DBB-06 - Technical Manual - ENG - 954en-R4
DBB-06 - Technical Manual - ENG - 954en-R4
954en-R4
Technical Manual
DBB-06
2016-05
Issuance
NIKKISO CO., LTD.
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.
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
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.
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
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.
A,Art : Arterial
AC : Alternating current
BP : Blood pump
BV : Blood volume
CL : Conductivity cell
CV : Check valve
DC : Direct current
DH : Dialysate heater
DI : Dialyzer inlet
DP : Duplex pump
FL : Filter
FR : Flow restrictor
HD : Hemodialysis
L : Relief valve L
MC : Mixing chamber
PC : Personal computer
PT : Pressure transducer
Rx : Prescription
SV : Solenoid valve
TH : Thermistor
THS : Thermostat
Tx. : Treatment
UF : Ultrafiltration
V,Ven : Venous
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.
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.
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)
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)
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.
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)
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.)
1.2.3. Symbols
Date of manufacture
SN
Serial number
Alternating current
Network outlet
Water supply
Drain
RS-232 interface
1.3. Introduction
1.3.1. Indication for Use
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.
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.
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.
Please ensure that the automatic start-up test has been completed before beginning the
treatment.
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.
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.
Inverter
[P11-209B00]
Speaker
LCD connection
PCB
[X71-283Z00]
Auto response
sensor
Distrbution DC PowerPCB
[X71-263Z00]
Battery
[B17-073B01]
Power unit
LAP BP
PT15
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
Ground L N Ground L N
Power Heater1
Fig. 1.5
2
4 3 2
16 9 20 11
8 1 10 2 1 1
1
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.
Back pressure
valve 1(H1)
PT3
TPT4
TPT3
SV42
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
TPT6
H-C2
SV4 SV7
TH4
SV41
(optional)
TH3
SV66 (optional)
SV68 (optional)
SV65 (optional)
TH2
TH1
THS
SV21,SV22
DH
HEX
SV61 (optional)
SV70 (optional)
SV62 (optional)
SV42 (optional)
FL41 (optional)
GC1
PRV
Water supply
tube connector
Drain tube
connector
SV1 SV3 TPT1 PT1
In this section additional keys which are only displayed with the password are
described. (See Operator’s manual Sec. 1.7.1)
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.
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)
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)
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
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.
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)
Dimensions
Weight
Class I equipment
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
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
Current
Operating current
Battery
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
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
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.
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.
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.
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.
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.
Operating conditions
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.
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 settings marked with an asterisk (*) in this section can be changed.
See Chapter 6 for information regarding setting the limits.
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
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
UFK
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%
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 45.0C (50 to 113 °F
Measurement accuracy: Measurement value 0.8C (±1.4 °F)
Flow rate of dialysate: 500 mL/min at a constant ambient
temperature
Fixed alarm limit: Upper limit: 41C
Auto alarm limit: Upper limit: Set value 1C* (+1.8 °F)
Lower limit: Set value 1C* (-1.8 °F)
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.
Definition
Pd PBi PBo
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
0.075
Qr Qba 1 Ap
100
HP
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.*
ta
Qm Qba Equation 1
Ct
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
Audible alarm
Loudness: 71.4 dB (Factory default)
Measurement range:
Alarm limits:
1.6.11. Blood volume monitor (BVM) (optional) (See Operator’s manual Chapter 11.)
1.6.12. Dialysis Dose Monitor (DDM) (optional) (See Operator’s manual Chapter 12.)
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)
Titanium
Polytetrafluoroethylene (PTFE)
Polyethersulfone (PES)
2. Hydraulic circuit
2.1. Block diagram
Fig. 2.1
Water supply Water drain
Heating system
Flushing
Deaeration system
Mixing system
UFC
system
Duplex pump UF pump
Bypass system
Dialyzer
Boost 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.
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.
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.
TH6
Qw+Qb
CL4
CL2
TH5
CL1 CL3
From deaeration system
Qw
MC1
MC2
H-C1
H-C2
Qb
Qa
SPB SPA
Control Protection
Electric 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.
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.
To inlet of CP1
Concentrate connector
TH11 SV63
Rinse port
FR3
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.
SV61
Atmosphere
FL44
SV42
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.
CCS A1 port
MC2
SV66 SV67
SV68 SV69
MC1
SV65
SPB
Bicarbonate cartridge
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.
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.
Fig. 2.10
Qd
DP
Qb-Qx
Qb-Qx
UFP
UFP
Qd
DP
Dialyzer Qd
Qx
Qb
Qb
Qd+Qx
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.
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.
Dialyzer coupling
Fig. 2.12
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.
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.
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.
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.
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
Control Protection
Maintenance Control Protection maintenance
communication serial I/O serial I/O communication
interface interface
Buzzer
Actuator power
Actuator Control
desital analog
converter
Control
stepping motor
controller
Control Protection
Control sensor analog digital analog digital Protection sensor
converter converter
Optional
Fig. 3.2
NIBP
Protection
sensor
P. CPU
Indicator
Protection
actuator
Alarm output
Maintenance
communication
Control
sensor
Computer
communication
C. CPU
Control
actuator
DDM P.CPU DDM C.CPU
Description Optional
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
Fig. 3.3
C.CPU
3PRAM
P.CPU C.CPU
counter counter
P.CPU
Fig. 3.4
Battery 24VDC
Power suply KA KG
35VDC
5VDC
Buzzer 12VDC
AC/DC unit
KB
DC/DC unit
24VDC
Manual
5V DOWN signal
SW 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
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.
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.
Fig. 3.5
KA
Power supply
AC/DC unit
KB
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
Fig. 3.6
AC/DC unit
KA 35VDC
Power supply
AC/DC
converter 24VDC
KB
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.
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.
Fig. 3.7
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)
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
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
+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:
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.
Fig. 3.9
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
+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:
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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4. Installation
4. 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.
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 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.
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.
4.3. Installation
4.3.1. Connections
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.
1. Connect the water supply connector to the water supply 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)
4.3.2. Installation
4. Touch the FUNCTION key, and then touch the CLEANING key.
(See Operator’s manual Sec. 1.7.1)
The cleaning screen is displayed.
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.
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.
9. Perform the adjustment, setting and safety inspection by following installation check list (See
Sec 4.4).
Option
Operating place: CCS
Operator: A clamp
Network
Connected devices: No / Yes: Running time meter
Other plugs
Plug type:
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. 37C (0,5C; 1,5C) - /
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
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. - - /
5. Maintenance
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.
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).
2. O-ring (P-10A)
1. Filter 3000h
3000h
5. O-ring (P-10)
3000h
3. O-ring (P-12.5)
3000h
4. O-ring (P-7)
3000h
6. O-ring (P-16)
3000h
7. Filter 8. Filter
6000h 6000h
9. Mechanical seal
6000h
16. Block
6000h
Fig. K UF pump
Fig. M Back pressure valves, Relief valve Fig. N Back pressure valves
25. Diaphragm
12000h 26. Diaphragm
12000h
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:
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. 37C (0,5C; 1,5C) /
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 /
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.
Fig. 6.1
Setting1 Setting 2
Database Database
Treatment
Database
Patient
Database
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.
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.
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.
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
: Initial UFK abnormal lower limit cannot be set above initial UFK abnormal upper limit.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
6. Screen customize
Fig. 7.2
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
7. Daily Program
Fig. 7.3
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. 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
*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.
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
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.
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.
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.
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.
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
43. Screensaver
Fig. 7.5
Central
monitor
Pressure monitor1
Pressure monitor2
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.
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.
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
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)
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.
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. 7.10
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
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. 7.17
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.
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.
M
These settings are overwritten, when 7.1-2. Conductivity indication adjustment is
performed. R
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.
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
M
Required tool: (See Appendix A)
- Pressure meter R
Adjustment procedure:
H1, H2
Adjustment procedure:
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.
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.
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.
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.
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
connector to
the A-concentrate
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
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.
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%
M
Required tool: (See Appendix A)
- Jeweler's screwdriver(-) R
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
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.
M
Required tools: (See Appendix A)
- Hemostat R
- PT adjustment tool
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.
M
Required tools: (See Appendix A)
- Hemostat R
- PT-adjustment tool
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.
M
Required tool: (See Appendix A)
- Blood line (clinic use) R
- Jeweler's screwdriver(-)
Fig. 7.55
Fig. 7.56
VR3
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
Saline Saline
0.9V
Blood
0V
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.
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.
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.
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.
Fig. 7.65
Close
Hinge
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.
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.
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
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.
Hemostat
Disconnect
water supply
connector
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.
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
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)
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.
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
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.
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.
5 cm
Fig. 7.85
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.
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
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. 7.93
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.
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.
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.
8. Self-tests
8.1. Computer tests
Start
Buzzer test
CPU test
1. Register test
2. Instruction command test
RAM test
ROM test
3PRAM test
Database test
End
Start
BM05 BP start
BM08 BP stop
BM16 BP stop
BM17 BP power on
End
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.
Triggered alarm
TFB202 V clamp open test failed
TFB203 V clamp close test failed
Indicator controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
C. A/D-System P. A/D-System
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.
Indicator controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
24V DC
KBP KBP
BP driver
BP
Outline
BP action is checked.
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)
Triggered alarm
TFB209 A clamp open test failure
TFB210 A clamp close test failure
Indicator controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
C. A/D-System P. A/D-System
Outline
AP transducers (PT11 and PT12) are checked.
Triggered alarm
TFB201 AP transducer compare test failed alarm
Indicator
controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
COMP
K1
1V K1
Outline
Air detector is checked.
Start
DM51 Preparation
End
Step number from Step1 to Step6 shows DM steps when DM test is performed
manually. (See Sec. 1.5.2)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
SV4
KDP
SV5
CP2 P. Relay driver
KDP
KSV
SV6
24VDC
KSV
P. SV driver PT3 PT2
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
P. Pressure circuit
SV1
SV2
SV3
24VDC
PT3 PT1
SV7
Indicator
controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
24VDC
P. Pressure circuit
KUFP
KUFP
UFP driver
PT3
UFP
SV7
24VDC
Indicator
controller
Screen
I. CPU
SV41
SV8
3PRAM
C. CPU P. CPU
KDP
SV4
PT2
SV5
KSV
24VDC
KSV
P. SV driver
SV6
Heater cut relay test (See DM36-37 Heater cut relay test)
Indicator
controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
KH
THS
AC
DH
KH
Indicator
controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
24VDC
UFP driver
P. Thermistor circuit P. Pressure circuit
KUFP
KUFP
TH4
PT3
UFP
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
KBLD
BLD
Outline
BLD received light voltage is checked continuously.
BLD test is performed in DM 44.
Conductivity test
Indicator controller
Screen
I. CPU
3PRAM
C. CPU P. CPU
C. A/D-System P. A/D-System
TH5 TH6
Outline
Conductivity test is performed during the conductivity calibration of the DM test.
Triggered alarm
A: TFD153 CL1, CL2 compare test alarm
B: TFD154 CL3, CL4 compare test alarm
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
Outline
Thermistors are compared at lower temperature.
Thermistors are compared at upper temperature.
Outlet
Transmit
Inlet
Outline
Reduction of the UF pump stroke volume is checked during the 100% conductivity
calibration.
Triggered alarm
TFD127 UF pump discharge down alarm
Outline
The one way valves of the DP are checked for leakage and flow rate by using dialysate
conductivity.
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
Open
Close
Transmitte 監視項
Plunger Transmitte
Open
Close
Outline
The back pressure valves (H1, H2) settings are checked by using the DP conductivity
protection.
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)
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.
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
OUT
Electrodes
IN
Outline
The conductivity of SV4, SV5, SV6, SV7 and SV8 is checked during the treatment.
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
SV66 SV67
VA1C
VA2C
SV68 SV69
Outline
The conductivity of SV66, SV67, SV68 and SV69 is checked when cleaning program is started.
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)
9. Troubleshooting
9.1. General description
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.
9.2.1. Messages A to Z
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
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)
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
F, G
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
Q, R
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
X, Y, Z
An alarm which starts with “TFC” is caused by problems in the computer process.
Initialize DBB-06
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.
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
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
Attached
BP adjustment tool T09-065A00
1pc. / DBB-06
Hemostat X
Hex wrench X
Timer X
Soldering iron X
Solder X
Wire stripper X
Open syringe
100cc (Minimum
Graduated cylinder scale value is 0.7ml
or less) or
or X
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
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
Needle-nose pliers X
Nipper X
Recommended tools
Tool name Order number Remarks Picture
■■ ■ ■ ■ ■
(optional)
Back pressure valve C1 Back pressure valve C2 [Dialysate filter]
(Concentrate pump 1) (Concentrate pump 2)
Filter
(Bicarbonate/acetate)
(optional)
[Central supply]
■ ■
DDM ■ ■ ■ ■ ■
■
Electrode 2
(Duplex pump)
■ ■■
■ ■
Conductivity calibration
Temperature indication
adjustment transducer
Pressure transducer 3
Pressure transducer 1
Blood/Saline detector
SW condition check
Clamp action check
DDM calibration
Relief valve (L)
Balance test
transducer
Setting and adjustment check
voltage
voltage
setting
Name
(PRV)
Micro computer test
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
Optional
32 X06-706W00 UF pump 1 V V C
33 X06-712W00 Mixing chamber(A or B) 2 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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