D Circuit diagram

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1. General description

1. General description
1.1. How to use technical manual
 Scope of the technical manual

This technical manual provides specific information for installation, maintenance and repair of the
DBB-06 and is not intended to describe the operation nor the treatment of patient.
The operator’s manual must be read completely prior to the operation DBB-06.

This technical manual is intended to be read and used by trained techncial staff who have the
following qualifications or preconditions.
 Read operator’s manual completely.
 Basic dialysis knowledge
 Basic technical knowledge
 Attend NIKKISO CO., LTD’s basic technical training course and qualified for maintenance,
repair.

Do not attempt to modify or alter the DBB-06. A modified or altered DBB-


06 may result in serious or fatal patient injury and damage to the DBB-06.

Installation, adjustment and repair of the DBB-06 must be performed only


by trained technical staff. Failure to do so may result in device
malfunctions and improper treatment, resulting in serious or fatal patient
injury.

Inspection and preventive maintenance must be performed prior to use.


Failure to perform required inspections and preventive maintenance may
result in device malfunction, which can cause serious or fatal patient
injury during treatment.

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1. General description

 Safety Messages

The following symbols cautions identify special cautionary measures that shall be implemented
before operation and starting treatment, as well as during and following treatment. The warning,
cautions and notices in this manual indicate possible hazards regarding operational safety and
should be read carefully before starting operation.

Symbol Description

DANGER indicates a hazardous situation which, if not avoided, will


result in death or serious injury.

WARNING indicates a hazardous situation which, if not avoided, could


result in death or serious injury.

CAUTION indicates a hazardous situation which, if not avoided, could


result in minor or moderate injury.

NOTICE is used to address practices not related to personal injury.

 Spare parts used in the DBB-06

 Spare parts are specified in the parts list.


 Only parts approved by Nikkiso shall be used.
 Spare parts can be ordered at NIKKISO CO., LTD. or local representative.

 Other important documents

NIKKISO CO., LTD. will deliver circuit diagrams, operation manuals, spare parts list, and other
documents at the customer’s request. These documents may assist the personnel servicing and
maintaining the components of the DBB-06.
Additionally, testing procedures to verify sterilization and disinfection can also be provided upon
request.
Data is available upon request, for the recirculation of blood in the extracorporeal circuit for single
needle dialysis when the recommend bloodline set, dialyzer, fistula needles, and catheters are
used.

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1. General description

1.2. Abbreviation and symbols


1.2.1. Abbreviation

A,Art : Arterial

AC : Alternating current

A/D : Analog / Digital

AP,Art : Arterial pressure

BFR : Blood flow rate

BM test : Blood monitor test

BP : Blood pump

BLD : Blood leak detector

BPM : Blood pressure monitor

BV : Blood volume

BVM : Blood volume monitor

BV-COC : Blood volume conductivity control

BV-UFC : Blood volume ultrafiltration rate control

C.CPU : Control CPU

CCS : Central concentrate supply system

CL : Conductivity cell

CP1 : Deaeration pump

CP2 : Booster pump

CV : Check valve

dBV : Relative blood volume change

DC : Direct current

DDM : Dialysis Dose Monitor

DH : Dialysate heater

DI : Dialyzer inlet

DIA : Diastolic blood pressure

DIP : Dialyzer inlet pressure

DM test : Dialysate monitor test

DP : Duplex pump

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1. General description

FL : Filter

FR : Flow restrictor

GC : Gas separator chamber

HD : Hemodialysis

HEX : Heat exchanger

HP,Hep : Heparin pump

H1 : Back pressure valve of duplex pump supply side

H2 : Back pressure valve of duplex pump drain side, ultrafiltration pump

H-C1 : Back pressure valve of bicarbonate concentrate pump

H-C2 : Back pressure valve of acid concentrate pump

ISO-UF/I-UF: Isolated ultrafiltration

I.CPU : Interface CPU

I/O : Input / output

L : Relief valve L

LVS : Level switch

LAP Level adjust pump

MAP : Mean arterial pressure

MC : Mixing chamber

PC : Personal computer

P.CPU : Protection CPU

PRV : Pressure reducing valve

PM kit : Preventive maintenance kit

PT : Pressure transducer

RV1 : Relief valve 1

Rx : Prescription

SPA : Acid concentrate pump

SPB : Bicarbonate concentrate pump

SN : Single needle dialysis

SN-KK : Single needle dialysis (click-clack method)

SSR : Solid state relay

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1. General description

SV : Solenoid valve

SYS : Systolic blood pressure

TH : Thermistor

THS : Thermostat

TMP : Transmembrane pressure

Tx. : Treatment

UF : Ultrafiltration

UFK : Ultrafiltration coefficient

UFP : Ultrafiltration pump

URR : Urea removal ratio

V,Ven : Venous

VP,Ven : Venus pressure

1.2.2 Glossary
Alarm limit: The value at which the alarm is triggered

Auto alarm limit: The value at which the auto alarm is triggered. This limit is set based
on the current level (current level +/- alarm limit). This monitor
become active 30 or 120 sec (Factory default) after treatment is
started.

Blood monitor test: The part of the start up test which check the function of
extracorporeal circuit.

Central concentrate supply system:


The system which supply the acid concentrate to the bed side
instead of acid container, and can be connected to central
concentrate supply port (optional) of DBB-06. (See Operator’s
manual Fig. 1.13)

Clinic default setting: Clinic default settings are changes that have been made in setting 1,
setting 2 and the treatment data base to change operational
procedures and actions of the DBB-06 specific to each clinic’s
established procedures which may differ from the factory default
settings. Clinic default setting can be changed only by trained
technical staff and trained head nurse.

Computer test: The part of the start up test which check the function of
microcomputer computer system.

Concentrate: The concentrated solution which forms dialysate when diluted with
treated water.

Concentrate connector: The part of DBB-06 that attaches to the concentrate container for
intake of the concentrate.

Dialysate monitor test: The part of the start up test which check the function of hydraulic
circuit.

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1. General description

Dialyzer coupling: The connector that is connected to the dialyzer and delivers dialysate
to dialyzer and returns spent dialysate from dialyzer.

Extracorporeal circuit:: The part of DBB-06 which controls and monitors the blood flow. (See
Operator’s manual Sec. 1.5.1)

Factory default setting: The settings in setting 1, setting 2, and the treatment database when
DBB-06 is shipped from the factory.

Fixed alarm limit: The value at which the fixed alarm is triggered. This monitor is active
at all times from connection to disconnection.

Heamodialysis: The treatment method which removes the wast product and water
from blood, and maintein electorode and pH by using ultrafiltration,
difusion osmotic pressure.

Hydraulic circuit: The part of the DBB-06 which controls the treated water, concentrate,
and dialysate. (See Operator’s manual Sec. 1.5.2)

Isolated ultrafiltration: Ultrafiltration without dialysis. Fluid removal without diffusion.

Key pad: The key pad that can be displyaed on the screen has 10 numeric
keys (numbers 0 through 9) and is used to input numeric parameters.
(See Oprator’s manual Sec.4.1.1)

Kt/V: Kt/V is the relative indicator of treatment adequacy based on the


amount of urea removed in dialysis session.
At the DDM Kt/V is measured based on UV absorbance change of
spent dialysis fluid which is closely correlated with BUN change. (See
Sec 12.1.3.)

Maximum setting range (auto alarm):


The range for setting the auto alarm upper limit. If the auto alarm
upper limit is higher than the maximum setting range, the auto alarm
will be triggered at the maximum setting range (auto alarm). (See
Operator’s manual Sec. 1.7.4)

Minimum setting range (auto alarm):


The range for setting the auto alarm lower limit. If the auto alarm
lower limit is less than the minimum setting range, the auto alarm will
be triggered at the minimum setting range (auto alarm). (See
Operator’s manual Sec. 1.7.4)

Profile: The fuction which program the ultrafiltratioin (UF) rate, total
conductivity and bicarbonate conductivity of the treatment. (See
Operator’s manual Sec. 9.1)

Reminder: The information which the DBB-06 gives to the operator for actions
that should be taken. (e.g. that the operator should turn on the blood
pump.)

Rinse port: The part of DBB-06 which concentrate connector is connected for
cleaning.

Trained head nurse: Nursing staff who have successfully completed operational training
on the DBB-06 by NIKKISO CO., LTD, and have HN password.

Trained operator: Clinical staff who have successfully completed operating instructions
on the DBB-06 by trained technical staff or trained head nurse.

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1. General description

Trained technical staff: Technical staff who have successfully completed technical training by
NIKKISO CO., LTD and have TK password.

Treated water: The water has been treated using a reverse osmosis system and/or
other appropriate water treatment method and conform appropriate
standard. (See Sec. 1.6.5)

Treatment database: The treatment database contains settings such as treatment


conditions and alarm limits that can be changed by the operator for
one treatment. These changes are overwritten by the factory setting
or the clinic default setting for the next patient during the start up test.
The operator is prevented from making any changes in the treatment
database that is not within the operational conditions set as a factory
default or clinic default.

Ultrafiltration: The process by which water (with electrolytes) moves across the
dialyzer membrane from the blood side to the dialysate side as a
result of transmembrane pressure (TMP) and oncotic pressure
between the blood and dialysate. Blood cell and solutes of high
molecular weight are retained, while water and low molecular weight
solutes pass through the dialyzer membrane.

Ultrafiltration coefficient:: Dialyzer performance that shows UF rate (mL/h) at 1 mmHg TMP.

Urea reduction ratio: Urea reduction ratio is the relative indicator of treatment adequacy
based on the amount of urea removed in dialysis session.
At the DDM Urea reduction ratio is measured based on UV
absorbance change of spent dialysis fluid which is closely correlated
with BUN change. (See Sec 12.1.3.)

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1. General description

1.2.3. Symbols

Emphasizes information or tips related to operation and performance of


the DBB-06.

IPX1 Protection against dripping water

Degree of protection against electric shock (Hydraulic unit)


: Type B Applied part

Degree of protection against electric shock (Blood pressure cuff)


: Defibrillation-proof Type BF Applied part

Date of manufacture

SN
Serial number

Alternating current

Protective ground terminal (Grounding)

ON (Turns the power to the DBB-06 on)

OFF (Turns the power to the DBB-06 off)

ON (Main power switch)

OFF (Main power switch)

Do not dispose of the equipment as general waste.

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1. General description

Recycle the batteries


Ni-MH

Potential equalization conductor

Outlet for external status display

Alarm output outlet (staff call)

Alarm input outlet

Nurse call outlet

Output outlet for external equipment

Network outlet

ESD (Electrostatic Discharge) warning

Blood pressure cuff

Water supply

Drain

Battery operation switch

RS-232 interface

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1. General description

1.3. Introduction
1.3.1. Indication for Use

The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by


physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis
clinics by qualified operators.
The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not
for home use.

1.3.2. Side effects


Nausea, vomiting, hypotension, hypertension, spasms, hypovolemia, hypervolemia and related
symptoms, headache, cramping or other muscular discomfort are occasionally caused by dialysis
treatment in some patients. Itching, hypothermia, hyperthermia, anxiety disorders, convulsions,
seizure, and other neurologic symptoms may also be observed in some patients. These
symptoms are thought to occur due to inadequate treatment such as excessive water removal or
electrolyte imbalance. In addition, more serious complications such as hemorrhage, air embolism,
acidosis, alkalosis or hemolysis, can cause serious patient injury or death. The patient’s blood
pressure and general physical conditions must be closely monitored during dialysis treatment.
Proper monitoring of dialysis treatment and patients’ conditions can reduce the risk of these
physiological reactions or complications. Of particular importance is the control of the patient’s
serum potassium level to prevent cardiac dysrhythmia and the patient’s blood clotting time to help
prevent clotting abnormalities.

Aseptic technique must be used for all blood circuit connections. Infections or pyrogenic reactions
may result from contamination of the extracorporeal circuit or inadequate procedures used to
reuse dialyzers, which can cause serious or fatal patient injury.

Pyrogenic reactions may also result from contamination of the hydraulic circuit which can cause
patient injury. The AAMI standards for water and dialysate solution for dialysis treatment (See
Sec. 1.6.5) must be observed. A regular program for disinfection and testing of the water
treatment system, piping, inlet lines, filters, concentrate feed containers or system, and the
dialysate delivery machine must be established and followed. This program will vary from facility
to facility.

Allergic reactions or serious complications may result from residual chemical disinfectants in the
hydraulic circuit, which can cause serious patient injury or death. Chemical disinfectants are used
for dialyzers disinfection, machine disinfection, or for disinfection of water treatment and
distribution systems. All dialysis treatment must be started after using sufficient procedure to
remove or maintain the residual chemical disinfectants at acceptable levels.

All tubes and connections must be secured and closely monitored to prevent loss of blood or
entry of air into the extracorporeal circuit or errors in the ultrafiltration control system. The patient
may require blood transfusion or other medical intervention to prevent respiratory or cardiac
disorders if these occur.

These instructions are for the DBB-06 hemodialysis machine. The machine must only be used in
accordance with these instructions. All operators of this machine must be thoroughly trained and
have read this entire manual and any applicable appendices before using the machine. Improper
care/use of this machine may cause serious patient injury or death.

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1. General description

1.3.3. Contraindications
The DBB-06 is not designed or intended for use except as indicated and there are no absolute
contraindications to hemodialysis. Many patients are taking medicinal therapy prescribed by their
physicians. Some of the medication may be removed from patient’s blood during dialysis
treatment and the therapeutic level in the blood may be lowered, therefore the prescribing
physician should consider the appropriate dosage of the medicine to maintain the desired medical
response in the patients. The parameters of dialysis treatment should be optimized for each
patient to help prevent patient’s physiological reactions or complications. Anticoagulants may be
required to help prevent blood clotting in an extracorporeal circuit.

Regarding the use of an optional blood pressure monitor, peripheral circulation problem, severe
arrhythmia, ectopic beats, convulsions, Spasms tremors, tachycardia and/or use of a heart lung
machine are generally accepted contraindications for using a timed automatic blood pressure
instrument utilizing the oscillometric principle. This is a guide only. Final determination of the
suitability of any medical instrument for use with any patient is the full responsibility of the treating
physician.

1.3.4. General description

Dialysis can be performed using the DBB-06 without any additional hardware units.
The DBB-06 consists of a hydraulic circuit for the dialysate (See Operator’s manual Sec. 1.5.2)
and an extracorporeal blood circuit (See Operator’s manual Sec. 1.5.1.).

The treated water is heated and deaerated in the hydraulic section. The deaerated water is then
mixed with the concentrate and fed into the dialyzer via the dialysate filter and the dialysate
supply connector.

Duplex pump supplies and drains same amount of dialysate to and from the dialyzer.
On the duplex pump drain side, the UF pump drains the amount of dialysate which is ultrafiltrated
from the patient's blood plasma through the dialyzer.

The interior pressure of the dialyzer is automatically defined based on the treatment data that is
entered.

It is possible to heparinize the extracorporeal blood circuit before it enters the dialyzer using the
heparin pump (HP), either continuously or with a single injection.

The extracorporeal blood circuit is monitored by pressure sensors and air, blood, and bloodline
detectors.

The DBB-06 can be set up for both acetate dialysis and bicarbonate dialysis. (See Operator’s
manual Sec. 3.2.2.)

The conductivity profile and the UF profile can be programmed using the variable function of the
DBB-06. (See Operator’s manual Sec. 9.1.)

The basic version of the DBB-06 incorporates all of the functions necessary for double needle
dialysis as well as for single needle dialysis (click-clack method) (SN-KK). (See Operator’s
manual Sec. 1.6. and 9.2.)

The hydraulic circuit of the DBB-06 can be cleaned and disinfected using a selectable cleaning
program. (See Operator’s manual Chapter 6.)

The DBB-06 is equipped with the protective systems and features to help ensure patient safety
and correct operation.

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1. General description

The DBB-06 complies with the following standards:


 ANSI/AAMI RD52 (2004)
 IEC 60601-1, ED.1.0 (1995)
 IEC 60601-1-2, ED.3.0 (2007)
 IEC 60601-2-16, ED2.0 (1998)

Please ensure that the automatic start-up test has been completed before beginning the
treatment.

The following accessories (optional*) are available.

 SN-KK with arterial clamp* (See Operator’s manual Sec. 9.2.)


The patient with catheter or only one needle can be treated.
 Blood volume monitor (BVM)* (See Operator’s manual Chapter 11.)
The patient’s Blood Volume (BV) can be measured to help prevent treatment complications.
(e.g. hypotension)
 Kt/V calculator function* (See Operator’s manual Sec. 9.3.)
The estimated and actual patient Kt/V can be calculated from treatment parameters and
patient and dialyzer information.
 Blood pressure monitor (BPM)* (See Operator’s manual Chapter 10.)
The patient blood pressure can be measured.
 Level adjust pump* (See Operator’s manual Sec. 1.7.5.)
The chamber level of each drip chamber can be adjusted.
 Dialyzer inlet blood pressure (See Operator’s manual Sec.1.9.9.)
The internal pressure of a blood circuit can be measured.
 Hep (syringe type: 30mL, 20 mL or 10 mL) (See Operator’s manual Fig. 1.9)
Different type of syringe can be used.
 Dialysate filter holder* (See Operator’s manual Fig. 1.2)
Dialysate is filtrated before dialyzer for purification.
 Bicarbonate cartridge holder* (See Operator’s manual Fig. 1.2)
Bicarbonate cartridge can be used.
 Central concentrate supply* (See Operator’s manual Fig. 1.13)
Acid concentrate from central concentrate supply system can be used.
 Concentrate connector cleaner* (See Operator’s manual Fig. 1.12)
Concentrate connectors are cleaned in cleaning program.
 External status display (See Operator’s manual Fig. 1.2)
States of DBB-06 (alarm, normal, complete and nurse call) is displayed.
 Alarm output (Staff call)* (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
Output signal (normal, alarm, complete, nurse call, reminder and RO) is output.
 Alarm input* (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
This input signal is not used.
 Nurse call* (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
Audible buzzer sounds, external states display is lit and alarm output signal is output when
nurse call switch is pressed.
 Output for external equipment (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
This output signal is not used.
 RS232 interface1 (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
BV data can be output, maintenance data can be input and output.
 RS232 interface2 (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
Computer network can be connected.
 Network* (See Sec. 1.6.7., Operator’s manual Fig. 1.5)
Computer network can be connected.
 Alarm output conversion box* (See Sec. 1.6.7.)
Conversion box can be connected to Alarm output (staff call), if used voltage does not meat
specifications of alarm output (staff call).

Accessories not listed above may only be used if they have been tested
and approved for operation and compliance with all applicable standards
by NIKKISO CO., LTD. Use of unapproved accessories may result in
serious or fatal injury to the patient and damage to the DBB-06.

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1. General description

1.4. Configuration and function of mechanical components

In this section only internal mechanical components in the DBB-06 are described.
See Operator’s manual section 1.5. Configuration and function of mechanical
components for other mechanical components.

1.4.1. Electrical section (Inside of monitor)


Fig. 1.1

Inverter
[P11-209B00]

Speaker

LCD connection
PCB
[X71-283Z00]
Auto response
sensor

1.4.2. Front side


Fig. 1.2

Distrbution DC PowerPCB
[X71-263Z00]

Battery
[B17-073B01]

BPM controller Brushless motor 4 PCB


[C16-085A00] [X71-093Z00]
(optional)

Power unit

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1. General description

1.4.3. Electrical section (Inside of front door)


Fig. 1.3

LAP BP

PT15

PT13 From left to right:


SV54, SV52, SV51

DDM PCB
Distribution PCB [X71-262Z00]
[X71-227Z00]
PT12
Air detector PCB
[X71-109Z00] PT11

PT16
Venous clamp
Air detector Syringe detector switch
Bloodline detector
Blood detector Arterial clamp
(optional)

HP motor

HP Red rinse port Blue rinse port

1.4.4. Power unit


Fig. 1.4

Ground L N Ground L N

Power Heater1

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1. General description

Fig. 1.5
2

4 3 2

16 9 20 11

8 1 10 2 1 1
1

P3 (Battery) P6 (DC output) P7 (DC output)


1 Battery + 1 +24 VDC Output 1 +5 VDC Output
2 Battery - 2 +24 VDC Output 2 +5 VDC Output
3 Battery + 3 +24 VDC Output 5 +12 VDC Output
4 Battery - 9 Battery Output 8 -12 VDC Output
P4 (Fan 1) 10 Battery Output 9 +5 VDC Output
1 Fan 1 power 11 +24 VDC Output 10 +5 VDC Output
2 Fan 1 GND 12 +24 VDC Output 13 +12 VDC Output
P5 (Fan 2) 13 +24 VDC Output 16 -12 VDC Output
1 Fan 2 power 19 Battery Output Power GND is except above.
2 Fan 2 GND 20 Battery Output
Power GND is except above.

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1. General description

1.4.5. Electrical section (rear side)


Fig. 1.5

Connector
plate
[X71-226Z00]

Main PCB
[X71-287Z00]

Main memory
Date memory
[X71-281Z00]
VR1 to 3
Test pins
LEDs Dip switches
(See below) Battery
LEDs
(See below)

BV P.C.B.
[X71-087Z00]
(optional)

VR3

Power
failure
buzzer
L28 LED

L31
TP64 (3.3V) LED
L27 LED

VR1

TP60 (DG)
Battery
(clock)
Variable register
VR1 BLD test
VR3 BD(venous)
Test pins
TP60 DG LED on Main PCB
TP64 3.3 V L27 lights when venous clamp is on
L28 lights when arterial clamp is on
L31 lights when P-CPU closes venous clamp.
L31 does not light when C-CPU closes
venous clamp.

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1. General description

1.4.6. Hydraulic section (front side)


Fig. 1.6
Back pressure valve 2(H2) TPT5 SV6 SV5

Back pressure
valve 1(H1)
PT3

TPT4

TPT3
SV42

Duplex pump UFP

MC2
Blood leak
detector
MC1
TH5 TH6 TPT2

PT2

SV64
Conductivity cells
From left side: SV63
CL1,CL2,CL3,CL4
TH11
SV2
DDM

SV8 GC2

Relief valve (L)


H-C1

TPT6
H-C2

SPB SPA CP1 CP2

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1. General description

1.4.7. Hydraulic section (right side)


Fig. 1.7

SV5 behind SV6

SV4 SV7

TH4

SV41
(optional)

TH3

SV66 (optional)
SV68 (optional)
SV65 (optional)

SV67 (optional) SV69 (optional)

TH2
TH1
THS

SV21,SV22

DH
HEX

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1.4.8. Hydraulic section (left side)


Fig 1.8

SV61 (optional)
SV70 (optional)
SV62 (optional)
SV42 (optional)
FL41 (optional)

GC1

SV2 behind SV8

PRV

Water supply
tube connector

Drain tube
connector
SV1 SV3 TPT1 PT1

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1. General description

1.5. Screen description


1.5.1. Functional description of the menu bar

In this section additional keys which are only displayed with the password are
described. (See Operator’s manual Sec. 1.7.1)

TK HN FUNCTION MONITOR OPERATOR PATIENT GRAPHIC

PREPARATION

TREATMENT

CLEANING

SERVICE-MODE

TK
Touch and hold the TK key to display the keypad to enter TK password. The TK key turns red
TK
when password is entered. The keys with are displayed only when the TK key is red.

HN
Touch the HN key to display the keypad to enter HN password. The HN key turns red when
HN
password is entered. The keys with are displayed only when the HN key is red.

FUNCTION
Touch the FUNCTION key to display PREPARATION, TREATMENT, CLEANING and
SERVICE-MODE keys.

SERVICE-MODE ( TK )
Touch the SERVICE-MODE key to display SERVICE-MODE screen. (See Chapter 7)

When opening the SERVICE-MODE, the DBB-06 has to be in standby and not the
bypass alarm.

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TK HN FUNCTION MONITOR OPERATOR PATIENT GRAPHIC

KEYS

ALARM LIMITS

SETTING 1

SETTING 2

TREATMENT

OPERATOR
Touch the OPERATOR key to display KEYS, ALARM LIMIT, SETTING 1, SETTING 2 and
TREATMENT keys.

SETTING 1 ( TK , HN )
Touch SETTING 1 key to display Setting 1 screen. (See Chapter 6)

SETTING 2 ( TK , HN )
Touch SETTING 2 key to display Setting 2 screen. (See Chapter 6)

TREATMENT ( TK )
Touch TREATMENT key to display Treatment screen. (See Chapter 6)

TK HN FUNCTION MONITOR OPERATOR PATIENT GRAPHIC

PAT.-SELECTION

PAT.-ADJUST.

PATIENT
Touch the PATIENT key to display the PAT.-SELECTION, PAT.-ADJUST. key.

PAT.-ADJUST. ( TK , HN )
Touch the PAT.-ADJUST. key to display Patient adjustment screen. (See Chapter 6)

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1. General description

1.5.2. Description of keys

In this section additional keys which are only displayed with red TK password are
described. (See Operator’s manual Sec. 1.7.3)

Fig. 1.9
1st page

2nd page

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In the keys screen the Second page can be displayed only when the TK key is red.
Touch ▼ key in the keys screen to display the Second page.

Description of key functions

Test reset
Touch the Test reset key to reset the following alarms. The TK password is required to reset
following alarms. (See Sec. 9.2.4)
TFD 320 SV4 leak alarm (quantity)
TFD 321 SV5 leak alarm (quantity)
TFD 322 SV6 leak alarm (quantity)
TFD 323 SV7 leak alarm (quantity)
TFD 324 SV8 leak alarm (quantity)

Touch and hold the Test reset key to reset the following alarm. SERVICE MODE, 17. Option
17.17. Dialysate filter test reset has to be used to skip the following alarms. (See Sec. 9.2.4)
TFD 214 Dialysate filter leak test failed
TFD 216 SV41 test failed
It is possible to continue treatment after resetting the alarms.

D-flow select
Touch and hold the D-flow select key to change the dialysate flow. Dialysate flow is reduced
when D-flow select is ON.
In dialyzer rinse mode it is automatically turned ON. (See Operator’s manual Sec. 3.5.4)

UFC Off
Touch and hold the UFC Off key to open/close SV7. If SV7 is open UF rate is not controlled.

To reduce the risk of serious or fatal patient injury from unexpected UF,
do not use the UFC Off key during treatment when the patient is
connected to the dialyzer via the bloodline.

TMP initial.
Touch and hold the TMP initial. key to measure TMP zero calibration value and Initial UFK.

BLD initial.
Touch and hold the BLD initial. key to start BLD initialization.

manual DM test
Touch the manual DM test key to display keypad. Enter the desired DM step to perform DM
test manually.
Manual DM test can be performed only after all DM test is passed.
DM steps: (See Sec. 8.3.1)
Step 1: DM1-19, 51 Dialysate pressure transducer test
Step 2: DM20-24, 51 UF pump test
Step 3: DM25-34, 51 Dialysate filter leak test
Step 4: DM35-38, 51 Heater cut relay test
Step 5: DM39-42, 51 Balance test
Step 6: DM43-51 SV leak test
Step 7: DM1-51 All DM test

BLD test
Touch the BLD test key to start blood leak detector test. BLD test is automatically performed
during DM test. (See Sec. 8.3.1)

BLD Offset manual


Touch the BLD Offset manual key to offset BLD. BLD Offset has to be performed before BLD
voltage adjusting in SERVICE-MODE. (See Sec. 7.2)

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1. General description

1.6. Technical data


1.6.1. Dimensions and weight

 Dimensions

Height: 142 cm (56 in)


Width: 39 cm (16 in)
Depth: 48 cm (19 in)
Base: 55 cm (W) 70 cm (D), (22 in [W] x 28 in [D])

 Weight

Standard system: Approximately 75 kg (166 lb)


System with all options: Approximately 85 kg (188 lb)

1.6.2. Electric safety (Classified according to IEC60601-1)

 Type of protection against electric shock

Class I equipment

 Degree of protection against electric shock(Hydraulic circuit)

Type B Applied part Symbol:

 Degree of protection against electric shock (Blood pressure cuff)

Defibrillation-proof Type BF Applied part Symbol:

 Degree of protection against ingress of water

Protection against dripping water Symbol: IPX1

 Degree of safety of application in the presence of a flammable anesthetic mixture with


air or with oxygen or nitrous oxide

To reduce the risk of serious or fatal injury from fires, never use the DBB-
06 in the presence of flammable anesthetic or gases, such as high
pressure oxygen room or oxygen tent.

This equipment is not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.

 Mode of operation

Continuous operation

 Rating label (See Sec. 1.2.3.)

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1.6.3. Electrical power supply

Ground reliability can only be achieved when the DBB-06 is connected to


an equivalent receptacle marked “Hospital only” or “Hospital grade”
according to UL60601-1 57.2.
The leakage current may exceed the allowable limits, if the DBB-06 is not
connected to the appropriate receptacle, which can result in the risk of
electric shock.

To reduce risk of serious or fatal patient or operator injury from electric


shock, never use any adapter that does not connect properly to the
grounding cable.

To reduce the risk of serious or fatal patient injury from electric shock,
always connect potential equalization terminal to the potential
equalization when a patient with central venous catheter is being treated.

 Line voltage

115 V Alternating current (AC), 10 %, 50/60 Hz ±1Hz


120 V Alternating current (AC), 10 %, 50/60 Hz ±1Hz

Rated power input


1.38kVA

 Current

12.5 A (115 V AC)

 Operating current

Dialysis: 8 A Max. (115 V AC)


(at water temperature: 5 C (41 °F), dialysate temperature:
37 C (98.6 °F) and dialysate flow: 500 mL/min)

Heat disinfection: 12 A Max. (115 V AC)


(at hot water circulation temperature: 90 C (194 °F) (heater
outlet) and hot water circulation flow rate: 800 mL/min)

 Battery

Type: Nickel-metal hydride battery (Ni-MH battery)


Capacity: 24 V/1.9 Ah

Battery is to be disposed of according to the applicable federal, state and


local laws and regulations. Failure to follow these instructions may result
in groundwater contamination and/or a fine from governing authorities.
Consult NIKKISO CO., LTD. or its local representative for disposal.

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1.6.4. Operating conditions (Delivery system)

To reduce the risk of minor or moderate patient injury / illness from


infection the following measures must be taken:
- an air gap must be provided between the DBB-06 drain line and the
main drain port to help prevent back siphoning and possible
contamination,
- one way valve must be provided between the DBB-06 and water
supply system to prevent back flow into the water supply system,
in accordance with the applicable federal, state and local laws and
regulations.

 Water supply

Pressure range of water supply: 100 to 700 kPa (15 to 101 PSI)
Temperature range of water supply:
Minimum: At low voltage: 8 °C (47 °F) (500 mL/min)
At normal voltage: 5 °C (41 °F) (500 mL/min)
10°C (50 °F) (600 mL/min)
15°C (59 °F) (700 mL/min)
20°C (68 °F) (800 mL/min)
Maximum: 30 C (86 °F)
Minimum flow rate of water supply: 800 mL/min average

 Drain

Minimum drain capacity: 800 mL/min average


Drain height: Maximum 50 cm (20 in)

The main drain line should have the gradient, and the height of the drain port should
be lower than the dialyzer and not exceed a maximum height of 50 cm (20 inches).

 Concentrate supply

Inlet pressure: 0 to 50 kPa (0 to 7 PSI)

Do not exceed maximum pressure of 50 kPa (7 PSI) to help avoid conductivity


fluctuations, especially with a central concentrate supply.

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 Electromagnetic emission and immunity

To reduce the risk of minor or moderate patient injury from DBB-06


malfunction, never operate devices that cause electromagnetic
interference, such as mobile phones or CB wireless transmitters in the
vicinity of the DBB-06 during operation.
The use of any devices that emit electromagnetic waves in the vicinity of
the DBB-06 may cause a DBB-06 malfunction.

To reduce the risk of minor or moderate patient injury from other device
malfunctions, the users must try to correct the interference by using the
following measures if the DBB-06 causes harmful interference with any
other devices, which can be determined by turning off and on the DBB-
06:
 Reorient or relocate the device receiving interference.
 Increase the distance between the devices.
 Connect the DBB-06 to an outlet on a different circuit from that of the
other devices.
 Consult the NIKKISO CO., LTD. or its local representative.
The DBB-06 has been tested and found to comply with the limit for
medical devices according to the IEC 60601-1-2:2001.
These limits are designed to provide a reasonable protection against
harmful interference in a typical medical facility. The DBB-06 generates,
uses, and radiates radio frequency energy, which may cause harmful
interference with other devices in the vicinity if not installed and used in
accordance with the instructions. However there is no guarantee that
interference will not occur in any particular installation.

To reduce the risk of minor or moderate patient injury from a DBB-06


malfunction due to Electrostatic Discharge (ESD), the DBB-06 must be
installed in a room with wood, concrete, or ceramic tiled floors.
If the floors are covered with synthetic material, the relative humidity
should be at least 30%.

Compliance
Emissions test Electromagnetic environment - guidance
level
RF emissions Group 1 The DBB-06 uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.

RF emissions Class B The DBB-06 is suitable for use in all establishments,


CISPR 11 including domestic establishments and those directly
Harmonic Class A connected to the public low-voltage power supply network
emissions that supplies the electric power to the buildings for
IEC 61000-3-2 domestic purposes.
Voltage Complies
fluctuations/
flicker emissions
IEC 61000-3-3

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IEC 60601 Compliance Electromagnetic


Immunity test
test level level environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) concrete or ceramic tile.
IEC 61000-4-2 ±8 kV air ±8 kV air If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast ±2 kV for power ±2 kV for power Mains power quality
transient/burst supply lines supply lines should be that of a
IEC 61000-4-4 typical commercial or
±1 kV for ±1 kV for hospital environment.
input/output lines input/output lines
Surge ±1 kV differential ±1 kV differential Mains power quality
IEC 61000-4-5 mode mode should be that of a
typical commercial or
±2 kV common ±2 kV common hospital environment.
mode mode
Voltage dips, short <5% Ut <5% Ut Mains power quality
interruptions and (>95% dip in Ut) (>95% dip in Ut) should be that of a
voltage variations on for 0.5 cycle for 0.5 cycle typical commercial or
power supply input hospital environment. If
lines 40% Ut 40% Ut the user of the DBB-06
IEC 61000-4-11 (60% dip in Ut) (60% dip in Ut) requires continued
for 5 cycles for 5 cycles operation during power
mains interruptions, it is
70% Ut 70% Ut recommended that the
(30% dip in Ut) (30% dip in Ut) DBB-06 be powered from
for 25 cycles for 25 cycles an uninterruptible power
supply or a battery.
<5% Ut <5% Ut
(>95% dip in Ut) (>95% dip in Ut)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency
(50/60 Hz) magnetic magnetic fields should be
field at levels characteristic of
IEC 61000-4-8 a typical location in a
typical commercial or
hospital environment.
NOTE
"Ut" is the a.c. mains voltage prior to application of the test level.

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IEC 60601 Compliance


Immunity test Electromagnetic environment - guidance
test level level
Portable and mobile RF communications
equipment should be used no closer to
any part of the DBB-06, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.

Conducted RF 3 Vrms 3 Vrms Recommended separation distance


IEC 61000-4-6 (150 kHz to d=1.2√P
80 MHz)

Radiated RF 3 V/m 3 V/m d=1.2√P (80 MHz to 800 MHz)


IEC 61000-4-3 (80 MHz to d=2.3√P (800 MHz to 2.5 GHz)
2.5 GHz)
Where "P" is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and "d" is the recommended separation
distance in meters (m).

Field strengths from fixed RF


transmitters, as determined by an
electromagnetic site survey "a", should be
less than the compliance level in each
frequency range "b".

Interference may occur in the vicinity of


equipment marked with the following
symbol:

NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

"a" For example, field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the DBB-06 is
used exceeds the applicable RF compliance level above, the DBB-06 should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the DBB-06.

"b" Over the frequency range 150kHz to 80MHz, it is preferable that the field strengths should
be less than 3 V/m.

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1. General description

Recommended separation distances between portable and mobile RF communications equipment


and the DBB-06

The DBB-06 is intended for use in an electromagnetic environment in which radiated RF


disturbances are controlled. The customer or the user of the DBB-06 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the DBB-06 as recommended below, according
to the maximum output power of the communications equipment.

Rated maximum output Separation distance according to frequency of transmitter


power of transmitter m
W 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
d=1.2√P d=1.2√P d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance "d" in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where "P" is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

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1. General description

1.6.5. Water , concentrate and dialysate used

The water used in the DBB-06 must have been treated using a reverse
osmosis system and/or other water treatment methods and must conform
to the applicable standards (see below). Failure to follow this water
standard can result in minor or moderate patient injury / illness, including
hemolysis and inflammation.

 Standards for water, concentrate and dialysate quality

American National Standard ; Dialysate for hemodialysis


AAMI/ANSI/ISO13958: 2014
AAMI/ANSI/ISO13959: 2014
AAMI/ANSI/ISO11663: 2014

 Water and Dialysate quality

A total viable microbial count shall be 100 CFU/mL or less.


An endotoxin concentration shall be 0.5 EU/mL or less.

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1.6.6. Environmental conditions

 Operating conditions

Ambient temperature: 10 to 35 C (50 to 95 °F)


Relative humidity: 30 to 85% (No condensation allowed)
Barometric pressure: 70 to 106 kPa (11 to 15 PSI)

 Storage and transportation (dry machine)

Ambient temperature: -20 to +60 C (-4 to 140 °F)


Relative humidity: 10 to 95 % (Non-condensation.)

Strictly adhere to these environmental requirements when storing the


DBB-06 for more than 15 weeks to help prevent minor or moderate patient
injury from fall or loss of control.

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1.6.7. External connection options (See Operator’s manual Fig. 1.5)

Status display For connecting an external status display.

Alarm output (Staff call) For connection to an external device (e.g. RO system,
centralized display of alarm and / or nurse call).
Contact output (Direct current (DC) 24 V/120 mA max.)
If voltage does not meat specifications, alarm output
conversion box can be used.

If the alarm output conversion box is connected to hospital or facility


equipment, double insulation (See Sec. 1.2.2.) must be used to help
protect the patient and operator from serious or fatal injury from electric
shock.

Do not use the alarm output instead of audible and/or visible alarm from
the DBB-06. The alarm output is not intended to replace the audible
and/or visible alarm. Audible and visible alarms must be used correctly
to help prevent minor or moderate patient injury. The operator must
directly check the patient’s condition and status of the DBB-06 during
treatment.

Alarm input This input signal is not used.

Nurse call For connection to an external pushbutton switch.

Output for external equipment This output signal is not used.

RS-232 interface 1 Connection for data transfer to a personal computer (PC).

RS-232 interface 2 Connection for data transfer to a PC.

Network For connection to a computer network.


This outlet can be used to output treatment data and log data
in defined communication protocol.
Consult NIKKISO CO., Ltd or local representative before use.

Data on the network should be used for treatment information reference


only, and the operator should not make any decisions of medical
relevance without additional verification of the accuracy of this data.
The accuracy of the data must be verified by the operator before starting
further treatment.
The operator should routinely provide direct care to the patient at the
bedside even if the network system is used. Failure to properly monitor
the patient can result in serious patient injury or death.

To reduce the risk of serious or fatal injury, accessory equipment


connected to the analog and digital 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 IEC 60601-1-1 system standard.
Anyone who connects additional equipment to the signal input or signal
output is configuring a medical system and is, therefore, responsible to
ensure that the system complies with the IEC 60601-1-1 requirements. If
in doubt, consult your local representative.

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1. General description

To reduce the risk of minor or moderate patient injury from a DBB-06


malfunction due to ESD, always discharge any static electricity to the
metallic ground before touching the connector with the ESD warning
symbol.
The connector with the ESD warning symbol tends to be affected by
static electricity.

Attach a ferrite-core fitting to the network cable to help prevent ESD


damage to the DBB-06.

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1. General description

1.6.8. Hydraulic circuit

Alarm settings marked with an asterisk (*) in this section can be changed.
See Chapter 6 for information regarding setting the limits.

 Blood leak detector


Protective system (Blood leak)
Method: Optical
Sensitivity: 0.5 mL* Blood / 1L Dialysate
(Blood: Hematocrit 20%, Dialysate temperature: 37 C
[98.6 °F])

Alarm response: The response from the blood leak detector is delayed to rule
out turbulence. The delayed response may depend on the
volume between the dialyzer and the blood leak detector as
well as on the UF rate in isolated ultrafiltration (ISO-UF).

The sensitivity of the blood leak detector can be set specifically for ISO-UF and
Hemodialysis (HD).
(The filtrate of ISO-UF is more yellowish than the dialysate of HD.)

 TMP
Protective system (Ultrafiltration)
Method: Monitoring of TMP
Measurement range: 100 to 500 mmHg
Measurement accuracy: 10 mmHg
Auto alarm limit: Upper limit: 70 mmHg*
Lower limit: 70 mmHg*
Auto forecast alarm limit: Upper limit: 20 mmHg*
50 mmHg*(SN)
Lower limit: 20 mmHg*
50 mmHg*(SN)
Fixed alarm limits: Upper limit: 500 mmHg*
Lower limit: 30 mmHg*

Definitions
When DIP monitor is used,
 PBi  PBo   PDi  PDo 
TMP      Offset
 2   2 

When DIP monitor is not used,


 PDi  PDo 
TMP  PBo     Offset
 2 

PDi  dialysate pressure on the inlet side of the dialyzer


PDo  dialysate pressure on the outlet side of the dialyzer
PBi  blood pressure on the inlet side of the dialyzer
PBo  blood pressure on the outlet side of the dialyzer
Offset  flow-dependent pressure variations, head pressure, etc.

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 Dialysate pressure
Protective system (Ultrafiltration)
Method: Monitoring of Dialysate pressure
Measurement range: 600 to 600 mmHg
Measurement accuracy: 10 mmHg
Auto alarm limit: Upper limit: 70 mmHg*
Lower limit: 70 mmHg*
Fixed alarm limits: Upper limit: 300 mmHg*
Lower limit: 300 mmHg*

 Water pressure

Measurement range: 0 to 100 kPa (0 to 14 PSI)


Measurement accuracy: 2 kPa (±0.3 PSI)
Alarm limit: Upper limit 55 kPa (8 PSI)*
Lower limit 15 kPa (2 PSI)*

 UF (See Sec. 1.2.2.)

UF rate: 0.00; 0.10 to 4.00* L/h


UF 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)
UF profile: UF profile with step change
Continuous UF profile without step change
Protective system (Ultrafiltration)
Method: Monitoring of UF pump rate with cell
Alarm limit: Upper limit: 5%*0.05L/h
Lower limit: 5%*0.05L/h
Protective system (Ultrafiltration)
Method: Monitoring of UF pump valve leak with cell
Alarm limit: 0.7V*
Protective system (Ultrafiltration)
Method: Monitoring of SV leak with cell
Alarm limit: Small: 0.4V*
Large: 2.5V*

 UFK

Measurement range: 0 to 300 mL/h/mmHg


Measurement accuracy: 10%

 Acetate dialysis

 Total conductivity
Setting range: 12.5 to 15.5 mS/cm
Dilution rate Acetate concentrate: Treated water = 1:16 to 1: 46
Total conductivity profile: Conductivity profile with step change (See Operator’s manual
Sec. 9.1.1.)
Continuous conductivity profile without step change
(See Operator’s manual Sec. 9.1.1.)
Protective system (Dialysate composition)
Method: Monitoring of Total conductivity
Measurement range: 10.0 to 20.0 mS/cm (100 to 200 mmol/L)
Measurement accuracy: 0.2 mS/cm (2 mmol/L)
Alarm limit: Upper limit: Set value 5%
Lower limit: Set value 5%

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1. General description

 Bicarbonate dialysis

 Bicarbonate conductivity
Setting range: 2.3 to 7.0 mS/cm
Dilution rate Bicarbonate concentrate: Treated water = 1:16 to 1: 46
Bicarbonate Conductivity profile with step change (See Operator’s manual
Sec. 9.1.1.)
Conductivity profile: Continuous conductivity profile without step change
(See Operator’s manual Sec. 9.1.1.)
Protective system (Dialysate composition)
Method: Monitoring of Bicarbonate conductivity
Measurement range: 2.00 to 8.00 mS/cm
Measurement accuracy: 0.1 mS/cm
Alarm limit: Upper limit: Set value 5%
Lower limit: Set value 5%
Alarm delay time: 10 minutes Max.

 Total conductivity
Setting range: 12.5 to 15.5 mS/cm
Dilution rate Acid concentrate: Bicarbonate solution = 1:16 to 1: 46
Total conductivity profile: Conductivity profile with step change (See Operator’s manual
Sec. 9.1.1.)
Continuous conductivity profile without step change
(See Operator’s manual Sec. 9.1.1.)
Protective system (Dialysate composition)
Method: Monitoring of Total conductivity
Measurement range: 10.0 to 20.0 mS/cm (100 to 200 mmol/L)
Measurement accuracy: 0.2 mS/cm (2 mmol/L)
Alarm limit: Upper limit: Set value 5%
Lower limit: Set value 5%

 Dialysate temperature
Setting range: 34.0* to 40.0*C (93.2 to 104 °F)
Protective system (Dialysate temperature)
Method: Monitoring of Dialysate temperature
Measurement range: 10.0 to 45.0C (50 to 113 °F
Measurement accuracy: Measurement value 0.8C (±1.4 °F)
Flow rate of dialysate: 500 mL/min at a constant ambient
temperature
Fixed alarm limit: Upper limit: 41C
Auto alarm limit: Upper limit: Set value 1C* (+1.8 °F)
Lower limit: Set value 1C* (-1.8 °F)

 Dialysate flow rate


Setting range: 300 to 800 mL/min
Flow rate accuracy: Set value 10%
Protective system (Ultrafiltration)
Method: Monitoring of Duplex pump rate with cell
Alarm limit: Upper limit: 10%*
Lower limit: 10%*
Protective system (Ultrafiltration)
Method: Monitoring of Duplex pump valve leak with cell
Alarm limit: 0.7V*

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1. General description

1.6.9. Extracorporeal blood circuit and alarm

Alarm settings marked with an asterisk (*) in this section can be changed.
See Chapter 6 for information regarding setting the limits.

 Arterial pressure
Protective system (Arterial pressure)
Method: Monitoring of Arterial pressure
Measurement range: AV06: 300 to 300 mmHg
Streamline: 300 to 0 mmHg
Measurement accuracy: 10 mmHg
Auto alarm limit: Upper limit: 70 mmHg*
Lower limit: 70 mmHg*
Fixed alarm limit: Upper limit: 100 mmHg*
Lower limit: 250 mmHg*
Alarm delay time: 2 seconds Max.

 Venous pressure
Protective system (Extracorporeal blood loss to the environment)
Method: Monitoring of Venous pressure
Measurement range: AV06: 200 to 500 mmHg
Streamline: 0 to 500 mmHg
Measurement accuracy: 10 mmHg
Auto alarm limit: Upper limit: 60 mmHg*
Lower limit: 40 mmHg*
Fixed alarm limit: Upper limit: 300 mmHg*
400 mmHg*(SN)
Lower limit: 10 mmHg*
10 mmHg*(SN)
Alarm delay time: 2 seconds Max.

To reduce risk of minor or moderate patient injury / illness from wrong


pressure measurement, ensure that POD flexible diaphragm is in correct
position according Streamline for DBB-06 instruction for use when
Streamline for DBB-06 is used.

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1. General description

 Dialyzer inlet blood pressure (optional)

Measurement range: 200 to 735 mmHg


Measurement accuracy: 10 mmHg
Auto alarm limit: Upper limit: 70 mmHg*
Lower limit: 70 mmHg*
Fixed alarm limits: Upper limit: 500 mmHg*
Lower limit: 50 mmHg*
Alarm delay time: 2 seconds Max.

 Pressure loss (Dialyzer pressure difference)

Measurement range: 300 to 600 mmHg


Measurement accuracy: 10mmHg
Fixed alarm limits: Upper limit: 400 mmHg*
Lower limit: 60 mmHg*
Alarm delay time: 2 seconds Max.

Definition

Pd  PBi  PBo

Pd  dialyzer pressure difference


PBi  blood pressure on the inlet side of the dialyzer
PBo  blood pressure on the outlet side of the dialyzer

 Air detector
Protection system (Air infusion)
Method: Ultrasonic waves
Sensitivity: 0.02 mL (Normal air bubbles)
(At Blood flow rate: 250 mL/min)
0.0003 mL (microbubbles: blood/air mixture)
(At Blood flow rate: 250 mL/min)

 Blood pump

To reduce the risk of minor or moderate patient injury from inadequate


treatment , use only bloodline sets approved by NIKKISO CO., LTD. for
use with the DBB-06. (See Operator’s manual, Sec. 1.8.2.)

Setting range: 40 to 600 mL/min


Display method: Blood flow rate = Rotation of blood pump
Flow rate accuracy: Set value 10%
Inflow pressure: 150 mmHg minimum
150 mmHg maximum
Outlet pressure: 500 mmHg maximum
Protection system (Extracorporeal blood loss due to coagulation)
Method: Monitoring of Blood pump (PUMP) flow rate
Protection system: Monitoring of stoppage
Monitoring of rotation (Reverse rotation)
Display method: Blood flow rate = Rotation of blood pump
Reminder alarm (BP OFF, BP cover open, blood flow set 0):
20 seconds

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1. General description

 Effective blood flow rate


Measurement range: 0 to 999 mL/min
Measurement accuracy: 10%
The effective blood flow refers to the blood flow rate compensated by the arterial pressure.
The effective blood flow is obtained using equation below.

  0.075 
Qr  Qba  1  Ap  
 100 

Qr  Effective blood flow (mL/min)


Qba  Flow rate of the arterial blood pump (mL/min)
Ap  Arterial pressure (mmHg)
Constant: 0.075*

 Blood flow volume

Measurement range: 0 to 999.9 L


Measurement accuracy: 10%

 HP

Setting range: 0.0 to 9.9 mL/h


Output rate accuracy: Set value 10%
Back pressure: 500 mmHg
Syringe type: 30 mL (Luer Lock) or 20 mL (Luer Lock),
20 mL (Luer Lock) or 10 mL (Luer Lock) (optional)
Bolus process: 0.0 to 9.9 mL
Max. bolus accumulation
capacity: 1  syringe capacity (30 mL, 20 mL, or 10 mL)
Alarm limit: Upper limit +20%
Lower limit -20%

 HP total flow volume

Measurement range: 0 to 99.9 mL


Measurement accuracy: 10%

The HP is used only for infusion of heparin solution.


Do not use this pump for the infusion of any other chemicals or
medications under any circumstances. Doing so can cause serious
patient injury or death.

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1. General description

 SN-KK with Arterial clamp (optional)

Single needle dialysis cannot be performed with Streamline for DBB-06.


To reduce the risk of serious or fatal patient injury from inadequate
treatment, always use only AV06 series for single needle dialysis.

Single needle dialysis (SN) pressure (Venous pressure):


Measurement range: -200 to 500 mmHg
Measurement accuracy: 10 mmHg

Control:
SN control pressure: Upper limit: 200 mmHg*
Lower limit: 100 mmHg*

Monitoring
SN pressure alarm limits: Upper limit: 50 mmHg*
Lower limit: -50 mmHg*
SN switching time alarm limits:
Arterial phase: 18 sec.*
Venous phase: 18 sec.*

Average blood flow:


Measurement range: 0 to 999 mL/min
Measurement accuracy: 10 %
The average blood flow rate refers to the average rate of the blood flowing through the dialyzer in
a particular period.
The average blood flow rate is obtained using equation 1 below.

ta
Qm  Qba  Equation 1
Ct

Qm  Average blood flow (mL/min)


Qba  Flow rate of the arterial blood pump (mL/min)
Ct  Cycle time (sec.)  ta  tsn
ta  Arterial phase period (sec.)
tsn  Venous phase period (sec.)

Stroke volume:
Measurement range: 0 to 99.9 mL
Measurement accuracy: 10 %
The stroke volume here refers to the amount of blood sent to the dialyzer by the blood pump
(PUMP).
The stroke volume is obtained using equation 2 below.
Ct
Sv  Qm  Equation 2
60

Qm  Average blood flow (mL/min)


Sv  Stroke volume (mL)
Ct  Cycle time (sec.)  ta  tsn
ta  Arterial phase period (sec.)
tsn  Venous phase period (sec.)

 Audible alarm
Loudness: 71.4 dB (Factory default)

 Alarm over ride


Override time: 10 seconds (Factory default)

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1. General description

1.6.10. BPM (optional) (See Operator’s manual Chapter 10.)

Measurement technology: Oscillometric

Measurement method: Linear deflation method

Pressure display range: 0 to 300 mmHg

Pressure display accuracy: Less than 3 mmHg

Measurement range:

Adult Systolic blood pressure (SYS) 60 to 250 mmHg


Mean arterial pressure (MAP) 45 to 235 mmHg
Diastolic blood pressure (DIA) 40 to 200 mmHg
Pulse rate 40 to 200 beat per minutes

Pulse rate accuracy: 2 % or 2 beats

Degree of protection against electrical shock (Blood pressure cuff):


Defibrillation- proof Type BF Applied part

Alarm limits:

Adult SYS alarm upper limit 200 mmHg


SYS alarm lower limit 80 mmHg
MAP alarm upper limit 180 mmHg
MAP alarm lower limit 60 mmHg
DIA alarm upper limit 160 mmHg
DIA alarm lower limit 50 mmHg
Pulse rate alarm upper limit 170 beats per minute
Pulse rate alarm lower limit 50 beats per minute

Reference standard: IEC60601-2-30, ED.2.0 (1999)


EN1060-1 (1995)
EN1060-3 (1997)

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1. General description

1.6.11. Blood volume monitor (BVM) (optional) (See Operator’s manual Chapter 11.)

Measurement principle: Near-infrared reflection method

Applicable blood flow rate range: 40 to 600mL/min

Applicable hematocrit range: 15 to 50%

Dimension: Height 66mm × Width 67mm × Depth 58mm (Module part)


(2.6 in) (2.6 in) (2.3 in)
dBV monitoring:
Accuracy: ±2.3dBV% (Double needle)
±3.2dBV% (Single needle)

Alarms: dBV drop alarm 1,


dBV drop alarm 2,
dBV changed rate alarm,
dBV deviation alarm (Lower, Upper)

1.6.12. Dialysis Dose Monitor (DDM) (optional) (See Operator’s manual Chapter 12.)

Measurement principle : Absorptiometry


Applicable Treatment mode : HD
Applicable Kt/V range : 0~2.0
Kt/V monitoring accuracy : ±0.1 (Kt/V 0~1)
±10% (Kt/V 1~2)
Applicable URR range : 0%~100%
URR monitoring accuracy : ±5%

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1. General description

1.6.13. Materials utilized for piping

The DBB-06 or any of its parts is to be disposed of according to the


applicable federal, state and local laws and regulations. Failure to follow
these instructions may result in groundwater contamination and/or a fine
from governing authorities.
Consult NIKKISO CO., LTD. or its local representative for disposal.

Materials which contact the water, concentrates, and dialysate are listed below.

 Stainless steel

 Fluoro-rubber

 Silicon (SI)

 Ceramic

 Carbon

 Polysulfone (PSU)

 Polyimide (PI)

 Glass

 Polypropylene (PP)

 Polyphenylene ether (PPE)

 Methylpentene polymer (TPX)

 Titanium

 Polytetrafluoroethylene (PTFE)

 Polyethersulfone (PES)

 Ethylene-tetrafluoroethylene plastic (ETFE)

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2. Hydraulic circuit

2. Hydraulic circuit
2.1. Block diagram
Fig. 2.1
Water supply Water drain

Water supply control system

Heating system

Flushing

Deaeration system

Mixing system

UFC
system
Duplex pump UF pump

Bypass system

Dialyzer

Blood leak detector

Boost system

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2.2. Explanation of flow diagrams


2.2.1. Water supply control system

Fig. 2.2

Water supply
PRV

RV1
To drain

SV1

PT1
SV3

To heating system

Functions:
The water supply pressure is reduced and monitored.
It also maintains a single pass flow path, supplying treated water from the water supply connector,
sending spent solutions to the drain connector, and recirculating spent solutions during the
cleaning program.

Used actuator:
PRV: Pressure reducing valve which reduces the water supply pressure to the appropriate
pressure level.
Adjustment pressure: 45 to 50 kPa (6.6 to 7.2 psi)
RV1: Relief valve which is a mushroom type relief valve. If the pressure reduced by the
pressure reducing valve exceeds the specified level, the relief valve is opened to relieve
excess pressure to the drain port.
Adjustment pressure: 64 to 83kPa (9.3 to 12.0 psi)
PT1: Pressure transducer which monitors the pressure reduced by the PRV.
SV1: Solenoid valve which closes when abnormal high pressure is detected by PT1.This
solenoid valve is closed for recirculation in cleaning program.
SV2: Solenoid valve which opens for recirculation in cleaning program.
SV3: Solenoid valve which closes for recirculation in cleaning program.

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2. Hydraulic circuit

2.2.2. Heating system


Fig. 2.3

Functions:
HEX transfers heat energy from the spent dialysate to the treated water.
The control system measures DH outlet temperature with TH1. The control system compares the
temperature at TH1 with the target temperature and controls the DH through SSR.
Then the concentrate is mixed and the water temperature drops and measured by TH3.
The control system compares the temperature at TH3 with the target temperature and controls
DH through SSR.
The protection system monitors the DH outlet temperature by TH2, and the temperature before
the dialyzer by TH4. The temperature at TH4 is displayed as the dialysate temperature.
The THS controls power to the DH to prevent overheating. If the heater temperature exceeds the
defined limit, the power to the heater is cut by a separate electrical relay.

Used actuator:
HEX: Heat exchanger transfers heat energy from the spent dialysate to the treated water.
DH: Dialysate heater heats the treated water.
THS: Thermostat which stops the power to the DH, when the temperature of heater housing
exceeds 120°C (248°F).
TH1: Control thermistor which measures the DH outlet temperature.
TH2: Protection thermistor which measures the DH outlet temperature.
TH3: Control thermistor which measures the temperature before dialyzer.
TH4: Protection thermistor which measures the temperature before dialyzer.

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2. Hydraulic circuit

2.2.3. Deaeration system


Fig. 2.4

To drain

GC1

CP1

FR1

To mixing system
From heating system

To heating system

Functions:
Negative pressure is created between FR1 and CP1. The dissolved air in the treated water is
removed by the negative pressure. The removed air is trapped at GC1 and vented from the upper
port of GC1.
In order to increase the deaeration and heating efficiency, the flow rate of CP1 is much higher
than the dialysate flow. Part of the deaerated water is returned to the heating system and
recirculated. This recirculation increases the flow to heating and deaeration systems. Water
required for the mixing system is supplied from the bottom port of GC1.

Used actuator:
FR1: Flow restrictor 1 restricts flow to the CP1.
CP1: Deaeration pump is a rotor pump which creates circulation flow.
GC1: Gas separator chamber 1 traps the removed air, which lowers the water level and float
(stop valve). The upper port is opened and the trapped air is vented.

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2. Hydraulic circuit

2.2.4. Mixing system


Fig. 2.5
To duplex pump
Qd=Qw+Qb+Qa

TH6

Qw+Qb
CL4
CL2

TH5

CL1 CL3
From deaeration system
Qw
MC1

MC2
H-C1
H-C2

Qb
Qa

SPB SPA

Bicarbonate concentrate Acid concentrate


(Acetate concentrate)

Control Protection

Electric circuit

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2. Hydraulic circuit

Functions:
Bicarbonate concentrate (acetate concentrate) and treated water are mixed to make bicarbonate
solution (acetate dialysate) and the conductivity is measured. SPB is controlled to achieve target
bicarbonate conductivity.
Acid concentrate and the bicarbonate solution are mixed to make dialysate and the conductivity
and temperature are measured. SPA is controlled to achieve target total conductivity.
The measured temperature of the dialysate is used for temperature compensation of the
conductivity of the bicarbonate and dialysate solutions.

The flow rate of the dialysate is calculated as follows.


Qd = Qw + Qb + Qa Qd= Flow rate of dialysate (DP)
Qw = Flow rate of treated water
Qb = Flow rate of bicarbonate concentrate (SPB)
Qa = Flow rate of acid concentrate (SPA)

Used actuator:
SPB: Concentrate pump which discharges bicarbonate (acetate) concentrate.
SPB is a plunger pump which consists of a motor, cam, and pump head. The pump head
has a ceramic plunger, cylinder, and one way valves for inlet and outlet.
SPB has two phases. In one phase, the plunger moves backward and bicarbonate
(acetate) concentrate is suctioned into the cylinder. In the other phase, the plunger moves
forward and bicarbonate (acetate) concentrate is discharged from the cylinder.
SPA: Concentrate pump which discharges acid concentrate.
SPA is a plunger pump which consists of a motor, cam, and pump head. The pump head
has a ceramic plunger, cylinder, and one way valves for inlet and outlet.
SPA has two phases. In one phase, the plunger moves backward and acid concentrate is
suctioned into the cylinder. In the other phase, the plunger moves forward and acid
concentrate is discharged from the cylinder.
H-C1: Back pressure valve which creates back pressure at the outlet of SPB.
Adjustment pressure: 80kPa (11.7psi)
H-C2: Back pressure valve which creates back pressure at the outlet of SPA.
Adjustment pressure: 80kPa (11.7psi)
MC1: Mixing chamber which mixes the bicarbonate concentrate (acetate concentrate) and
treated water to make bicarbonate solution (acetate dialysate).
MC2: Mixing chamber which mixes the acid concentrate and bicarbonate solution to make
dialysate.
CL1: Control conductivity cell which measures the bicarbonate solution conductivity.
CL2: Protection conductivity cell which measures the bicarbonate solution conductivity.
CL3: Control conductivity cell which measures the dialysate conductivity.
CL4: Protection conductivity cell which measures the dialysate conductivity.
TH5: Control thermistor which measures the dialysate temperature for temperature
compensation of the conductivity at CL1, CL3.
TH6: Protection thermistor which measures the dialysate temperature for temperature
compensation conductivity at CL2, CL4.

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2. Hydraulic circuit

Nozzle rinse system


Fig. 2.6
SV64

To inlet of CP1

Concentrate connector

TH11 SV63

Rinse port

FR3

From outlet of CP1

Functions:
SV63 and SV64 are opened to clean the concentrate connectors during cleaning program. The
flow is generated by CP1 and restricted by FR3.

Used actuator:
SV63: Solenoid valve which closes during treatment and opens during cleaning program.
SV64: Solenoid valve which closes during treatment and opens during cleaning program.
FR3: Flow restrictor which restricts flow to the nozzle rinse system to appropriate level.
TH11: Protection thermistor which measures the temperature of nozzle rinse system to check if
the nozzle rinse system is cleaned.

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2. Hydraulic circuit

Bicarbonate powder cartridge (optional):


Fig. 2.7 CP1 outlet

SV61
Atmosphere
FL44
SV42

CP1 inlet FL43


CV42

SPB inlet
CV61

SV62

SV70

FL45

Functions:
The treated water is supplied to the cartridge through SV61. In the cartridge, the treated water is
mixed with the bicarbonate powder and becomes saturated bicarbonate concentrate. Bicarbonate
concentrate is supplied to the SPB for mixing. Since the bicarbonate concentrate is saturated
concentrate (not fixed) the concentrate is diluted during treatment. The conductivity is measured
by CL1 and SPB is controlled to achieve target bicarbonate conductivity.

Used actuator:
SV42: Solenoid valve which opens during bicarbonate cartridge draining to supply air to the
cartridge.
SV61: Solenoid valve which opens during bicarbonate cartridge priming and when bicarbonate
concentrate is used by the mixing system to supply treated water to the cartridge.
SV62: Solenoid valve which opens during bicarbonate cartridge priming.
SV70: Solenoid valve which opens when a bicarbonate container is used.
FL43: Filter which prevents entry of particles from the atmosphere into the hydraulic circuit .
FL44: Filter which prevents entry of particles from the atmosphere into the hydraulic circuit.
FL45: Filter which prevents entry of particles into the SPB.
CV42: One way valve which prevents treated water leakage from the hydraulic circuit.

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2. Hydraulic circuit

Central concentrates supply (optional)


Fig. 2.8

CCS A1 port
MC2
SV66 SV67

SPA CCS A2 port

SV68 SV69

MC1
SV65

SPB

Bicarbonate cartridge

Bicarbonate concentrate Acid concentrate

Treated Water

Functions:
Opens the solenoid valve to supply selected concentrate to SPA.

Used actuator:
SV65: Solenoid valve which opens when acid container is used.
SV66: Solenoid valve which opens when CCS A1 port is used.
SV67: Solenoid valve which opens when CCS A1 port is used.
SV68: Solenoid valve which opens when CCS A2 port is used.
SV69: Solenoid valve which opens when CCS A2 port is used.

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2. Hydraulic circuit

2.2.5. Booster system

Fig. 2.9

To drain

FR2

SV8
GC2

CP2

To UFC system

Functions:
Pressure is boosted and kept at the appropriate level in the recirculation circuit. This constant
positive pressure is applied to the inlet of UFP, and the drain side of the DP.
Air which comes into the closed loop circuit (e.g. during connection and disconnection of dialyzer)
is trapped in the GC2. The trapped air is vented through SV8.

Used actuator:
CP-2: Booster pump is the rotor pump which boosts pressure.
L: Relief valve which adjusts the boost pressure.
Adjustment pressure: 40 to 45kPa (5.9 to 6.5psi)
GC2: Gas separator chamber which traps the air with the LVS (level switch). When air is
trapped it lowers the water level and turns ON the LVS.
SV8: Solenoid valve which opens, when the LVS is ON to drain the trapped air in GC2.
FR2: Flow restrictor which restricts flow to SV8 to the appropriate level.

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2. Hydraulic circuit

2.2.6. UFC system

Fig. 2.10

Qd
DP

Qb-Qx
Qb-Qx

UFP
UFP

Qd
DP
Dialyzer Qd

Qx

Qb

Qb
Qd+Qx

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Functions:
DP supplies and drains the same amount of dialysate (Qd) to and from the closed loop system.
On the DP drain side, the UFP drains Qx which is ultrafiltered from the patient’s blood plasma
through the dialyzer.
For the accuracy of the UFC system, the inlet and outlet pressure of the DP and UFP are kept at
the appropriate level. The pressure maintained by the PRV is applied to supply side inlet of the
DP and the boost pressure maintained by L is applied to the drain side inlet of the DP and the
UFP. Back pressure maintained by H1 is applied to the supply side outlet of the DP and the back
pressure maintained by H2 is applied to drain side outlet of the DP and the UFP.

Used actuator:
DP: Duplex pump consists of a motor, gearbox, and two pump heads. One ceramic plunger
has two plunger heads on both ends and each plunger head works as a pump head
(supply, drain) with a cylinder, and one way inlet and outlet valves.
Rotary movement of the motor and gearbox is transferred to reciprocate movement of the
plunger via a cam and block slider. The DP has two phases. In one phase, the plunger
moves from supply side to drain side and dialysate is sucked into the supply cylinder, and
spent dialysate is discharged from the drain cylinder at the same time. In the other phase,
the plunger moves from drain side to supply side and dialysate is discharged from the
supply cylinder to the closed loop circuit and spent dialysate is sucked from the closed
loop circuit into the drain cylinder.
Since both plunger heads have the same volume, the same amount of dialysate is
discharged from supply side as is sucked into the drain side.
UFP: Ultrafiltration pump is a plunger pump which consists of a motor, cam, and pump head.
The pump head has a ceramic plunger, cylinder, and one way inlet and outlet valves.
UFP has two phases. In one phase, the plunger moves backwards and spent dialysate is
sucked from the closed loop system into the cylinder. In the other phase, the plunger
moves forward and spent dialysate is discharged from cylinder.
H1: Back pressure valve maintains back pressure to the supply side of the DP.
Adjustment pressure: 80 to 85kPa (11.7 to 12.3psi)
H2: Back pressure valve maintains back pressure to the drain side of the DP drain side and
the UFP.
Adjustment pressure: 80 to 85kPa (11.7 to 12.3psi)
SV7: Solenoid valve which opens when dialysate pressure exceeds the alarm limit to open the
closed loop system and reduce the pressure.

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2. Hydraulic circuit

2.2.7. Bypass system

Fig. 2.11

SV5 SV4
Dialyzer
SV6 PT2

PT3

Dialysate filter

Functions:
Dialysate is supplied to the dialyzer, and drained from the dialyzer.
Dialysate is bypassed when a dialysate alarm (e.g. dialysate pressure alarm, conductivity alarm,
dialysate temperature alarm) occurs. Therefore the dialyzer is isolated from abnormal dialysate
for patient safety.

Used actuator:
SV4: Solenoid valve which opens when dialysate is supplied to the dialyzer.
SV5: Solenoid valve which opens when dialysate is drained from the dialyzer.
SV6: Solenoid valve which opens when dialysate is bypassed from the dialyzer.
PT2: Pressure transducer which monitors dialysate pressure before dialyzer.
PT3: Pressure transducer which monitors dialysate pressure after dialyzer.

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2. Hydraulic circuit

Dialyzer coupling

Fig. 2.12

In treatment In cleaning program

Dialyzer coupling has 2 sealing points. One sealing point is used during treatment and the other
sealing point is used during the cleaning program. The sealing point used during treatment is
disinfected in the cleaning program.

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2. Hydraulic circuit

Dialysate filter (optional):

Fig. 2.13

B A

Functions:
Dialysate is filtered before it is supplied to the dialyzer.
In the DM test air is supplied to the hydraulic circuit and the dialysate filter is tested for leaks.
(See Sec.8.3.1)

Used actuator:
Dialysate filter:Dialysate is supplied to the bottom of the filter to the inside of the hollow fibers.
Dialysate from outlet port A is filtered and dialysate from outlet port B is not filtered.
The membrane of the hollow fiber has a characteristic which allows liquid to cross the
membrane but not air. The dialysate filter leak test uses this characteristic to check the
filter for leaks.
SV41: Solenoid valve which opens to supply air into the dialysate filter in the DM test.
FL41: Filter which prevents particles from entering the hydraulic circuit in the DM test.
FL42: Filter which prevents particles from entering the hydraulic circuit in the DM test.
CV41: One way valve which prevents dialysate leaks from the hydraulic circuit in the DM test.

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2. Hydraulic circuit

2.2.8. Blood leak detector

Fig. 2.14
From bypass system

Transmitter side

To booster system

Reciever side

Functions:
Only green light is adsorbed by blood cells, while both red and green light are adsorbed by non
blood particles.
The blood leak alarm is triggered when the green light voltage is reduced.

Used actuator:
BLD: The blood leak detector has a transmiter and receiver which transmit and receive red and
green light through the spent dialysate.

2.2.9. DDM module

Fig. 2.15

Functions:
The Dialysis Dose Monitor (DDM) is a measurement function which estimates the Kt/V value and
Urea Reduction Ratio (URR) by optical measurement of the composition change in the spent
dialysis fluid.

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3. Electrical system

3. Electrical system
3.1. Microcomputer system
3.1.1. System configuration

Fig. 3.1
Touch key
LCD LCD controller Touch key
controller

FM controller Maintenance
Interface communication
serial I/O interface

4 LED Indication Interface


Computer
pararel I/O
communication
Key interface
DDM C.CPU
NIBP I.CPU
DDM P.CPU

C.CPU 3PRAM P.CPU

Control Protection
Maintenance Control Protection maintenance
communication serial I/O serial I/O communication
interface interface

Buzzer

Control Control Protection Protection


Signal switch pararel I/O pararel I/O Signal switch

Actuator power
Actuator Control
desital analog
converter

Control
stepping motor
controller

Control Protection
Control sensor analog digital analog digital Protection sensor
converter converter

Control clock Control Protection Protection clock


counter timer counter timer
circuit circuit

Control gate Protection gate

Optional

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3. Electrical system

3.1.2. System block diagram

Fig. 3.2

NIBP

Protection
sensor

P. CPU

Indicator
Protection
actuator

Alarm output

Key input I. CPU 3PRAM

Maintenance
communication

Control
sensor
Computer
communication
C. CPU

Control
actuator
DDM P.CPU DDM C.CPU

Description Optional

The CPU system is composed of C.CPU, P.CPU. and I.CPU.

Each CPU has the following functions:

Control system
C.CPU controls control actuators with input from the control sensor.

Protection system
P.CPU monitors the control system with input from the protection sensor.
P.CPU checks that the control system functions correctly.
If protection system detect a value at the protection sensor exceeds the alarm limit, the protection
actuators are controlled to protect the patient.

Interface system
I.CPU communicates with the operator and outputs alarms visually and audibly.

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3. Electrical system

3.1.3. Mutual monitoring system

Fig. 3.3

C.CPU

Check the counter Count one by one


every 500msec every 1msec

3PRAM
P.CPU C.CPU
counter counter

Check the counter


Count one by one
every 500msec
every 1msec

P.CPU

Three CPUs have the following mutual monitoring systems:


 Mutual monitoring system between C.CPU and P.CPU.
 Mutual monitoring system between C.CPU and I.CPU.
 Mutual monitoring system between P.CPU and I.CPU
The mutual monitoring is always performed after the start up test.

Mutual communication system between C.CPU and P.CPU is described as an example.

P.CPU monitors C.CPU


1. The C.CPU counts one by one on 3PRAM every 1msec.
2. The P.CPU checks the C.CPU counter every 500msec.
3. The P.CPU compares the previous counter and current counter
Alarm limit: 10%
4. If a data discrepancy exceeds the alarm limit, the P. CPU triggers TFC322 Time Base Error (C).

C.CPU monitors P.CPU


1. The P.CPU counts one by one on 3PRAM every 1msec.
2. The C.CPU checks the P.CPU counter every 500msec.
3. The C.CPU compares the previous counter and current counter
Alarm limit: 10%
4. If a data discrepancy exceeds the alarm limit, the C. CPU triggers TFC222 Time Base Error (P).

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3. Electrical system

3.2. Power supply system


3.2.1. Power unit

Fig. 3.4

Battery 24VDC

Power suply KA KG
35VDC
5VDC

Buzzer 12VDC
AC/DC unit

KB

DC/DC unit
24VDC

Battery operation unit


Bypass 1
switch
Battery operation
switch
Auto Bypass 2
switch

Manual

5V DOWN signal

SW signal

Battery operation signal

AC POWER signal

24VDC

24VDC
Supply mains unit

Monitor SW

SW 1 ([ON] key)

SW 2 ([OFF] key)

SW 3
(System-start switch)

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3. Electrical system

The power unit is composed of the following four units.

 Supply mains unit


 AC/DC unit
 Battery operation unit
 DC/DC unit

Supply mains unit


The AC power to the AC/DC unit is turned ON and OFF with KA and KB relays based on the
operation of [ON], [OFF] keys and [System start] switch.
SW signal is output when DBB-06 is turned ON.

AC/DC unit
Converts AC power to 35VDC and 24VDC.
35VDC is supplied to the Battery operation unit.
24VDC is supplied to the Battery operation unit and Supply mains unit and actuators.
AC power signal is output when AC power is supplied.

Battery operation unit


Supplies 24VDC to DC/DC unit, Supply mains unit and actuator out of 24VDC from AC/DC unit. If a
power failure occurs, the supplied voltage from AC/DC unit is automatically switched to the supplied
voltage from the battery.
Audible buzzer sounds when 5V DOWN signal is input from DC/DC unit.
Battery operation signal is output during battery operation.

DC/DC unit
Produces 5VDC, 12VDC, -12VDC out of 24VDC from battery operation unit. 5VDC and 12 VDC are
supplied to actuator.
5V DOWN signal is output when 5VDC exceeds upper limit.

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3. Electrical system

3.2.2. Supply mains unit

Fig. 3.5
KA
Power supply

AC/DC unit
KB

Supply mains unit

SW 3 KA KB
(System-start switch)

KC
24VDC 24VDC
24VD

SW 1 KF
([ON] key) Battery operation
unit

KD 24VDC

KE KE
24VDC AC/DC unit
24VDC

SW 2 KF KC KD
([OFF] key)

KE KF
Moniotr SW

When SW1 is touched, KC and KD are turned and held ON with 24VDC from the battery operation
unit. KA and KB are turned ON with AC power and AC power is supplied to the AC/DC unit.
If the battery is not charged, KC is not turned ON when SW1 is touched and AC power is not
supplied to AC/DC unit.

When SW3 is touched, KA and KB are turned ON with AC power and AC power is supplied to the
DC unit. 24VDC from battery operation is not used, when SW3 is touched. Therefore KA and KB
are turned ON, even if the battery is not charged.
Once AC power is supplied to the AC/DC unit, KC and KD are turned and held ON with 24VDC from
the AC/DC unit.

When SW2 is touched, KE is turned ON, and KC is turned OFF, and KA and KB are turned OFF.

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3. Electrical system

3.2.3. AC/DC unit

Fig. 3.6
AC/DC unit

KA 35VDC
Power supply

AC/DC
converter 24VDC
KB

Stop conversion signal

Voltage monitoring
circuit
(24VDC)
Supply mains unit

AC POWER
signal

AC POWER
signal circuit

24VDC

The AC/DC unit produces the following two voltages from AC power supply.

35VDC
24VDC

The AC/DC unit has an over voltage monitoring circuit and always monitors the following voltages.
The overvoltage monitoring circuit monitors the following voltage limits.

24VDC: Upper limit 30.0V (26.5 to 30.0V)

If output voltage exceeds the upper limit, the Stop conversion signal is output, and the AC/DC unit
stops the voltage conversion.

If 24VDC output is stopped in defined condition, the battery operation unit switches to Battery
operation.

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3. Electrical system

3.2.4. Battery operation unit

Fig. 3.7

Battery operation unit


Battery operation
switch (AUTO)

Signal (high)
Bypass 1 switch Relay (KH) ON KH
(OFF)
Battery operation
signal (ON)
Bypass 2 switch AND
(OFF) OR
AND Latch

Battery operation
switch (MANUAL)

SW signal (ON)

5V DOWN signal AND


(ON)
21.0V 


KJ
16.0V
0.5V 
Signal (high) KI
Relay (KJ) ON 
Signal (high)
Relay (KI) ON

Buzzer

KJ

Battery

KI
KH
AC/DC unit
24VDC
35VDC
KH

19.5V
 DC/DC
0.5V
KH

24VDC 24VDC

AC/DC unit
Actuator

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3. Electrical system

The battery is charged with 35VDC from AC/DC unit, when relay KH is OFF.

The Battery operation signal and relay KH is ON, if the following conditions are met.
- Battery operation switch is AUTO
- Bypass 1 switch is OFF (Dialyzer coupling is not connected to the rinse port)
- Bypass 2 switch is OFF (Dialyzer coupling is not connected to the rinse port)
- 24VDC supplied from AC/DC unit is lower than 19.5VDC
- SW signal is ON
- DCV from Battery is higher than 21.0VDC
OR
- Battery operation switch is MANUAL
- SW signal is ON
- DCV supplied from Battery is higher than 21.0VDC

Output 24DCV to the DC/DC unit and Actuator is switched from 24VDC supplied from the
AC/DC unit to DCV supplied from the Battery, when relay KH is turned ON.
Relay KI is turned ON and DCV supplied from the Battery is stopped, when voltage becomes
lower than 19.5V.

Relay KJ is turned ON and the audible buzzer sounds, when the following conditions are met.
- SW signal is ON
- 5V DOWN signal is ON

Always select "Automatic" with the "battery operation switch" to help


ensure continued operation with only critical monitor functions operational.
Failure to use emergency battery operation during a power failure could
result in minor or moderate patient injury from either manual blood return
with no active safety monitors or clotting of the entire extracorporeal blood
circuit. Battery operation can also be started manually by turning on the
battery operation switch.

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3. Electrical system

3.2.5. DC/DC unit


Fig. 3.8
24VDC DC/DC unit
KG
DC/DC IN
+5VDC
Battery DC/DC +5VDC
operation converter +12VDC
unit +12VDC
-12VDC
-12VDC

5VDC OVP
monitor
Conversion
stop signal
5VDC OVP
monitor

5VDC UVP
monitor

5VDC UVP
monitor

+/-12VDC OVP
monitor

+/-12VDC OVP
monitor

+/-12VDC UVP
monitor

+/-12VDC UVP
monitor

DC/DC IN OVP
monitor

AC/DC
unit 24VDC
DC/DC IN OVP
monitor

+24V OVP
monitor DC/DC IN UVP
monitor

DC/DC IN UVP
+24V OVP
monitor
monitor

KG OR

DC down
Signal

OR

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3. Electrical system

The DC/DC unit produces the voltages from 24VDC as follows:

+5VDC
12VDC
12VDC

The DC/DC unit has an over voltage monitoring circuit and always monitors all the voltages
produced by the DC/DC unit. Two independent circuits monitor the output voltage of the DC/DC unit.
The monitoring circuit monitors the voltage limits as follows:

+5VDC: Upper limit +5.5VDC (5.3 to 5.5V)


Lower limit +4.6VDC (4.6 to 4.85V)
12VDC: Upper limit 15.0VDC (12.7 to 15.0V)
Lower limit + 8.4VDC (8.4 to 11.2V)
12VDC: Upper limit 15.0VDC (12.7 to 15.0V)
Lower limit  8.4VDC (8.4 to 11.2V)
+24VDC Upper limit + 31.5VDC (26.5 to 31.5V)
Lower limit +18.0VDC (18.0 to 21.5V)

If the DC voltage exceeds the limits, the conversion stop signal is output to the DC/DC converter,
and relay KG is turned ON and the DC down Signal is output to the DC/DC unit.

The +5VDC over voltage monitoring circuit protects ICs in the system.
The absolute maximum voltage for ICs is 7V. The over voltage monitoring circuit is set to monitor
that the +5VDC voltage is always less than 7V.

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3. Electrical system

3.3. MAIN P.C.B. voltage monitoring system


3.3.1 +3.3VDC, +2.5VDC, +1.2VDC

Fig. 3.9

Power Unit MAIN PCB


+5VDC +3.3VDC
DC/DC DC/DC ICPU
unit converter

Reset A
3.3VDC OVP
OR
monitor

CCPU

3.3VDC UVP
monitor

3.3VDC OVP
PCPU
monitor
Reset B
OR

3.3VDC UVP
monitor

+2.5VDC_C

I.FPGA_0
DC/DC
converter

+1.2VDC_C

DC/DC
converter

+2.5VDC_A

C.FPGA_0
DC/DC
converter

+1.2VDC_A

DC/DC
converter

+2.5VDC_D

C.FPGA_1
DC/DC
converter

+1.2VDC_D

DC/DC
converter

+2.5VDC_B

P.FPGA_0
DC/DC
converter

+1.2VDC_B

DC/DC
converter

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3. Electrical system

DC/DC converters produce the voltage from +5 VDC as follows:

+3.3 VDC
+2.5 VDC
+1.2 VDC

ICPU, CCPU and PCPU use +3.3 VDC from the same DC / DC converter. Therefore the MAIN PCB
has 2 sets of +3.3VDC over voltage monitoring circuits which are separated from each other.
The monitoring circuit monitors the voltage limits as follows:

+3.3VDC Upper limit +3.5VDC (3.434 to 3.500V)


Lower limit +3.1VDC (3.053 to 3.100V)

If the voltage exceeds the limit, the monitoring circuit stops the CPU by outputting the reset signal.

I. Field Programmable Gate Array (FPGA), C. FPGA and P. FPGA use different DC/DC converters
for 1.2 VDC and 2.5 VDC. Therefore if any of the DC/DC converters output abnormal voltage, CCPU
and PCPU can stop each other, and there is no need for voltage monitoring circuit.

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3. Electrical system

This page is intended to be blank

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4. Installation

4. Installation

To reduce the risk of serious or fatal patient injury, installation,


adjustment and repair of the DBB-06 must be performed only by trained
technical staff. Failure to do so may result in device malfunctions and
improper treatment.

4.1. Unpacking and visual inspection

If the DBB-06 is damaged, safe operation and functionality of the DBB-06


are not guaranteed. If any damage is found on the DBB-06, immediately
notify NIKKISO CO., LTD or the local representative.

The DBB-06 is securely packed to prevent damage during transportation.


Trained technical staff is licensed by NIKKISO CO., LTD must carefully unpack and inspect the
DBB-06, so that it is not damaged.

4.2. Precautions before installation

To reduce the risk of serious or fatal injury from fires, never use the DBB-
06 in the presence of flammable anesthetic or gases, such as high
pressure oxygen room or oxygen tent.

To reduce the risk of serious or fatal patient injury, keep this Operator’s
manual together with DBB-06 where all concerned personnel can refer to
it. Do not discard this manual.

Accessories not listed in Operator’s manual may only be used if they


have been tested and approved for operation and compliance with all
applicable standards by NIKKISO CO., LTD. Use of unapproved
accessories may result in serious or fatal patient injury and damage to
the DBB-06.

If the alarm output conversion box is connected to hospital or facility


equipment, double insulation (See Sec. 1.2.2.) must be used to help
protect the patient and operator from serious or fatal injury from electric
shock.

To reduce the risk of serious or fatal injury, accessory equipment


connected to the analog and digital 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 IEC 60601-1-1 system standard.
Anyone who connects additional equipment to the signal input or signal
output is configuring a medical system and is, therefore, responsible to
ensure that the system complies with the IEC 60601-1-1 requirements. If
in doubt, consult your local representative.

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4. Installation

Data on the network should be used for treatment information reference


only, and the operator should not make any decisions of medical
relevance without additional verification of the accuracy of this data.
The accuracy of the data must be verified by the operator before starting
further treatment.
The operator should routinely provide direct care to the patient at the
bedside even if the network system is used. Failure to properly monitor
the patient can result in serious or fatal patient injury.

The DBB-06 should only be operated under the specified operating


conditions stated in Sec. 1.6 and the operator’s manual Sec. 1.9.
NIKKISO CO., LTD shall be held responsible for safety, reliability, and
performance of the DBB-06 only if the DBB-06 is operated under the
specified conditions.

The operator’s manual must be read through completely prior to the trial
operation.
Failure to following this instruction can result injury to the staff and
damage to the DBB-06.

To reduce the risk of minor or moderate patient injury from DBB-06


malfunction, never operate devices that cause electromagnetic
interference, such as mobile phones or CB wireless transmitters in the
vicinity of the DBB-06 during operation.
The use of any devices that emit electromagnetic waves in the vicinity of
the DBB-06 may cause a DBB-06 malfunction. (See Sec 1.6.4.)

To reduce the risk of minor or moderate patient injury from other device
malfunctions, the users must try to correct the interference by using the
following measures if the DBB-06 causes harmful interference with any
other devices, which can be determined by turning off and on the DBB-
06:
 Reorient or relocate the device receiving interference.
 Increase the distance between the devices.
 Connect the DBB-06 to an outlet on a different circuit from that of the
other devices.
 Consult the NIKKISO CO., LTD. or its local representative.
The DBB-06 has been tested and found to comply with the limit for
medical devices according to the IEC 60601-1-2:2001.
These limits are designed to provide a reasonable protection against
harmful interference in a typical medical facility. The DBB-06 generates,
uses, and radiates radio frequency energy, which may cause harmful
interference with other devices in the vicinity if not installed and used in
accordance with the instructions. However there is no guarantee that
interference will not occur in any particular installation.

To reduce the risk of minor or moderate patient injury from a DBB-06


malfunction due to Electrostatic Discharge (ESD), the DBB-06 must be
installed in a room with wood, concrete, or ceramic tiled floors.
If the floors are covered with synthetic material, the relative humidity
should be at least 30%.

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4. Installation

Do not use the alarm output instead of audible and/or visible alarm from
the DBB-06. The alarm output is not intended to replace the audible
and/or visible alarm. Audible and visible alarms must be used correctly
to help prevent minor or moderate patient injury. The operator must
directly check the patient’s condition and status of the DBB-06 during
treatment.

Attach a ferrite-core fitting to the network cable to help prevent ESD


damage to the DBB-06.

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4. Installation

4.3. Installation
4.3.1. Connections

Ground reliability can only be achieved when the DBB-06 is connected to


an equivalent receptacle marked “Hospital only” or “Hospital grade”
according to UL60601-1 57.2.
The leakage current may exceed the allowable limits, if the DBB-06 is not
connected to the appropriate receptacle, which can result in the risk of
electric shock.

To reduce risk of serious or fatal patient or operator injury from electric


shock, never use any adapter that does not connect properly to the
grounding cable.

To reduce the risk of serious or fatal patient injury from electric shock,
always connect potential equalization terminal to the potential
equalization when a patient with central venous catheter is being treated.

The water used in the DBB-06 must have been treated using a reverse
osmosis system and/or other water treatment methods and must conform
to the applicable standards (See Sec. 1.6.5.). Failure to follow this water
standard can result in minor or moderate patient injury / illness, including
hemolysis and inflammation.

To reduce the risk of minor or moderate patient injury / illness from


infection the following measures must be taken:
- an air gap must be provided between the DBB-06 drain line and the
main drain port to help prevent back siphoning and possible
contamination,
- one way valve must be provided between the DBB-06 and water
supply system to prevent back flow into the water supply system,
in accordance with the applicable federal, state and local laws and
regulations (e.g. IEC6060-1-2-30).

1. Connect the water supply connector to the water supply port of the facility.
(See Operator’s manual Fig. 1.13)

2. Connect the drain connector to the drain port of the facility.


(See Operator’s manual Fig. 1.13)

3. Connect the CCS connector (optional) to the CCS port of the facility.
(See Operator’s manual Fig. 1.13)

A maximum pressure of 50 kPa (7 PSI) must not be exceeded in order to avoid


conductivity fluctuations, especially with a central concentrate supply.

4. Connect the power plug to the receptacle of the facility.

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4. Installation

4.3.2. Installation

1. Supply water to the DBB-06.

2. Confirm the following connections.


 Both concentrate connectors are securely connected to the respective rinse ports.
(See Operator’s manual Fig. 1.12)
 Both dialyzer couplings are securely connected to the bypass ports.
(See Operator’s manual Fig. 1.3)

3. Touch the [ON] key. (See Operator’s manual Fig. 1.4)

4. Touch the FUNCTION key, and then touch the CLEANING key.
(See Operator’s manual Sec. 1.7.1)
The cleaning screen is displayed.

5. Touch and hold the Pro 5 key (rinsing program).


(See Operator’s manual Fig. 1.17)

To reduce the risk of damage to the DBB-06, always rinse for at least 5
minutes (cold) after transporting, and check the DBB-06 carefully during
this rinse.

6. Touch and hold the Cleaning key to start cleaning program.


(See Operator’s manual Fig. 1.17)

The DBB-06 will be automatically turned OFF when the cleaning program is completed.

7. Always check if a nut in hydraulic part were securely fastened after disinfection performed at
the end of installation.
-Inlet and outlet of the UFP
-Inlet and outlet of the SPA and the SPB
-2 inlets and 2 outlets of the DP
-The fliter (dialysate return); FL1
-The back pressure valve; H1 and H2
-The relief valve; L
-The back pressure valve; H-C1 and H-C2
-The water pressure transducer; PT1
-The dialysate pressure transducers; PT2 and PT3
-The check valve; CV41, CV42, and CV61

To avoid cracking a nut due to much force, fasten manually without any
tools.

8. Touch the [ON] key. (See Operator’s manual Fig. 1.4)

The adjustment, setting and safety inspection must be carried out


according to the installation check list to verify all the functions of the
DBB-06 prior to starting the operation.

9. Perform the adjustment, setting and safety inspection by following installation check list (See
Sec 4.4).

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4. Installation

4.4. Installation check list


7 minutes rinse has to be performed before starting this check list.
If a problem is detected during this check list, repair the problem and start the check list again from the beginning.
Yes: The inspection has been successfully finished or the measured value is within the criterion value.
No: The inspection has not been successfully finished or the measured value is not within the criterion value.
N/A: Not applicable
General information:
Serial number:  Bicarbonate catridge
Inventory number:  BPM
Software version:  BVM
Language:  Nurse call switch
 EF-02D

Option
Operating place:  CCS
Operator:  A clamp
 Network
Connected devices:  No /  Yes:  Running time meter

 Other plugs
Plug type:

1. Visual inspections and maintenance measures: Mode N/A YES/NO


1.1 The security related marking, labels and labeling are legible and complete. - - /
1.2 The integrity of mechanical parts. - - /
1.3 Any damage or contamination. - - /
1.4 Assess the relevant accessory together with DBB-06. - - /
1.5 The required documentation is present and reflects current revision. - - /
2. Monitor:
2.1 Touch screen, LCD function - - /
2.2 Keys, LED function - - /
2.3 External status display function - - /
3. Tube clamp:
3.1 Venous clamp function: Clamp is closed/ Hinge is not cracked 13.2 - /
3.2 Arterial clamp function: Clamp is closed/ Hinge is not cracked (optional) 13.2  /
4. Air detector:
4.1 Air detector function Voltage adjustment, alarm function 13.5 - /
5. Blood pump:
Occlusion check: ID6.6mm, ID8.0mm - - /
Revolution speed check: 69±0.5rpm,
5.1 BP 13.7 - /
8.63-8.76sec / 10 revolutions in 600mL/min
Cover switch: BP is stopped when cover is opened 13.7 - /

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4. Installation

6. Pressure transducer:
-200±50 mmHg (±10 mmHg) 11.1 - /
6.1 Arterial pressure (PT 11 / PT 12)
0±50 mmHg (±10 mmHg) 11.2 - /
0±50 mmHg (±10 mmHg) 11.3 - /
6.2 Venous pressure / LAP (PT 15 / PT 16)
+200±50 mmHg (±10 mmHg) 11.4 - /
0±50 mmHg (±10 mmHg) 11.5 - /
6.3 Dialyzer inlet pressure (PT 13)
+200±50 mmHg (±10 mmHg) 11.6 - /
-200±50 mmHg (±10 mmHg) 3.1 - /
6.4 Dialysis fluid pressure before dialyzer (PT 2)
+200±50 mmHg (±10 mmHg) 3.2 - /
-200±50 mmHg (±10 mmHg) 3.3 - /
6.5 Dialysis fluid pressure after dialyzer (PT 3)
+200±50 mmHg (±10 mmHg) 3.4 - /
0±50 mmHg (±10 mmHg) 3.5 - /
6.6 Water supply pressure (PT 1)
+200±50 mmHg (±10 mmHg) 3.6 - /
7. UFC system:
7.1 Pressure check PRV, H1, H2 and L 5. - /
7.2 Balance check (5 ml/10 min) 5.3 - /
7.3 UF Pump discharge check 100 strokes volume (±1%) 6.1 - /
8. Conductivity:
CL2 display Reference value
Bicarbonate conductivity (CL 1/2) [TC 2.20]
8.1 7.3 - /
Approx. 3.0mS/cm (0.1 mS/cm)
………..mS/cm ………….mS/cm
CL4 display Reference value
Total conductivity (CL 3/4) [TC 2.05] 7.3
8.2 - /
Approx. 14.0 mS/cm (0.2 mS/cm) Treat.
………..mS/cm ………….mS/cm
9. Temperature:
7.4
9.1 Comparative measurement (TH 3/4) Approx. 37C (0,5C; 1,5C) - /
Treat.
10. Concentrate:
Bicarbonate (Bicarbonate cartridge), Acetate
10.1 Concentrate 1 B-concentrate:…………………. A-concentrate:………………….. 8.1  /
B conductivity:………….mS/cm Total conductivity:………mS/cm
Bicarbonate (Bicarbonate cartridge), Acetate
10.2 Concentrate 2 B-concentrate:…………………. A-concentrate:…………………. 8.2  /
B conductivity:………….mS/cm Total conductivity:……...mS/cm
Bicarbonate (Bicarbonate cartridge), Acetate
10.3 Concentrate 3 B-concentrate:…………………. A-concentrate:…………………. 8.3  /
B conductivity:………….mS/cm Total conductivity:……...mS/cm
Bicarbonate (Bicarbonate cartridge), Acetate
10.4 Concentrate 4 B-concentrate:…………………. A-concentrate:…………………. 8.4  /
B conductivity:………….mS/cm Total conductivity:……...mS/cm
Bicarbonate (Bicarbonate cartridge), Acetate
10.5 Concentrate 5 B-concentrate:…………………. A-concentrate:…………………. 8.5  /
B conductivity:………….mS/cm Total conductivity:……...mS/cm

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4. Installation

BPM (optional):
11. This inspection shall be performed every 24 months according to EN1060-3, as well as after repair work.
For this inspection only a pressure manometer which fulfills the requirement of EN1060-3 shall be used.
11.1 No electrical connection between DBB-06 and the cuff -  /
11.2 Air leakage test 300 mmHg(- 6 mmHg/min, -18 mmHg/3 min.) 19.1  /
0 mmHg (±3mmHg)
11.3 Cuff pressure 150 mmHg (±3mmHg) 19.2  /
300 mmHg (±3mmHg)
11.4 The external measurement switch function 19.3  /
12. BVM (optional):
12.1 BVM tube detected 13  /
Confirmation tool value [Refer to Tool
12.2 Calibration check 20  /
box] (Tolerance: ±2)
13. Electrical safety test:
Resistance of protective ground cable Potential equalization
13.1 IEC60601-1: Clause 18 terminal………………………………….. - - /
Allowable limit is 200m Heater housing……………………….…
Ground leakage current
13.2 IEC60601-1: Clause 19 …………………mA / …..….…………. V Treat. - /
Allowable limit is 0.50mA
Patient leakage current DC …………………mA / …..….…………. V Treat. - /
IEC60601-1: Clause 19
13.3
Allowable limit are
AC …………………mA / …..….…………. V Treat. - /
0.01mA (DC), 0.10mA (AC)
Patient leakage current
IEC60601-1: Clause 19
(If a central venous catheter is
13.4 AC …………………mA / …..….…………. V Treat. - /
used)
Allowable limit are
0.01 mA
14. Final tests:
14.1 Power failure alarm function The audible buzzer stops within 10 sec. Treat. - /
14.2 Data setting Setting1, Setting2 - - /
DM/
14.3 DM test and BM test are performed - /
BM
14.4 Disinfection is performed - - /
14.5 Check that there are no fluid leaks from the hydraulic circuit (include FL1) - - /
14.6 Check if a nut in hydraulic part is securely fastened. Tighten if loosened. - - /

Measurement equipment Type name Identification number


Analog pressure meter
Digital pressure meter
Digital pressure meter for BPM
Test instrument for Electrical safety test
Conductivity meter
Mesuring cylinder
Scale
Multimeter

Comments / repaired parts:

Evaluation result:  YES  NO

Testing organization Personal code Name of testing person in block letters

Place Date Signature

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5. Maintenance

5. Maintenance

To reduce the risk of serious or fatal patient injury, installation,


adjustment and repair of the DBB-06 must be performed only by trained
technical staff. Failure to do so may result in device malfunctions and
improper treatment.

Inspection and preventive maintenance must be performed prior to use.


Failure to perform required inspections and preventive maintenance may
result in device malfunction, which can cause serious or fatal patient
injury during treatment.

5.1. PM kit
5.1.1. Principle of PM kit

It is recommended that PM kit described in this chapter be replaced once per defined running
times.

For example after 3000 h running time, replace 3000 h kit. After 6000 h running time, replace
3000 h kit and 6000 h kit.

Running time of DBB-06 3000 h kit 6000 h kit 12000 h kit


After approx. 3000 h running time X
After approx. 6000 h running time X X
After approx. 9000 h running time X
After approx. 12000 h running time X X X
After approx. 15000 h running time X

Replace appropriate PM kit for the DBB-06 type and options.

For example:
After 12000 h running time of Type F (with B cartridge, dialysate filter, without CCS), replace PM
kit as follows:
- 3000 h Standard (Y91-057Z10) + B cartridge (Y91-057Z11),
- 6000 h Standard (Y91-057Z20),
- 12000 h Standard (Y91-057Z30) + B cartridge (Y91-057Z31) + dialysate filter (Y91-057Z33).

Parts name Part number Standard Type B Type C Type D


(Type E*) (Type F*) (Type G*) (Type H*)
Standard Y91-057Z10 X X X X
3000 h
B cartridge Y91-057Z11 X X
6000h Standard Y91-057Z20 X X X X
Standard Y91-057Z30 X X X X
B cartridge Y91-057Z31 X X
12000h CCS Y91-057Z32 X X
Dialysate Any type with dialysate filter.
Y91-057Z33
filter
*): Type E, Type F, Type G and Type H are with dialysate filter.
For example: Type F is Type B with dialysate filter.

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5. Maintennace

5.1.2. Every 3000 hours

Denomination Item Replacement parts Qty Fig.


Fan 2 Filter 2 A
Bypass ports 2 O-ring (P-10A) 2 B
Dialyzer coupling 3 O-ring (P-12.5) 2 C
Concentrate connector 4 O-ring (P-7) 2 D
Option: Bicarbonate cartridge holder
Cartridge holder 5 O-ring (P-10) 2 E
6 O-ring (P-16) 1

Fig. A Fan Fig. B Bypass ports

2. O-ring (P-10A)
1. Filter 3000h
3000h

Fig. C Dialyzer coupling Fig. E Bicarbonate cartridge

5. O-ring (P-10)
3000h

3. O-ring (P-12.5)
3000h

Fig. D Concentrate connector

4. O-ring (P-7)
3000h

6. O-ring (P-16)
3000h

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5. Maintenance

5.1.3. Every 6000 hours

Denomination Item Replacement parts Qty Fig.


Concentrate line filter 7 Filter 2 F
(FL61, FL62)
Dialysate pathway filter (FL1) 8 Filter 1 G
Deaeration pump (CP-1) 9 Mechanical seal 2 H
Booster pump (CP-2) 10 O-ring (S-55) 2
11 O-ring (S-28) 2
12 E-ring (E-5) 2
Duplex pump (DP) 13 Cap seal 2 I
14 O-ring (S-16) 4
15 One way valve 4
16 Block 1
Concentrate pumps (SPB, SPA) 17 One way valve (inlet) 2 J
18 One way valve (outlet) 2
19 Cap seal 4
20 O-ring 2
UF pump (UFP) 21 One way valve (inlet) 1 K
22 One way valve (outlet) 1
23 Cap seal 1
Disinfectant suction tube 24 Disinfectant suction tube 2 L

Fig. F Concentrate line filter Fig. G Dialysate pathway filter

7. Filter 8. Filter
6000h 6000h

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5. Maintennace

Fig. H Deaeration pump, booster pump


11. O-ring (S-28)
6000h

10. O-ring (S-55)


6000h

9. Mechanical seal
6000h

12. E-ring (E-5)


6000h 29. Impeller
12000h

Fig. I Duplex pump

16. Block
6000h

15. One way valve


6000h

30. Tape bearing


12000h

14. O-ring (S-16)


6000h
13. Cap seal
6000h

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5. Maintenance

Fig. J Concentrate pump

18. One way valve (outlet)


6000h

19. Cap seal


6000h

20. O-ring (S-12.5)


6000h

17. One way valve (inlet)


6000h

Fig. K UF pump

22. One way valve (outlet)


6000h

23. Cap seal


6000h

21. One way valve (inlet)


6000h

Fig. L Disinfectant suction tube

24. Disinfectant suction tube


6000h

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5. Maintennace

5.1.4. Every 12000 hours

Denomination Item Replacement parts Qty Fig.


Back-pressure valves (H1, H2) 25 Diaphragm 3 M
Relief valve (L)
Back-pressure valves 26 Diaphragm 2 N
(H-C1, H-C2)
Solenoid valves 27 Valve kits 10 O
(SV1, SV2, SV3, SV4, SV5,
SV6, SV7, SV8, SV63, SV64)
Disinfectant valves 28 Solenoid valve 1 P
(SV21, SV22)
Deaeration pump (CP-1) 29 Impeller 2 H
Booster pump (CP-2)
Duplex pump (DP) 30 Tape bearing 1 I
Bicarbonate powder cartridge (optional)
Solenoid valves 27 Valve kits 3 O
(SV61, SV62, SV70)
Hydrophobic filter (FL43, FL44) 31 Hydrophobic filter 2 Q
One way valves (CV42, CV61) 32 One way valve 2 R
33 O-ring (S-16) 2
Dialysate filter (optional)
Hydrophobic filter (FL41, FL42) 31 Hydrophobic filter 2 Q
One way valve (CV41) 32 One way valve 1 R
33 O-ring (S-16) 1
Central concentrate supply (optional)
Solenoid valves (SV65, SV66, 27 5 O
Valve kits
SV67, SV68, SV69)
LAP
Hydrophobic filter 31 Hydrophobic filter 1 Q
LAP 34 Pump segment 1 S

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5. Maintenance

Fig. M Back pressure valves, Relief valve Fig. N Back pressure valves

25. Diaphragm
12000h 26. Diaphragm
12000h

Fig. O Solenoid valves


27. Valve kit
12000h

Fig. P Disinfectant valves Fig. Q Hydrophobic filter

28. Disinfectant valve


12000h 31. Hydrophobic filter
12000h

Fig. R One way valve Fig. S LAP


34. Pump segment
12000h

32. Oneway valve


12000h

33. O-ring (S-16)


12000h

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5. Maintennace

5.2. Maintenance with technical safety inspection


This inspection must be performed at least once every 12 months.
7 minutes rinse has to be performed before starting this check list.
After repairs, inspection must be performed based on required action after replacement (See Appendix C)
If a problem is detected during this check list, repair the problem and start the check list again from the beginning.
Yes: The inspection has been successfully finished or the measured value is within the criterion value.
No: The inspection has not been successfully finished or the measured value is not within the criterion value.
N/A: Not applicable
General information:
Serial number:  Bicarbonate catridge
Inventory number:  BPM
Software version:  BVM
Running hours:  SW /  HW: h  Nurse call switch
Operating place:  EF-02D

Option
Operator:  CCS
Last test on:  A clamp
Connected devices  No /  Yes:  Network
Same configuration as in the past TSI:  Yes /  No:  Running time meter
 Test before putting into service  Other plugs
Status prior to safety inspection:  Recurrent test
 Test after modification or repair Plug type:

1. Visual inspections and maintenance measures: Mode N/A YES/NO


The security related marking, labels and labeling are legible and
TSI 1.1 -  /
complete.
TSI 1.2 The integrity of mechanical parts. -  /
TSI 1.3 Any damage or contamination. -  /
TSI 1.4 Assess the relevant accessory together with DBB-06. -  /
TSI 1.5 The required documentation is present and reflects current revision. -  /
1.6 Maintenance parts replaced based on the running time. -  /
2. Monitor:
TSI 2.1 Touch screen, LCD function -  /
TSI 2.2 Keys, LED function -  /
TSI 2.3 External status display function -  /
3. Tube clamp:
TSI 3.1 Venous clamp function: Clamp is closed/ Hinge is not cracked 13.2  /
TSI 3.2 Arterial clamp function: Clamp is closed/ Hinge is not cracked (optional) 13.2  /
4. Air detector:
TSI 4.1 Air detector function Voltage adjustment, alarm function 13.5  /
5. Blood pump:
TSI Occlusion check: ID6.6mm, ID8.0mm -  /
Revolution speed check: 69±0.5rpm,
5.1 BP 13.7  /
8.63-8.76sec / 10 rotations in 600mL/min
TSI Cover switch: BP is stopped when cover is opened 13.7  /

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5. Maintenance

6. Pressure transducer:
-200±50 mmHg (±10 mmHg) 11.1  /
TSI 6.1 Arterial pressure (PT 11 / PT 12)
0±50 mmHg (±10 mmHg) 11.2  /
Venous pressure / LAP 0±50 mmHg (±10 mmHg) 11.3  /
TSI 6.2
(PT 15 / PT 16) +200±50 mmHg (±10 mmHg) 11.4  /
0±50 mmHg (±10 mmHg) 11.5  /
TSI 6.3 Dialyzer inlet pressure (PT 13)
+200±50 mmHg (±10 mmHg) 11.6  /
Dialysis fluid pressure before -200±50 mmHg (±10 mmHg) 3.1  /
TSI 6.4
dialyzer (PT 2) +200±50 mmHg (±10 mmHg) 3.2  /
Dialysis fluid pressure after dialyzer -200±50 mmHg (±10 mmHg) 3.3  /
TSI 6.5
(PT 3) +200±50 mmHg (±10 mmHg) 3.4  /
0±50 mmHg (±10 mmHg) 3.5  /
TSI 6.6 Water supply pressure (PT 1)
+200±50 mmHg (±10 mmHg) 3.6  /
7. UFC system:
7.1 Pressure check PRV, H1, H2 and L 5  /
TSI 7.2 Balance check (5 ml/10 min) 5.3  /
TSI 7.3 UF Pump discharge check 100 strokes volume (±1%) 6.1  /
8. Conductivity:
Bicarbonate conductivity (CL 1/2) CL2 display Reference
TSI 8.1 [TC 2.20] value 7.3  /
Approx. 3.0mS/cm (0.1 mS/cm) ………….mS/cm ………..mS/cm
Total conductivity (CL 3/4) CL4 display Reference
7.3
TSI 8.2 [TC 2.05] value  /
Approx. 14.0 mS/cm (0.2 mS/cm) Treat.
………….mS/cm ………..mS/cm
9. Temperature:
7.4
TSI 9.1 Comparative measurement (TH 3/4) Approx. 37C (0,5C; 1,5C)  /
Treat.
10. BLD:
10.1 BLD received light voltage adjustment 9.1  /
BPM (optional):
This inspection shall be performed every 24 months according to EN1060-3, as well as after repair
11.
work. For this inspection only a pressure manometer which fulfills the requirement of EN1060-3 shall
be used.
TSI 11.1 No electrical connection between DBB-06 and the cuff -  /
TSI 11.2 Air leakage test 300 mmHg(- 6 mmHg/min, -18 mmHg/3 min.) 19.1  /
0 mmHg (±3mmHg)
TSI 11.3 Cuff pressure 150 mmHg (±3mmHg) 19.2  /
300 mmHg (±3mmHg)
11.4 The external measurement switch function 19.3  /
12. BVM (optional):
12.1 BVM check Zero voltage / Span voltage = 1.6 ±0.1 20  /

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5. Maintennace

13. Electrical safety test:


Resistance of protective ground cable Potential equalization
TSI 13.1 IEC60601-1: Clause 18 terminal………………………... -  /
Allowable limit is 200m Heater housing………………..
Ground leakage current
TSI 13.2 IEC60601-1: Clause 19 ………….….mA / ……..……… V Treat.  /
Allowable limit is 0.50mA
Patient leakage current
DC ………….….mA / ……..……… V Treat.  /
IEC60601-1: Clause 19
TSI 13.3
Allowable limit are
0.01mA (DC), 0.10mA (AC) AC ………..……mA / ……..……… V Treat.  /
Patient leakage current
IEC60601-1: Clause 19
(If a central venous catheter is
TSI 13.4 AC ……….…..…mA /……..……… V Treat.  /
used)
Allowable limit are
0.01 mA
14. Final tests:
TSI 14.1 Power failure alarm function The audible buzzer stops within 10 sec. Treat.  /
DM/
TSI 14.2 DM test and BM test are performed  /
BM
TSI 14.3 Disinfection is performed -  /
TSI 14.4 Check that there are no fluid leaks from the hydraulic circuit (include FL1) -  /
TSI 14.5 Check if a nut in hydraulic part is securely fastened. Tighten if loosened. -  /

Measurement equipment Type name Identification number


Analog pressure meter
Digital pressure meter
Digital pressure meter for BPM
Test instrument for Electrical safety test
Conductivity meter
Mesuring cylinder
Scale
Multimeter

Comments / repaired parts:

Evaluation result:  YES  NO

Testing organization Personal code Name of testing person in block letters

Place Date Signature

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6. Setting

6. Setting

6.1. Classification
To reduce the risk of serious or fatal patient injury from incorrect
machine settings, do not change any settings in the setting 1, setting 2 or
patient database categories without reading the operator’s and technical
manuals, and without the direction of a physician.
The settings in setting 1, setting 2, or the patient database categories can
be changed only by trained technical staff or a trained head nurse.

To reduce the risk of serious or fatal patient injury from incorrect


machine settings, safe and correct operation must be confirmed by
trained technical staff or a trained head nurse if any settings in the setting
1, setting 2 or patient database categories has been changed from the
factory default setting.
To reduce the risk of serious or fatal/injury patient, some critical factory
default settings cannot be changed. Those that can be changed are
marked with the notation (Factory default).

Fig. 6.1

Setting1 Setting 2
Database Database

Treatment
Database

Patient
Database

Can be set by trained operator without password.

Can be set by trained head nurse.


(It is necessary to input the HN (head nurse) password)

Can be set /adjust by trained technical staff.


(It is necessary to input the TK (technical) password)

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6. Setting

Setting 1, Patient and Treatment database


All Setting 1, Patient, and Treatment database fields contain some setting items which relate to
patient or treatment.
Setting 1 database is the clinic default setting. Entered values in Setting 1 database overwrite the
treatment database, when the computer test is performed before each treatment start. (See Fig.
6.1 A)

When the Setting1 database is changed during the treatment, it does not affect the
current treatment. Changes made during a treatment will take effect for the next
treatment when the computer test is performed.

The Patient database is the patient default setting. Entered values in the patient database
overwrite the treatment database, when the patient is selected. (See Fig. 6.1 B)

When the Patient database is changed during the treatment, it does not affect the
current treatment. It takes effect for the next treatment when the patient is selected.

The Treatment database is used for the current treatment. A value entered in the Treatment
database takes effect immediately for the current treatment.

Even if the Treatment database is changed, it is overwritten by the Setting 1 database


at the computer test for the next treatment.

Setting 2 database
The Setting 2 database contains setting items which relate to the dialysis machine or center.
Values entered in the Setting 2 database take effect immediately, and are not overwritten.

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6. Setting

6.2. Table of setting


Title Factory default Setting range (Unit)
Comment
Title Factory default Setting range (Unit)
Comment
Each label color shows priority.
Safety related setting which must be explained to the
Orange : High
trained operator.
Non safety related setting which is recommended to be
Yellow : Middle
explained to the trained operator.
Grey : Low Non safety related setting and no need to change.
Setting 1
1. Treatment condition
1.1 Treatment condition 1
Treatment time 4:00 0:00 to 10:00 hour: min
Enter the desired treatment time.
UF goal 0.00 0.00 to 40.00L
Enter the desired UF goal.
See Setting1-5.1 Setting range, UF goal maximum setting range.
UF rate 0 0.00 to 4.00 L/hr
Enter the desired UF rate.
See Setting1-5.1 Setting range, UF rate maximum setting range.
Treatment mode 0 0: HD mode
Select the desired treatment mode.
SN mode 0 0: Double needle mode
1: Single pump SN mode
Select the desired SN mode.
SN control pressure upper limit 200 0 to 400mmHg
Enter the desired SN pressure at which the arterial phase is switched to the venous phase.
It can only be set above the SN control pressure lower limit.
SN control pressure lower limit 100 0 to 400mmHg
Enter the desired SN pressure at which the venous phase is switched to the arterial phase.
It can only be set below SN control pressure upper limit.
ISO-UF time 0:30 0:00 to 10:00 hour: min
Enter the desired ISO-UF time.
ISO-UF goal 0.00 0.00 to 40.00L
Enter desired ISO-UF goal.
ISO-UF time count selection 0 0: Not count, 1: Count
Select if ISO-UF time is counted as part of the treatment time.

1.2 Treatment condition 2


Concentrate selection 1 1: Concentrate 1, 2:Concentrate 2
3: Concentrate 3, 4:Concentrate 4
5: Concentrate 5
Select the desired concentrate.
Concentrate which is selected as Used in SERVICE-MODE 8. Conductivity calibration can be
selected. (See Sec. 7.2)
Dialysate temperature 37.0 35.0 to 39.0°C
Enter desired dialysate temperature.
See Setting1-5.1 Setting range, dialysate temperature setting range.
Dialysate flow 500 300 to 800mL/min
Enter the desired dialysate flow.
Continuous HP start 1 0: Manual, 1: Automatic
Select if continuous HP starts automatically when blood is detected in connect mode and
treatment mode.

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6. Setting

HP bolus start 0 0: Manual, 1: Automatic


Select if HP bolus starts automatically when blood flow reaches to 30mL (factory default) in
connect mode and treatment mode.
If HP bolus has been performed manually, HP bolus does not start automatically.
See Setting2-14. HP, HP bolus start blood flow.
Total conductivity 14.0 12.5 to 15.5mS/cm
Enter the desired total conductivity.
Bicarbonate conductivity 3.00 2.30 to 3.99mS/cm, 4.00 to 7.00mS/cm
Enter the desired bicarbonate conductivity.
Setting range can be changed based on set target bicarbonate conductivity in SERVICE-MODE
8. Conductivity calibration. (See Sec. 7.2)
HP rate 0.0 0.0 to 9.9mL/hr
Enter the desired HP rate.
See Setting1-5.1 Setting range, HP rate maximum setting range.
HP bolus volume 0.0 0.0 to 9.9mL
Enter the desired HP bolus volume.
HP stop time 0 0 to 120min
Enter desired HP stop time.
HP stops when Time remaining reaches HP stop time.
Bicarbonate cartridge switch selection 0 0: Hardware SW, 1: Software SW
Select if B cart. SW select key is ON as clinic default setting.
(See Operator’s manual Sec. 1.7.3.)

1.3 Treatment condition 3


Arterial priming continue 0 0: Stopped, 1: Go into next phase
Select if venous priming phase is automatically started after arterial priming phase.
See Setting2-2.1 Priming with saline bag, Arterial priming.
Dialyzer selection 0 0: WET dialyzer, 1: DRY dialyzer
2: Plate dialyzer
Select the desired dialyzer type.
WET dialyzer: BM test is started when BM test key is touched after fill dialyzer. (See Operator’s
manual Sec. 3.5.4)
DRY dialyzer: BM test starts automatically after dialyzer filling.
PLATE dialyzer: BM test does not start automatically and Bypass key is turned OFF after
dialyzer filling. (See Operator’s manual Sec. 3.5.4)

2. Alarm limit
See Operator’s manual Sec. 1.7.4
2.1 VP alarm
HD, SN
ISO-UF
Fixed upper limit 300 400
-200 to 500mmHg*1*3
Maximum setting 300
range (Auto alarm) -200 to 500mmHg*1
Auto upper limit 60
0 to 400mmHg
Auto lower limit -40
-400 to 0mmHg
Minimum setting 10
range (Auto alarm) -200 to 500mmHg*2
Fixed lower limit -10 10
-200 to 500mmHg*2*3
*1
: Upper limit / maximum setting range can not be set below lower limit / minimum setting range.
*2
: Lower limit / minimum setting range can not be set above upper limit / maximum setting range.
*3
: See Setting2-9.1/2 Setting range (Fixed alarm), Setting range (VP fixed alarm).
See Setting 1-7 Alarm monitoring, VP alarm (auto) selection.

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6. Setting

2.2 AP alarm
HD, SN
ISO-UF
Fixed upper limit 100 100
*1*3
-300 to 300mmHg
Maximum setting 100
range (Auto alarm) -300 to 300mmHg*1
Auto upper limit 70
0 to 300mmHg
Auto lower limit -70
-300 to 0mmHg
Minimum setting -250
range (Auto alarm) -300 to 300mmHg*2
Fixed lower limit -250 -250
-300 to 300mmHg*2*3
*1
: Upper limit / maximum setting range can not be set below lower limit / minimum setting range.
*2
: Lower limit / minimum setting range can not be set above upper limit / maximum setting range.
*3
: See Setting2-9.1/2 Setting range (Fixed alarm), Setting range (AP fixed alarm).
See Setting 1-7 Alarm monitoring, AP alarm (auto) selection.

2.3 Dialysate pressure alarm


HD, SN
ISO-UF
Fixed upper limit 300 300
-400 to 400mmHg*1*3
Maximum setting 300 300
range (Auto alarm) -400 to 400mmHg*1
Auto upper limit 70 70
0 to 400mmHg
Auto lower limit -70 -70
-400 to 0mmHg
Minimum setting -300 -300
range (Auto alarm) -400 to 400mmHg*2
Fixed lower limit -300 -300
-400 to 400mmHg*2*3
*1
: Upper limit / maximum setting range can not be set below lower limit / minimum setting range.
*2
: Lower limit / minimum setting range can not be set above upper limit / maximum setting range.
*3
: See Setting2-9.1/2 Setting range (Fixed alarm), Setting range (dialysate pressure fixed alarm).
See Setting 1-7 Alarm monitoring, Dialysate pressure alarm (auto) selection.

2.4 TMP alarm


HD, SN
ISO-UF
Fixed upper limit 500 500
-100 to 500mmHg*1*3
Maximum setting 500 500
range (Auto alarm) -100 to 500mmHg*1
Auto upper limit 70 70
0 to 400mmHg
Auto forecast 20 50
upper limit 0 to 400mmHg
Auto forecast -20 -50
lower limit -400 to 0mmHg

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6. Setting

Auto lower limit -70 -70


-400 to 0mmHg
Minimum setting -30 -30
range (Auto alarm) -100 to 500mmHg*2
Fixed lower limit -30 -30
-100 to 500mmHg*2*3
*1
: Upper limit / maximum setting range can not be set below lower limit / minimum setting range.
*2
: Lower limit / minimum setting range can not be set above upper limit / maximum setting range.
*3
: See Setting2-9.1/2 Setting range (Fixed alarm), Setting range (TMP fixed alarm).
See Setting 1-7 Alarm monitoring, TMP alarm monitoring selection.

2.5 Pressure loss alarm


HD, SN
ISO-UF
Fixed upper limit 400
-200 to 600mmHg*1
Fixed lower limit -60
-200 to 600mmHg*2
*1
: Upper limit / maximum setting range can not be set below lower limit / minimum setting range.
*2
: Lower limit / minimum setting range can not be set above upper limit / maximum setting range.

2.6 DIP alarm


HD, SN
ISO-UF
Fixed upper limit 500 500
-200 to 735mmHg*1*3
Maximum setting 500
range (Auto alarm) -200 to 735mmHg*1
Auto upper limit 70
0 to 400mmHg
Auto lower limit -70
-400 to 0mmHg
Minimum setting -50
range (Auto alarm) -200 to 735mmHg*2
Fixed lower limit -50 -50
-200 to 735mmHg*2*3
*1
: Upper limit / maximum setting range can not be set below lower limit / minimum setting range.
*2
: Lower limit / minimum setting range can not be set above upper limit / maximum setting range.
*3
: See Setting2-9.1/2 Setting range (Fixed alarm), Setting range (DIP fixed alarm).
See Setting 1-7 Alarm monitoring, DIP alarm (auto) selection.

2.7 UFK alarm


Initial UFK abnormal upper limit 200.00 0.00 to 300.00mL/hr/mmHg*1
Enter the desired initial UFK abnormal upper limit.
It can only be set above lower limit.
Initial UFK is measured in initial UFK measurement.
Initial UFK abnormal lower limit 1.00 0.00 to 300.00mL/hr/mmHg*2
Enter the desired initial UFK abnormal lower limit.
It can only be set below upper limit.
Initial UFK is measured in initial UFK measurement.
UFK drop alarm limit 30 0: Not monitored, 1 to 95%
Enter the desired UFK drop alarm limit.
ActualUFK
UFKdrop   100
InitialUFK
Actual UFK: Actual UFK during the treatment
Initial UFK: Initial UFK at the beginning of treatment
*1
: Initial UFK abnormal upper limit cannot be set below initial UFK abnormal lower limit.

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6. Setting

*2
: Initial UFK abnormal lower limit cannot be set above initial UFK abnormal upper limit.

2.8 TMP zero calibration abnormal


HD, ISO-UF
Middle point -30 -40
-200 to 200 mmHg
Enter the desired middle point for TMP zero calibration abnormal.
Upper limit 80 80
0 to 100 mmHg
Enter the desired upper limit for TMP zero calibration abnormal.
TMP zero calibration abnormal upper limit = Middle point + upper limit
Lower limit -70 -70
-100 to 0 mmHg
Enter the desired lower limit for TMP zero calibration abnormal.
TMP zero calibration abnormal lower limit = Middle point + lower limit
See Setting1-7 Alarm monitoring, TMP zero calibration.

3. UF profile
Step No. 1 2 3 4 5 6 7 8 9 10 Final On/
step Off
A Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 200 200 200 200 150 140 130 120 110 100
B Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 200 190 180 170 160 150 140 130 120 60
C Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 200 200 200 200 200 200 120 120 120 60
D Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 100 200 110 190 120 180 150 150 150 150
E Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 200 200 160 160 120 120 80 80 40 40
F Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 40 40 80 80 120 120 160 160 200 200
G Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 150 150 150 150 150 150 150 150 50 50
H Mode HD HD HD HD HD HD HD HD HD HD 10 Off
UFR* 50 50 150 150 150 150 150 150 150 150
I Mode HD HD HD HD HD HD HD HD HD HD Off
Course 1.0 0.0 - 2.0
Start UFR* 100 0 to 200
End UFR* 100 0 to 200
See Operator’s manual Sec. 9.1
Only one of A to I profiles can be selected (set ON).
See Setting1-1.1 Treatment condition 1, UF goal.

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6. Setting

4. Conductivity profile
Step No. 1 2 3 4 5 6 7 8 9 10 Final Step On/
step time Off
A Total 14.0 14.0 14.0 14.0 14.0 13.5 13.5 13.5 13.5 13.5 10 30 Off
Bic. 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50
B Total 13.5 13.5 13.5 13.5 13.5 14.0 14.0 14.0 14.0 14.0 10 30 Off
Bic. 2.50 2.50 2.50 2.50 2.50 3.00 3.00 3.00 3.00 3.00
C Total 14.0 14.0 13.5 13.5 13.5 13.5 13.5 13.5 14.0 14.0 10 30 Off
Bic. 3.00 3.00 3.00 3.00 3.00 2.50 2.50 2.50 2.50 2.50
D Total 13.5 13.5 13.5 14.0 14.0 14.0 14.0 13.5 13.5 13.5 10 30 Off
Bic. 3.00 3.00 2.50 2.50 2.50 3.00 3.00 2.50 2.50 2.50
E Total 13.5 13.5 14.0 14.0 13.5 13.5 14.0 14.0 13.5 13.5 10 30 Off
Bic. 3.00 2.50 2.50 3.00 3.00 3.00 3.00 2.50 2.50 3.00
F Total 13.5 13.5 14.0 14.0 14.0 14.0 14.0 14.0 13.5 13.5 10 30 Off
Bic. 3.00 3.00 3.00 2.50 2.50 2.50 2.50 3.00 3.00 3.00
G Total 14.0 14.0 13.5 13.5 13.5 13.5 13.5 13.5 14.0 14.0 10 30 Off
Bic. 2.50 2.50 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00
H Total 13.5 14.0 13.5 14.0 13.5 14.0 13.5 14.0 13.5 14.0 10 30 Off
Bic. 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 2.50 2.50
I Total Start conductivity 14.8 12.5 to 15.5mS/cm Off
End conductivity 14.0 12.5 to 15.5mS/cm
Course 1.0 0.0 to 2.0
Bic. Start conductivity 3.8 2.30 to 3.99mS/cm
4.00 to 7.00mS/cm
End conductivity 3.0 2.30 to 3.99mS/cm
4.00 to 7.00mS/cm
Bicarbonate cause 1.0 0.0 to 2.0
See Operator’s manual Sec.9.1
Only one of A to I profiles can be selected (set ON).

5. Setting range
5.1 Setting range
Blood flow maximum setting range 500 0 to 600mL/min
Enter the desired blood flow maximum setting range.
HP rate maximum setting range 9.9 0 to 9.9mL/hr
Enter the desired HP rate maximum setting range.
See Setting 1-1.2 Treatment condition 2, HP rate.
UF rate maximum setting range 2.00 0.00 to 4.00L/hr
Enter the desired UF rate maximum setting range.
See Setting 1-1.1 Treatment condition 1, UF rate.
UF rate maximum setting range 3.00 0.00 to 4.00L/hr
(ISO-UF)
Enter the desired UF rate maximum setting range in ISO-UF mode.
If UF profile is used, this set value is not used.
See Setting 1-1.1 Treatment condition 1, UF rate.
Dialysate temperature maximum setting 39.0 34.0 to 40.0°C
range
Enter the desired dialysate temperature maximum setting range.
Maximum setting range can only be set above minimum setting range.
See Setting 1-1.2 Treatment condition 2, Dialysate temperature.
Dialysate temperature minimum setting 35.0 34.0 to 40.0°C
range
Enter the desired dialysate temperature minimum setting range.
Minimum setting range can only be set below maximum setting range.
See Setting 1-1.2 Treatment condition 2, Dialysate temperature.
HP selection 1 0: Not used, 1: Used
Select if HP is used.

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6. Setting

6. BPM (optional)
6.1 BPM (measurement setting)
Automatic measurement interval 60 2 to 180min
Enter the desired interval time of automatic measurement.
Manual inflation pressure (Adult) 180 120 to 220mmHg
Enter the desired inflation pressure for adult.
If manual inflation pressure is selected, this set value is used.
Inflation pressure type selection 1 0: Manual inflation pressure
1: Automatic inflation pressure
2 :Smart inflation pressure
Select the desired inflation pressure type.
Smart inflation pressure can be used.
Continuous measurement type selection 0 0: 12min, 1: 5min
Select the desired continuous measurement type.
See Operator’s manual Sec. 10.2.2
High speed measurement 1 0: Not used, 1: Used
Select if high speed measurement is used.
High speed measurement can only be used.

6.2 BPM (alarm limit 1)


Adult
SYS alarm upper limit 200 60 to 250 mmHg*1
Enter desired SYS alarm upper limit.
SYS alarm lower limit 80 60 to 250 mmHg*2
Enter desired SYS alarm lower limit.
DIA alarm upper limit 160 40 to 200 mmHg*1
Enter desired DIA alarm upper limit.
DIA alarm lower limit 50 40 to 200 mmHg*2
Enter desired DIA alarm lower limit.
*1
Upper limit can only be set above lower limit.
*2
Lower limit can only be set below upper limit.

6.3 BPM (alarm limit 2)


Adult
MAP alarm upper limit 180 45 to 235mmHg*1
Enter desired MAP alarm upper limit.
MAP alarm lower limit 60 45 to 235mmHg*2
Enter desired MAP alarm lower limit.
Pulse alarm upper limit 170 40 to 200bpm*1
Enter desired Pulse alarm upper limit.
Pulse alarm lower limit 50 40 to 200bpm*2
Enter desired Pulse alarm lower limit.
*1
Upper limit can only be set above lower limit.
*2
Lower limit can only be set below upper limit.

6.4 BPM (Reaction in SYS alarm)


Selection Rate
Blood flow reaction in SYS alarm 0 0: Not used 100 40 to 600mL/min
upper 1: Used
Select if blood flow reaction is used in SYS alarm upper.
Enter desired blood flow when SYS alarm upper is triggered.

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6. Setting

Blood flow reaction in SYS alarm 0 0: Not used 100 40 to 600mL/min


lower 1: Used
Select if blood flow reaction is used in SYS alarm lower.
Enter desired blood flow when SYS alarm lower is triggered.
UF rate reaction in SYS alarm 0 0: Not used 0.10 0.00 to 0.50L/hr
upper 1: Used
Select if UF rate reaction is used in SYS alarm upper.
Enter desired UF rate when SYS alarm upper is triggered.
UF rate reaction in SYS alarm 0 0: Not used 0.10 0.00 to 0.50L/hr
lower 1: Used
Select if UF rate reaction is used in SYS alarm lower.
Enter desired UF rate when SYS alarm lower is triggered.

6.5 BPM (BP alarm/setting change)


Measurement delay time after resetting 0 0: Not measured, 1 to 120min
VP alarm
Enter the desired measurement delay time when venous pressure alarm is reset.
If it is set 0, measurement is not started.
Measurement delay time after setting 0 0: Not measured, 1 to 120min
change
Enter the desired measurement delay time when blood flow, UF rate is changed.
If it is set 0, measurement is not started.
BP measurement pause by VP alarm 0 0: Not paused, 1: Paused
Select the BP measurement pause when venous pressure alarm is triggered.
BP measurement pause by setting 0 0: Not paused, 1: Paused
change
Select the BP measurement pause when blood flow, UF rate is changed.
BPM start condition 0 0:BPM does not start after treatment start
1:BPM start after treatment start
Please check the BPM cuff is sttached to the arm.
When [1:BPM start after treatment start] is selected,bellow setting are used.
BPM mode selection after treatment 2 0:Manual measurement
start 1:Continuous measurement
2:Auto measurement
Select desired measurement mode of BPM auto start.

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6. Setting

7. Alarm monitoring
TMP alarm monitoring selection 1 0: TMP alarm (Auto forecast)
1: TMP alarm (Auto)
2: Dialysate pressure alarm
Select the desired monitoring method of TMP alarm.
TMP zero calibration selection 0 0: Used, 1: Not used
Select if TMP zero calibration is used.
See Setting1-2.8 TMP zero calibration abnormal.
VP alarm (Auto) selection 1 0: Not used, 1: Used
Select if VP alarm (Auto) is used.
If it is not used, it is monitored by VP alarm (fixed).
See Setting 1-2.1 VP alarm.
AP alarm (Auto) selection 1 0: Not used, 1: Used
Select if AP alarm (Auto) is used.
If it is not used, it is monitored by AP alarm (fixed).
See Setting 1-2.2 AP alarm.
Dialysate pressure alarm (Auto) 1 0: Not used, 1: Used
selection
Select if dialysate pressure alarm (Auto) is used.
If it is not used, it is monitored by dialysate pressure alarm (Fixed).
See Setting 1-2.3 Dialysate pressure alarm.
TMP alarm (Auto) selection 1 0: Not used, 1: Used
Select if TMP alarm (Auto) is used.
If it is not used, it is monitored by TMP alarm (Fixed).
See Setting 1-2.4 TMP alarm.
DIP alarm (Auto) selection 1 0: Not used, 1: Used
Select if DIP alarm (Auto) is used.
If it is not used, it is monitored by DIP alarm (Fixed).
See Setting 1-2.6 DIP alarm.

9. BVM (optional)
9.1 BVM 1
BV measurement selection 0 0: Not used, 1: Used
Select if BV measurement is used.
BV measurement start time 10 0 to 60 min
Enter the desired time to start BV measurement.
Initial BV is measured when BV measurement is started.
 ActualBV 
dBV    1  100
 InitialBV 
dBV drop 1 alarm limit -100*1 -100: Not monitored, -99.9 to 0.0%
Enter the desired dBV drop 1 alarm limit.
It can only be set above dBV 2 alarm limit.
dBV drop 2 alarm limit -100 -100: Not monitored, -99.9 to 0.0%
Enter the desired dBV drop 2 alarm limit.
It can only be set below dBV 1 alarm limit.
If it is set -100, dBV drop 2 alarm is not monitored.
dBV change rate alarm limit -20*1 0: Not monitored, -50 to 0.1%/min
Enter the desired dBV change rate alarm limit.
dBV minimum UF rate 0.1 0.00 to 2.00L/hr
Enter the desired dBV minimum UF rate.
dBV minimum UF reminder delay time 5 0 to 30min
Enter the desired dBV minimum UF reminder delay time.
When dBV exceeds the dBV drop 2 alarm limit, dBV minimum UF is turned ON. If dBV is
recovered, reminder is started after the delay time.
*1
If it is set 0, it is not monitored.

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6. Setting

9. 2 BVM 2
Automatic BV data output selection 0 0: Not used, 1: Used
Select if automatic BV data output is used.
If it is set used, BV data output is automatically started in drain mode.
dBV change per 1L UF -2.0 -8.0 to 0.0%/L
Enter the desired value to calculate Predicted dBV and Target at end.
Predicted dBV = Target at end = dBV change per 1L UF x UF goal

9.3 BV-UFC 1
BV-UFC selection 0 0: Not used, 1: Used
Select if BV-UFC is used.
BV-UFC start time 10 0 to 480 min
Enter the desired time to start BV-UFC.
It can only be set above Setting1 9.1 BVM 1 BV measurement start time.
dBV deviation alarm upper limit 5.0 0.0 to 50.0%
Enter the desired dBV deviation alarm upper limit.
dBV deviation alarm lower limit -3.0 -50.0 to 0.0%
Enter the desired dBV deviation alarm lower limit.
BV-UFC maximum coefficient value 4.00*1 1.00 to 4.00
(Cd)
Enter the desired BV-UFC maximum coefficient value (Cd).
remainnainingUFVolume
UFRate( BV  UFC )   Cd
remainingTreatmentTime
dBV difference to stop UF rate (BV- 3.0*1 0.0 to 10.0%
UFC)
Enter the desired dBV difference to stop the UF rate (BV-UFC).
dBV difference = |actual dBV| - |dBV reference line|
UF rate (BV-UFC) maximum setting 2.00 0.00 to 4.00L/hr
range
Enter the desired UF rate maximum setting range in BV-UFC.
It can only be set below UF rate maximum setting range Setting 5.1 Setting range
*1
See Operator’s manual Sec. 11.2

9.4 BV-UFC 2
UF rate coefficient value before start 1.0 0.5 to 2.5
BV-UFC
Enter the desired UF rate coefficient value before start BV-UFC.
UF rate (before start BV-UFC) = UF rate x coefficient value.

9.5 BV-UFC 3
dBV reference line adjustment 3*1 1 to 5
Select the desired dBV reference line adjustment.
If it is set closed to 5, the dBV reference line progressively falling.
If it is set closed to 1, the dBV reference line linearly falling.
dBV target at treatment end 0.0*1 -40.0 to 10.0%
Enter the desired dBV target of reference line.
dBV target at treatment end is overwritten, when UF goal is entered.
*1
See Operator’s manual Sec. 11.2

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6. Setting

9.6 BV-COC 1
BV-COC selection 0 0: Not used, 1: Used
Select if BV-COC is used.
BV-COC start time 10 0 to 60 min
Enter the desired time to start BV-COC.
It can only be set above Setting1 9.1 BVM 1 BV measurement start time.
Total conductivity at BV-COC start 14.0*1 12.5 to 15.5mS/cm
Enter the desired total conductivity at BV-COC start.
Total conductivity at BV-COC end 14.0*1 12.5 to 15.5mS/cm
Enter the desired fixed conductivity at BV-COC end.
Fixed conductivity time at BV-COC end 10 10 to 60min
Enter the desired fixed conductivity time at BV-COC end.
Magnification calculation line No. (dBV > 3*2 1 to 5
reference line)
Enter the desired magnification calculation line number when actual dBV is above reference line.
Magnification calculation line No. (dBV < 3*2 1 to 5
reference line)
Enter the desired magnification calculation line number when actual dBV is below reference line.
*1
It can only be set above lower limit. It can only be set below upper limit.
*2
See Operator’s manual Sec. 11.2

9.7 BV-COC 2
Conductivity upper limit at BV-COC start 14.8 14.0 to 15.5mS/cm
Enter the desired conductivity alarm upper limit at BV-COC start.
Conductivity lower limit at BV-COC start 13.2 12.5 to 14.0mS/cm
Enter the desired conductivity alarm lower limit at BV-COC start.
Conductivity upper limit at BV-COC end 14.2 14.0 to 15.5mS/cm
Enter the desired conductivity alarm upper limit of fixed conductivity time at BV-COC end.
Conductivity lower limit at BV-COC end 13.8 12.5 to 14.0mS/cm
Enter the desired conductivity alarm lower limit of fixed conductivity time at BV-COC end.
Conductivity control time interval 3 3 to 8 min
Enter the desired conductivity control time interval.

10. Kt/V
Dialyzer Name
Select used dialyzer from the list.
Urea clearance 186 1 to 500mL/min
Enter the urea clearance of the dialyzer selected for use.
Blood flow of urea clearance 200 40 to 600mL/min
Enter the blood flow rate at which urea clearance was measured.
Dialysate flow of urea clearance 500 100 to 800mL/min
Enter the dialysate flow rate at which urea clearance was measured.
Patient gender 0 0: Male, 1: Female
Enter the patient gender.
Patient height 175 100 to 250cm
Enter the patient height.
Patient weight 60 30 to 350kg
Enter the patient weight.
Patient age 40 10 to 100years old
Enter the patient age.
Blood flow to estimate Kt/V 200 40 to 600mL/min
Enter the expected blood flow to calculate estimate Kt/V.
This set value is used only for Kt/V calculation, not for actual treatment condition.

11.Wash back assist


Wash back volume 300mL 0~500mL
Enter the wash back volume of wash back assist.

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6. Setting

Setting 2
1. Blood flow
1. 1 Blood flow 1
BP
Blood flow (Connect mode) 100 0 to 600mL/min
Enter the desired default blood flow in connect mode.
Blood flow (Disconnect mode) 100 0 to 600mL/min
Enter the desired default blood flow in disconnect mode.
Blood flow (Dialyzer rinse) 200 0 to 600mL/min
Enter the desired default blood flow in dialyzer rinse mode.
BP short slow up time 5 2 to 60sec
Enter the desired time at which blood pump reaches the set blood flow after it is started.

1.2 Blood flow 2


BP
BP stop when detecting blood 1 0: Not used,
selection 1: Used
Select if BP is stopped when blood is detected in connect mode.
Blood flow (Start up test) 100 0 to 600 mL/min
Enter the desired default blood flow in start up test.

1.3 Blood flow 3


BP activation after BM test selection 0 0: Stopped, 1: Run, 2: Previous status
Select BP activation after BM test is finished.
BP has to be run to ultrafiltrate saline in dialyzer rinse mode.

2. Priming
2.1 Priming with saline bag
Volume Flow rate
Arterial priming 55 0 to 1000mL 100 0 to 500mL/min
Enter the desired volume and flow rate for arterial priming phase.
See Setting1-1.3 Treatment condition 3, Arterial priming continue.
Venous priming 750 0 to 2000mL 100 0 to 500mL/min
Enter the desired volume and flow rate for venous priming phase.
See Setting1-1.3 Treatment condition 3, Venous priming continue.
Saline bag replacement 1000 0 to 10000mL
Enter the used saline bag volume.
If more than 2 bags are used for the priming, BP stops when set volume is reached for
replacement.

3. Dialyzer rinse
Dialyzer rinse mode time 120*1 0 to 120min
Enter the desired time for dialyzer rinse mode.
Dialyzer rinse mode UF goal 0.20*1 0.00 to 8.00L
Enter the desired UF goal for dialyzer rinse mode.
*1
UF rate = UF goal / time can only be set below 4.00 L/h.

4. Audible buzzer
4.1 Complete buzzer
Melody ON/OFF
Treatment completion 9 0 to 20*1
Enter the desired melody for treatment completion.
Heparin completion 0 0 to 20*1
Enter the desired melody for HP completion.
Timer completion 11 0 to 20*1
Enter the desired melody for timer completion.

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6. Setting

UF completion 0*1 0 to 20 0 0: Not sound


1: Sound
Enter the desired melody for UF completion.
Select if audible buzzer sounds for UF completion.
*1
0: Buzzer, 1: Polovetsian dances, 2: For Elise, 3: Nocturne, 4: Meistersinger, 5: Valse Triste,
6: The marriage of Figaro, 7: La Primavera, 8: Traeumerei, 9: Turkish March,
10: Brandenburger concert No.1, 11: An der schoenen blauen Donau,
12: Orchestral Suite No.2 Badinerie, 13: Orchestral Suite No.3 Air, 14: Fluehlingslied,
15: From the new world, 16: Die leichte Kavallerie : Ouvertuere, 17: Liebestraeume No.3,
18: La priera d’une Vierge, 19: Sinfonie No.9, 20: Prelude

4.2 Buzzer sound


Tone Volume Octave Frequency
Alarm 6 1 to 10*1 0 0 to 15*3 4 0 to 7 343 1 to 511 Hz
Enter desired tone, volume, octave, frequency for alarm.
Complete 6 1 to 15*2 0 0 to 15*3 4 0 to 7 343 1 to 511 Hz
Enter desired tone, volume, octave, frequency for alarm sound.
Key 12 1 to 15*2 5 0 to 15*3 5 0 to 7 257 1 to 511 Hz
Enter desired tone, volume, octave, frequency for key sound.
Nurse call 6 1 to 15*2 0 0 to 15*3 4 0 to 7 343 1 to 511 Hz
Enter desired tone, volume, octave, frequency for nurse call sound
Reminder 1 3 1 to 15*2 0 0 to 15*3 4 0 to 7 432 1 to 511 Hz
Enter desired tone, volume, octave, frequency for reminder 1.
Reminder 2 3 1 to 15*2 0 0 to 15*3 4 0 to 7 343 1 to 511 Hz
Enter desired tone, volume, octave, frequency for reminder 2.
BPM alarm 14 1 to 15*2 0 0 to 15*3
Enter desired tone, volume for BPM alarm.
*1
1: Violin, 2: Guitar, 3: Piano, 4: Flute, 5: Clarinet, 6: Oboe, 7: Trumpet, 8: Organ, 9: Horn,
10: Synthesizer
*2
1: Violin, 2: Guitar, 3: Piano, 4: Flute, 5: Clarinet, 6: Oboe, 7: Trumpet, 8: Organ, 9: Horn,
10: Synthesizer, 11: Harpsichord, 12: Vibraphone, 13: Synthesizer bass, 14: Wood bass,
15: Electric bass
*3
If it is set close to 15, audible sound is silent.
If it is set close to 0, audible sound is loud.

4.3 Reminder 1
UF control is OFF 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when UF control is OFF.
BP is OFF 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when BP is OFF.
BP cover is open 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when BP cover is open.
Blood flow is set 0 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when Blood flow is set 0.
HP is OFF 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when HP is 0.

4.4 Reminder 2
HP rate is set 0 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when HP rate is set 0.
UF rate is set 0 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when UF rate is set 0.
UF goal is set 0 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when UF goal is set 0.
Maximum UF rate per blood flow 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when Maximum UF rate per blood flow is exceeded.

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6. Setting

Bypass ON 1 0: Not sound, 1: Sound


Select if reminder buzzer sounds when Bypass is ON.
Bloodline is not detected 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when bloodline is not detected.

4.5 Reminder 3
Syringe is not detected 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when syringe is not detected.
Dialyzer coupling is not detected 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when dialyzer coupling is not detected.
Minimum UF is ON 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when Minimum UF is ON.
UF rate exceeds maximum setting 1 0: Not sound, 1: Sound
range
Select if reminder buzzer sounds when recalculated UF rate result exceeds maximum setting
range.
The maximum setting range can be exceeded, when UF rate automatic recalculation is used.
Reminder buzzer stops, when UF renew key is touched and UF rate is permitted. Reminder
buzzer sounds again if recalculated UF rate exceeds the UF rate exceeding ratio of permitted UF
rate.
UF rate exceeds limited range 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when UF rate recalculated result exceeds limited range
(4.05L/hr).

4.6 Reminder 4
Treatment is not started 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when treatment is not started in connect mode.
Saline is detected 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when saline is detected.
Cleaning program is not started 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when cleaning program is not started in drain mode.
Drain is not started 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when drain is not started in disconnect mode.

4.7 Reminder 5
Reaction in SYS alarm is ON 1 0: Not sound, 1: Sound
Select if reminder buzzer sounds when blood flow / UF rate reaction in SYS alarm is ON.

4.8 Buzzer time


Alarm buzzer repeat time 120 0 to 120 sec
Enter the desired alarm buzzer repeat time.
Alarm buzzer repeat time is the time until buzzer sound is repeated after Mute key is touched.
Reminder buzzer repeat time 70 0 to 1800 sec
Enter the desired reminder buzzer repeat time.
Reminder buzzer repeat time is the time until buzzer sound is repeated after the previous
reminder buzzer sound.
BPM automatic measurement start 0 0: Not sound, 1: Sound
buzzer selection
Select if audible buzzer sounds when BPM automatic measurement is started.
BPM alarm buzzer repeat time 25 0 to 60 sec
Enter the desired BPM alarm buzzer repeat time.
BPM alarm buzzer repeat time is the time until buzzer sound is repeated after the previous BPM
alarm buzzer sound.

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6. Setting

5. LCD
5. 1 Display time
LCD display time in standby mode 0 0 to 600 sec*1
Enter the desired time LCD is kept displayed in stand by mode.
LCD display time in cleaning program 0 0 to 600 sec*1
Enter the desired time LCD is kept displayed in cleaning program.
LCD display time in preparation mode 0 0 to 600 sec*1
Enter the desired time LCD is kept displayed in preparation mode.
Preparation mode is from DM test to dialyzer rinse.
LCD display time in treatment mode 0 0 to 600 sec*1
Enter the desired time LCD is kept displayed in treatment mode.
Keypad display time 180 0 to 600 sec
Enter the desired time keypad is kept displayed.
If it is set 0, keypad is kept displayed.
Screen / window display time 60 0 to 600 sec
Enter the desired time screen / window is kept displayed.
If it is set 0, screen / window is kept displayed.
BPM screen display time 1 0 to 60 min
Enter the desired time BPM screen is kept displayed after the measurement.
If it is set 0, BPM screen is kept displayed.
*1
If it is set 0, LCD is kept displayed.

5.2 Message screen


Message screen display method 0 0: Manual, 1: Automatic
selection
Select if message screen is displayed automatically when alarm is triggered.
Time to message screen redisplayed 180 0 to 600 sec
Enter the desired time the message screen is automatically redisplayed again after it is closed
manually.
If it is set 0, message screen is not redisplayed again.
Message screen displayed time 20 3 to 180sec
Enter the desired message screen displayed time.

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6. Setting

6. Screen customize
Fig. 7.2

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6. Setting

6. 1 Connect screen
Monitor Key Bar graph
No. 1 20 0 to 99*1 0 0 to 99*2 0 0 to 99*3
*1 *2
No. 2 7 0 to 99 5 0 to 99 1 0 to 99*3
*1 *2
No. 3 6 0 to 99 26 0 to 99 99 0 to 99*3
No. 4 13 0 to 99*1 40 0 to 99*2
*1
No. 5 9 0 to 99 99 0 to 99*2
Select the desired Monitor, Key, Bar graph which is displayed on connect screen.
Bar graph changing selection 0 0 :Not used, 1: Used
Select if bar graph is changed when it is touched in connect screen.

6. 2 Treatment screen
Monitor Key Bar graph
No. 1 20 0 to 99*1 0 0 to 99*2 0 0 to 99*3
*1 *2
No. 2 8 0 to 99 1 0 to 99 1 0 to 99*3
*1 *2
No. 3 6 0 to 99 2 0 to 99 6 0 to 99*3
*1 *2
No. 4 13 0 to 99 40 0 to 99
No. 5 9 0 to 99*1 6 0 to 99*2
Select the desired Monitor, Key, Bar graph which is displayed on treatment screen.
Bar graph changing selection 1 0 :Not used, 1: Used
Select if bar graph is changed when it is touched in treatment screen.

6. 4 Disconnect screen
Monitor Key Bar graph
*1 *2
No. 1 33 0 to 99 0 0 to 99 0 0 to 99*3
*1 *2
No. 2 8 0 to 99 5 0 to 99 1 0 to 99*3
No. 3 99 0 to 99*1 99 0 to 99*2 99 0 to 99*3
*1 *2
No. 4 43 0 to 99 32 0 to 99
No. 5 9 0 to 99*1 99 0 to 99*2
Select the desired Monitor, Key, Bar graph which is displayed on disconnect screen.
Bar graph changing selection 0 0 :Not used, 1: Used
Select if bar graph is changed when it is touched in disconnect screen.
*1
0: Arterial pressure, 1: Venous pressure, 3: Pressure loss, 4: TMP, 5: UF coefficient, 6: UF rate,
7: UF goal, 8: UF volume, 9: Blood flow, 11: Blood flow volume, 12: HP rate,
13: Total conductivity, 14: Bicarbonate conductivity, 15: Dialysate temperature,
16: Dialysate flow, 20: Remaining time, 21: Completion time, 23: Dialysate pressure,
24: Water supply pressure, 29: Elapsed time, 30: Dialyzer inlet pressure,
31: Averaged blood flow 32: Volume/stroke, 33: HP total volume, 35: Treatment start time,
36: Na+, 42: Effective blood flow, 43: Effective blood flow volume, 58: dBV, 62: Pulse
63: SYS/DIA, 99: Clear
*2
0: Alarm reset, 1: Bypass, 2: Minimum UF, 4: Override, 5: Start, 6: Disconnect,
7: Bicarbonate cartridge set, 11: Dialysate sampling, 12: Widen alarm limit,
15: UF volume reset, 16: Fill Dialyzer, 19: HP, 20: HP Prime
23: ISO-UF, 24: Dialysate filter replacement, 25: Bicarbonate cartridge priming,
26: Treatment data, 28: Conductivity calibration, 32: Bicarbonate cartridge drain, 35: BM test,
36: HP bolus, 38: Timer, 40: HP, 44: Bicarbonate cartridge SW selection,
45: TMP zero calibration OFF, 51: Bicarbonate replacement, 52: Acid replacement,
53: dBV initial, 54: BV data output, 99: Clear
*3
0: Arterial pressure, 1: Venous pressure, 3: Total conductivity, 4: Bicarbonate conductivity,
5: Dialysate temperature, 6: TMP, 7: Dialysate pressure, 8: Dialyzer inlet pressure, 99: Clear

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6. Setting

7. Daily Program
Fig. 7.3

Date / session Cleaning program Completion time


Monday 1 0 0 to 5 8:00 0:00 to 23:59
2 0 0 to 5 14:00 0:00 to 23:59
3 0 0 to 5 20:00 0:00 to 23:59
Tuesday 1 0 0 to 5 8:00 0:00 to 23:59
2 0 0 to 5 14:00 0:00 to 23:59
3 0 0 to 5 20:00 0:00 to 23:59
Wednesday 1 0 0 to 5 8:00 0:00 to 23:59
2 0 0 to 5 14:00 0:00 to 23:59
3 0 0 to 5 20:00 0:00 to 23:59
Thursday 1 0 0 to 5 8:00 0:00 to 23:59
2 0 0 to 5 14:00 0:00 to 23:59
3 0 0 to 5 20:00 0:00 to 23:59
Friday 1 0 0 to 5 8:00 0:00 to 23:59
2 0 0 to 5 14:00 0:00 to 23:59
3 0 0 to 5 20:00 0:00 to 23:59
Saturday 1 0 0 to 5 8:00 0:00 to 23:59
2 0 0 to 5 14:00 0:00 to 23:59
3 0 0 to 5 20:00 0:00 to 23:59
Enter the desired cleaning program and completion time when Daily program is used.
(See Operator’s manual Sec. 6.3)

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6. Setting

8. Clock
Year 00 00 to 99
Enter the last 2 digits of the year.
Date 1.01 1.01 to 12.31
Enter the date in month.day format.
Day of the week 0 0: Sunday, 1: Monday, 2: Tuesday,
3: Wednesday, 4: Thursday, 5: Friday,
6: Saturday
Enter the day of the week.
Time 0.00 0.00 to 23.59
Enter the time in hour.minute format.
Clock cannot be set in cleaning program.

9. Alarm monitoring (Fixed/Auto.)


9.1 Setting range (fixed alarm)
Maximum Minimum
Setting range (VP fixed alarm) 300 -10 -200 to 500mmHg*1*2
Enter the desired minimum maximum setting range of VP fixed alarm limit.
Setting range (AP fixed alarm) 300 -300 -300 to 300mmHg*1*2
Enter the desired minimum maximum setting range of AP fixed alarm limit.
Setting range (dialysate pressure fixed 300 -300 -400 to 400mmHg*1*2
alarm)
Enter the desired minimum maximum setting range of dialysate pressure fixed alarm limit.
Setting range (TMP fixed alarm) 500 -30 -100 to 500mmHg*1*2
Enter the desired minimum maximum setting range of TMP fixed alarm limit.
Setting range (DIP fixed alarm) 600 -50 -200 to 735mmHg*1*2
Enter the desired minimum maximum setting range of DIP fixed alarm limit.
*1
It can only be set above minimum range.
*2
It can only be set below maximum range.

9.2 Setting range (fixed alarm) in SN


Maximum Minimum
Setting range (VP fixed alarm) 400 -10 -200 to 500mmHg*1*2
Enter the desired minimum maximum setting range of VP fixed alarm limit in SN-KK.
Setting range (AP fixed alarm) 300 -300 -300 to 300mmHg*1*2
Enter the desired minimum maximum setting range of AP fixed alarm limit in SN-KK.
Setting range (dialysate pressure fixed 300 -300 -400 to 400mmHg*1*2
alarm)
Enter the desired minimum maximum setting range of dialysate pressure fixed alarm limit in SN-
KK.
Setting range (TMP fixed alarm) 500 -30 -100 to 500mmHg*1*2
Enter the desired minimum maximum setting range of TMP fixed alarm limit in SN-KK.
Setting range (DIP fixed alarm) 600 -50 -200 to 735mmHg*1*2
Enter the desired minimum maximum setting range of DIP fixed alarm limit in SN-KK.
*1
It can only be set above minimum range.
*2
It can only be set below maximum range.

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6. Setting

9.4 Auto alarm set time


DN/SN
VP alarm (Auto) set time 30 10 to 300sec
Enter the desired time to set VP alarm (Auto).
AP alarm (Auto) set time 30 10 to 300sec
Enter the desired time to set AP alarm (Auto).
Dialysate pressure alarm (Auto) set time 120 60 to 300sec
Enter the desired time to set dialysate pressure alarm (Auto).
TMP alarm (Auto) set time 120 60 to 300sec
Enter the desired time to set TMP alarm (Auto).
DIP alarm (Auto) set time 120 10 to 300sec
Enter the desired time to set DIP alarm (Auto).

9. 5 Alarm monitoring
Auto alarm monitoring selection in 0 0: Not used, 1: Used
disconnect mode
Select if auto alarm is used in disconnect mode.
If it is not used, it is monitored by fixed alarm.
Auto alarm automatic reset selection 1 0: Not used, 1: Used
Select if auto alarm automatic reset is used.
If it is set used, AP alarm (Auto upper / lower), VP alarm (Auto upper) are reset automatically
when pressure return to within the alarm limit.

10. SN
SN-KK
Arterial phase SN control time alarm limit 18 0 to 60sec
Enter the desired arterial phase SN control time alarm limit.
Venous phase SN control time alarm limit 18 0 to 60sec
Enter the desired venous phase SN control time alarm limit.
SN control pressure alarm upper limit 50 50 to 100mmHg
Enter the desired SN control pressure upper alarm limit.
SN control pressure alarm upper limit = SN control pressure upper limit + this value
SN control pressure alarm lower limit -50 -100 to -50mmHg
Enter the desired SN control pressure lower alarm limit.
SN control pressure alarm lower limit = SN control pressure lower limit + this value

11. Fill dialyzer


Fill dialyzer time 2 1 to 60min
Enter the desired fill dialyzer time.
Fill dialyzer delay time 5 5 to 120sec
Enter the desired delay time dialysate flows to dialyzer after Fill dialyzer key is touched.

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6. Setting

12. Cleaning program 1


12.1 Cleaning program
Status after cleaning program 1 1*1 1 to 3
selection
Select the desired status after cleaning program 1 is finished.
Status after cleaning program 2 1*1 1 to 3
selection
Select the desired status after cleaning program 2 is finished.
Status after cleaning program 3 1*1 1 to 3
selection
Select the desired status after cleaning program 3 is finished.
Status after cleaning program 4 1*1 1 to 3
selection
Select the desired status after cleaning program 4 is finished.
Status after cleaning program 5 1*1 1 to 3
selection
Select the desired status after cleaning program 5 is finished.
Default cleaning program selection 1*2 1 to 5
Select desired clinic default cleaning program.
Clinic default cleaning program is not selected if daily program is ON.
Turned OFF time to display disinfection 72 0 to 99hr
message
Enter the desired turned OFF time to display the message “Disinfection is necessary” after
cleaning program is finished.
*1
0: Go into Standby mode, 1: Turned OFF, 2: Go into Start up test
If it is set 1, DBB-06 goes into start up test, if bloodline is set, when cleaning program is
finished.
*2
1: Cleaning program 1, 2: Cleaning program 2, 3: Cleaning program 3, 4: Cleaning program 4,
5: Cleaning program 5

12.2 Hot rinse


Dialysate flow in heating phase 200 100 to 800mL/min
Enter the desired dialysate flow in heating phase of hot rinse mode.
Dialysate flow in cooling phase 200 100 to 800mL/min
Enter the desired dialysate flow in cooling phase of hot rinse mode.
Target temperature in heating phase 92.0 0.0 to 95.0°C
Enter the desired target temperature in heating phase of hot rinse mode.
Cooling phase time 10 8 to 60min
Enter the desired cooling phase time in hot rinse mode.
Heating phase time = hot rinse time – cooling phase time

12.3 Cleaning program key name


Key title Cleaning Program 1 Citric heat
Enter desired cleaning program 1 key name
The maximum number of letters is 20 letters
Key title Cleaning Program 3 Heat disinfection
Enter desired cleaning program 3 key name
The maximum number of letters is 20 letters
Key title Cleaning Program 4 Rinse 30min
Enter desired cleaning program 4 key name
The maximum number of letters is 20 letters
Key title Cleaning Program 5 Rinse 7min
Enter desired cleaning program 5 key name
The maximum number of letters is 20 letters

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6. Setting

13. Cleaning program 2


Fig. 7.4

*1
Citric acid (CA), Sodium hypochlorite (SH), Acetic acid, Standby, Dwell, Rinse, Heat
disinfection (HeatD), Powder citric, Hot rinse
*2
Minimum time to 999min
Refer the disinfection setting table for minimum time.

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6. Setting

Disinfection setting table


Mode Suction Temperature Suction Conductivity Conductivity Minimum
volume Target port lower upper time
With W/O
DF*3 DF*3
Citric acid 66 54 92.00°C Yellow 1.0mS/cm 18min(220V)
1 to 100mL 26min(100V)
Sodium 29 22 Orange*4 1.0mS/cm 6.0mS/cm 20min
hypochlorite 1 to 100mL
Acetic 48 37 Orange*4 30min
Aacid 1 to 100mL
*3
Dilysate filter
*4
Orange, Yellow

Cleaning program 1
1 2 3 4 5
Mode*1 Rinse CA Rinse
Time*2 7 26 10
6 7 8 9 10
Mode*1
Time*2

Cleaning program 2
1 2 3 4 5
Mode*1 Rinse PA Rinse
Time*2 7 26 12
6 7 8 9 10
Mode*1
Time*2

Cleaning program 3
1 2 3 4 5
Mode*1 Rinse HeatD Rinse
Time*2 7 50 12
6 7 8 9 10
Mode*1
Time*2

Cleaning program 4
1 2 3 4 5
Mode*1 Rinse
Time*2 30
6 7 8 9 10
Mode*1
Time*2

Cleaning program 5
1 2 3 4 5
Mode*1 Rinse
Time*2 7 18 10
6 7 8 9 10
Mode*1
Time*2

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6. Setting

14. HP
Syringe inner diameter 22.2 14.0 to 24.0mm
Enter the used syringe inner diameter.

30mL syringe
Dispomed: 22.2, Fresenius: 22.0, B&D: 21.6, B.Braun: 22.0, TERUMO: 23.1,
20mL syringe
B&D (PLASTIPAK): 18.9, B&D (DISCARD): 19.9, B.Braun(PERFUSOR-SPRITZE): 18.8,
B.Braun (INJECT): 19.9
Syringe size 3 1: 10mL, 2: 20mL, 3: 30mL
Enter the used syringe size.
HP prime rate 1500*1 10 to 1500mL/hr
Enter the desired HP rate in HP prime.
HP bolus rate 1500*1 10 to 1500mL/hr
Enter the desired HP rate in HP bolus.
External status display (yellow) selection 0 0: Not used, 1: Used
in HP complete
Select if external status display (Yellow) is used in HP complete.
HP bolus start blood flow 30 0 to 100mL
Enter the desired blood flow to start HP bolus automatically in connect mode.
*1
If 10mL syringe is used, 1000mL/hr is set as factory default.
If 20, 30mL syringe is used, 1500mL/hr is set as factory default.

15. Dialysate temperature


Temperature alarm (Auto upper) limit 1.0 0.0 to 5.0°C
Enter the desired dialysate temperature alarm (Auto upper) limit.
Temperature alarm (Auto lower) limit -1.0 -5.0 to 0.0°C
Enter the desired dialysate temperature alarm (Auto lower) limit.

16. Water supply pressure


Water supply pressure alarm (upper) 0.55 0.20 to 1.00bar
limit
Enter the desired water supply pressure alarm (upper) limit.
Water supply pressure alarm (lower) 0.15 0.00 to 0.20bar
limit
Enter the desired water supply pressure alarm (lower) limit.
Measurement unit selection 0 0: bar, 1: kPa, 2: kgf/cm2
Select desired measurement unit for water supply pressure.
Water supply pressure alarm (lower) 0.20 0.00 to 0.50bar
limit in disinfection
Enter the desired water supply pressure alarm (lower) limit in disinfection mode.
Water supply pressure alarm (lower) 0.10 0.00 to 0.50bar
limit in rinse
Enter the desired water supply pressure alarm (lower) limit in rinse mode.
Water supply pressure to open SV1 in 0.30 0.00 to 0.50bar
disinfection
Enter the desired water supply pressure to open SV1 in disinfection mode.
Water supply pressure to close SV1 in 0.40 0.00 to 0.70bar
disinfection
Enter the desired water supply pressure to close SV1 in disinfection mode.

17. Parts running time


17.1 Parts running time 1
Group 1 0 0 to 65000hr
Running time of Group 1 is displayed.
Enter 0 after parts replacement.

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6. Setting

Group 2 0 0 to 65000hr
Running time of Group 2 is displayed.
Enter 0 after parts replacement.
Group 3 0 0 to 65000hr
Running time of Group 3 is displayed.
Enter 0 after parts replacement.
DBB-06 0 0 to 65000hr
Running time of DBB-06 is displayed.

17.2 Parts running time 2


One way valve (DP) 0 0 to 65000hr
Running time of duplex pump (DP) one way valve is displayed.
Enter 0 after parts replacement.
Cap seal (DP) 0 0 to 65000hr
Running time of duplex pump (DP) cap seal is displayed.
Enter 0 after parts replacement.
Block (DP) 0 0 to 65000hr
Running time of duplex pump (DP) block is displayed.
Enter 0 after parts replacement.
Diaphragm (H1, H2, L) 0 0 to 65000hr
Running time of back pressure valve (H1, H2, L) diaphragm is displayed.
Enter 0 after parts replacement.
One way valve (UFP) 0 0 to 65000hr
Running time of UF pump (UFP) one way valve is displayed.
Enter 0 after parts replacement.
Cap seal (UFP) 0 0 to 65000hr
Running time of UF pump (UFP) cap seal is displayed.
Enter 0 after parts replacement.
Mechanical seal (CP1) 0 0 to 65000hr
Running time of deaeration pump (CP1) mechanical seal is displayed.
Enter 0 after parts replacement.

17.3 Parts running time 3


Mechanical seal (CP2) 0 0 to 65000hr
Running time of booster pump (CP2) mechanical seal is displayed.
Enter 0 after parts replacement.
One way valve (SPB, SPA) 0 0 to 65000hr
Running time of concentrate pump (SPB, SPA) one way valve is displayed.
Enter 0 after parts replacement.
Cap seal (SPB, SPA) 0 0 to 65000hr
Running time of concentrate pump (SPB, SPA) cap seal is displayed.
Enter 0 after parts replacement.
Diaphragm (HC-1, 2) 0 0 to 65000hr
Running time of back pressure valve (HC-1, 2) diaphragm is displayed.
Enter 0 after parts replacement..
Filter (FL61, 62) 0 0 to 65000hr
Running time of filters (FL61, 62) is displayed.
Enter 0 after parts replacement.
Dialysate filter 0 0 to 65000hr
Running time of dialysate filter is displayed.
Enter 0 after parts replacement.
Filter (FL41, 42) 0 0 to 65000hr
Running time of filters (FL41, 42) is displayed.
Enter 0 after parts replacement.

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DBB-06 Electronic Manual Technical Manual 954en-R4
1611
6. Setting

17.4 Parts running time 4


Filter (FL21, 22) 0 0 to 65000hr
Running time of filters (FL21, 22) is displayed.
Enter 0 after parts replacement.
Filter (FL1) 0 0 to 65000hr
Running time of filter (FL1) is displayed.
Enter 0 after parts replacement.
Filter (FL43, 44) 0 0 to 65000hr
Running time of filters (FL43, 44) is displayed.
Enter 0 after parts replacement.
LAP segment 0 0 to 65000hr
Running time of segment (LAP) is displayed.
Enter 0 after parts replacement.
Power unit fan filter 0 0 to 65000hr
Running time of PU fan filter is displayed.
Enter 0 after parts replacement.
Bicarbonate cartridge holder O rings 0 0 to 65000hr
Running time of bicarbonate cartridge holder O rings is displayed.
Enter 0 after parts replacement.
Concentrate connectors O rings 0 0 to 65000hr
Running time of concentrate connector O rings is displayed.
Enter 0 after parts replacement.

17.5 Parts running time 5


Bypass ports O rings 0 0 to 65000hr
Running time of bypass port O rings is displayed.
Enter 0 after parts replacement.
Dialyzer coupling O rings 0 0 to 65000hr
Running time of dialyzer coupling O rings is displayed.
Enter 0 after parts replacement.
Solenoid valves 0 0 to 65000hr
Running time of solenoid valves is displayed.
Enter 0 after parts replacement.
Disinfectant valves (SV21, 22) 0 0 to 65000hr
Running time of Disinfectant valves (SV21, 22) is displayed.
Enter 0 after parts replacement.
Impeller (CP1) 0 0 to 65000hr
Running time of deaeration pump (CP1) impeller is displayed.
Enter 0 after parts replacement.
Impeller (CP2) 0 0 to 65000hr
Running time of booster pump (CP2) impeller is displayed.
Enter 0 after parts replacement.

17.6 Parts running time 6


Tape bearing (DP) 0 0 to 65000hr
Running time of duplex pump (DP) tape bearing is displayed.
Enter 0 after parts replacement.
Check valve (CV41) 0 0 to 65000hr
Running time of check valve (CV41) is displayed.
Enter 0 after parts replacement.
Check valve (CV42,CV61) 0 0 to 65000hr
Running time of check valve (CV42, 61) is displayed.
Enter 0 after parts replacement.

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1611
6. Setting

18. Parts replacement time


*1
When running time reaches replacement time the message is displayed.
If it is set 0, message is not displayed.

18.1 Parts replacement time 1


Group 1 0 0 to 65000hr*1
Enter the replacement time of Group 1.
Group 2 0 0 to 65000hr*1
Enter the replacement time of Group 2.
Group 3 0 0 to 65000hr*1
Enter the replacement time of Group 3.

18.2 Parts replacement time 2


One way valve (DP) 0 0 to 65000hr*1
Enter the replacement time of duplex pump (DP) one way valve.
Cap seal (DP) 0 0 to 65000hr*1
Enter the replacement time of duplex pump (DP) cap seal.
Block (DP) 0 0 to 65000hr*1
Enter the replacement time of duplex pump (DP) block.
Diaphragm (H1, H2, L) 0 0 to 65000hr*1
Enter the replacement time of back pressure valve (H1, H2, L) diaphragm.
One way valve (UFP) 0 0 to 65000hr*1
Enter the replacement time of UF pump (UFP) one way valve.
Cap seal (UFP) 0 0 to 65000hr*1
Enter the replacement time of UF pump (UFP) cap seal.
Mechanical seal (CP1) 0 0 to 65000hr*1
Enter the replacement time of deaeration pump (CP1) mechanical seal.

18.3 Parts replacement time 3


Mechanical seal (CP2) 0 0 to 65000hr*1
Enter the replacement time of booster pump (CP2) mechanical seal.
One way valve (SPB, SPA) 0 0 to 65000hr*1
Enter the replacement time of concentrate pump (SPB, SPA) one way valve.
Cap seal (SPB, SPA) 0 0 to 65000hr*1
Enter the replacement time of concentrate pump (SPB, SPA) cap seal.
Diaphragm (HC-1, 2) 0 0 to 65000hr*1
Enter the replacement time of back pressure valve (HC-1, 2) diaphragm.
Filter (FL61, 62) 0 0 to 65000hr*1
Enter the replacement time of filters (FL61, 62).
Dialysate filter 750 0 to 65000hr*1
Enter the replacement time of dialysate filter.
Filter (FL41, 42) 0 0 to 65000hr*1
Enter the replacement time of filters (FL41, 42).

18.4 Parts replacement time 4


Filter (FL21, 22) 0 0 to 65000hr*1
Enter the replacement time of filters (FL21, 22).
Filter (FL1) 0 0 to 65000hr*1
Enter the replacement time of filter (FL1).
Filter (FL43, 44) 0 0 to 65000hr*1
Enter the replacement time of filters (FL43, 44).
LAP segment 0 0 to 65000hr*1
Enter the replacement time of segment (LAP).
Power unit fan filter 0 0 to 65000hr*1
Enter the replacement time of PU fan filter.
Bicarbonate cartridge holder O rings 0 0 to 65000hr*1
Enter the replacement time of bicarbonate cartridge holder O rings.

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DBB-06 Electronic Manual Technical Manual 954en-R4
1611
6. Setting

Concentrate connectors O rings 0 0 to 65000hr*1


Enter the replacement time of concentrate connector O rings.

18.5 Parts replacement time 5


Bypass ports O rings 0 0 to 65000hr*1
Enter the replacement time of bypass port O rings.
Dialyzer coupling O rings 0 0 to 65000hr*1
Enter the replacement time of dialyzer coupling O rings.
Solenoid valves 0 0 to 65000hr*1
Enter the replacement time of solenoid valves.
Disinfectant valves (SV21, 22) 0 0 to 65000hr*1
Enter the replacement time of Disinfectant valves (SV21, 22).
Impeller (CP1) 0 0 to 65000hr*1
Enter the replacement time of deaeration pump (CP1) impeller.
Impeller (CP2) 0 0 to 65000hr*1
Enter the replacement time of booster pump (CP2) impeller.

18.6 Parts replacement time 6


Tape bearing (DP) 0 0 to 65000hr*1
Enter the replacement time of duplex pump (DP) tape bearing.
Check valve (CV41) 0 0 to 65000hr*1
Enter the replacement time of check valve (CV41).
Check valve (CV42,CV61) 0 0 to 65000hr*1
Enter the replacement time of check valve (CV42, 61).

19. UF
19.2 UF
Bypass time count selection 1 0: Count, 1: Not count
Select if bypass time is counted as treatment time.
Minimum UF time count selection 0 0: Count, 1: Not count
Select if minimum UF time is counted as treatment time.
UF rate after UF completion selection 0 0: Minimum UF, 1: Not stopped
Select desired UF rate after UF completion.
Minimum UF rate 0.10 0.00 to 2.00L/hr
Enter desired minimum UF rate.
Maximum UF rate per blood flow 30 0 to 100%
Enter the desired maximum UF rate per blood flow.
UF rate auto recalculation selection 1 0: Not used, 1: Used
Select if UF rate automatic recalculation is used.
If it is used, UF rate is recalculated automatically with remaining treatment time and remaining
UF goal after Minimum UF or UF stop.
UF rate exceeding ratio 10 1 to 100%
Enter the desired UF rate exceeding ratio from maximum setting range when permission is
required.
UF renew key in hidden menu is displayed and required when recalculated UF rate exceeds
exceeding ratio of maximum setting range.
After the previous permission UF renew key is displayed and required again when recalculated
UF rate exceeds UF rate exceeding ratio of previous permitted UF rate.

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1611
6. Setting

39. Drain
Dialyzer drain selection 1 0: Not used, 1: Used
Select if dialyzer drain is automatically started at drain mode start.
Dialyzer drain can be manually started by touching and holding Drain key.

40. BVM (optinal)


dBV initialize key available time 30 5 to 600min
Enter the desired dBV initialize key available time after treatment start.
UF rate 0L/hr in BV-UFC reminder delay 1 0 to 60min
time
Enter the desired reminder delay time of UF rate 0L/hr in BV-UFC.
If it is set 0, reminder is not triggered when UF rate is 0L/hr in BV-UFC.
BV-UFC recalculation interval time 60 60 to 600sec
Enter the desired recalculation interval time of BV-UFC.
Maximum UF rate per blood flow in BV- 1 0: Not used, 1: Used
UFC selection
Select if UF rate is automatically decreased when UF rate exceed the maximum UF rate per
blood flow in BV-UFC.

42. Kt/V
Dialyzer name Urea clearance Blood flow of urea Dialysate flow of urea
clearance clearance
FDX-120GWS*1 186 1 to 500 200 50 to 600 500 100 to 800
FDX-150GWS*1 190 1 to 500 200 50 to 600 500 100 to 800
FDX-180GWS*1 192 1 to 500 200 50 to 600 500 100 to 800
FDY-150GWS*1 191 1 to 500 200 50 to 600 500 100 to 800
*1
FDY-180GWS 193 1 to 500 200 50 to 600 500 100 to 800
Enter the information for the 5 dialyzers in use which are listed on dialyzer table for Kt/V.
*1
Enter the dialyzer name with key pad.

45. BPM
BPM delay time after treatment start 0 0 to 30 min
Enter desired BPM auto start time
When 0 is set,BPM starts just after treatment start

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1611
6. Setting

43. Screensaver
Fig. 7.5

Central
monitor

Pressure monitor1
Pressure monitor2

Screensaver displayed time 10 1 to 60min


Enter the desired time when screensaver screen is displayed if operator does not operate.
If it is set 0, screensaver is not used.
Auto response sensor selection 1 0: Not used, 1: Used
Select if screensaver screen is changed to treatment screen when operator is detected.
Buzzer selection 1 0: Not sound, 1: Buzzer sound
Select if audible buzzer sounds, when the screensaver screen is displayed.
Central monitor customize 0 0: Remaining time, 1: Elapsed time
2: Remaining UF
Select the desired information to display inside of circular meter in screensaver screen.
Pressure monitor 1 customize 0 0: Not displayed, 1: AP, 2: VP
Select desired information to display on pressure monitor 1 in screensaver screen.
Pressure monitor 2 customize 0 0: Not displayed, 1: AP, 2: VP
Select desired information to display on pressure monitor 2 in screensaver screen.

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1611
6. Setting

44. Screen background color


Fig. 7.6

Touch the desired mode key from Cleaning, Preparation, Treatment, Bypass Disconnect.
Touch the desired color key, and SET key to select back ground color.
Touch the Default key to go back to the factory default setting.

46.Wash back assist


Wash back assist selection 0 0:Not used,1:Used
Select if wash back assist is used.

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1611
6. Setting

This page is intended to be blank.

6-34 DBB-06 Technical Manual No.954en-R4


DBB-06 Electronic Manual Technical Manual 954en-R4
1611
7. SERVICE-MODE

7. SERVICE-MODE

To reduce the risk of serious or fatal patient injury from incorrect adjustments,
always check the adjusted sensor after the adjustment to comfirm the
adjustment result.

7.1. General instruction

1. Required accuracy of measurement tool


The measurement tool used for adjustment of the DBB-06 should have at least the same or a better
accuracy compared to the specification of the DBB-06 as well as equal precision (decimal places).

Fig. 7.1
2. How to collect deaerated water
Deaerated water is required in SERVICE-MODE 6 and 12.
It can be collected by following step:
1. Open 5. 3 Relief valve (L) adjustment.
Ensure that the SV7 key is activated.
2. Open the front door of the DBB-06.
3. Connect one end of the extension tube (ID2, 5) to TPT5
(H2) and put the other end into a graduated cylinder (at
least 1 L in volume). (See Fig. 7.1)
4. Open TPT5 (H2).
5. Fill the cylinder with the deaerated treated water to
Fig. 7.2
approximately 1000ml.
6. Close TPT5 (H2).

3. Test port
Opened
The test port is open, when the lever faces the opposite side of
the tube connector side. (See Fig. 7.2.)
The test port is closed, when the lever faces the tube connector
side.

Closed

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DBB-06 Technical Manual No.954en-R4 1611 7-1
7. SERVICE-MODE

Fig. 7.3 4. Height of pressure meter


When adjusting or measuring pressure, the pressure meter has
to be on the same level as the back pressure valve or pressure
transducer. (See Fig. 7.3)

Ensure valve and pressure


meter are on the same level

Fig. 7.4
5. How to read water volume with a graduated
cylinder
When reading the volume in the graduated cylinder, the
lowest level has to be read from a horizontal view. (See Fig.
7.4)

6. Pressure conversion table


kPa kgf/cm2 psi atm bar mmHg,Torr mH2O

1 10.19×10-3 0.1455 9.869×10-3 0.01 7.501 0.10197

40 0.41 5.82 0.39 0.40 300 4.08

45 0.46 6.55 0.44 0.45 338 4.59

50 0.51 7.28 0.49 0.50 375 5.10

80 0.82 11.6 0.79 0.80 600 8.16

85 0.87 12.4 0.84 0.85 638 8.67

130 1.32 18.9 1.28 1.30 975 13.3

150 1.53 21.8 1.48 1.50 1.13×103 15.3

300 3.06 43.7 2.96 3.00 2.25×103 30.6

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7-2 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

7. 2 point calibration (See Fig. 7.5)


Fig. 7.5
2 point calibration is performed in the following
adjustment items.
Upper point • Pressure transducer
• Conductivity cell
• BVM
• Thermistor
0
Enter the measured value on the reference meter at the
lower and upper points to draw the calibration curve.
The displayed values are calculated from the measured
voltage based on the calibration curve.
Lower point

Definition of the icons V

I Installation: Check or adjustment used for installation.

M Maintenance: Check used for Maintenance. (TSI and PM)

R Repair: Check or adjustment used for repair.

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DBB-06 Technical Manual No.954en-R4 1611 7-3
7. SERVICE-MODE

7.2. Table of SERVICE-MODE


I

1. 1. Setting Password (Technician) M


Setting of technician password
R
Fig. 7.6
Setting procedure:
1. Open 1.1 Setting Password (Technician) (See Fig.
7.6)
2. Touch the CLR key.
3. Enter the desired password.

I
1. 2. Setting Password (Nurse)
Setting of head nurse password M

Fig. 7.7 R
Setting procedure:
1. Open 1.2 Setting Password (Nurse) (See Fig. 7.7)
2. Touch the CLR key.
3. Enter the desired password.

1. 3. Serial NO. I
Setting of serial number
Fig. 7.8 M
Setting procedure: R
1. Open 1.3 Serial No. (See Fig.7.8)
2. Enter the serial number of the DBB-06.

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7. SERVICE-MODE

1. 4-5 IP address and Protocol converter selection


Setting of IP address I
Select the protocol converter type.
M

Check protocol converter type: Check the number of LED beside network outlet. R
(See Fig. 7.9)
2 LED: Old type
3 LED: New type

Fig. 7.9 Setting procedure:


1. Open 1.5 Protocol converter selection. (See Fig.
7.9)
2. Select the protocol converter type. (old or new).
3. Open the 1.4 IP address. (See Fig. 7.10)
4. Turn OFF the DBB-06.
5. Disconnect the network cable.
6. Turn ON the DBB-06.
7. Ensure that LEDs beside network outlet are
blinking red and orange.
8. Enter the desired IP address.

LEDs 9. Ensure that LEDs are turned off.


10. Turn OFF the DBB-06.
11. Connect network cable. And Turn ON the
DBB-06.
Network 12. Ensure that LEDs beside network outlet are
outlet blinking green.

Fig. 7.10

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DBB-06 Technical Manual No.954en-R4 1611 7-5
7. SERVICE-MODE

2. 1-4. Amplitude circuit adjustment


Adjustment of the amplitude circuit I
Required tool: (See Appendix A) M
- Amplifier adjustment tool
Adjustment procedure: R
Fig. 7.11 1. Open 2.1 Amplitude circuit lower point adjustment
(L). (See Fig. 7.11)
2. Turn OFF the DBB-06.
3. Disconnect the P21 of the Main PCB. (See Fig.
1.5 and Fig. 7.12)
4. Connect P1 of the amplifier adjustment tool and
P22 of MAIN P.C.B. with a cable. (See Fig. 7.13)
5. Turn ON the DBB-06.
6. Wait for 20 sec. Ensure that all data fields for the
voltage turn green.

Fig. 7.12 P21 P22 7. Touch and hold the Set key.
8. Ensure that all thermistor displays read 29.93 ±
0.10 ºC (89.87 ± 0.18 ºF).
9. Open 2.2 Amplitude circuit upper point
adjustment (L). (See Fig. 7.14)
10. Turn OFF the DBB-06.
11. Connect P2 of the amplifier adjustment tool and
P22 of MAIN P.C.B. with a cable. (See Fig. 7.13)
12. Turn ON the DBB-06.
13. Wait for 20 sec. Ensure that all data fields for the
voltage turn green.
14. Touch and hold the Set key.
15. Ensure that all thermistor displays read 45.20 ±
0.10 ºC (113.36 ± 0.18 ºF).
Fig. 7.13
DBB-06 serial number :until 71050 DBB-06 serial number :from 71051

P1

P2

P3

P4

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7-6 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

Fig. 7.14 16. Open 2.3 Amplitude circuit lower point adjustment
(H). (See Fig. 7.15)
17. Turn OFF the DBB-06.
18. Connect P3 of the amplifier adjustment tool and
P22 of MAIN.P.C.B. with a cable. (See Fig. 7.13)
19. Turn ON the DBB-06.
20. Wait for 20 sec. Ensure that all data fields for the
voltage turn green.
21. Touch and hold the Set key.
22. Ensure that all thermistor displays read 70.18 ±

Fig. 7.15 0.50 ºC (158.32 ± 0.9 ºF).


23. Open 2.4. Amplitude circuit upper point
adjustment (H). (See Fig. 7.16)
24. Turn OFF the DBB-06.
25. Connect P4 of the amplifier adjustment tool and
P22 of the MAIN P.C.B. with a cable. (See Fig.
7.13)
26. Turn ON the DBB-06.
27. Wait for 20 sec. Ensure that all data fields for the
voltage turn green.

Fig. 7.16 28. Touch and hold the Set key.


29. Ensure that all thermistor displays read 95.20 ±
0.50 ºC (203.36 ± 0.9 ºF).
30. Turn OFF the DBB-06.
31. Connect the P21 and P22 of the Main PCB with
the cable. (See Fig. 7.12)

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DBB-06 Technical Manual No.954en-R4 1611 7-7
7. SERVICE-MODE

3. 1-2. Pressure transducer 2 adjustment


Adjustment of PT2 I
Required tools: (See Appendix A) M
- 3 Hemostats
- PT adjustment tool R

Fig. 7.17
Adjustment procedure:
1. Open 3.1. PT2 lower point adjustment. (See Fig.
7.17)
2. Open the front door of the DBB-06.
3. Clamp the inlet and outlet tubes of PT2 (See Fig.
1.6) with hemostats.
4. Connect the PT-adjustment tool to TPT2 (PT2)
and open it.
5. Use the syringe to apply pressure to a reading of
-500 ± 50mmHg.
Then clamp the tube of the syringe with a
Fig. 7.18
hemostat.
6. Enter the data shown on the PT-adjustment tool.
7. Open 3.2. PT2 upper point adjustment. (See Fig.
7.18)
8. Use the syringe to apply pressure to a reading of
+500 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
9. Enter the data shown on the PT-adjustment tool.
10. Open TPT2 (PT2) to atmosphere by removing the
PT-adjustment tool and ensure that PT2 (P)
reads 0 ± 10 mmHg.
11. Close TPT2 (PT2) and remove the hemostats.
Check procedure:
1. Follow adjustment procedure 1 - 4.
2. Use the syringe to apply pressure to a reading of -200 ± 50mmHg.
Then clamp the tube of the syringe with a hemostat.
3. Ensure that difference between PT2 (P) and the PT-adjustment tool is within
±10mmHg.
4. Use the syringe to apply pressure to a reading of +200 ± 50mmHg.
Then clamp the tube of the syringe with a hemostat.
5. Ensure that difference between PT2 (P) and the PT-adjustment tool is within
±10mmHg.

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7-8 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

3. 3-4. Pressure transducer 3 adjustment I


Adjustment of PT3
Required tools: (See Appendix A) M
- 3 Hemostats R
- PT adjustment tool

Fig. 7.19
Adjustment procedure:
1. Open 3.3. PT3 lower point adjustment. (See Fig.
7.19)
2. Open the front door of the DBB-06.
3. Clamp the inlet and outlet tubes of PT3 (See Fig.
1.6) with hemostats.
4. Connect the PT-adjustment tool to TPT3 (PT3)
and open it.
5. Use the syringe to apply pressure to a reading of
-500 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.

Fig. 7.20 6. Enter the data shown on the PT-adjustment tool.


7. Open 3.4. PT3 upper point adjustment. (See Fig.
20)
8. Use the syringe to apply pressure to a reading of
+500 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
9. Enter the data shown on the PT-adjustment tool.
10. Open TPT3 (PT3) to atmosphere by removing the
PT-adjustment tool and ensure that PT3 (P) and
PT3 (C) read 0 ± 10 mmHg.
11. Close TPT3 (PT3) and remove the hemostats.
Check procedure:
1. Follow adjustment procedure 1-4.
2. Use the syringe to apply pressure to a reading of -200 ± 50mmHg.
Then clamp the tube of the syringe with a hemostat.
3. Ensure that difference between PT3 (P) and the PT-adjustment tool is within
±10mmHg.
4. Use the syringe to apply pressure to a reading of +200 ± 50mmHg.
Then clamp the tube of the syringe with a hemostat.
5. Ensure that difference between PT3 (P) and the PT-adjustment tool is within
±10mmHg.

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DBB-06 Technical Manual No.954en-R4 1611 7-9
7. SERVICE-MODE

3. 5-6. Pressure transducer 1 adjustment I


Adjustment of PT1
M
Required tools: (See Appendix A) R
- 2 Hemostats
- PT adjustment tool
Adjustment procedure:
Fig. 7.21 1. Open 3. 5 PT1 lower point adjustment. (See Fig.
7.21)
2. Open the left side of the DBB-06.
3. Clamp the outlet tube of PT1 (See Fig. 1.8) with a
hemostat. The inlet tube is closed by the solenoid
valve.
4. Open TPT1 (PT1).
5. Enter 0.
6. Open 3. 6 PT1 upper point adjustment. (See Fig.
7.22)
Fig. 7.22 7. Connect the PT-adjustment tool to TPT1 (PT1).
8. Use the syringe to apply pressure to a reading of
+400 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
9. Enter the data shown on the PT-adjustment tool.
10. Use the syringe to apply pressure to a reading of
+200 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
11. Ensure that the difference between PT1 (P)
shown on the display and the PT-adjustment tool
is within ± 10mmHg.
12. Close TPT1 (PT1) and remove the PT-adjustment
tool and the hemostats.
Check procedure:
1. Follow adjustment procedure 1 - 4.
2. Ensure that PT1 (P) is 0 ±10mmHg.
3. Connect the PT-adjustment tool to TPT1 (PT1).
4. Use the syringe to apply pressure to a reading of +200 ± 50mmHg.
Then clamp the tube of the syringe with a hemostat.
5. Ensure that difference between PT1 (P) and the PT-adjustment tool is within
±10mmHg.

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7-10 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

4. Conductivity cell constant setting. (See Fig. 7.23)


Setting of CL constant and compensation coefficient and temperature coefficient I

M
These settings are overwritten, when 7.1-2. Conductivity indication adjustment is
performed. R

Fig. 7.23 The cell constant and compensation coefficient are


specific values which are dependent on the cell body.

Relation of these settings is as follows.


L = SJ + Lo
L: Conductivity
J: Cell constant
Lo: Cell compensation coefficient
S: 1/R
R: Resistance

Fig. 7.24 Temperature coefficient setting


Actual conductivity is changed with temperature.
Therefore actual conductivity is always compensated
and conductivity at 25 ºC (77 ºF) is displayed.
Temperature coefficient setting is the factor used for
temperature compensation of conductivity reading.
(Bicarbonate solution: 2.20%/ ºC Dialysate : 2.05%/
ºC)

Setting procedure:
1. Open 4.1 CL1 constant setting. (See Fig. 7.24)
Fig. 7.25 2. Enter cell constant of CL1.
3. Open 4.2 Conductivity cell 1 compensation
coefficient setting. (See Fig. 7.25)
4. Enter compensation coefficient of CL1.
5. Follow the setting procedure 1 - 4 for 4.4 - 4.11.

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DBB-06 Technical Manual No.954en-R4 1611 7-11
7. SERVICE-MODE

5. 1. Pressure reducing valve (PRV) adjustment


Adjustment of the PT1 with the PRV I

M
Required tool: (See Appendix A)
- Wrench (7 mm) R

Adjustment procedure:
Fig. 7.26
1. Open 5. 1 PRV adjustment. (See Fig. 7.26)
2. Open the left side of the DBB-06.
3. Loosen the lock nut of the PRV with a wrench.
(See Fig. 1.8 and Fig. 7.27)
4. Adjust PT1 by turning the adjustment screw until
max pressure of 45 - 50 kPa (6.6 - 7.2 PSI) is
shown on monitor PT1. (Clockwise  raises
Monitor PT1
pressure)
5. Tighten the adjustment screw again with the lock
nut.
Fig. 7.27 6. Afterwards check that the pressure has not
Adjustment screw changed.

Lock nut

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7. SERVICE-MODE

5. 2. Back pressure valve (H1, H2) adjustment


Adjustment of H1, H2 I

M
Required tool: (See Appendix A)
- Pressure meter R

Adjustment procedure:

Adjust only when at operating temperature.

1. Open 5. 2 H1, H2 adjustment. (See Fig. 7.28)


Fig. 7.28
2. Open the front door of the DBB-06.
3. Connect the pressure meter to the test port of H1
or H2 and open the test port. (See Fig. 1.6)
4. Lift up the adjustment ring to unlock.
5. Adjust the minimum pressure to 80 - 85 kPa (11.6
-12.4 PSI) by turning the adjustment ring.
(Clockwise  raises pressure) (See Fig. 7.29)
6. Ensure that the pressure meter is on the same
level as H1, H2.
7. Ensure that the maximum pressure is less than
Fig. 7.29 130 kPa (18.9 PSI).

Max .less than 130kPa (18.9PSI) 8. Touch the STOP key.


9. Ensure that the pressure is kept at more than 80
kPa (11.6 PSI) for 3 seconds.
10. Close the test port and remove the pressure
Min.80-85kPa (11.6-12.4 PSI)
meter.

H1, H2

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DBB-06 Technical Manual No.954en-R4 1611 7-13
7. SERVICE-MODE

5. 3. Relief valve (L) adjustment


Adjustment of L I
Balance checking
M

Required tools: (See Appendix A) R


- Open syringe
- Pressure meter

Adjustment procedure:

Adjust only when at operating temperature.

1. Open 5. 3 L adjustment. (See Fig. 7.30)


Fig. 7.30
2. Open the front door of the DBB-06.
3. Connect the pressure meter to TPT6 (L) and
open it. (See Fig. 1.6)
4. Connect the open syringe to TPT3 (TP3) and
open the port. (See Fig. 1.6)
5. Touch the SV7 OFF key when the open syringe is
filled to approx 20mL.
To refill the open syringe touch SV7 ON.
To stop filling touch SV7 OFF.
6. Adjust the height of the open syringe to obtain a
Fig. 7.31 reading of 0 ± 10mmHg for (PT3).
Max.40-45kPa 7. Lift up the lock nut for adjusting the relief valve
(5.9-6.5 PSI) and adjust it to the max pressure of 40 - 45 kPa
(5.9 - 6.5 PSI). (See Fig 7.31)

Min.
L Check procedure:
1. Follow adjustment procedure 1 - 7.
2. Ensure that the changing volume of open syringe
is within ± 5 mL / 10 minutes.
3. Close the test port and remove the pressure
meter.

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7-14 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

6. 1. UF pump stroke volume setting


Measure and enter the one stroke volume of UFP I

M
Required tools: (See Appendix A)
- Extension tube (Silicon tube ID 5mm, L: approximately 1000mm) R
- Extension tube (Silicon tube ID2,5mm, L: approximately 500mm)
- Graduated cylinder (100cc)
- Bucket filled with deaerated water
- Hemostat

Adjustment procedure:
Fig. 7.32
1. Open 6. 1 UFP stroke volume setting. (See Fig.
7.32)
2. Put the red dialyzer coupling (See Operator’s
manual Fig. 1.3) into the bucket filled with
deaerated water. (See Fig. 7.33)
Water will be drawn in to avoid negative pressure
in the closed loop system.
3. Clamp the outlet tube of H2 (See Fig. 1.6) with a
hemostat and disconnect it.
4. Connect an extension tube (ID5, 0) to H2 and put
the other end into the graduated cylinder.

Fig. 7.33 5. Touch the Bypass key so that it is OFF (main


flow).
6. Touch the Priming key to fill the extension tube.
The UFP starts.
7. Touch the Priming key again when the extension
tube is primed in order to stop the UFP.
8. Discard the water in the graduated cylinder and
ensure that it is empty.
9. Place the extension tube into the graduated cylinder and touch and hold the Measure key to start
the measurement.
The discharged water of 100 strokes should be collected in the cylinder.
10. Read the volume on the cylinder when the Measure key turns OFF.
11. Divide the measured volume by 100 to calculate the one stroke volume.
12. Enter the one stroke volume.
13. Write down the one stroke volume on the UFP (See Fig. 1.6) motor’s label if the one stroke volume
has changed.

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DBB-06 Technical Manual No.954en-R4 1611 7-15
7. SERVICE-MODE

Check procedure:
1. Follow adjustment procedure 1 - 11.
2. Ensure that the difference between the measured volume and the one stroke volume shown on the
display is within ±1%.

If a value greater than the actual UF stroke volume is entered at SERVICE MODE 6.1, the
UF pump discharges less volume than expected.
For example:
Condition 1
Measured stroke volume = 0.750 Entered stroke volume = 0.750 UF goal = 75ml
UF pump runs 100 strokes and discharges 75ml.
Condition 2
Measured stroke volume = 0.750 Entered stroke volume = 0.800 UF goal = 75ml
UF pump runs approximately 94 strokes and discharges approximately 70.5ml.

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7-16 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

7. 1-2. Conductivity indication adjustment


Adjustment of the conductivity cell I

M
To reduce the risk of serious or fatal patient injury from incorrect
adjustments, always check the adjusted sensor after the adjustment to R
comfirm the adjustment result.
Adjustment results can be comfirmed at 7.3 Confirmation of
conductivity indication.

Required tools: (See Appendix A)


- B-concentrate (Bicarbonate cartridge)
- A-concentrate
- Conductivity meter

Fig. 7.34 Adjustment procedure:


1. Open 7.1 Conductivity indication lower point
adjustment. (See Fig. 7.34)
2. Connect the conductivity meter to the dialyzer
couplings (See Operator’s manual Fig. 1.3).
3. Connect the blue concentrate connector (See
Operator’s manual Fig. 1.12) to the B-concentrate.
(See Fig. 7.37) If the bicarbonate cartridge is used,
connect the bicarbonate cartridge and touch B
powder key to turn it green.
4. Touch the Bypass key to turn it OFF (main
flow). dialysate flow goes through the dialyzer
Fig. 7.35 couplings.
5. Wait until the conductivity is stabilized.
6. Enter the measured data shown on the
conductivity meter.
7. Open 7.2. Conductivity indication upper point
adjustment. (See Fig. 7.35)
8. Connect the blue concentrate connector to the
A-concentrate. (See Fig. 7.37)
9. Wait until the conductivity is stabilized.
10. Enter the measured data shown on the
conductivity meter.
11. Open 7.3 Confirmation of conductivity indication.

Displayed conductivity is changed, when the value is entered in 7.2.

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DBB-06 Technical Manual No.954en-R4 1611 7-17
7. SERVICE-MODE

7. 3. Confirmation of conductivity indication


Confirmation of the conductivity indication I

M
Required tools: (See Appendix A)
- B-concentrate (bicarbonate cartridge) R
- A-concentrate
- Conductivity meter

Check procedure:
1. Open 7. 3 Confirmation of conductivity indication.
Fig. 7.36 (See Fig. 7.36)
2. Connect the conductivity meter to the dialyzer
couplings (See Operator’s manual Fig. 1.3).
3. Connect the blue concentrate connector (See
Operator’s manual Fig. 1.12) to the B-concentrate.
(See Fig. 7.37) If the bicarbonate cartridge is
used, connect the bicarbonate cartridge and
touch B powder key to turn it green.
4. Touch the Bypass key to turn it OFF (main flow).
 dialysate flow goes through the dialyzer

Fig. 7.37 couplings.


5. Touch the 3mS/cm key.
6. Wait until the conductivity is stabilized.
7. Ensure that the difference between the

Connect the conductivity meter indication and the displayed

blue concentrate value B conductivity (C) and B conductivity (P) is

connector to within ± 0.1 mS/cm.

the B-concentrate 8. Touch the 14mS/cm key.


9. Connect the blue concentrate connector to the
A-concentrate. (See Fig. 7.37)
10. Wait until the conductivity is stabilized.
11. Ensure that the difference between the
conductivity meter indication and the displayed

Connect the value A conductivity (C) and A conductivity (P) is

blue concentrate within ± 0.2 mS/cm.

connector to
the A-concentrate

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7-18 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

7. 4. Temperature indication adjustment


Adjustment of the temperature indication I

M
TH1 controls the temperature at heater outlet (See Fig. 7.38)
[setting value + temperature drop between TH1 and TH3] R
7.4 Temperature indication adjustment compensates the temperature drop between TH3 to dialyzer

Fig. 7.38

Temperatur 38.5ºC
1.5ºC
Temperature drop
37.0ºC

TH1 TH3 Dialyze


Heater

Required tools: (See Appendix A)


- Temperature meter

Adjustment procedure:
Fig. 7.39 1. Open 7. 4 Temperature indication adjustment.
(See Fig. 7.39)
2. Connect a temperature meter to the dialyzer
couplings (See Operator’s manual Fig. 1.3).
3. Touch the Bypass key to turn it OFF (main flow).
 dialysate flow goes through the dialyzer
couplings.
4. Wait until the temperature of TH3 (pre) is
stabilized at around 37ºC (98.60 ºF).
5. Enter the measured data shown on the
temperature meter.

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DBB-06 Technical Manual No.954en-R4 1611 7-19
7. SERVICE-MODE

8. Conductivity calibration I
Draw the conductivity calibration curve with the concentrates used in the dialysis center.
M
Conductivity calibration is performed during the service mode program and the self test before
R
treatment.
During this test the 100% and 90% dilution rates are used to draw the curve “Y=aX+b” which shows the
relation between “dilution rate” and “conductivity” with the concentrate in use. The curve from the self
test is compared with the curve from the Service mode. When the deviation is more than 10%, the
conductivity calibration curve alarm is triggered to prevent using the wrong concentrate for the treatment.
(See Fig. 7.40)

Required tools:
Fig. 7.40 - A-concentrate
- B-concentrate (bicarbonate cartridge)
100%
Conductivity

Calibration procedure:
90%

1. Open 8 Conductivity calibration. (See Fig. 7.41)


2. Select one of the five concentrates to display the
conductivity calibration screen of concentrate 2.
(See Fig. 7.42)
3. Touch the date field for Acid name, Bicarbonate
name to enter the desired concentrate name.
90% 100%
4. Touch the Bicarb. key when acetate is used.
Dilution rate
Bicarbonate  Key turns to blue
Fig. 7.41 Acetate  Key turns to red
5. Select the port used for A-concentrate from
Conc.Tank, A1 port or A2 port
6. Select the type of bicarbonate in use.
When the bicarbonate cartridge is used, B.
cartridge select is ON. When bicarbonate
concentrate is used, B. cartridge select is OFF.
7. Connect the A-concentrate and B-concentrate
(cartridge) in use to the selected port.
8. Touch the date field for Total target, Bicarb. target
to enter the desired target conductivity.
9. Touch the AdjStart key.
10. The DBB-06 performs the calibration
automatically.
Finish is displayed when the calibration is
completed.

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7-20 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

11. Touch No displayed key to display the selected


concentrate. The total conductivity table for the
Fig. 7.42 selected concentrate is shown. (See Fig. 7.43)
Wait for conductivity stabilization.
12. Touch the data field for Zero-Conductivity to enter
the displayed total conductivity.
13. Take a dialysate sample from the sample port and
measure the sodium concentration with an
external analyzer.
14. Touch the data field for Zero-Molality to enter the
measured sodium concentration.
15. Touch the SPAN key.
The total conductivity is increased based on
Fig. 7.43
defined pump speed.
Wait for conductivity stabilization.
16. Touch the date field for Span-Conductivity to enter
the displayed total conductivity.
17. Take a dialysate sample from the sample port and
measure the sodium concentration with an
external analyzer.
18. Touch the data field for Span-Molality to enter the
measured sodium concentration.
19. Touch the Back key to display 8. Conductivity
calibration screen.
20. Follow the calibration procedure 2 - 19 to perform
the calibration for other concentrates to be used.
21. Touch the USE key for any concentrate that is not
used. (Key turns to OFF)

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DBB-06 Technical Manual No.954en-R4 1611 7-21
7. SERVICE-MODE

9. 1. Blood leak received light voltage adjustment


Adjustment of the blood leak detector received light voltage. I

M
Required tool: (See Appendix A)
- Jeweler's screwdriver(-) R

Fig. 7.44 Adjustment procedure:


1. Open 9. 1. Blood leak received light voltage
adjustment. (See Fig. 7.44)
2. Open the front door of the DBB-06.
3. Wait until the temperature reaches around 37ºC
(98.60 ºF).
4. Touch the Bld offset Volt Measure key. The key
turns to ON for 3 sec.
5. Open the transmitter side of the blood leak
detector (See Fig. 1.6 and Fig. 7.45).
6. Adjust the received light voltages BLD(G)(P) to
Fig. 7.45 2.50 V by turning VR1 of the LED PCB (BLD) with
a Jewelers screwdriver (-). If the value is between

Transmitter side 2.00~4.00V, it is in the acceptable range.


7. Adjust the received light voltages BLD(R)(P) to
2.50 V by turning VR2 of the LED PCB (BLD) with
VR1 VR2 a Jewelers screwdriver (-). If the value is between
2.00~4.00V, it is in the acceptable range. If the
voltage does not reach the acceptable range,
even when VR is turned to its endpoint, clean the
bulkhead plate glass or replace the LED PCB
(BLD).

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7-22 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

9. 2. Blood leak test alarm limit


Setting of the blood leak test alarm limit and Adjustment of the BLD test relay I

M
Required tool: (See Appendix A)
- Jeweler's screwdriver(-) R

Adjustment procedure:
Fig. 7.46
1. Open 9. 2. Blood leak test alarm limit. (See Fig.
7.46)
2. Touch the BLD test relay key when temperature
is around 37 ºC (98.60 ºF).
3. Adjust Change rate value to 86±2% by VR1 on
the MAIN PCB. (See Fig. 1.5 and Fig. 7.47)
4. Touch the BLD test key.
5. Ensure that Test result value is between 84 and
88%.

Fig. 7.47

VR1

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DBB-06 Technical Manual No.954en-R4 1611 7-23
7. SERVICE-MODE

11. 1-2. Arterial pressure transducer adjustment


Adjustment of the AP transducer I

M
Required tools: (See Appendix A)
- Hemostat R
- PT adjustment tool

Adjustment procedure:
Fig. 7.48 1. Open 11. 1. AP transducer lower point adjustment.
(See Fig. 7.48)
2. Connect the PT-adjustment tool to the arterial
pressure port (See Operator’s manual Fig. 1.7).
3. Use the syringe to apply pressure to a reading of
-300 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
4. Enter the data shown on the PT-adjustment tool.
5. Open 11. 2. AP transducer upper point
adjustment. (See Fig. 7.49)
6. Open the arterial pressure port to atmosphere by
Fig. 7.49 removing the PT-adjustment tool.
7. Enter 0.
8. Connect the PT-adjustment tool to the arterial
pressure port again.
9. Use the syringe to apply pressure to a reading of
-150 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
10. Ensure that the difference between PT11 (P),
PT11 (C), PT12 (P), PT12 (C) shown on the
display and the PT-adjustment tool is within ±
10mmHg.
Check procedure:
1. Follow adjustment procedure for 1 – 2.
2. Use the syringe to apply pressure to a reading of -200 ± 50mmHg.
Then clamp the tube of the syringe with a hemostat.
3. Ensure that the difference between PT11 (P), PT11 (C), PT12 (P), PT12 (C) shown on the display
and PT-adjustment tool is within ± 10mmHg.
4. Open the AP port to atmosphere by removing the PT-adjustment tool.
5. Ensure that PT11 (P), PT11 (C), PT12 (P), PT12 (C) shown on the display is within 0 ± 10mmHg.

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7-24 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

11. 3-4. Venous pressure / level adjustment transducer adjustment


Adjustment of the VP transducer / level adjustment transducer I

M
Required tools: (See Appendix A)
- Hemostat R
- PT adjustment tool

Fig. 7.50 Adjustment procedure:


1. Open 11. 3. VP transducer lower point adjustment.
(See Fig. 7.50)
2. Open the VP port (See Operator’s manual Fig.
1.7) to atmosphere.
3. Enter 0.
4. Open 11.4. VP transducer upper point adjustment.
(See Fig. 7.51)
5. Connect the PT-adjustment tool to the VP port.
6. Use the syringe to apply pressure to a reading of
500 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
7. Enter the data shown on the PT-adjustment tool.
Fig. 7.51 8. Use the syringe to apply pressure to a reading of
+250 ± 50mmHg.
9. Ensure that the difference between PT15 (P),
PT15 (C), PT16 (P), PT16 (C) and the
PT-adjustment tool is within ± 10 mmHg.

Check procedure:
1. Follow adjustment procedure 1 – 2.
2. Ensure that PT15 (C), PT15 (P), PT16 (C), PT16
(P) shown on the display is within 0 ± 10mmHg.
3. Connect the PT-adjustment tool to the VP port.
4. Use the syringe to apply pressure to a reading of
+200 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
5. Ensure that difference between PT15 (C), PT15
(P), PT16 (C), PT16 (P) shown on the display
and the PT-adjustment tool is within ± 10mmHg.

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DBB-06 Technical Manual No.954en-R4 1611 7-25
7. SERVICE-MODE

11. 5-6. Dialyzer inlet pressure transducer adjustment


Adjustment of the DIP transducer I

M
Required tools: (See Appendix A)
- Hemostat R
- PT-adjustment tool

Fig. 7.52 Adjustment procedure:


1. Open 11. 5. DIP transducer lower point
adjustment. (See Fig. 7.52)
2. Open the DIP port (See Operator’s manual Fig.
1.7) to atmosphere.
3. Enter 0.
4. Open 11. 6. DIP transducer upper point
adjustment. (See Fig. 7.53)
5. Connect the PT-adjustment tool to the DIP port.
6. Use the syringe to apply pressure to a reading of
+500 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
7. Enter the data shown on the PT-adjustment tool.
Fig. 7.53 8. Use the syringe to apply pressure to a reading of
+250 ± 50mmHg.
9. Ensure that the difference between PT13 (C),
PT13 (P) and the PT-adjustment tool is within ±
10 mmHg.

Check procedure:
1. Follow adjustment procedure 1 – 2.
2. Ensure that PT13 (C), PT13 (P) shown on the
display is within 0 ± 10mmHg.
3. Connect the PT-adjustment tool to the DIP port.
4. Use the syringe to apply pressure to a reading of
+200 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
5. Ensure that difference between PT13 (C), PT13
(P) shown on the display and the PT-adjustment
tool is within ± 10mmHg.

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7-26 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

11. 9. Blood/Saline detector voltage adjustment


Adjustment of the blood/saline detector voltage I

M
Required tool: (See Appendix A)
- Blood line (clinic use) R
- Jeweler's screwdriver(-)

Fig. 7.54 Adjustment procedure:


1. Open 11.9 Blood/ Saline detector voltage
adjustment. (See Fig. 7.54)
2. Place the primed blood line (clinic use) filled with
saline into the blood/saline detector. (See Fig.
7.55)
3. Adjust V.BSD(C) and V.BSD(P) to 3.5 ~ 4.0V
using the VR3 on the MAIN P.C.B. (See Fig. 1.5
and Fig. 7.56)

Fig. 7.55
Fig. 7.56

VR3

Place the primed blood line

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DBB-06 Technical Manual No.954en-R4 1611 7-27
7. SERVICE-MODE

11. 10-11. Blood detector threshold voltage


Setting of the blood detector threshold voltage when blood is detected (11.10) and when saline I
is detected (11.11). (See Fig. 7.57)
M

Blood detector threshold voltage (Blood) can only be set below blood detector R
threshold voltage (Saline). Blood detector threshold voltage (Saline) can only be set above
blood detector threshold voltage (Blood).

Fig. 7.57
Voltage

11.10 (Blood) 11.11 (Saline)

Saline Saline

0.9V
Blood

0V

Connect Treatment Disconnect

Fig. 7.58
Adjustment procedure:
1. Open 11.10 Blood detector threshold voltage
(Blood). (See Fig. 7.58)
2. Enter the desired blood detector threshold voltage.
The voltage is determined from the color of
bloodline when the blood pump is supposed to be
stopped in connect mode. If “Setting 2, 1.2 Blood
flow 2, BP stop when detecting blood selection” is
used.
3. Open 11.11 Blood detector threshold voltage
Fig. 7.59 (Saline) (See Fig. 7.59)
4. Enter the desired blood detector threshold voltage.
The voltage is determined from the color of
bloodline when disconnect mode is finished. If
blood is detected when disconnect is finished
DBB-06 does not accept going into the drain
mode.

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7-28 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

12. 1. BP discharge volume adjustment (ID_8.0)


Adjustment of BP (ID_8.0) discharge volume I

M
Required tool: (See Appendix A)
- Blood line (clinic use) R
- Graduated cylinder

Fig. 7.60
Adjustment procedure:
1. Open 12.1 BP discharge volume adjustment
(ID_8.0). (See Fig. 7.60)
2. Install the blood line on the DBB-06.
3. Touch the Priming key.
BP starts to prime the blood line.
4. Place the outlet of the blood line in the graduated
cylinder.
5. Touch and hold the Measure key.
BP runs 23 rotations.
6. Enter the value on graduated cylinder.

12. 2. BP discharge volume adjustment (ID_6.6)


Adjust discharge volume of BP (ID_6.6). I

M
Required tool: (See Appendix A)
- Blood line (clinic use) R
- Graduated cylinder

Adjustment procedure:
Fig. 7.61
1. Open 12.2 BP discharge volume adjustment
(ID_6.6). (See Fig. 7.61)
2. Install the blood line on the DBB-06.
3. Touch the Priming key.
BP starts to prime the blood line.
4. Place the outlet of blood line in the graduated
cylinder.
5. Touch and hold the Measure key.
BP runs 26 rotations.
6. Enter the value on the graduated cylinder.

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DBB-06 Technical Manual No.954en-R4 1611 7-29
7. SERVICE-MODE

13. 1. Hydraulic circuit action check


Check of the Hydrocircuit action. I

Check procedure: R
1. Open 13.1 Hydraulic circuit action check. (See Fig.
Fig. 7.62
7.62)
2. Touch the desired actuator to turn it ON and OFF.
Touch the BYPASS key to turn it orange and to
turn ON/OFF SV4, SV5, SV6.
Touch the A1 key to turn it orange and to turn
ON/OFF SV66, SV67.
Touch the A2 key to turn it orange and to turn
ON/OFF SV66, SV67.
SV1, 2, 6, 7 are automatically open, when DP is
ON.
SV7 is automatically open, when UFP is ON.
SV63, SV70 are automatically open, when SPB is
ON.
SV63, SV65 are automatically open, when SPA is
ON.
Only one of SV21, SV22 can be open at any time.

The bypass alarm is monitored in 13.1. Hydraulic circuit action check. The bypass alarm is
triggered, when the dialyzer coupling is disconnected from the bypass port.

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7-30 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

13. 2. Clamp action check I


Check of the clamp action
M
Fig. 7.63
R
Check procedure:
1. Open 13. 2 Clamp action check. (See Fig. 7.63)
2. Ensure that ACLP(C) key is OFF.
3. Ensure that the arterial clamp is opened (See Fig.
7.64) and ACLP (P) shows Open on the screen.
4. Touch ACLP(C) key to turn it ON.
5. Ensure that it the arterial clamp is closed (See Fig.
7.64) and ACLD (P) shows Close on the screen.
6. Ensure that both VCLP(C) key and VCLP (P) key
Fig. 7.64 are OFF.
7. Ensure that the venous clamp is opened (See Fig.

Open 7.64) and VCLP (P) shows Open on the screen.


8. Touch VCLP(C) key or VCLP (P) key (key turns
to orange).
9. Ensure that the venous clamp is closed (See Fig.
7.64) and VCLP (P) shows Close on the screen.
10. Ensure that the hinge is not broken. (See Fig.
7.65)

Fig. 7.65
Close
Hinge

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DBB-06 Technical Manual No.954en-R4 1611 7-31
7. SERVICE-MODE

13. 3. Deaeration/booster pump action check I


Check of the deaeration/booster pump action.
M
Check procedure: R
1. Open 13.3 Deaeration/booster pump
action check. (See Fig. 7.66)
2. Touch the 2500 key. Deaeration/booster pump

Fig. 7.66 (See Fig. 1.6) revolution changes to 2500 rpm.


3. Ensure that the overload alarm is not triggered.
4. Clamp the outlet side of the deaeration pump and
check that the overload alarm is triggered.
5. Clamp the outlet of the booster pump and check
that the overload alarm is triggered.
6. Touch the 2200 key. Deaeration/booster pump
revolution changes 2200 rpm.
7. Touch the STOP key to turn it OFF.
The deaeration/booster pump stops.
8. Connect the pressure meter to inlet side of the
deaeration pump.
9. Touch the STOP key again to turn it ON.
Deaeration/booster pump is running.
10. Ensure that the pressure is less than -600mmHg.

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7-32 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

13. 4. Output signal action check I


Check of the output signal action from Alarm output outlet (Staff call) (See Sec. 1.6.7. and
Operator’s manual Fig. 1.5) M

R
Check procedure:
Fig. 7.67 1. Open 13.4 Output signal action check.
(See Fig. 7.67)
2. Touch the Normal key.
3. Ensure the output of the normal signal.
4. Follow check procedure 2 – 3 to check the other
keys.
5. Touch the Out put in order key to output signals
in the following order to check the output signals:
Normal > Alarm > comp. > Nurse call > OK
monitor sig. > RO signal
These are output every 0.5 seconds.
6. Touch the Hard Buzzer key to sound Hard
buzzer.
The Conc. supply key is not used.

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DBB-06 Technical Manual No.954en-R4 1611 7-33
7. SERVICE-MODE

13. 5. Air detector action check


Adjustment and action check of the air detector I

M
Required tools: (See Appendix A)
- Blood line (clinic use) R

Adjustment procedure:
Fig. 7.68 1. Open 13. 5. Air detector action check. (See Fig.
7.68)
2. Place the primed venous blood line on the
DBB-06. (See Fig. 7.55)
3. Adjust the voltage AD (P) shown on the display to
3000 mV by touching the following keys
Volt + + Volt + Volt - Volt - - .
The voltage monitor turns to green when the
value is within the range (3000 mV ± 100 mV).

Check procedure:
4. Touch the Air det. ON key.
5. Ensure that an alarm is triggered when the door is
slightly open.

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7-34 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

13. 7. BP action check


Check of the blood pump action I

M
Required tools: (See Appendix A)
- Hex box driver (7mm) R
- BP adjustment tool
- Timer

Check procedure:
Fig. 7.69
1. Open 13.7. BP action check. (See Fig. 7.69)
2. Adjust the gap between the stator and rotor of BP
to the thickness of the adjustment tool (thicker
side) with a Hex box driver. (See Fig. 7.70)
3. Touch 600ml/min key to turn it orange.
4. Press the [Pump] key.
5. Measure the BP rotation speed for 10 rotations
after the BP rotation speed has stabilized at
600ml/min. The time for 10 rotations should be

Fig. 7.70 between 8.63 and 8.76 seconds (69 ± 0.5 rpm).
6. Ensure that the BP stops, when the BP cover is
Adjustment tool
opened.

Gap adjustment

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DBB-06 Technical Manual No.954en-R4 1611 7-35
7. SERVICE-MODE

13. 8. Hydraulic circuit drain


Drain of the hydraulic circuit I

M
Required tool: (See Appendix A)
- Hemostat R

Fig. 7.71
Procedure:
1. Open 13.8 Drain of Hydro circuit. (See Fig. 7.71)
2. Disconnect the water supply connector. (See Fig.
7.72 and Operator’s manual Fig. 1.13)
3. Clamp upper tube of GC1 (See Fig. 1.8) with a
hemostat. (See Fig. 7.73)
Wait for the hydraulic circuit to drain.
4. Remove the hemostat from GC1.
5. Reconnect the water supply connector.

Fig. 7.72 Fig. 7.73

Hemostat

Disconnect
water supply
connector

Some water may remain after drain.


(For example in MC1, MC2 etc)

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7-36 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

13. 9. Switch condition check I


Check of the SW condition
States of switches at control and protection side are displayed. M

Fig. 7.74 R
Check procedure:
1. Open 13.9 SW condition check. (See Fig. 7.74)
2. Open the BP cover. Ensure S51 (BP) changes to
Open.
3. The other switches can be checked in the same
way.

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DBB-06 Technical Manual No.954en-R4 1611 7-37
7. SERVICE-MODE

13. 10. HP action check


Check of the HP action I

M
Required tools: (See Appendix A)
- Syringe (clinic use) R
- Pressure meter
- Hemostat

Fig. 7.75
Check procedure:
1. Open 13.10 HP action check. (See Fig. 7.75)
2. Enter desired HP rate.
3. Touch the HP power key to turn ON the HP.
4. Touch the HP Prime key to prime HP.
5. Confirm that HP prime is activated

Adjustment procedure of completion pressure:


1. Install the syringe (clinic use) on the DBB-06.
Then connect the pressure meter to the outlet of

See Fig. 7.76 the syringe and clamp the outlet of the pressure
meter tube with a hemostat.
2. Touch and hold the HP Prime key.
3. Confirm HP stops, when HP complete pressure is
reached.
4. Adjust the adjustment screw, so that HP complete
is done when the pressure meter displays 120 –
Adjustment screw
300kPa (17.4 - 43.7 PSI). (Clock wise  raise
completion pressure) (See Fig. 1.3 and Fig. 7.76)

15. 1. Battery test1 alarm limit


Setting of alarm limit. I

M
Fig. 7.78

Setting procedure: R
1. Open 15.1 Battery test1 alarm limit. (See Fig.
7.78)
2. Enter the desired battery test1 alarm limit.

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7-38 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

17. Option
Used and Not used keys are used to activate needed option. I

M
If the DBB-06 includes the following optional accessories, used key must be selected to
activate these features. R

 17.4 Dialysate filter (See Operator’s manual Fig. 1.2)


 17.5 Level adjust (See Fig. 1.3)
 17.11 1kW Heater (See Fig. 1.7)
 17.13 Concentrate B pipe rinsing (See Operator’s manual Fig. 1.12)
 17.16 Concentrate A pipe rinsing (See Operator’s manual Fig. 1.12)
 17.18 A clamp (See Operator’s manual Fig. 1.7)

Fig. 7.79 17.4 Dialysate filter (See Fig. 7.79)


Select if dialysate filter is used.
17.5 Level adjust
Select if Level adjust is used.
17.6 10mL syringe
Select if 10mL syringe is used.
17.7 BPM
Select if BPM (See Fig. 1.2) is used.
17.9 BVM (See Fig. 7.80)
Select if BVM (See Operator’s manual Fig. 1.7),

Fig. 7.80 BV-UFC, BV-COC is used. dBV is monitored, if


BVM is used. dBV is monitored and UFR is
controlled, if BV-UFC is used. dBV is monitored
and UFR and total conductivity controlled, if
BV-COC is used.
17.10 Clearance monitor
This key is Not used.
17.11 1kW Heater
Select if 1kW Heater is used.
17.12 DIP
Select if bloodline with DIP monitor is used.

To reduce the risk of serious or fatal patient injury from incorrect settings,
BV-UFC, BV-COC must not be used without training from NIKKISO CO., LTD.
For training consult NIKKISO CO.,LTD or your local representative.

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DBB-06 Technical Manual No.954en-R4 1611 7-39
7. SERVICE-MODE

17.13 Bicarbonate cartridge (See Fig. 7.81)


Select if Bicarbonate cartridge (See Operator’s manual Fig. 1.2) is used.
17.14 Concentrate B pipe rinsing
Select if concentrate B pipe rinsing is used.
17.15 Central concentrate supply A1
Select if central concentrate supply A1 (See Operator’s manual Fig. 1.13) is used.
17.16 Central concentrate supply A2
Select if central concentrate supply A2 (See Operator’s manual Fig. 1.13) is used.
17.17 Concentrate A pipe rinsing
Fig. 7.81
Select if concentrate A pipe rinsing is used.
17.18 CF leak test skip
Select if CF leak test skip is used. TFD214
Dialysate filter leak failed can be skipped, if used
is selected.
17.19 A Clamp
Select if A clamp is used.
17.20 Kt/V
Select if Kt/V is used.

A1, A2 port is tested for conductivity of concentrate, when cleaning program is started.
Therefore Not used has to be selected to start cleaning program, if Central Concentrate
Supply (CCS) is not connected.

I
18. Computer communication
Download upload of data from DBB-06 with DBCT. M

Fig. 7.82 R
Procedure:
1. Open 18. Computer communication (See Fig.
7.82)
2. Touch 18.1 Computer communication START to
start computer communication.
3. Touch 18.2 Computer communication END to
finish computer communication. Computer test is
automatically performed when computer
communication is finished.

See operator’s manual of DBCT for connection and operation of DBCT.

18.5. BV data communication is not used.


See Operator’s manual section 11. BVM to output BV data.

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7-40 1611 DBB-06 Technical Manual No.954en-R4
7. SERVICE-MODE

19. 1. Air leak test (optional) I


Check for air leaks in the BPM
M
Fig. 7.83 Check procedure: R
1. Open 19.1 Air leak test. (See Fig. 7.83)
2. Wind the cuff so that the inner diameter becomes
about 5 cm. (See Fig. 7.84)
3. Connect it to the port [BPM cuff] on the rear of the
DBB-06 (See Fig. 7.85 and Operator’s manual
Fig. 1.6).
4. Touch and hold the Set key.
5. The DBB-06 increases the pressure and
measures for air leaks.
6. After 5 minutes the air leak test result will be

Fig. 7.84 displayed on the screen.


7. Ensure the value is less than 18 mmHg.

5 cm

Fig. 7.85

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DBB-06 Technical Manual No.954en-R4 1611 7-41
7. SERVICE-MODE

19. 2. Pressure check test (optional) I


Check of the displayed pressure of BPM
M
Required tool: (See Appendix A) R
- PT adjustment tool.
- Hemostat

Mercury PT-adjustment tool with accuracy of 3mmHg should be used.

Fig. 7.86
Check procedure:
1. Open 19.2 Pressure check test. (See Fig. 7.86)
2. Open the BPM cuff port on the rear of the DBB-06
to atmosphere. (See Fig. 7.85 and Operator’s
manual Fig. 1.6)
3. Ensure that the displayed pressure is 0 ±
3mmHg.
4. Connect the PT adjustment tool to the [BMP cuff]
port. (See Fig. 7.87)
5. Touch and hold the Set key.
6. Use the syringe to apply pressure to a reading of
150 ± 50mmHg.
Fig. 7.87
Then clamp the tube of the syringe with a
hemostat.
7. Ensure that the difference between the pressure
shown on the display and the one shown on the
PT-adjustment tool is within ± 3mmHg.
8. Use the syringe to apply pressure to a reading of
300 ± 50mmHg.
Then clamp the tube of the syringe with a
hemostat.
9. Ensure that the difference between the pressure
shown on the display and the one shown on the
PT-adjustment tool is within ± 3mmHg.

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7. SERVICE-MODE

19. 3. Manual BPM switch check (optional)


Check of the BPM switch I

R
Fig. 7.88 Check procedure:
1. Open 19.3 Manual BPM switch check. (See Fig.
7.88)
2. Connect the BPM switch to the rear of the
DBB-06. (See Operator’s manual Fig. 1.6)
3. Press the BPM switch ON and OFF (See Fig.
7.89) and ensure that the SW CMF monitor
changes consistent with the BPM switch actions.

Fig. 7.89

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DBB-06 Technical Manual No.954en-R4 1611 7-43
7. SERVICE-MODE

20. 1-2. BVM adjustment tool (resin) adjustment value (optional) I


Enter the adjustment value of BVM adjustment tool (resin)
M
This adjustment is necessary only when BVM adjustment tool (resin) is used.
R

Each BVM adjustment tool (resin) has unique adjustment value.


Adjustment value is written on its box. (See Fig. 7.90)

Required tool: (See Appendix A)


- BVM adjustment tool (resin)

Fig. 7.90

Adjustment value

Adjustment procedure:
Fig. 7.91
1. Open 20.1 BVM lower point adjustment tool
(resin) adjustment value (See Fig. 7.91)
2. Enter the adjustment value of BVM lower point
adjustment tool (resin).

Fig. 7.92 3. Open 20.2 BVM upper point adjustment tool


(resin). (See Fig. 7.92)
4. Enter the adjustment value of BVM upper point
adjustment tool (resin).

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7. SERVICE-MODE

20. 3-4. BV-Receiving light voltage adjustment (optional) I


Adjustment of BV-Receiving light voltage
M
To reduce the risk of serious or fatal patient injury from incorrect calibration,
R
DBB-06 with BVM has to be turned ON for stabilization at least 10 minutes
before the calibration.

Required tool: (See Appendix A)


- BVM adjustment tool (resin)
- BVM adjustment tool (tube)

Fig. 7.93
Adjustment procedure <resin type>:
1. Open 20.3 BV-RLV lower point adjustment. (See
Fig. 7.93)
2. Select resin type adjustment tool.
3. Ensure that BVM lower point adjustment tool
(resin) adjustment value is same with the
adjustment value written on its box.

4. Put the BVM lower point adjustment tool (White) in


Fig. 7.94.
the BVM module so that lot number face toward
the cover side. (See Fig. 7.94 and Operator’s
manual Fig. 1.2)
5. Close the cover.
6. Wait one minute for stabilization.
7. Touch and hold the Set key.

Fig. 7.95
8. Open 20.4 BV-RLV upper point adjustment. (See
Fig. 7.95)
9. Select resin type adjustment tool.
10. Ensure that BVM upper point adjustment tool
(resin) adjustment value is same with the
adjustment value written on its box.

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DBB-06 Technical Manual No.954en-R4 1611 7-45
7. SERVICE-MODE

Fig. 7.96 11. Put the BVM upper point adjustment tool (Purple)
in the BVM module so that serial number faces
toward the cover side. (See Fig. 7.96).
12. Close the cover.
13. Wait one minute for stabilization.
14. Touch and hold the Set key.

15. Put the BVM check tool (Red) in the BVM module
Fig. 7.97 so that serial number faces toward the cover side.
(See Fig. 7.97 and Operator’s manual Fig. 1.2)
16. Close the cover.
17. Wait one minute for stabilization.
18. Ensure that confirmation value is within ±2 from
the adjustment value written on its tool box.

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8. Self-tests

8. Self-tests
8.1. Computer tests
Start

Buzzer test

CPU test

1. Register test
2. Instruction command test

RAM test

1. Inside RAM test


2. Outside RAM test

ROM test

3PRAM test

Database test

End

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1611
8. Self-tests

8.2. Blood monitor tests


8.2.1. BM test

Start

BM01 V clamp open and Battery voltage test

BM02 V clamp close

BM03 V clamp close check

BM04 Lower pressure check

BM05 BP start

BM06 BP rotation check

BM07 Press. check (boost) and Battery voltage test

BM08 BP stop

BM09 BP stop check

BM10 Upper pressure check

BM11 Venous clamp open

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1611
8. Self-tests

BM12 BP start (left rotation)

BM13 BP rotation check (left rotation)

BM14 BP power off

BM15 BP stop check

BM16 BP stop

BM17 BP power on

BM18 V clamp open check

BM19 V clamp close

BM20 V clamp close check

BM21 V clamp open

BM22 A clamp open check & close (optional)

BM23 A clamp close check & open (optional)

End

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DBB-06 Electronic Manual Technical Manual 954en-R4 8-3
1611
8. Self-tests

 Venous clamp test

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. I/O-System P. I/O-System
24V DC

C. driver P. driver

V clamp

Outline
V clamp action is checked.

Procedure and criteria


BM01: P.CPU checks if V clamp is opened.
BM02: P.CPU closes V clamp.
BM03: P.CPU checks if V clamp is closed.
BM11: P.CPU opens V clamp.
BM18: P.CPU checks if V clamp is opened.
BM19: C.CPU closes V clamp.
BM20: P.CPU checks if V clamp is closed.
BM21: C.CPU opens V clamp.

Triggered alarm
TFB202 V clamp open test failed
TFB203 V clamp close test failed

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954en-R4 Technical Manual No.954en-R4
1611
8. Self-tests

 BM pressure transducer test

Indicator controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. A/D-System P. A/D-System

C. Pressure circuit P. Pressure circuit

VP transducer (PT15) DIP / LAP transducer (PT13 / PT16)

Outline
VP and DIP / LAP are checked at lower and upper points.
Procedure and criteria
BM04: PT13 and PT15 / PT16 are compared.
a - 10mmHg < VP – DIP / LAP < b + 10mmHg ---A
VP ≤ 100mmHg. ---A
BM07: VP ≥ 200mmHg or DIP / LAP ≥ 200mmHg ---B
PT13 and PT15 are compared.
a - 10mmHg < VP – DIP / LAP < b + 10mmHg ---C
(a, b: Correction value of head pressure: When DIP is used, a=3, b=27)
( When LAP is used, a=0, b=0)
Triggered alarm
A: TFB206 Blood transducer open test failure
B: TFB207 Blood transducer boosted time has expired
C: TFB208 Blood transducer boosted test failure

When bloodline with DIP is used, VP and DIP are checked. When bloodline without
DIP is used, VP and LAP are checked.

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1611
8. Self-tests

 Blood pump test

Indicator controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. Counter circuit BP controller BP revolution P. I/O-System


detector circuit

24V DC

KBP KBP

BP driver

BP

Outline
BP action is checked.

Procedure and criteria


BM05: C.CPU starts BP to CW.
BM06: P.CPU checks if BP is started to CW.
BM08: C.CPU stops BP.
BM09: P.CPU checks if BP is stopped.
BM12: C.CPU starts BP to CCW.
BM13: P.CPU checks if BP is started to CCW.
BM14: P.CPU turns KBP OFF so that BP power is OFF.
BM15: P.CPU checks if BP is stopped.
BM16: C.CPU stops BP.
BM17: P.CPU turns KBP ON so that BP power is ON.
(CW: clockwise CCW: counterclockwise)
Triggered alarm
TFB204 BP stop test failure
TFB205 BP revolution test failure

8-6 DBB-06 Electronic Manual Technical ManualDBB-06


954en-R4 Technical Manual No.954en-R4
1611
8. Self-tests

 Arterial clamp test (optional)

Indicator controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. I/O-System P. I/O-System

24V DC

C. driver

A clamp

Outline
A clamp action is checked. (optional)

Procedure and criteria


BM22: P.CPU checks if A clamp is opened.
BM22: C.CPU closes A clamp.
BM23: P.CPU checks if A clamp is closed.
BM23: C.CPU opens A clamp.

Triggered alarm
TFB209 A clamp open test failure
TFB210 A clamp close test failure

DBB-06 Technical Manual No.954en-R4


DBB-06 Electronic Manual Technical Manual 954en-R4 8-7
1611
8. Self-tests

8.2.2. Continuous test (Blood monitor)

 Arterial pressure transducer test

Indicator controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. A/D-System P. A/D-System

C. Pressure circuit P. Pressure circuit

AP transducer (PT11) AP transducer (PT12)

Outline
AP transducers (PT11 and PT12) are checked.

Procedure and criteria


PT11 and PT12 are compared.
|PT11 - PT12| ≤ ±10mmHg.

Triggered alarm
TFB201 AP transducer compare test failed alarm

8-8 DBB-06 Electronic Manual Technical ManualDBB-06


954en-R4 Technical Manual No.954en-R4
1611
8. Self-tests

 Air detector test

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. Normal / Micro P. Normal / Micro P. I/O-System


bubble counter bubble counter

Air detector P.C.B.

COMP

K1
1V K1

AMP Oscillator (3MHz)

Outline
Air detector is checked.

Procedure and criteria


P.C.P.U turns K1 OFF for the air detector test (Test).
The received signal is checked if it is stopped. --A
The test signal is transmitted for the air detector test (Normal and Micro bubble).
The received signal is checked if Normal bubble counter (C and P) receives the test signal.--B
The received signal is checked if Micro bubble counter (C and P) receives the test signal. --C
Triggered alarm
A: TFB151 Air detector alarm (Test)
B: TFB152 Air detector alarm (Normal bubble)
C: TFB153 Air detector alarm (Micro bubble)

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1611
8. Self-tests

8.3. Dialysate monitor tests


8.3.1. DM test

Start

DM01 Air purge

DM02-03 Pressure transducer test

DM04-05 SV5 test

DM06-7 SV4, 6 test

DM08-09 Bypass relay test

DM10-12 Hydraulic circuit leak test (- pressure)

DM13-15 Pressure transducer 1


& HEX leak test

DM16-19 Hydraulic circuit leak test (+ pressure test)

DM20-22 UF pump test

DM23-24 UF pump relay test

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954en-R4 Technical Manual No.954en-R4
1611
8. Self-tests

DM25-35 Dialysate filter leak test (optional)

DM36-38 Heater cut relay test

Bicarbonate cartridge priming (optional)

Conductivity calibration 90%

Conductivity calibration 100%

DM13 39-42 Balance test

DM43-50 SV leak detector test

DM51 Preparation

End

Step number from Step1 to Step6 shows DM steps when DM test is performed
manually. (See Sec. 1.5.2)

DBB-06 Technical Manual No.954en-R4


DBB-06 Electronic Manual Technical Manual 954en-R4 8-11
1611
8. Self-tests

Step 1
Air purge

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM1

Outline
Air in the closed loop circuit is removed for DM test.
Thermistors are compared at lower temperature. (See Sec. Thermistor test)

Control side
SV1 open SV8 LVS SV8 is opened, when
SV2 open SV41 close LVS of GC2 is ON.
SV3 close CP1 run SV8 is closed, when
SV4 open CP2 run LVS of GC2 is OFF.
SV5 open DP run
SV6 close UFP run
SV7 open Heater off
Procedure and criteria
Air in the closed loop circuit is removed for DM test.
Temperature of TH2 and TH4 is checked for DM test.
TH2 ≤ 35 ºC (95 ºF) TH4 ≤ 35 ºC (95 ºF)
LVS off time is checked for DM test.
LVS off time ≥ 5sec
These checks are run for 5min.

Triggered alarm

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954en-R4 Technical Manual No.954en-R4
1611
8. Self-tests

Step 1
Pressure transducer 2&3 test (1)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM2

Outline
Closed loop circuit is checked for capacity to open to drain pressure.
PT2 and PT3 are compared at drain pressure. (See Sec. PT2&3 test)

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
Closed loop system is open to the drain pressure.
PT3 ≤ 100mmHg (Service mode 16.3)
PT2 and PT3 are compared.
PT2 - PT3 - height (Service mode 16.1) ≤ 20 mmHg (Service mode 16.2)

Triggered alarm
TFD205 PT2, PT3 test failure

DBB-06 Technical Manual No.954en-R4


DBB-06 Electronic Manual Technical Manual 954en-R4 8-13
1611
8. Self-tests

Step 1
Pressure transducer 2&3 test (2)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM3

Outline
Closed loop circuit is checked for capacity to create negative pressure.
PT2 and PT3 are compared at negative pressure.

Control side
SV1 close SV8 open
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 run
SV5 open DP stop
SV6 open UFP stop
SV7 close Heater off
Procedure and criteria
The dialysate in closed loop circuit is forced to be drained and negative pressure is created.
PT3 ≤ -200mmHg (Service mode 16.4)
PT2 and PT3 are compared
PT2 - PT3 - height (Service mode 16.1) ≤ 20 mmHg (Service mode 16.2)

Triggered alarm
TFD205 PT2, PT3 test failure

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1611
8. Self-tests

Step 1
SV5 test (1)

SV41
PT1

TH2

TH3

TH4

PT2
TH1

SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM4

Outline
PT2 is open to drain pressure.

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
PT2 is open to the drain pressure.
PT2 ---Sample1

Triggered alarm

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1611
8. Self-tests

Step 1
SV5 test (2)

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM5

Outline
Check if negative pressure is reached to PT2 via SV5

Control side
SV1 close SV8 open
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 run
SV5 open DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
The dialysate in closed loop circuit is forced to be drained and negative pressure is created.
PT2 is monitored
PT2 - Sample1 ≤ -100 mmHg (Service mode 16.5)

Triggered alarm
TFD220 SV5 test failure

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8. Self-tests

Step 1
SV4, 6 test (1)

SV41
PT1

TH2

TH3

TH4

PT2
TH1

SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM6

Outline
PT2 is open to drain pressure.

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
PT2 is open to the drain pressure.
PT2 ---Sample 2

Triggered alarm

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8. Self-tests

Step 1
SV4, 6 test (2)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM7

Outline
Check if negative pressure is reached to PT2 via SV4 and SV6.

Control side
SV1 close SV8 open
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 run
SV5 close DP stop
SV6 open UFP stop
SV7 close Heater off
Procedure and criteria
The dialysate in closed loop circuit is forced to be drained and negative pressure is created.
PT2 is monitored
PT2 – Sample 2 ≤ -100 mmHg (Service mode 16.6)

Triggered alarm
TFD221 SV4, 6 test failure

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8. Self-tests

Step 1
Bypass relay test (1)

SV41
PT1

TH2

TH3

TH4

PT2
TH1

SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM8

Outline
PT2 and PT3 are open to drain pressure. (See Sec. Bypass relay test)

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
PT2 and PT3 are open to the drain pressure.

Triggered alarm

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8. Self-tests

Step 1
Bypass relay test (2)

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM9

Outline
Check if PT2 is bypassed (isolated) from closed loop circuit with bypass relay.

Control side
SV1 close SV8 open
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 run
SV5 close DP stop
SV6 open UFP stop
SV7 close Heater off
Procedure and criteria
The dialysate in closed loop circuit is forced to be drained and negative pressure is created.
SV4/5 are closed and SV6 is opened with bypass relay (protection side)
PT2 and PT3 are compared
PT2 - PT3 - height (Service mode 16.1) > 200 mmHg (Service mode 16.7)

Triggered alarm
TFD206 SV6 relay test failure

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8. Self-tests

Step 1
Hydraulic circuit leak test (- pressure)

SV41
PT1

TH2

TH3

TH4

PT2
TH1

SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM10-12

Outline
Closed loop circuit is checked for leaks with negative pressure.
Float switch of GC2 is checked for correct function. (See Sec. Hydraulic circuit leak test (-
pressure))

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 open UFP stop
SV7 close Heater off
Procedure and criteria
Negative pressure of DM9 is kept in closed loop circuit.
PT3 and GC2 float switch are monitored
PT3 ≤ -100mmHg (Service mode 16.11) --- Sample 3
After 10 seconds (Service mode 16.10)
PT3 ≤ -100mmHg (Service mode 16.11) --- Sample 4
Sample 4 – Sample 3 ≤ 20mmHg (Service mode 16.12) ---A
On time of GC2 flout switch < 2 seconds ---B

Triggered alarm
A: TFD 207 Hydraulic circuit leak test (- pressure type) failure
B: TFD 215 LVS test failure

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8. Self-tests

Step 1
Pressure transducer 1 & Heat exchanger leak test (1)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM13

Outline
PT1 and PT3 are open to drain pressure. (See Sec. Pressure transducer 1 & Hheat exchanger
test)

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 open CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 close UFP stop
SV7 open Heater off
Procedure and criteria
PT1 and PT3 are open to the drain pressure.
PT1 and PT3 are monitored
PT1 ≤ 100mmHg (Service mode 16.8) ---A
PT3 --- Sample 5

Triggered alarm
A: TFD208 PT1 test failed

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8. Self-tests

Step 1
Pressure transducer 1 & Heat exchanger leak test (2)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM14-15

Outline
PT1 is checked for upper pressure.
PT3 is checked that HEX is not leaking.

Control side
SV1 open SV8 close
SV2 close SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 close UFP stop
SV7 open Heater off
Procedure and criteria
PT1 is open to Water inlet pressure.
PT1 and PT3 are monitored
PT1 ≥ 200 mmHg (Service mode 16.9) ---A
PT3 --- Sample 6
Sample 6 – Sample 5 ≤ 20mmHg ---B

Triggered alarm
A: TFD208 PT1 test failed
B: TFD209 HEX leak test failure

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8. Self-tests

Step 1
Hydraulic circuit leak test + pressure (1)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM16

Outline
Closed loop circuit is open to drain pressure.

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
Closed loop circuit is open to drain pressure.

Triggered alarm

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8. Self-tests

Step 1
Hydraulic circuit leak test + pressure (2)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM17

Outline
Closed loop circuit is open to water inlet pressure.

Control side
SV1 open SV8 close
SV2 close SV41 close
SV3 open CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
Closed loop circuit is open to water inlet pressure.

Triggered alarm

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8. Self-tests

Step 1
Hydraulic circuit leak test + pressure (3)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV2

SV7

DM18-19

Outline
Closed loop circuit is checked for leaks with positive pressure.

Control side
SV1 close SV8 close
SV2 close SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 open UFP stop
SV7 close Heater off
Procedure and criteria
Positive pressure at DM17(2) is kept in closed loop circuit
PT3 is monitored
PT3 ≥ 200 mmHg (Service mode 16.16) ---Sample 7
After 10 seconds (Service mode 16.15)
PT3 ≥ 200 mmHg (Service mode 16.16) ---Sample 8
Sample 8 - Sample 7 ≥ -50mmHg (Service mode 16.17)

Triggered alarm
TFD222 Hydraulic circuit leak test (+ pressure type) failure

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8. Self-tests

Step 2
Air purge

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM20

Outline
Air in the closed loop circuit is removed for DM test.

Control side
SV1 open SV8 LVS
SV2 open SV41 close
SV3 close CP1 run
SV4 close CP2 run
SV5 close DP run
SV6 open UFP run
SV7 open Heater off
Procedure and criteria
Air in the closed loop circuit is removed for DM test.

Triggered alarm

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8. Self-tests

Step 2
UF pump test (1)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM21

Outline
Closed loop circuit is open to drain pressure. (See Sec. UF pump test)

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
Closed loop circuit is open to drain pressure.

Triggered alarm

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8. Self-tests

Step 2
UF pump test (2)

SV41
PT1

TH2

TH3

TH4

PT2
TH1

SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM22

Outline
UFP is checked if it creates negative pressure.

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 open UFP run
SV7 close Heater off
Procedure and criteria
UFP is run with 4.0L/h (Service mode 16.18)
PT3 is monitored
PT3 < -200mmHg (Service mode 16.19)

Triggered alarm
TFD210 UF pump test failure

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8. Self-tests

Step 2
UF pump relay test (1)

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM23

Outline
Closed loop circuit is open to drain pressure. See Sec. UF pump relay test

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
Closed loop circuit is open to drain pressure.

Triggered alarm

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8. Self-tests

Step 2
UF pump relay test (2)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM24

Outline
UFP relay is checked if it stops UF pump.

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 open UFP run
SV7 close Heater off
Procedure and criteria
UFP is run with 4.0L/h (Service mode 16.18)
UF pump is stopped with UF pump relay (protection side)
PT3 is monitored
PT3 ≥ -100mmHg (Service mode 16.20)

Triggered alarm
TFD217 UF pump relay test failure

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8. Self-tests

Step 3
Air purge

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM25

Outline
Air in the closed loop circuit is removed for DM test.

Control side
SV1 open SV8 LVS
SV2 open SV41 close
SV3 close CP1 run
SV4 o/c CP2 run
SV5 o/c DP run
SV6 o/c UFP stop
SV7 open Heater on
Procedure and criteria
Air in the closed loop circuit is removed for DM test.

Triggered alarm

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8. Self-tests

Step 3
Dialysate filter leak test (1) (optional)

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM26

Outline
Closed loop circuit is open to drain pressure. See Sec. Dialysate filter leak test

Control side
SV1 close SV8 close
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 open DP stop
SV6 close UFP stop
SV7 open Heater off
Procedure and criteria
Closed loop circuit is open to drain pressure.

Triggered alarm

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8. Self-tests

Step 3
Dialysate filter leak test (2) (optional)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV2

SV7

DM27

Outline
Negative pressure is created in closed loop circuit.

Control side
SV1 close SV8 open
SV2 open SV41 close
SV3 close CP1 stop
SV4 open CP2 run
SV5 open DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
The dialysate in closed loop circuit is forced to be drained and negative pressure is created.
PT2 is monitored
PT2 ---Sample 9

Triggered alarm

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8. Self-tests

Step 3
Dialysate filter leak test (3) (optional)

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM27-29

Outline
Air passes into the closed loop circuit.
SV41 and dialysate filter are checked that air is blocked.

Control side
SV1 close SV8 open
SV2 open SV41 open
SV3 close CP1 stop
SV4 open CP2 run
SV5 open DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
Air passes into the closed loop circuit and the negative pressure is raised.
1st side of dialysate filter is filled with air
PT2 is monitored
PT2 ---Sample 10
Sample 9 – Sample 10 > 100mmHg (Service mode 16.21)

Triggered alarm
TFD216 SV41 test failure

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8. Self-tests

Step 3
Dialysate filter leak test (4) (optional)

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM30-35

Outline
Dialysate filter is checked for leaks.

Control side
SV1 close SV8 close
SV2 open SV41 open
SV3 close CP1 stop
SV4 open CP2 stop
SV5 close DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
Dialysate filter does not pass the air, so negative pressure is held
PT2 is monitored
PT2 ≤ -150 mmHg (Service mode 16.23) ---Sample 11
After 10 seconds
PT2 ≤ -150 mmHg (Service mode 16.23) ---Sample 12
Sample 12 – Sample 11 ≤ 100 mmHg

Triggered alarm
TFD214 Dialysate filter leak test failure

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8. Self-tests

Step 4
Heater cut relay test (1)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM36-37

Outline
Heater is checked for capacity to heat. See Sec. Heater cut relay test

Control side
SV1 close SV8 LVS
SV2 open SV41 close
SV3 close CP1 run
SV4 close CP2 run
SV5 close DP stop
SV6 open UFP stop
SV7 open Heater on
Procedure and criteria
TH2 is monitored
TH2 ---Sample 15
30 seconds after (Service mode 16.35)
TH2 ---Sample 16
Sample 16 – Sample 15 > 3 ºC (37.4 ºF)

Triggered alarm
TFD201 Heater cut relay test failure

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8. Self-tests

Step 4
Heater cut relay test (2)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM38

Outline
Heater is checked for capacity to heat.

Control side
SV1 close SV8 LVS
SV2 open SV41 close
SV3 close CP1 run
SV4 close CP2 run
SV5 close DP stop
SV6 open UFP stop
SV7 open Heater on
Procedure and criteria
TH2 is monitored
TH2 ---Sample 15
60 seconds after (Service mode 16.36)
TH2 ---Sample 16
Sample 16 – Sample 15 > 5 ºC (41 ºF)

Triggered alarm
TFD201 Heater cut relay test failure

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8. Self-tests

Step 5
Balance test

SV41
TH2

TH3

TH4
PT1

TH1

PT2
SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV2

SV7

DM39-42

Outline
Balance of closed loop circuit is checked. See Sec. Balance test

Control side
SV1 open SV8 close
SV2 open SV41 close
SV3 close CP1 run
SV4 close CP2 run
SV5 close DP run
SV6 open UFP stop
SV7 close Heater on
Procedure and criteria
After 20 strokes
PT3, TH4 ---Sample 17
After 25 strokes
PT3, TH4 ---Sample 18
Sample 17 – Sample 18 ≤ 1.5 ºC (2.7 ºF)(Service mode 16.33) ---A
Sample 17 – Sample 18 ≤ ±55 mmHg ---B
During DM42, PT3 ≤ ±200 mmHg
The range of alarm limit
CF optional is used ±55 mmHg
CF optional is not used ±80 mmHg
Triggered alarm
A: TFD211 Temperature abnormal (balance test)
B: TFD212 Balance test failed (-) failure
B: TFD213 Balance test failed (+) failure

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8. Self-tests

Step 6
SV leak test (1)

DM43

Outline
Air in the closed loop circuit is removed for DM test.
Thermistors are compared at upper temperature. (See Sec. Thermistor test)

Control side
SV1 open SV8 LVS
SV2 open SV41 close
SV3 close CP1 run
SV4 close CP2 run
SV5 close DP run
SV6 open UFP stop
SV7 open Heater on
Procedure and criteria
Air in the closed loop circuit is removed for DM test.

Triggered alarm

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8. Self-tests

Step 6
SV leak test (2)

SV41
PT1

TH2

TH3

TH4

PT2
TH1

SV4
SV1

HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV2

SV7

DM44

Outline
Each valve is checked that it is closed.
BLD test. See Sec. Blood leak detector test

Control side
SV1 close SV8 close
SV2 close SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
The conductivity of each valve is monitored
Measured voltage < 400mV (Service mode 16.27)

Triggered alarm
TFD223 SV4 leak test failure
TFD224 SV5 leak test failure
TFD225 SV6 leak test failure
TFD226 SV7 leak test failure
TFD227 SV8 leak test failure

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8. Self-tests

Step 6
SV leak test (3)

SV41
TH1
TH2

TH3

TH4
PT1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM45

Outline
SV4 is checked that it is opened.

Control side
SV1 close SV8 close
SV2 close SV41 close
SV3 close CP1 stop
SV4 open CP2 stop
SV5 close DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
The conductivity of SV4 is monitored
Measured voltage ≥ 4000mV (Service mode 16.28)

Triggered alarm
TFD223 SV4 leak test failure

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8. Self-tests

Step 6
SV leak test (4)

SV41
PT1

TH2

TH3

TH4
TH1

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM46-47

Outline
SV5 is checked that it is opened.

Control side
SV1 close SV8 close
SV2 close SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 open DP stop
SV6 close UFP stop
SV7 close Heater off
Procedure and criteria
The conductivity of SV5 is checked
Measured voltage ≥ 4000mV (Service mode 16.28)

Triggered alarm
TFD224 SV5 leak test failure

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8. Self-tests

Step 6
SV leak test (5)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM48

Outline
SV6 is checked that it is opened.

Control side
SV1 close SV8 open
SV2 close SV41 close
SV3 close CP1 stop
SV4 close CP2 stop
SV5 close DP stop
SV6 open UFP stop
SV7 open Heater off
Procedure and criteria
The conductivity of SV6 is checked
Measured voltage ≥ 4000mV (Service mode 16.28)

Triggered alarm
TFD225 SV6 leak test failure

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8. Self-tests

Step 6
SV leak test (6)

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM49-50

Outline
SV7 and SV8 are checked that they are opened.

Control side
SV1 close SV8 open
SV2 close SV41 close
SV3 close CP1 stop
SV4 close CP2 run
SV5 close DP stop
SV6 close UFP stop
SV7 open Heater off
Procedure and criteria
The conductivity of SV7 and SV8 is checked
Measured voltage ≥ 4000mV (Service mode 16.28)

Triggered alarm
TFD226 SV7 leak test failure
TFD227 SV8 leak test failure

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8. Self-tests

Preparation

SV41
PT1

TH1
TH2

TH3

TH4

PT2
SV1

SV4
HEX
Mixing
system

SV6

SV8

PT3
SV3

SV5
SV7
SV2

DM51

Outline
Air in the closed loop circuit is removed for DM test.

Control side
SV1 open SV8 close
SV2 open SV41 close
SV3 close CP1 run
SV4 o/c CP2 run
SV5 o/c DP run
SV6 c/o UFP stop
SV7 open Heater off
Procedure and criteria
Air in the closed loop circuit is removed for DM test.

Triggered alarm

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8. Self-tests

 Pressure transducer 2&3 test (See DM2 Pressure transducer 2&3 test)
 Bypass relay test (See DM8 Bypass relay test)
 Hydraulic circuit leak test (- pressure) (See DM10-12 Hydraulic circuit leak test (- pressure))

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. SV driver C. I/O-system CP controller P. I/O-System P. A/D-System

SV4

CP driver P. Pressure circuit

KDP

SV5
CP2 P. Relay driver

KDP

KSV
SV6

24VDC
KSV
P. SV driver PT3 PT2

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8. Self-tests

 Pressure traducer 1/Heat exchanger leak test (See DM13 Pressure transducer 1 & Heat
exchanger test)

Indicator
controller Screen

I. CPU

3PRAM

C. CPU P. CPU

C. SV driver C. I/O-system P. A/D-System

P. Pressure circuit

SV1

SV2

SV3

24VDC
PT3 PT1

SV7

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8. Self-tests

 UF pump test (See DM21 UF pump test)


 UF pump relay test (See DM23 UF pump relay test)

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. SV driver C. I/O-system UFP controller P. I/O-System P. A/D-System

24VDC
P. Pressure circuit
KUFP
KUFP

UFP driver

PT3

UFP
SV7

24VDC

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8. Self-tests

 Dialysate filter test (See DM26 Dialysate filter leak test)


24VDC

Indicator
controller
Screen

I. CPU

SV41

SV8
3PRAM

C. CPU P. CPU

C. SV driver C. I/O-system CP controller P. I/O-System P. A/D-System

CP driver P. Pressure circuit

KDP

SV4

PT2

KDP P. Relay driver


CP2

SV5
KSV

24VDC
KSV
P. SV driver

SV6

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8. Self-tests

 Heater cut relay test (See DM36-37 Heater cut relay test)

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. I/O-system P. I/O-System P. A/D-System

Zero cross driver P. Relay circuit P. Thermistor circuit

Zero cross circuit


TH2

KH
THS
AC

DH

KH

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8. Self-tests

 Balance test (See DM39-42 Balance test)

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

UFP controller P. I/O-System P. A/D-System

24VDC
UFP driver
P. Thermistor circuit P. Pressure circuit
KUFP
KUFP

TH4

PT3

UFP

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8. Self-tests

 Blood leak detector test (See SV leak test (2))

Indicator
controller Screen

I. CPU

3PRAM

C. CPU P. CPU

P. A/D-System P. I/O-System

Green Red
KBLD
P. Relay driver
Green

Red BLD circuit

KBLD

BLD

Outline
BLD received light voltage is checked continuously.
BLD test is performed in DM 44.

Procedure and criteria


BLD received light voltage is checked.
LED (Green) > 1.25V ---A LED (Red) > 0.75V ---B
LED (Green) < 4.75V ---C LED (Green) > 1.00V ---D
LED (Red) < 4.75V ---E LED (Red) > 0.50V ---F
KBLD is ON for the BLD test.
R Rt
Y   100(%) ≤ 90% ---G
G Gt
R : LED(Red) before test voltage G : LED(Green) before test voltage
Rt: LED(Red) test voltage Gt: LED(Green) test voltage
Triggered alarm
A: TFD202 BLD (G) was contamination
B: TFD203 BLD (R) was contamination
C: TFD131 Blood leak detector vol. abnormal (G upper)
D: TFD132 Blood leak detector vol. abnormal (G lower)
E: TFD133 Blood leak detector vol. abnormal (R upper)
F: TFD134 Blood leak detector vol. abnormal (R lower)
G: TFD204 BLD test failed

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8. Self-tests

 Conductivity test

Indicator controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. A/D-System P. A/D-System

C. Conductivity circuit P. Conductivity circuit

TH5 TH6

CL3 CL1 CL4 CL2

Outline
Conductivity test is performed during the conductivity calibration of the DM test.

Procedure and criteria


The conductivity of CL1 and CL2 is compared.
CL1 - CL2 ≤ ±5% ---A
The conductivity of CL3 and CL4 is compared.
CL1 - CL2 ≤ ±5% ---B

Triggered alarm
A: TFD153 CL1, CL2 compare test alarm
B: TFD154 CL3, CL4 compare test alarm

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8. Self-tests

 Thermistor test (See DM1 Air purge, DM43 SV leak test (1))

Indicator
controller
Screen

I. CPU

3PRAM

C. CPU P. CPU

C. A/D-System P. A/D-System

C. Thermistor circuit P. Thermistor circuit

TH3 TH1 TH4 TH2

Outline
Thermistors are compared at lower temperature.
Thermistors are compared at upper temperature.

Procedure and criteria


Thermistors are compared at lower temperature (TH2 and TH4 ≤ 35 ºC (95 ºF)).
Start DM2 when TH2 and TH4 are not less than 35 ºC (95 ºF) in five minutes.
TH1 - TH2 ≤ 0.5 ºC (0.9 ºF) ---A
TH3 - TH4 ≤ 0.5 ºC (0.9 ºF) ---B
TH5 - TH6 ≤ 0.5 ºC (0.9 ºF) ---C Lower point test Upper point test
TH3 is controlled to upper temperature TH3 ≤ 25 ºC (77 ºF) 36 ºC (96.8 ºF)
as shown in table based on DM1. 25 ºC < TH3 ≤ 29 ºC 37 ºC (98.6 ºF)
Thermistors are compared. (77 ºF) (84.2 ºF)
TH1 - TH2 ≤ 0.5 ºC (0.9 ºF) ---D 29 ºC < TH3 ≤ 32 ºC 38 ºC (100.4 ºF)
TH3 - TH4 ≤ 0.5 ºC (0.9 ºF) ---E (84.2 ºF) (89.6 ºF)
TH5 - TH6 ≤ 0.5 ºC (0.9 ºF) ---F 32 ºC < TH3 ≤ 35 ºC 39 ºC (102.2 ºF)
(89.6 ºF) (95 ºF)
Triggered alarm
A: TFD 251 TH1, TH2 compare test (lower point) failure
B: TFD 252 TH3, TH4 compare test (lower point) failure
C: TFD 257 TH5, TH6 compare test (lower point) failure
D: TFD 253 TH1, TH2 compare test (upper point) failure
E: TFD 254 TH3, TH4 compare test (upper point) failure
F: TFD 258 TH5, TH6 compare test (upper point) failure

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8. Self-tests

 UF pump discharge down test

Outlet

Transmit

Inlet

<Transmit signal and received signal of UF pump>

Outline
Reduction of the UF pump stroke volume is checked during the 100% conductivity
calibration.

Procedure and criteria


The cylinder has an electrode (transmitter) and each one way valve has an electrode
(receiver).
The transmitting signal is received when the one way valve is opened.
If the bearing of the plunger has too much play, the reciprocating distance of the plunger is
decreased and the plunger stops for a short moment at the top and bottom dead points.
Both valves are closed (both receivers do not receive the signal) when the UF pump plunger
is stopped (See D of above Fig.).

UF pump is run at 0.5L/h.


Both received voltages are checked every 0.1 second for 1 minute (600 times).
Count if both received voltages are less than 1000mV. --- Sample 1
Sample 1 ≤ 60 times

Triggered alarm
TFD127 UF pump discharge down alarm

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8. Self-tests

8.3.2 Continuous test (Dialysate monitor)

 Duplex pump conductivity protection

Received signal wave


Receiver B Receiver D Valve open
A
Valve close
Open
Close
B
Transmitte 監視項 Transmitte
Plunger
Open
C
Close

one way valves D


Receiver A Receiver C

Outline
The one way valves of the DP are checked for leakage and flow rate by using dialysate
conductivity.

Procedure and criteria


Each housing has an electrode (transmitter) and each one way valve has an electrode
(receiver).
The transmitting signal is received when the one way valve is opened.
The flow rate is calculated with the measured open / close cycle time and compared with the
set dialysate flow.
Set dialysate flow - Flow rate ≤ ±10% ---A
The received voltage is checked when the one way valve closed.
The received voltage ≤ 700mV ---B

Triggered alarm
A: TFD109 DP (supply) flow abnormal (Upper)
A: TFD110 DP (supply) flow abnormal (Lower)
A: TFD160 DP (drain) flow abnormal (Upper)
A: TFD161 DP (drain) flow abnormal (Lower)
B: TFD105 DP cell1-1 leak
B: TFD106 DP cell1-2 leak
B: TFD107 DP cell2-1 leak
B: TFD108 DP cell2-2 leak

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8. Self-tests

 Back pressure setting failure test


E

Receiver B Receiver D Outlet

Open
Close

Transmitte 監視項
Plunger Transmitte

Open
Close

one way valves Inlet


Receiver A Receiver C

Outline
The back pressure valves (H1, H2) settings are checked by using the DP conductivity
protection.

Procedure and criteria


Each housing has an electrode (transmitter) and each one way valve has an electrode
(receiver).
The transmitting signal is received when the one way valve is opened.
Both valves of the DP supply side are opened (both receivers receive the signal) when the
back pressure valve (H1) is lower than inlet pressure (over feed phenomenon) (See E of above
Fig.).
Both received voltages are checked every 0.1 second for 1 minute. (supply side of DP)
Count if both received voltages are more than 3000mV. ---Sample 1
Sample 1 ≤ 10 times
When sample1 exceeds the alarm limit continuously 3 times, the alarm is triggered. ---A

Both valves of the DP drain side are opened (both receivers receive the signal) when the back
pressure valve (H2) is lower than inlet pressure (over feed phenomenon).
Both received voltages are checked every 0.1 second for 1 minute. (drain side of DP)
Count if both received voltages are more than 3000mV. ---Sample 2
Sample 2 ≤ 10 times
When sample 2, exceeds the alarm limit continuously 3 times, the alarm is triggered. ---B

Triggered alarm
A: TFD170 Back press. valve (H1) set. failure alarm (Supply)
B: TFD171 Back press. valve (H2) set. failure alarm (Drain)

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8. Self-tests

 UF pump conductivity protection

Receive
Received signal wave shape
A Valve open
A
Valve close

Transmitte B

B
Receive

Outline
The one way valves of the UFP are checked for leaks and flow rate by using dialysate
conductivity.

Procedure and criteria


The cylinder has an electrode (transmitter) and each one way valve has an electrode
(receiver).
The transmitting signal is received when the one way valve is opened.
The flow rate is calculated with the measured open / close cycle time and compared with the
set UF rate.
Set UF rate - Flow rate ≤ ±5% ---A
The received voltage is checked when each one way valve is closed.
The received voltage ≤ 0.5V ---B
The received voltage is checked when each one way valve is opened.
The received voltage > 2V ---C

Triggered alarm
A: TFD121 UFP rate abnormal (Upper)
A: TFD122 UFP rate abnormal (Lower)
B: TFD124 UFP cell1 leak
B: TFD126 UFP cell2 leak
C: TFD123 UFP cell1 abnormal
C: TFD125 UFP cell2 abnormal

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8. Self-tests

 Solenoid valves conductivity protection (SV4, 5, 6, 7, 8)

OUT
Electrodes
IN

Outline
The conductivity of SV4, SV5, SV6, SV7 and SV8 is checked during the treatment.

Procedure and criteria


Each solenoid valves has two electrodes (transmitter and receiver) at inlet and outlet.
The transmitting signal is received when the solenoid valve is opened.
The received voltage is checked when the solenoid valves are closed. (SV4, 5, 6, 7, 8)
The received voltage ≤ 400mV ---A
The received voltage ≤ 2500mV ---B
The received voltage is checked when the solenoid valves are opened. (SV4, 5, 6, 7, 8)
The received voltage ≥ 4000mV ---C

Triggered alarm
A: TFD300 SV4 leak alarm (small leak)
A: TFD301 SV5 leak alarm (small leak)
A: TFD302 SV6 leak alarm (small leak)
A: TFD303 SV7 leak alarm (small leak)
A: TFD304 SV8 leak alarm (small leak)
B: TFD320 SV4 leak alarm (quantity)
B: TFD321 SV5 leak alarm (quantity)
B: TFD322 SV6 leak alarm (quantity)
B: TFD323 SV7 leak alarm (quantity)
B: TFD324 SV8 leak alarm (quantity)
C: TFD308 SV4 Not open
C: TFD309 SV5 Not open
C: TFD310 SV6 Not open
C: TFD311 SV7 Not open
C: TFD312 SV8 Not open

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8. Self-tests

 CCS solenoid valves conductivity protection (SV66, 67, 68, 69)

SV66 SV67

VA1C
VA2C

SV68 SV69

Outline
The conductivity of SV66, SV67, SV68 and SV69 is checked when cleaning program is started.

Procedure and criteria


CCS solenoid valves have electrodes (VA1C and VA2C).
The transmitting signal is received when the solenoid valve is opened.
SV66 and SV67 are opened and the voltage of VA1C is checked.
The voltage ≥ 4000mV ---A
SV66 and SV67 are closed and the voltage of VA1C is checked.
The voltage ≤ 500mV ---B
SV66 and SV67 are opened. SV67 is closed and the voltage of VA1C is checked.
The voltage ≤ 500mV ---C
SV67 is opened. SV66 is closed and the voltage of VA1C is checked.
The voltage ≤ 500mV ---D
SV68 and SV69 are opened and the voltage of VA2C is checked.
The voltage ≥ 4000mV ---E
SV68 and SV69 are closed and the voltage of VA2C is checked.
The voltage ≤ 500mV ---F
SV68 and SV69 are opened. SV69 is closed and the voltage of VA2C is checked.
The voltage ≤ 500mV ---G
SV68 is closed and the voltage of VA2C is checked.
The voltage ≤ 500mV ---H

Triggered alarm
A: TFD330 SV alarm (c. conc. supply A1:Not open or air)
B: TFD331 SV leak alarm (c. conc. supply A1: Protect)
C: TFD333 SV67 leak alarm (c. conc. supply A1)
D: TFD332 SV66 leak alarm (c. conc. supply A1)
E: TFD334 SV alarm (c. conc. supply A2:Not open or air)
F: TFD335 SV leak alarm (c. conc. supply A2:Protect)
G: TFD337 SV69 leak alarm (c. conc. supply A2)
H: TFD336 SV68 leak alarm (c. conc. supply A2)

A or E alarm occurs if the concentrate is disconnected from the CCS port.


These alarms can be only skipped by touching the Alarm reset key with TK password.

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8. Self-tests

This page is intended to be blank.

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9. Troubleshooting

9. Troubleshooting
9.1. General description

Always strictly observe the general cautions.

The DBB-06 must be repaired using the following procedure.


1. Touch and hold the [OFF] key on the DBB-06 and disconnect the DBB-
06 from the main power supply.
2. Open the cover of the DBB-06.
3. Replace parts or disassemble and reassemble.
4. Calibrate or verify the replaced or reassembled parts.

Function check
After any repair has been carried out, always perform the start-up test to
check that the DBB-06 functions correctly.

Service mode screen, Data view screen, and Keys screen are necessary to enter the password.

9.2. Messages (See also Operator’s manual Chapter 7)

How to reset messages


Touch the [MUTE] key to stop the audible alarm.
Touch the Alarm reset key.

9.2.1. Messages A to Z

Adjust AP transducer after treatment end


Adjust DIP transducer after treatment end
Adjust VP transducer after treatment end
Cause Adjusted value of the pressure sensors has changed.
Solution Adjust each blood line sensors.
Pressure transducers (TP11 to TP16 )
Items to check
Hydrophobic filters
Remarks SERVICE MODE - 11.Blood line sensor adjust.

Air alarm (Micro bubble)


Air alarm (Normal bubble)
The air detector has detected micro-bubbles or normal-bubbles in the
Cause
extracorporeal circuit.
Solution Check the voltage of the air detector.
Air detector
Items to check
Air detector PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.5 Air detector act. check

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9. Troubleshooting

AP alarm (Full range upper)


AP alarm (Full range lower)
AP alarm (Fixed upper)
AP alarm (Fixed lower)
AP alarm (Auto upper)
AP alarm (Auto lower)
Cause The arterial pressure has exceeded the alarm limit.
Solution Check the measured value of the arterial pressure port.
Arterial pressure transducer (PT11, PT12)
Items to check
Hydrophobic filter
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.1 Art. press. transducer ZERO adj.
- 11.2 Art. press. transducer SPAN adj.

Bicarbonate conductivity alarm (Full range upper)


Bicarbonate conductivity alarm (Full range lower)
Bicarbonate conductivity alarm (Upper)
Bicarbonate conductivity alarm (Lower)
Cause The bicarbonate conductivity has exceeded the alarm limit.
Solution Adjust the calibration curve.
Concentrate pump B (SPB)
Concentrate filter (FL61)
Concentrate back pressure valve (H-C1)
Duplex pump (DP)
Solenoid valve (SV70)
Items to check
Conductivity cell (CL1 to CL4)
Thermistor (TH5, TH6)
Concentrate filter (FL45) *Bicarbonate powder cartridge option
Check valve (CV61) *Bicarbonate powder cartridge option
Solenoid valve (SV61, SV62) *Bicarbonate powder cartridge option
Remarks SERVICE MODE - 8.Conductivity adjustment

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9. Troubleshooting

B conductivity calibration curve alarm (Upper)


B conductivity calibration curve alarm (Lower)
Cause The bicarbonate conductivity has exceeded the alarm limit.
Solution Adjust the calibration curve.
Concentrate pump B (SPB)
Concentrate filter (FL61)
Concentrate back pressure valve (H-C1)
Duplex pump (DP)
Solenoid valve (SV70)
Items to check
Conductivity cell (CL1 to CL4)
Thermistor (TH5, TH6)
Concentrate filter (FL45) *Bicarbonate powder cartridge option
Check valve (CV61) *Bicarbonate powder cartridge option
Solenoid valve (SV61, SV62) *Bicarbonate powder cartridge option
Remarks SERVICE MODE - 8.Conductivity adjustment

Bicarbonate cartridge priming alarm


Cause The bicarbonate cartridge priming is faulty.
Check that the bicarbonate powder in the cartridge is diluted with water.
Solution
The alarm occurs when filling time is over (5minutes).
Concentrate filter (FL45)
Concentrate filter (FL45)
Items to check
Check valve (CV61)
Solenoid valve (SV61, SV62)
Remarks

Bicarbonate dilution alarm (Upper)


Bicarbonate dilution alarm (Lower)
The bicarbonate dilution ratio exceeded the alarm limit when using
Cause
bicarbonate powder cartridge.
Check that the treated water has zero conductivity before mixing with the
Solution
bicarbonate powder.
Items to check Treated water
Remarks

Blood leak alarm


Cause Blood has been detected in the dialysate.
Touch and hold the BLD initial. key to initialize voltage of blood leak
Solution detector.
Check the voltage of the blood leak detector.
Items to check Blood leak detector
OPERATOR - KEYS - ▼ - BLD initial.
Remarks SERVICE MODE - 9.Blood leak detector adjustment
- 9.1 Blood leak rece. light volt. adj.

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9. Troubleshooting

BP cover is opened
Cause The cover of blood pump has been opened when BP is on.
Solution Check the status of the switch.
Reed Switch
Items to check
BP cover Assembly
Remarks MONITOR - DATA VIEW - SW -BP cover SW = ON

BPM alarm
Cause Problems which interrupt the measurement have occurred.
Check the cuff, cuff tube, and BPM module.
Solution
Perform the BPM test after replacing the parts
Cuff
Items to check Cuff tube
BPM module
SERVICE MODE - 19.BPM test - 19.1 Air leak test
Remarks
- 19.2 Pressure check test

BPM failure
Cause Internal problems have occurred with the BPM.
Touch the [OFF] key, and then touch the [ON] key.
Solution
Perform the BPM test after replacing the parts
Items to check BPM module
Remarks

Bypass alarm
Cause The dialyzer coupling has been disconnected from the bypass port.
Solution Check the status of the switch (Bypass SW 1/2) is “on”.
Items to check Reed switch (Bypass port)
MONITOR - DATA VIEW - SW - Bypass SW1 = ON
Remarks
MONITOR - DATA VIEW - SW - Bypass SW2 = ON

Connect cartridge holder arm (Lower)


The movable bicarbonate cartridge holder arm is not correctly fastened at the
Cause
bottom during cleaning program.
Solution Check the status of the switch.
Items to check Bicarbonate powder cartridge
Remarks MONITOR - DATA VIEW - SW -BP POW SW1 = ON

Connect cartridge holder arm(Upper)


The movable bicarbonate cartridge holder arm is not correctly fastened at the
Cause
bottom during cleaning program.
Solution Check the status of the switch.
Items to check Bicarbonate powder cartridge
Remarks MONITOR - DATA VIEW - SW -BP POW SW2 = ON

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9. Troubleshooting

Connect blue concentrate connector to the rinse port


The bicarbonate concentrate connector has removed from the rinse port
Cause
during cleaning program.
Solution Check the status of the switch.
Bicarbonate concentrate connector
Items to check
Rinse port
Remarks MONITOR - DATA VIEW - SW - B port SW = ON

Connect red concentrate connector to the rinse port


The acid concentrate connector has been removed from the rinse port during
Cause
cleaning program.
Solution Check the status of the switch.
Acid concentrate connector
Items to check
Rinse port
Remarks MONITOR - DATA VIEW - SW -A port SW = ON

Citric acid lower alert


Cause The disinfectant conductivity exceeded the alarm limit.
Check if the disinfectant valve can be opened.
Solution
Check that the disinfectant tube is not clogged.
Disinfectant tube assembly
Items to check
Disinfectant valve (SV21, SV22)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

Detection of blood
Cause Before treatment, blood has been detected in the venous blood line.
Check the voltage of blood detector.
Solution
Check the threshold voltage of blood detection.
Blood detector
Items to check
MAIN PCB
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.9 Blood/Sal. detec. volt. set. (saline)
- 11.10 Set. of blood detec. threshold volt.

Detection of saline
Cause During treatment, saline has been detected in the venous blood line.
Check the voltage of blood detector.
Solution
Check the threshold voltage of saline detection.
Blood detector
Items to check
MAIN PCB
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.9 Blood/Sal. detec. volt. set. (saline)
- 11.11 Set. of blood detec. threshold volt. (saline)

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9. Troubleshooting

Dialysate press. alarm (Full range upper)


Dialysate press. alarm (Full range lower)
Dialysate press. alarm (Fixed upper)
Dialysate press. alarm (Fixed lower)
Dialysate press. alarm (Auto upper)
Dialysate press. alarm (Auto lower)
Cause The dialysate pressure has exceeded the alarm limit.
Solution Check the measured value of the dialysate pressure port.
Items to check Dialysate pressure transducer (PT3)
SERVICE MODE - 3. Fluid circuit sensor
Remarks - 3.3 Dialysate press. trans.2 ZERO adj.
- 3.4 Dialysate press. trans.2 SPAN adj.

Dialyzer coupling reminder


Cause During treatment, the dialyzer couplings are connected to the bypass port.
Solution Check the status of the switch (Bypass SW1/2) is “off”.
Items to check Reed switch (Bypass port)
MONITOR - DATA VIEW - SW - Bypass SW1 = OFF
Remarks
MONITOR - DATA VIEW - SW - Bypass SW2 = OFF

DIP alarm (Full range upper)


DIP alarm (Full range lower)
DIP alarm (Fixed range upper)
DIP alarm (Fixed range lower)
DIP alarm (Auto. set. lower)
Cause The dialyzer blood inlet pressure has exceeded the alarm limit.
Solution Check the measured value of the dialyzer inlet pressure port.
Dialyzer inlet pressure transducer (PT13)
Items to check
Hydrophobic filter
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.5 Dial. inlet press. trans. ZERO adj.
- 11.6 Dial. inlet press. trans. SPAN adj.

DIP monitor is not used


Cause ‘DIP monitor is not used’ is selected at Service mode.
Solution Select ‘DIP monitor is used’ if bloodline with DIP is used.
Items to check
Remarks SERVICE MODE - 17.Option - 11.12 DIP

DIP has been exceeded auto upper limit.


Cause The dialyzer blood inlet pressure has exceeded the alarm limit.
Solution Check the measured value of the dialyzer inlet pressure port.
Dialyzer inlet pressure transducer (PT13)
Items to check
Hydrophobic filter
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.5 Dial. inlet press. trans. ZERO adj.
- 11.6 Dial. inlet press. trans. SPAN adj.

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9. Troubleshooting

Disinfectant empty alarm


The disinfectant container is empty.
Cause
The float switch is ON during disinfectant suction phase.
Solution Check the float switch.
Disinfectant tube assembly
Items to check Disinfectant valve (SV21, SV22)
Float switch (LVS)
Remarks MONITOR - DATA VIEW - SW - Deaerator SW

E
Ensure the blue concentrate connector states
The connection of the blue concentrate connector does not correspond to the
Cause
selected concentrate.
Solution Check the status of the switch.
Bicarbonate concentrate connector
Items to check
Rinse port
Remarks MONITOR - DATA VIEW – SW - B port SW = OFF

Ensure the cartridge holder arm (Lower) states


The status of the bicarbonate cartridge holder does not correspond to the
Cause
selected concentrate.
Solution Check the status of the switch.
Items to check Bicarbonate powder cartridge
Remarks MONITOR - DATA VIEW - SW - B POW port SW2 = ON

Ensure the cartridge holder arm (Upper) states


The status of the bicarbonate cartridge holder does not correspond to the
Cause
selected concentrate.
Solution Check the status of the switch.
Items to check Bicarbonate powder cartridge
Remarks MONITOR - DATA VIEW - SW - B POW port SW1 = ON

Ensure the red concentrate connector states


The connection of the red concentrate connector does not correspond to the
Cause
selected concentrate.
Solution Check the status of the switch.
Acid concentrate connector
Items to check
Rinse port
Remarks MONITOR - DATA VIEW - SW - A port SW = ON

F, G

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9. Troubleshooting

Heater outlet temperature abnormal alarm


Cause The temperature at the heater outlet has been too high during cleaning.
Check the thermistor.
Solution
Adjust the amplitude circuit
Thermistor (TH1, TH2)
Items to check
Heater (DH)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

Initial UFK abnormal (Upper)


Initial UFK abnormal (Lower)
Cause The initial measurement of UF factor exceeded the alarm limit.
Check the blood line and the dialyzer.
Solution
Touch and hold the TMP initial. key to retry TMP ZERO calibration.
Dialyzer
Items to check
Blood line
Remarks OPERATOR - KEYS - ▼ - TMP initial.

J, K, L, M

No bloodline
The venous blood line has not placed in the blood line detector while the
Cause
blood pump was running.
Solution Check the status of the switch.
Items to check Bloodline detector ; e.g. switch
Remarks MONITOR - DATA VIEW - SW - Blood cir. SW = ON

No syringe
Cause No syringe has been placed in the HP.
Solution Check the status of the switch.
Items to check Syringe holder switch
Remarks MONITOR - DATA VIEW - SW - Syringe SW = ON

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9. Troubleshooting

Pressure loss alarm (Fixed range upper)


Pressure loss alarm (Fixed range lower)
Cause The pressure loss in the dialyzer has exceeded the alarm limit.
Check the measured value of the dialyzer inlet pressure port.
Solution
Check the measured value of the venous pressure port.
Dialyzer inlet pressure transducer (PT13)
Items to check Venous pressure transducer (PT15)
Hydrophobic filters (behind the PT13, PT15)
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.3 Ven. press. level adj. trans. ZERO adj.
- 11.5 Dial. inlet press. trans. ZERO adj.

Pump key reminder


Cause BP power has been off during treatment.
Check the [PUMP] key and indicator lamp.
Solution
Check the status of the switch.
Items to check Label (monitor switch)
Remarks MONITOR- DATA VIEW - SW -BP SW = ON

Q, R

SN control time alarm (Arterial phase)


SN control time alarm (Venous phase)
Cause The single needle control timed out.
Check the blood line and the dialyzer.
Solution Check the alarm limit
Check the venous clamp function.
Blood line
Items to check Dialyzer
Venous clamp
OPERATOR - SETTING 2 - 10. Single needle
- SN withdrawing blood time alarm point
Remarks
- SN collecting blood time alarm point
SERVICE MODE - 13. Confirming operation - 13.2 Clamp act. Check

SN press. alarm (Fixed range upper)


SN press. alarm (Fixed range lower)
Cause SN pressure during single needle treatment has exceeded the alarm limit.
Solution Check the alarm limit.
Items to check
OPERATOR - SETTING 2 - 10. Single needle
Remarks - SN pressure alarm point (upper)
- SN pressure alarm point (lower)

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9. Troubleshooting

Sodium hypochlorite lower alert


Sodium hypochlorite upper alert
Cause The disinfectant conductivity exceeded the alarm limit.
Solution Check if the disinfectant valve can be opened and closed.
Disinfectant tube assembly
Items to check
Disinfectant valve (SV21, SV22)
SERVICE MODE - 13. Confirming operation - 13.1 Hydrocircuit act.
Remarks
Check

Syringe is empty
Cause The heparin syringe has been empty.
Solution Check the pressure of Heparin infusion completion.
Items to check Heparin pump(HP)
Rearks MONITOR - DATA VIEW - SW - HP completion SW

Temperature alarm (Full range upper)


Temperature alarm (Full range lower)
Temperature alarm (Auto upper)
Temperature alarm (Auto lower)
Cause The dialysate temperature exceeded the alarm limit.
Check the thermistor.
Solution
Adjust the amplitude circuit
Items to check Thermistor (TH3, TH4)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

TH1 disconnecting alarm


TH2 disconnecting alarm
TH3 disconnecting alarm
TH4 disconnecting alarm
TH5 disconnecting alarm
TH6 disconnecting alarm
TH11 disconnecting alarm
Cause An error occurred in the wire of thermistor.
Check the thermistor connection to the MAIN PCB.
Solution
Replace the thermistor.
Thermistor (TH1, TH2, TH3, TH4, TH5, TH6, TH11)
Items to check
MAIN PCB
Remarks

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9. Troubleshooting

Thermistor compare test time over


Cause The thermistor compare test timed out.
Check if the temperature of water for dialysis is less than 35°C (95 °F)
Solution
Adjust the amplitude circuit
Thermistor (TH1, TH2, TH3, TH4, TH5, TH6, TH11)
Items to check MAIN PCB
Heater (DH)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

TMP alarm (Fixed range upper)


TMP alarm (Fixed range lower)
TMP alarm (Auto upper)
TMP alarm (Auto lower)
TMP alarm (Auto forecast upper)
TMP alarm (Auto forecast lower)
Cause The TMP has exceeded the alarm limit.
Check the measured value of the dialysate pressure, venous, dialyzer inlet
Solution
pressure port.
Dialysate pressure transducer (PT2, PT3)
Items to check
Pressure transducer PCB (PT13, PT15)
SERVICE MODE - 3. Fluid circuit sensor
- 3.1 Dialysate press. trans.1 ZERO adj.
- 3.2 Dialysate press. trans.1 SPAN adj.
- 3.3 Dialysate press. trans.2 ZERO adj.
- 3.4 Dialysate press. trans.2 SPAN adj.
Remarks
SERVICE MODE - 11. Blood line sensor adjust.
- 11.3 Ven. press. level adj. trans. ZERO adj.
- 11.4 Ven. press. level adj. trans. SPAN adj.
- 11.5 Dial. inlet press. trans. ZERO adj.
- 11.6 Dial. inlet press. trans. SPAN adj.

TMP zero calibration abnormal (Upper)


TMP zero calibration abnormal (Lower)
The TMP zero calibration value has exceeded the alarm limit.
Cause
The TMP zero calibration value depends on the height of the dialyzer.
Check the blood line and the dialyzer.
Solution Touch and hold the TMP initial. key to retry TMP ZERO calibration.
Check the alarm limit.
Dialyzer
Items to check
Blood line
OPERATOR - KEYS - ▼ - TMP initial.
Remarks
OPERATOR - SETTING1 - 2. Alarm point - 2.8 TMP zero calibration alarm

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9. Troubleshooting

Total conductivity alarm (Full range upper)


Total conductivity alarm (Full range lower)
Total conductivity alarm (Upper)
Total conductivity alarm (Lower)
Cause The total conductivity has exceeded the alarm limit.
Adjust the calibration curve.
Solution
Check the A1 and A2 port. *CCS option
Concentrate pump A (SPA)
Concentrate filter (FL62)
Concentrate back pressure valve (H-C2)
Duplex pump (DP)
Items to check
Solenoid valve (SV65)
Conductivity cell (CL1 to CL4)
Thermistor (TH5, TH6)
Solenoid valve (SV66 to SV69) *CCS option
Remarks SERVICE MODE - 8. Conductivity adjustment

Total conductivity calibration alarm


Total conductivity calibration curve alarm (Upper)
Total conductivity calibration curve alarm (Lower)
Cause The total conductivity calibration curve has exceeded the alarm limit.
Adjust the calibration curve.
Solution
Check the A1 and A2 port. *CCS option
Concentrate pump A (SPA)
Concentrate filter (FL62)
Concentrate back pressure valve (H-C2)
Duplex pump (DP)
Items to check
Solenoid valve (SV65)
Conductivity cell (CL1 to CL4)
Thermistor (TH5, TH6)
Solenoid valve (SV66 to SV69) *CCS option
Remarks SERVICE MODE - 8. Conductivity adjustment

UFK drop alarm


Cause The UF factor has dropped below the alarm limit.
Check the blood line and the dialyzer.
Solution
Check the alarm limit.
Dialyzer
Items to check
Blood line
Remarks OPERATOR - SETTING 1 - 2. Alarm point - 2.7 UFR alarm

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9. Troubleshooting

VP alarm (Full range upper)


VP alarm (Full range lower)
VP alarm (Fixed upper)
VP alarm (Fixed lower)
VP alarm (Auto upper)
VP alarm (Auto lower)
Cause The venous pressure has exceeded the alarm limit.
Solution Check the measured value of the venous pressure port.
Venous pressure transducer (PT15)
Items to check
Hydrophobic filter
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.3 Ven. press. level adj. trans. ZERO adj.
- 11.4 Ven. press. level adj. trans. SPAN adj.

Water supply pressure alarm (Upper)


Water supply pressure alarm (Lower)
Cause The water pressure has exceeded the alarm limit.
Check the alarm limit
Check the measured value of the water inlet pressure transducer (PT1).
Solution
Check if the water supply pressure is within a range.
Check if SV1 is opened.
Pressure reduction valve (PRV)
Items to check Pressure transducer (PT1)
Solenoid valve (SV1)
OPERATOR - SETTING2 - 16.Water pressure

Remarks SERVICE MODE - 3.Fluid circuit sensor


- 3.5 Water supply press. trans. ZERO adj.
- 3.6 Water supply press. trans. SPAN adj.

X, Y, Z

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9. Troubleshooting

9.2.2. TFB Messages

TFB101 Blood flow alarm (Upper)


TFB102 Blood flow alarm (Lower)
The difference between the actual and desired revolutions of blood pump has
Cause
exceeded the alarm limit
Check if blood pump segment is correctly placed.
Solution Check the connection between blood pump and distribution PCB.
Check the function of the blood pump.
Blood pump (BP) ; e.g. Motor, Gear box
Brushless motor PCB
Items to check
MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.7 BP act. check

TFB103 BP control abnormal alarm


Cause The revolutions of blood pump have been uncontrolled.
Check the connection between blood pump and distribution PCB.
Solution
Check the function of the blood pump.
Blood pump (BP) ; e.g. Motor, Gear box
Brushless motor PCB
Items to check
MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.7 BP act. check

TFB104 BP overload alarm


Cause The blood pump has been overloaded.
Check if blood pump segment is correctly placed.
Solution Check the connection between blood pump and distribution PCB.
Check the function of the blood pump.
Blood pump (BP) ; e.g. Motor, Gear box
Brushless motor PCB
Items to check
MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.7 BP act. check

TFB105 BP reverse alarm


Cause The blood pump has rotated in reverse.
Check if blood pump segment is correctly placed.
Solution Check the connection between the blood pump and distribution PCB.
Check the function of the blood pump.
Blood pump (BP) ; e.g. Motor, Gear box
Brushless motor PCB
Items to check
MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.7 BP act. check

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9. Troubleshooting

TFB131 HP rate alarm (Upper)


TFB132 HP rate alarm (Lower)
TFB133 HP reverse alarm
The difference between the actual and desired rate of the heparin pump has
Cause
exceeded the alarm limit
Check the connection between the heparin pump and distribution PCB.
Solution Check the connection between the rotation sensor PCB and distribution PCB.
Check the rotation of the braded wheel.
Heparin pump (HP) ; e.g. Motor, Rotation sensor, Braded wheel
Items to check MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.10 HP act. Confirm

TFB141 Blood detector offset abnormal alarm


Cause The offset voltage of blood detector has exceeded the alarm limit
Check the connection between the blood detector and distribution PCB.
Solution
Adjust the voltage of blood detector.
Blood detector (BD) ; LED Photo transistor
Items to check MAIN PCB
Distribution PCB
SERVICE MODE - 11. Blood line sensor adjust.
Remarks
- 11.9 Blood/Sal. detec.volt. set. (saline)

TFB151 Air detector alarm (Test)


TFB152 Air detector alarm (Normal bubble)
TFB153 Air detector alarm (Micro bubble)
Cause An error has occurred during operation of the air detector.
Check the connection between the air detector and distribution PCB.
Solution
Adjust the voltage of air detector.
Air detector
Items to check MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.5 Air detector act. check

TFB201 AP transducer compare test failed alarm


The difference of the arterial pressure transducers (PT11 and PT12) has
Cause
exceeded the alarm limit
Check if hydrophobic filter in pressure monitor line is wet.
Solution Check the connection between the pressure transducer and distribution PCB.
Adjust the arterial pressure transducer.
Arterial pressure transducer (PT11, PT12)
Hydrophobic filter
Items to check
MAIN PCB
Distribution PCB
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.1 Art. press. transducer ZERO adj.
- 11.2 Art. press. transducer SPAN adj.

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9. Troubleshooting

TFB202 V clamp open test failed


TFB203 V clamp close test failed
The venous clamp detector has not detected desired function in BM test.
Cause
C-CPU or P-CPU did not open or close the venous clamp.
Check the connection between the optical sensor and distribution PCB.
Check the connection between the venous clamp and distribution PCB.
Solution
Clean up the optical sensor.
Check the function of the venous clamp.
Venous clamp ; e.g. Optical sensor, Solenoid,
Items to check MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.2 Clamp act. check

TFB204 BP stop test failed


TFB205 BP revolution test failed
The blood pump has not detected desired function in BM test.
Cause
C-CPU did not run or stop the blood pump.
Check if blood pump segment is correctly placed.
Solution Check the connection between the blood pump and distribution PCB.
Check the function of the blood pump.
Blood pump (BP)
Brushless motor PCB
Items to check
MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.7 BP act. check

TFB206 Blood transducer open test failed


The pressure transducer (zero) test failed in BM test.
P-CPU has detected more than 10 mmHg difference between the venous
Cause
pressure and dialyzer inlet pressure or venous pressure has exceeded
more than 100 mmHg.
Check if hydrophobic filter in pressure monitor line is wet.
Solution Check the connection between the pressure transducer and distribution PCB.
Adjust the pressure transducer.
Hydrophobic filter
Pressure transducer PCB (PT13, PT15)
Items to check
MAIN PCB
Distribution PCB
SERVICE MODE - 11.Blood line sensor adjust.
- 11.3 Ven. press. level adj. trans. ZERO adj.
Remarks - 11.4 Ven. press. level adj. trans. SPAN adj.
- 11.5 Dial. inlet press. trans. ZERO adj.
- 11.6 Dial. inlet press. trans. SPAN adj.

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9. Troubleshooting

TFB207 Blood transducer boosted time has expired


The blood transducer test was timed out in BM test.
Cause P-CPU has not detected more than 200 mmHg at the venous pressure or
dialyzer inlet pressure transducer during the blood pump was running.
Check if blood pump segment is correctly placed.
Check if hydrophobic filter in pressure monitor line is wet.
Check the connection between the pressure monitor line and port.
Solution
Check the function of the blood pump.
Check the function of the venous clamp.
Adjust the pressure transducer.
Hydrophobic filter
Pressure transducer PCB (PT13, PT15)
Items to check
Blood pump
Venous clamp
SERVICE MODE - 13. Confirming operation - 13.2 Clamp act. check
SERVICE MODE - 13. Confirming operation - 13.7 BP act. check
SERVICE MODE - 11.Blood line sensor adjust.
Remarks
- 11.3 Ven. press. level adj. trans. ZERO adj.
- 11.4 Ven. press. level adj. trans. SPAN adj.
- 11.5 Dial. inlet press. trans. ZERO adj.
- 11.6 Dial. inlet press. trans. SPAN adj.

TFB208 Blood transducer boosted test failed


The pressure transducer (span) test failed in BM test.
Cause P-CPU has detected more than 10 mmHg difference between the venous
pressure and dialyzer inlet pressure.
Check if blood pump segment is correctly placed.
Check if hydrophobic filter in pressure monitor line is wet.
Solution Check the connection between the pressure monitor line and port.
Check the function of the venous clamp.
Adjust the pressure transducer.
Hydrophobic filter
Items to check Pressure transducer PCB (PT13, PT15)
Venous clamp
SERVICE MODE - 13. Confirming operation - 13.2 Clamp act. check
SERVICE MODE - 11.Blood line sensor adjust.
Remarks - 11.3 Ven. press. level adj. trans. ZERO adj.
- 11.4 Ven. press. level adj. trans. SPAN adj.
- 11.5 Dial. inlet press. trans. ZERO adj.
- 11.6 Dial. inlet press. trans. SPAN adj.

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9. Troubleshooting

TFB209 A clamp open test failed


TFB210 A clamp close test failed
Cause The clamp detector has not detected desired function in BM test.
Check the connection between the optical sensor and distribution PCB.
Check the connection between the arterial clamp and distribution PCB.
Solution
Clean up the optical sensor.
Check the function of the arterial clamp.
Arterial clamp ; e.g. Optical sensor, Solenoid,
Items to check MAIN PCB
Distribution PCB
Remarks SERVICE MODE - 13. Confirming operation - 13.2 Clamp act. check

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9. Troubleshooting

9.2.3. TFC Messages

An alarm which starts with “TFC” is caused by problems in the computer process.

How to reset TFC messages

TFC alarm can be reset by 3 steps below.

Initialize the database 3

Touch the [OFF] key to turn off the DBB-06.


Turn on switch on the MAIN PCB following below.

Touch the [ON] key to turn on the DBB-06.


Touch the OK key in the monitor until initializing is finished.
Perform the start-up test

Initialize the database 2

Touch the [OFF] key to turn off the DBB-06.


Turn on switch on the MAIN PCB following below.

Touch the [ON] key to turn on the DBB-06.


Touch the OK key in the monitor until initializing is finished.
Perform the start-up test
Set the SETTING1, SETTING2

Initialize DBB-06

Touch the [OFF] key to turn off the DBB-06.


Turn on switch on the MAIN PCB following below.

Touch the [ON] key to turn on the DBB-06.


Touch the OK key in the monitor until initializing is finished.
Perform all calibration in DBB-06.
Set the SETTING1, SETTING2
Perform the start-up test

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9. Troubleshooting

9.2.4. TFD Messages

TFD101 Duplex pump revolution alarm (Upper)


TFD102 Duplex pump revolution alarm (Lower)
The flow rate of the duplex pump has exceeded the alarm limit.
Cause Revolution monitoring by hall element begins 60 seconds after the pump
is started or the rate is changed.
Check the function of the duplex pump.
Solution Check the connection between the duplex pump and Brushless motor PCB.
Disassemble and reassemble the duplex pump.
Duplex pump ; e.g. Motor, Gear box
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; ±20% of desired rate
Remarks SERVICE MODE - 6. Pump (UFP/DP) adjustment
- 6.2 Dia. flow rate adj. (measured value)

TFD103 Duplex pump control abnormal alarm


The duplex pump is not controlled.
Cause The alarm occurs when the duplex pump cannot be controlled at desired
rate, although controlled to maximum or minimum speed.
Check the function of the duplex pump.
Solution Check the connection between the duplex pump and Brushless motor PCB.
Disassemble and reassemble the duplex pump.
Duplex pump ; e.g. Motor, Gear box
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; ±20ml/min
Remarks SERVICE MODE - 6. Pump (UFP/DP) adjustment
- 6.2 Dia. flow rate adj. (measured value)

TFD104 Duplex pump overload alarm


The duplex pump has been overloaded.
Cause
The alarm occurs when over current is detected.
Check the function of the duplex pump.
Solution Check the connection between the duplex pump and Brushless motor PCB.
Disassemble and reassemble the duplex pump.
Duplex pump
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; 1.2V
Remarks SERVICE MODE - 6. Pump (UFP/DP) adjustment
- 6.2 Dia. flow rate adj. (measured value)

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9. Troubleshooting

TFD105 Duplex pump cell1-1 leak alarm


TFD106 Duplex pump cell1-2 leak alarm
TFD107 Duplex pump cell2-1 leak alarm
TFD108 Duplex pump cell2-2 leak alarm
One way valve of the duplex pump has leaked.
Cause The voltage which is monitored at duplex pump conductivity cell has
exceeded the alarm limit.
Check the one way valve of the duplex pump.
Solution
Check that there is no shorting in transmitter and receiver.
Duplex pump ; e.g. One way valve, Electrode
Items to check
MAIN PCB
Alarm limit ; 0.7V
Remarks
SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage

TFD109 Dialysate supply flow alarm (Upper)


TFD110 Dialysate supply flow alarm (Lower)
TFD160 Dialysate drain flow alarm (Upper)
TFD161 Dialysate drain flow alarm (Lower)
The flow rate of the duplex pump which is monitored by conductivity cell has
Cause
exceeded the alarm limit.
Check the one way valve of the duplex pump.
Check the function of the duplex pump.
Check the connection between the duplex pump and Brushless motor PCB.
Solution
Check the connection of transmitter and receiver cable.
Check the voltage of duplex pump cell.
Disassemble and reassemble the duplex pump.
Duplex pump ; e.g. One way valve, Motor, Electrode
Items to check
Brushless motor PCB.
Alarm limit ; ±10%
Remarks
SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage

TFD121 UF rate alarm (Upper)


TFD122 UF rate alarm (Lower)
The flow rate of the UF pump which is monitored by conductivity cell has
Cause
exceeded the alarm limit.
Check the one way valve of the UF pump.
Check the function of the UF pump.
Check the connection between the UF pump and MAIN PCB.
Solution
Check the connection of transmitter and receiver cable.
Check the voltage of UF pump cell.
Disassemble and reassemble the UF pump.
UF pump ; e.g. One way valve, Electrode
Items to check
MAIN PCB
Alarm limit ; ±5%
Remarks
SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage

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9. Troubleshooting

TFD123 UF pump cell1 abnormal alarm


TFD125 UF pump cell2 abnormal alarm
The voltage of UF pump which is monitored by conductivity cell has exceeded
Cause
the alarm limit.
Check the one way valve of the UF pump.
Check the function of the UF pump.
Check the connection between the UF pump and MAIN PCB.
Solution Check the connection of transmitter and receiver cable.
Check the voltage of UF pump cell.
Disassemble and reassemble the UF pump.
Measure the stroke volume of the UF pump.
UF pump ; e.g. One way valve, Electrode
Items to check
MAIN PCB
Alarm limit ; 2.0V
Remarks
SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage

TFD124 UF pump cell1 leak alarm


TFD126 UF pump cell2 leak alarm
One way valve of the UF pump has leaked.
Cause The voltage which is monitored at UF pump conductivity cell has
exceeded the alarm limit.
Check the one way valve of the duplex pump.
Solution
Check that there is no shorting in transmitter and receiver
UF pump ; e.g. One way valve, Electrode
Items to check
MAIN PCB
Alarm limit ; 0.5V
Remarks
SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage

TFD127 UF pump discharge down alarm


The stroke volume of the UF pump has decreased.
Cause Inlet and outlet of the signals which monitor the flow rate of the UF pump
has been superimposed with frequency.
Check the one way valve of the UF pump.
Check the function of the UF pump.
Check the connection between the UF pump and MAIN PCB.
Solution Check the connection of transmitter and receiver cable.
Check the voltage of UF pump cell.
Disassemble and reassemble the UF pump.
Measure the stroke volume of the UF pump.
Items to check UF pump ; e.g. One way valve, Electrode, Bearing, Cam
Remarks SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage

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9. Troubleshooting

TFD131 BLD green voltage alarm (Upper)


TFD132 BLD green voltage alarm (Lower)
TFD133 BLD red voltage alarm (Upper)
TFD134 BLD red voltage alarm (Lower)
Cause The voltage of the blood leak detector has exceeded the alarm limit.
Check that there is no blood leak
Solution Disassemble, clean, and reassemble the blood leak detector.
Adjust the blood leak detector voltage.
Items to check Blood leak detector (BLD)
SERVICE MODE - 9. Blood leak detector adjustment
Remarks
- 9.1 Blood leak rece. light volt. adj.

TFD135 BLD offset voltage abnormal alarm (G upper)


TFD136 BLD offset voltage abnormal alarm (R upper)
Cause The offset voltage of the blood leak detector has exceeded the alarm limit.
Check that there is no blood leak
Solution Disassemble, clean, and reassemble the blood leak detector.
Adjust the blood leak detector voltage.
Items to check Blood leak detector (BLD)
SERVICE MODE - 9. Blood leak detector adjustment
Remarks
- 9.1 Blood leak rece. light volt. adj.

TFD141 LVS abnormal alarm


Abnormal status of the float switch has been detected.
The float switch has been continuously ON more than 5 seconds in 10
Cause
seconds, or total time switch was ON has been more than 60 seconds
during treatment.
Check that there is no leak in hydraulic.
Check the level of the gas separator chamber 2 and the status of the float
Solution
switch.
Check if the flow restrictor (SL2) is clogged.
Gas separator chamber 2 (GC2) ; e.g. Float switch
Items to check
Flow restrictor (SL2)
Remarks MONITOR - DATA VIEW - SW - Deaerator SW

TFD153 CL1, CL2 compare test failed alarm


TFD154 CL3, CL4 compare test failed alarm
Conductivity cell compare test failed during conductivity calibration.
Cause
The alarm occurs when more than 5% difference is detected.
Check the connection between conductivity cell and MAIN PCB.
Solution
Adjust the conductivity cell.
Conductivity cell
Items to check
Thermistor
Alarm limit ; ±5%
SERVICE MODE - 7. Conductivity/Temp. indication
Remarks - 7.1 Condut. indication ZERO adjust.
- 7.2 Condut. indication SPAN adjust.
- 7.3 Confirmed of cond. indication

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9. Troubleshooting

TFD170 H1 adjustment failure alarm


TFD171 H2 adjustment failure alarm
The back pressure valve has been set abnormally.
Cause Inlet and outlet of the signals which monitor the flow rate of the duplex
pump have been superimposed with frequency.
Check the voltage of duplex pump cell.
Solution
Adjust the pressure of the back pressure valve.
Back pressure valve (H1, H2) ; e.g. diaphragm
Items to check
Duplex pump (DP) ; e.g. One way valve
SERVICE MODE - 6. Pump (UFP/DP) adjustment - 6.4 Pump cell voltage
Remarks SERVICE MODE - 5. Reducing valve/back press. valve/relief valve
- 5.2 Back press. valve (H1,H2) adj.

TFD181 CP1 revolution alarm (Upper)


TFD182 CP1 revolution alarm (Lower)
The flow rate of the deaeration pump has exceeded the alarm limit.
Cause Revolution monitoring by hall element begins 60 seconds after the pump
is started or the rate is changed.
Check the function of the deaeration pump.
Solution Check the connection between deaeration pump and Brushless motor PCB.
Disassemble and reassemble the deaeration pump.
Deaeration pump ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; ±20% of desired rate
Remarks SERVICE MODE - 13. Confirming operation
- 13.3 Deaeration/booster pump act. check

TFD183 CP1 control abnormal alarm


The deaeration pump is not controlled.
Cause The alarm occurs when the deaeration pump cannot be controlled at
desired rate, although controlled to maximum or minimum speed.
Check the function of the deaeration pump (CP1).
Solution Check the connection between deaeration pump and Brushless motor PCB.
Disassemble and reassemble the deaeration pump.
Deaeration pump ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; ±30rpm
Remarks SERVICE MODE - 13. Confirming operation
- 13.3 Deaeration/booster pump act. check

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9. Troubleshooting

TFD184 CP1 overload alarm


The deaeration pump has been overloaded.
Cause
The alarm occurs when over current is detected.
Check the function of the deaeration pump (CP1).
Solution Check the connection between deaeration pump and Brushless motor PCB.
Disassemble and reassemble the deaeration pump.
Deaeration pump ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; 2.6V
Remarks SERVICE MODE - 13. Confirming operation
- 13.3 Deaeration/booster pump act. check

TFD185 CP1 lock alarm


The deaeration pump is locked.
Cause
The alarm occurs when no revolution is detected.
Check the function of the deaeration pump (CP1).
Solution Check the connection between deaeration pump and Brushless motor PCB.
Disassemble and reassemble the deaeration pump.
Deaeration pump ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
SERVICE MODE - 13. Confirming operation
Remarks
- 13.3 Deaeration/booster pump act. check

TFD191 CP2 revolution alarm (Upper)


TFD192 CP2 revolution alarm (Lower)
The flow rate of the booster pump has exceeded the alarm limit.
Cause Revolution monitoring by hall element begins 60 seconds after the pump
is started or the rate is changed.
Check the function of the booster pump (CP2).
Solution Check the connection between booster pump and Brushless motor PCB.
Disassemble and reassemble the booster pump.
Booster pump (CP2) ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; ±20% of desired rate
Remarks SERVICE MODE - 13. Confirming operation
- 13.3 Deaeration/booster pump act. check

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9. Troubleshooting

TFD193 CP2 control abnormal alarm


The booster pump is not controlled.
Cause The alarm occurs when the booster pump cannot be controlled at desired
rate, although controlled to maximum or minimum speed.
Check the function of the booster pump (CP2).
Solution Check the connection between booster pump and Brushless motor PCB.
Disassemble and reassemble the booster pump.
Booster pump (CP2) ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; ±30rpm
Remarks SERVICE MODE - 13. Confirming operation
- 13.3 Deaeration/booster pump act. check

TFD194 CP2 overload alarm


The booster pump has been overloaded.
Cause
The alarm occurs when over current is detected.
Check the function of the booster pump (CP2).
Solution Check the connection between booster pump and Brushless motor PCB.
Disassemble and reassemble the booster pump.
Booster pump (CP2) ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
Alarm limit ; 2.6V
Remarks SERVICE MODE - 13. Confirming operation
- 13.3 Deaeration/booster pump act. check

TFD195 CP2 lock alarm


The booster pump has been locked.
Cause
The alarm occurs when no revolution is detected.
Check the function of the booster pump (CP2).
Solution Check the connection between booster pump and Brushless motor PCB.
Disassemble and reassemble the booster pump.
Booster pump (CP2) ; e.g. Motor, Mechanical seal
Items to check MAIN PCB
Brushless motor PCB
SERVICE MODE - 13. Confirming operation
Remarks
- 13.3 Deaeration/booster pump act. check

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9. Troubleshooting

TFD201 Heater cut relay test failed


Heater cut relay test failed during DM37 to DM39
Cause P-CPU was not able to stop the heater with heater cut relay. The function
of the heater cut relay is cut power to the heater to prevent overheating.
Check the connection of the heater and the power unit.
Solution
Adjust the amplitude circuit.
Thermistor (TH1, TH2)
Heater
Items to check Thermostat
Power unit
MAIN PCB
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

TFD202 BLD (G) was contaminated


TFD203 BLD (R) was contaminated
Blood leak detector test failed.
Cause
Contamination of the blood leak detector with optical decay is detected.
Check the voltage of the blood leak detector.
Check that there is no air in the blood leak detector.
Solution
Check the connection between the blood leak and MAIN PCB.
Disassemble and reassemble the blood leak detector.
Items to check Blood leak detector (BLD)
SERVICE MODE - 9. Blood leak detector adjustment
Remarks
- 9.1 Blood leak rece. light volt. adj.

TFD204 BLD test failed


Blood leak detector test failed.
Cause
The alarm function of the blood leak detector is checked with 85% light.
Check the voltage of the blood leak detector.
Check that there is no air in the blood leak detector.
Solution
Check the connection between the blood leak and MAIN PCB.
Disassemble and reassemble the blood leak detector.
Items to check Blood leak detector (BLD)
SERVICE MODE - 9. Blood leak detector adjustment
Remarks - 9.1 Blood leak rece. light volt. adj.
- 9.2 Blood leak test alarm point

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9. Troubleshooting

TFD205 PT2,PT3 test failed


Dialysate pressure transducer test failed during DM2 to DM3.
Cause The dialysate pressure transducer (PT2, PT3) is checked with high and
low pressure comparison.
Check the function of the solenoid valve.
Check the function of the booster pump.
Solution
Check the connection of the drain tube.
Check the dialysate pressure transducers.
Solenoid valve (SV2, SV4, SV5, SV6, SV7, SV8)
Items to check Booster pump (CP2)
Dialysate pressure transducer (PT2, PT3)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD206 Bypass SV relay test failed


Bypass SV relay test failed during DM8 to DM9.
Cause P-CPU was not able to open Bypass SV. The function of bypass SV relay
is checked with pressure comparison.
Check the function of the solenoid valve.
Check the function of the booster pump.
Solution
Check the connection of the drain tube.
Check the dialysate pressure transducers.
Solenoid valve (SV2, SV4, SV5, SV6, SV7, SV8)
Booster pump (CP2)
Items to check
Dialysate pressure transducer (PT2, PT3)
MAIN PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD207 Hydraulic circuit leak test (- pressure) failed


Piping leak test (negative) failed during DM10 to DM12
Cause
Closed loop circuit is checked for leaks with negative pressure.
Check for hydraulic leaks.
Check the function of the solenoid valve.
Solution
Check the function of the booster pump.
Check the dialysate pressure transducers.
Solenoid valve (SV4, SV5, SV6, SV7, SV8)
Booster pump (CP2)
Items to check
Gas separator chamber 2 (GC2)
Dialysate pressure transducer (PT3)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

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9. Troubleshooting

TFD208 PT1 test failed


Water inlet pressure transducer (PT1) test failed during DM13 to DM15.
Cause
PT1 is checked with measuring high and low pressure.
Check the function of the solenoid valve.
Check the water inlet pressure.
Solution
Check the connection of the drain tube.
Check the water inlet pressure transducer.
Solenoid valve (SV1, SV2, SV3, SV7, SV8)
Items to check
Water inlet pressure transducer (PT1)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD209 HEX leak test failed


Heat exchanger leak test failed during DM13 to DM15.
Cause
The heat exchanger is checked for leaks with pressure comparison.
Check for leaks in the heat exchanger.
Solution Check the function of the solenoid valve.
Check the dialysate pressure transducer (PT3).
Heat exchanger (HEX)
Items to check Solenoid valve (SV1, SV2, SV3, SV7, SV8)
Dialysate pressure transducer (PT3)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD210 UF pump test failed


UF pump test failed during DM21 to DM22
Cause
UF pump performance is checked with negative pressure.
Check the function of the UF pump.
Solution Check the function of the solenoid valve.
Check for hydraulic leaks.
UF pump
Items to check Solenoid valve (SV4, SV5, SV6, SV7, SV8)
Dialysate filter
SERVICE MODE - 6.Pump (UFP/DP) adjustment
Remarks
- 6.1 UF pump discharge volume setting

TFD211 Temp. abnormal (balance test)


Balance test failed during DM40 to DM42
Cause
Dialysate temperature is monitored during balance test.
Solution Adjust the amplitude circuit.
Items to check Thermistor (TH3, TH4)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

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9. Troubleshooting

TFD212 Balance test (-) failed


TFD213 Balance test (+) failed
Balance test failed during DM40 to DM42
Cause
The balance of the duplex pump is checked with pressure comparison.
Check the function of the duplex pump
Check the back pressure of the duplex pump (H1, H2).
Check the water inlet pressure (PT1).
Solution
Check the relief pressure (L).
Check the adjusted value of dialysate pressure transducer.
Disassemble and reassemble the duplex pump.
Duplex pump
Back pressure valve (H1,H2), Relief valve (L)
Items to check
Pressure reduction valve (PRV)
Dialysate pressure transducer (PT3)
Balance check
SERVICE MODE - 5. Reducing valve/back press. valve/relief valve
Remarks - 5.1 Reducing valve adjustment
- 5.2 Back press. valve (H1,H2) adj.
- 5.3 Relief valve (L) adjustment

TFD214 Dialysate filter leak test failed


Dialysate filter leak test failed during DM26 to DM36
Cause
Dialysate filter is checked for leaks with negative pressure.
Replace the dialysate filter.
Solution
Check for hydraulic leaks; e.g. Sampling valve, Particle filter
Dialysate filter
Items to check Booster pump
Solenoid valve
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD215 LVS test failed


Cause Float switch test failed during DM10 to DM12.
Check the function of the float switch
Solution
Check for leaks in gas separator chamber 2.
Items to check Gas separator chamber 2 (GC2)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

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9. Troubleshooting

TFD216 SV41 test failed


Cause SV41 test failed during DM26 to DM36
Check the function of Solenoid valve (SV41).
Check the function of check valve (CV41).
Solution Check if the hydrophobic filter is clogged.
Check for hydraulic leaks.
Replace the dialysate filter.
Solenoid valve (SV41)
Check valve (CV41)
Items to check
Hydrophobic filter (FL41, FL42)
Dialysate filter
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD217 UF pump relay test failed


UF pump relay test failed during DM23 to DM24
Cause P-CPU was not able to stop UF. The function of UF pump relay is
checked by pressure comparison.
Check the connection of the drain tube.
Solution
Check the dialysate pressure transducer (PT3).
UF pump
Items to check MAIN PCB
Dialysate pressure transducer (PT3)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD220 SV5 test failed


SV5 test failed during DM4 to DM5
Cause
The function of SV5 is checked with pressure comparison
Solution Check the solenoid valve (SV2, SV4, SV5, SV6, SV7, SV8).
Items to check Solenoid valve
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD221 SV4, 6 test failed


SV4,6 test failed during DM6 to DM7
Cause
The function of SV4 and SV6 is checked with pressure comparison
Solution Check the solenoid valve (SV2, SV4, SV5, SV6, SV7, SV8).
Items to check Solenoid valve
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

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9. Troubleshooting

TFD222 Hydraulic circuit leak test (+ pressure) failed


Piping leak test failed during DM16 to DM19
Cause
Closed loop circuit is checked for leaks with positive pressure.
Check for hydraulic leaks.
Check the function of the solenoid valve.
Solution
Check the dialysate pressure transducers.
Check the water inlet pressure
Solenoid valve (SV1, SV2, SV3, SV4, SV5, SV6, SV7, SV8)
Pressure reduction valve (PRV)
Items to check
Gas separator chamber 2 (GC2)
Dialysate pressure transducer (PT3)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD223 SV4 leak test failed


TFD224 SV5 leak test failed
TFD225 SV6 leak test failed
TFD226 SV7 leak test failed
TFD227 SV8 leak test failed
Solenoid valve leak test failed during DM43 DM50
Cause
The function of each solenoid valve is checked with conductivity.
Check the function of the solenoid valve.
Check the connection between each solenoid valve and MAIN PCB.
Solution
Check the connection of each electrode which monitors opening and closing.
Disassemble and reassemble the solenoid valve.
Solenoid valve ; e.g. Valve, electrode, cable
Items to check
MAIN PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD251 TH1, TH2 compare test (lower point) failed


TFD252 TH3, TH4 compare test (lower point) failed
TFD257 TH5, TH6 compare test (lower point) failed
Thermistor compare test failed during DM1
Cause Thermistor is checked with temperature comparison at less than 35°C
(95°F)
Check the thermistor.
Solution
Adjust the amplitude circuit
Items to check Thermistor (TH1, TH2, TH3, TH4, TH5, TH6)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

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9. Troubleshooting

TFD253 TH1, TH2 compare test (middle point) failed


TFD254 TH3, TH4 compare test (middle point) failed
TFD258 TH5, TH6 compare test (middle point) failed
Thermistor compare test failed during DM43
Cause Thermistor is checked with temperature comparison at approx.36°C
(96.8°F)
Check the thermistor.
Solution
Adjust the amplitude circuit
Items to check Thermistor (TH1, TH2, TH3, TH4, TH5, TH6)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

TFD255 TH1, TH2 compare test (upper point) failed


TFD256 TH3, TH4 compare test (upper point) failed
TFD259 TH5, TH6 compare test (upper point) failed
Thermistor compare test failed during heat disinfection.
Cause Thermistor is checked with temperature comparison at more
than.80°C(176°F)
Check the thermistor.
Solution
Adjust the amplitude circuit
Items to check Thermistor (TH1, TH2, TH3, TH4, TH5, TH6)
SERVICE MODE - 2. Amplitude circuit ZERO SPAN
- 2.1 Amplitude circuit ZERO adj. (L)
Remarks - 2.2 Amplitude circuit SPAN adj. (L)
- 2.3 Amplitude circuit ZERO adj. (H)
- 2.4 Amplitude circuit SPAN adj. (H)

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9. Troubleshooting

TFD300 SV4 leak alarm (small leak)


TFD301 SV5 leak alarm (small leak)
TFD302 SV6 leak alarm (small leak)
TFD303 SV7 leak alarm (small leak)
TFD304 SV8 leak alarm (small leak)
The solenoid valve leaked during treatment
Cause
The function of each solenoid valve is checked with conductivity.
Check the function of the solenoid valve.
Solution Check the connection of each electrode which monitors opening and closing.
Disassemble and reassemble the solenoid valve.
Solenoid valve ; e.g. Valve, electrode, cable
Items to check
MAIN PCB
Alarm limit ; 0.4V
Remarks
SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD308 SV4 Not open alarm


TFD309 SV5 Not open alarm
TFD310 SV6 Not open alarm
TFD311 SV7 Not open alarm
TFD312 SV8 Not open alarm
The solenoid valve did not open although it was signaled to open.
Cause
The function of each solenoid valve is checked with conductivity.
Check the function of the solenoid valve.
Check the connection between the solenoid valve and MAIN PCB.
Solution
Check the connection of each electrode which monitors opening and closing.
Disassemble and reassemble the solenoid valve.
Solenoid valve ; e.g. Valve, electrode, cable
Items to check
MAIN PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD314 SV63, 64 Not Open alarm


The solenoid valve did not open although it was signaled to open.
Cause
The function of SV63 and SV64 is checked with temperature (TH11).
Check the function of the solenoid valve.
Check the connection between the solenoid valve and MAIN PCB.
Solution Check the connection between TH11 and MAIN PCB
Check if the flow restrictor (SL3) is not clogged.
Disassemble and reassemble the solenoid valve.
Solenoid valve (SV63, SV64)
Thermistor (TH11)
Items to check
MAIN PCB
Flow restrictor (SL3)
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

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9. Troubleshooting

TFD320 SV4 leak alarm (large leak)


TFD321 SV5 leak alarm (large leak)
TFD322 SV6 leak alarm (large leak)
TFD323 SV7 leak alarm (large leak)
TFD324 SV8 leak alarm (large leak)
The solenoid valve leaked during treatment
Cause
The function of each solenoid valve is checked with conductivity.
Check the function of the solenoid valve.
Check the connection between the solenoid valve and MAIN PCB.
Solution
Check the connection of each electrode which monitors opening and closing.
Disassemble and reassemble the solenoid valve.
Solenoid valve ; e.g. Valve, electrode, cable
Items to check
MAIN PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

How to reset SV leak alarm (large leak)


Touch the [MUTE] key to stop the alarm sound.
Touch the Test reset key in the Keys screen with TK password.

TFD330 SV alarm (CCS A1:Not open or air)


TFD334 SV alarm (CCS A2:Not open or air)
The solenoid valve did not open although it was signaled to open.
Cause
The function of each solenoid valve is checked with conductivity.
Check the concentrate conductivity which has to be connected to CCS port.
Check the function of the solenoid valve.
Solution Check the connection between the solenoid valve and MAIN PCB.
Check the connection of each electrode which monitors opening and closing.
Disassemble and reassemble the solenoid valve.
Solenoid valve ; e.g. Valve, electrode, cable
Items to check
MAIN PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

TFD331 SV leak alarm (CCS A1: Protection)


TFD332 SV66 leak alarm (CCS A1)
TFD333 SV67 leak alarm (CCS A1)
TFD335 SV leak alarm (CCS A2:Protection)
TFD336 SV68 leak alarm (CCS A2)
TFD337 SV69 leak alarm (CCS A2)
The solenoid valve leaked.
Cause
The function of each solenoid valve is checked with conductivity.
Check the concentrate conductivity which has to be connected to CCS port.
Check the function of the solenoid valve.
Solution Check the connection between the solenoid valve and MAIN PCB.
Check the connection of each electrode which monitors opening and closing.
Disassemble and reassemble the solenoid valve.
Solenoid valve ; e.g. Valve, electrode, cable
Items to check
MAIN PCB
Remarks SERVICE MODE - 13.Confirming operation - 13.1 Hydrocircuit act. check

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9. Troubleshooting

9.2.5. TFE Messages

How to reset TFE alarms


1. Touch the [OFF] key and wait for 3 seconds.
2. Touch the [ON] key to reboot DBB-06.

TFE101 Screen failure


The monitor was abnormal.
Cause The alarm occurs when the monitor is touched continuously for 3
minutes.
Check if something is attached to the monitor.
Solution
Check the connection between monitor and LCD connection PCB.
Monitor ; e.g. Touch key
Items to check LCD connection PCB
MAIN PCB
Remarks

TFE102 Pump key failure


The [PUMP] key was abnormal.
Cause The alarm occurs when the [PUMP] key is touched continuously for 3
minutes.
Check if something is attached to the [PUMP] key.
Solution Check the connection between the Label (monitor switch) and the LCD
connection PCB.
Label (monitor switch)
Items to check LCD connection PCB
MAIN PCB
Remarks [PUMP] key is on the Label (monitor switch)

TFE104 Mute key failure


The [MUTE] key was abnormal.
Cause The alarm occurs when the [MUTE] key is touched continuously for 3
minutes.
Check if something is attached to the [MUTE] key.
Solution Check the connection between the Label (monitor switch) and the LCD
connection PCB.
Label (monitor switch)
Items to check LCD connection PCB
MAIN PCB
Remarks [MUTE] key is on the Label (monitor switch)

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9. Troubleshooting

TFE201 Battery not connected


Cause Battery was not connected to the power unit.
Solution Check the connection between the battery and the power unit.
Battery
Items to check
Power unit
MONITOR - DATA VIEW - Bat. Volt. AD60 (C-CPU)
Remarks
MONITOR - DATA VIEW - Bat. Volt. AD60 (P-CPU)

TFE202 Battery voltage too low


Cause Low battery voltage was detected during BM test.
Check the connection between the battery and the power unit.
Solution
The battery requires 48 hours to be fully charged.
Battery
Items to check
Power unit
Alarm limit ; 21.0V
Remarks MONITOR - DATA VIEW - Bat. Volt. AD60 (C-CPU)
MONITOR - DATA VIEW - Bat. Volt. AD60 (P-CPU)

DBB-06 Technical Manual No.954en-R4


DBB-06 Electronic Manual Technical Manual 954en-R4 9-37
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9. Troubleshooting

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954en-R4 Technical Manual No.954en-R4
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Appendix A Required tools

Appendix A Required tools


Required tools

The tool marked with X on Order number table is not available from NIKKISO CO., LTD.
Please purchase at the market.
Minimum order of the silicon tube is 10 meters.

Tool name Order number Remarks Picture

DBB-06
Amplifier adjustment tool X71-234Z00 Serial number :until
71050

DBB-06
Amplifier adjustment tool X71-294Z00 Serial number :from
71051

PT adjustment tool
S99-156A00
Manometer
T14-098A00
T-connector
Silicon tube H06-001A07
ID2.5mm

Syringe R07-020A20 20cc or more

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Appendix A Required tools

Pressure meter
G04-114A00
Pressure meter Rc1/4

T14-060B02
T-pipe R1/4 x R1/4 x Rc 1/4

H02-303A02
Tube connector R1/4 x ID2.5mm

H02-071A01
Tube connector Rc1/4 x ID5.0mm

H06-001A10
Silicon tube ID5.0mm

Silicon tube H06-001A07 ID2.5mm

Attached
BP adjustment tool T09-065A00
1pc. / DBB-06

Do not use similar


product which is not
High vacuum grease QSHM-004 tested and approved
by NIKKISO CO.,
LTD..

Mechanical seal tool S99-437A00

SV replacement tool T09-169B00

BVM adjustment tool


X07-970W00
(resin type)

Hemostat X

Open-ended spanner X 7mm

Hex wrench X

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Appendix A Required tools

Timer X

Soldering iron X

Solder X

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Appendix A Required tools

Wire stripper X

Open syringe

Syringe R07-020A20 20cc or more

Silicon tube H06-001A07 ID2.5mm

100cc (Minimum
Graduated cylinder scale value is 0.7ml
or less) or
or X

Scale in grams Minimum scale value


is 0.1g or less.

Bucket X

Measurement
accuracy:
± 0.1mS/cm, ± 0.8ºC
X
Conductivity meter (± 1.44 ºF)
e.g. Cond 340i
Temperature meter Measurement range:
(WTW)
2.0 – 20.0 mS/cm,
34 - 40 ºC
(93.2-104 ºF)

5.5mm
Hex box driver X
7.0mm

PH1
Phillips screw driver (+) X
PH2

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954en-R4 Technical Manual No.954en-R4
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Appendix A Required tools

Flathead screw driver (-) X 1.2 x 7mm

Jeweler's screwdriver X 0.4mm x 2.3mm

Extension tube
H06-001A10 ID5.0mm
Silicone tube
Electrical measurement X
tool e.g.
Gossen metrawatt
Bender
SECULIFE ST
Patient current
measurement tool
Bypass coupling T09-177A00
Screw (M4-8) QC5MA1-4008ST
Cable X20-506W03

Serial cross cable X20-204W30

USB to serial converter C16-080A00

Needle-nose pliers X

Nipper X

Clinic blood line


Blood line Arterial, venous line
set

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Appendix A Required tools

Blood line for BM test


Cut the red line.

Recommended tools
Tool name Order number Remarks Picture

Air detector clearance


X07-205Z00
adjustment tool

ESD wrist band X

ESD bench mat X

Molex tool T09-093A00

Digital voltage multimeter X


Possible to measure
e.g.
until 0.01V
fluke typ 79 III
SECULIFE ST

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Appendix B Flow diagram

■■ ■ ■ ■ ■
(optional)
Back pressure valve C1 Back pressure valve C2 [Dialysate filter]
(Concentrate pump 1) (Concentrate pump 2)

(optional) Concentrate pump1 Concentrate pump2


[Bicarbonate powder (Bicarbonate/acetate) (Acid)
cartridge holder]
Filter (acid)

Filter
(Bicarbonate/acetate)
(optional)
[Central supply]

Max 0.5kPa Duplex pump


inlet pressure

■ ■

DDM ■ ■ ■ ■ ■

Electrode 2
(Duplex pump)
■ ■■

■ ■

Same block parts


optional
Treated water
Bicarbonate solution
Dialysate
Spent dialysate

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Appendix B Flow diagram

DBB-06 Technical Manual No. 954en-R4

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Appendix C Required action after replacement

Amplitude circuit adjustment

Back pressure valve (H1,H2)

Arterial pressure transducer

Air detector action (Venous)

BPM (Pressure check test)


Blood leak test alarm limit
Blood leak received light

BV-Receive light voltage


Pressure reducing valve

UF pump stroke volume

Conductivity calibration

Venous pressure / level

(Adjustment of the gap)


Conductivity indication

Temperature indication

adjustment transducer

Dialyzer inlet pressure


Pressure transducer 2

Pressure transducer 3

Pressure transducer 1

Blood/Saline detector

SW condition check
Clamp action check

Blood pump action

BPM (Air leak test)


DM-test & Conductivity adjustment

DDM calibration
Relief valve (L)

Balance test

transducer
Setting and adjustment check

voltage

voltage
setting
Name

(PRV)
Micro computer test

Electrical safety test


Function check
Leakage check

Dialyzer filling
BM-test
No. Parts no. Parts name Remarks Quantity

Service-mode No.

2.1/2.2/2.3/2.4

7.1/7.2/7.3

11.1/11.2

11.3/11.4

11.5/11.6

20.1/20.2
3.1/3.2

3.3/3.4

3.5/3.6

13.5.1
11.9

13.2

13.7

13.9

19.1

19.2

22.1
5.1

5.2

5.3

6.1
5.3

7.4

9.1

9.2
8
P.C.B.
1 X71-089Z00 Data memory P.C.B. 1 V V V V

2 X71-093Z00 Brushless motor P.C.B. BP, DP, CP 1, CP 2 1 V V V


Arterial pressure detector (PT11,12) 2 V C
3 X71-118Z00 Pressure sensor P.C.B Venous pressure level adjustment detector (PT15,16) 2 V C
Dialyzer inlet pressure detector (PT13) 1 V C
4 X71-226Z00 Connector plate P.C.B. It is Battery switch function. 1 V V
5 X71-227Z00 Distribution P.C.B 1 V V
6 X71-225Z00 Main P.C.B. 1 V V V V C C C C V V C C C C C C V C C
7 B17-058A01 Battery For microcomputer P.C.B. 1 V V V V

8 X71-109Z00 Air detector P.C.B Venous air detector 1 C


9 X71-020Z00 Main memory P.C.B. (MMC) Program and Language 1 V V V V

10 X71-087Z00 BV P.C.B BVM (optional) 1 V C


11 C16-091B01 Controller Net work 1 V

LCD screen section

12 X71-283Z00 LCD connection P.C.B. 1 V

13 P11-209B00 Power unit inverter 1 V

14 S08-437B00 Switch Touch panel 1 V

Optional

15 C16-085A00 Controller Blood pressure monitor 1 V V V


16 X07-613W00 Module assembly BVM module 1 C
17 X06-284W02 Bicabonate powder cartridge holder 1 V V V

18 X07-648W01 Module assembly DDM module 1 C C

Power Unit / battery / heater

P11-237B02 NT-15S 115V


19 Power unit 1 V V V
P11-237B03 NT-15S 230V

20 B17-073B01 Battery HHR-21H20G1 1 V V

H05-051B01 AC230V 500W+1000W


21 Heater element 1 V V
H05-048B02 AC115V 1000W

Hydraulic part / others

22 X06-064W02 Gas separator chamber 2 1 V V

23 X06-063W00 Gas separator chamber 1 1 V V

24 X06-057W02 Relief valve(L) 1 V V C V


25 X06-057W01 Back pressure valve(H1 or H2) 2 V V C V
26 X05-858W00 Blood leak detector 1 V V C V
27 X06-865W00 Deaeration pump or Booster pump 2 V V

28 X06-784W00 Duplex pump 1 V V V


29 X07-724Z01 Arterial Blood pump 1 V C
30 X06-740W02 Heat exchanger 1 V V

31 V01-262B00 Valve Disinfection valves 1 V V V

32 X06-706W00 UF pump 1 V V C
33 X06-712W00 Mixing chamber(A or B) 2 V V

34 X06-302Z00 Conductivity cell 4 V V C C


35 X06-707W00 Concentrate pump(A or B) 2 V V

36 X06-617W00 Pressure reducing valve 1 V V C


37 X06-708W00 Concentrate back pressure valve (A or B) 2 V V

Water supply pressure 1 V V C


38 T17-038B01 Transducer Dialysate 1 pressure 1 V V C
Dialysate 2 pressure 1 V V C
39 X07-440W01 Arterial clamp 1 V V
40 X07-209W05 Air detector Venous clamp,Venous air detector,Blood/saline detector 1 V C V C
41 X07-557Z00 HP Heparin pump 1 V

42 X06-799W00 Level adjustment pump 1 V V

43 X05-866W00 Check valve Bicabonate powder cartridge holder section 1 V V V

44 X06-697W00 Check valve Air suction port 1 V V

L02-268A01 Red 1

L02-268A02 Yellow 1
45 LED unit V
L02-268A03 Green 1
L02-268A04 Blue 1
T02-031B00 TH1,2
46 Thermistor 7 V
T02-021B01 TH3,4,5,6,11
47 F05-061A05 Fan 1 V

SV1,2,3,4,5,6,7,8,63,64
48 V01-267B00 Solenoid valve kit 10(18) V
SV61,62,65,66,67,68,69,70(optional)

V:Verify C:Calibrate
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Appendix C Required action after replacement

DBB-06 Technical Manual No. 954en-R5

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Appendix D Circuit diagram

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ELECTRICAL SCHEMATIC (GENERAL, 1/8)

DBB-06 Technical Manual No.954en-R4 D-1


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-2


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-3


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-4


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-5


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-6


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-7


Appendix D Circuit diagram

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DBB-06 Technical Manual No.954en-R4 D-8

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