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Single patient dialysis machine

SURDIAL 55Plus

Instruction Manual
-- Maintenance Manual --

! CAUTION
Read this instruction manual carefully before use.
Improper handling can result in an accident or malfunction.
Use the unit in accordance with this manual.
Keep this manual in a safe place for future reference.

Original Instructions
Intended Use of This Machine
This machine should be used when physicians prescribe hemodialysis to patients with acute or
chronic renal failure.

Contraindications
This machine is not designed, manufactured, or sold for other use than hemodialysis on patients
with acute or chronic renal failure.
Attention should be paid to contraindications valid for extracorporeal treatment in general.

Safety
Equipment classification and handling precautions

This machine is classified as follows:


1 Type of protection from electric shock······Class I
2 Degree of protection from electric shock······Type B
Ensure to have a protective earth connection with the equipped power plug.

Precaution for fluid penetration

Keep the machine out of water.


Protection against water infiltration······Drip-proof equipment IPX1

Precaution for flammable atmospheres

Do no use this machine in flammable atmospheres..

Preface-1
Safety Precautions
Appropriate operation and regular maintenance are essential for safe use of this machine.
Read and understand careful the safety precautions described in this manual before using or servicing
this machine.
The operating procedures and precautions described in this manual are effective only when this
machine is used for its intended purposes. Users shall be liable for all deeds and the safety measures
taken when the machine is used in methods other than specified in this manual.

(1) Degree of damage to health and property, and its indication (Alert symbols and signal words)

The degree of the foreseeable damage to health and property when the machine is misused is
classified into the following three categories, and each category is expressed by the following alert
symbol and signal word.

! DANGER
This indicates an imminently hazardous situation which, if not avoided, will result
in death or serious injury.

! WARNING
It indicates a potentially hazardous which, if not avoided, could result in death or
injury.

! CAUTION
This indicates a potentially hazardous, if not avoided, may result in moderate
injury or damage in property.

(2) Note and its indication

NOTE
Indicates note sentences. Make reference when operating or servicing the
machine.

Due to our constant research and improvement, details of the design of the machine described in
this manual may be slightly different from those of the unit you purchased. If you have any question
about the unit you purchased or contents of this instruction manual, please contact the nearest branch
or agency.

Preface-2
Table of Contents
Intended Use of This Machine

Contraindications

Safety

Safety Precautions

1. Installation Environment································································· 1-1

1.1. Installation environment ·················································································· 1-2


1.2. Workspace required ······················································································· 1-2
1.3. Electric power equipment ················································································ 1-3
1.4. Water supply and drainage requirements ··························································· 1-3

2. Precautions for Maintenance··························································· 2-1

2.1. Precautions before handling ··········································································· 2-2


2.2. Handling the equipment ················································································ 2-2
2.3. Replacement parts ······················································································· 2-2
2.4. Liability for readjustment and repair ································································· 2-2

3. Daily Inspection ············································································· 3-1

3.1 Daily inspection by operator ··········································································· 3-2


3.2 Monthly inspection ······················································································· 3-2
3.3 Maintenance and inspection by Service Technician ············································· 3-2
3.4 Maintenance by Service Technician ································································· 3-2
3.5 Inspection after a long-term storage ································································· 3-2

4. Maintenance and Inspection Instructions ········································· 4-1

4.1. Maintenance and inspection instructions ··························································· 4-2


4.2. Instructions on the maintenance and inspection log············································· 4-3

5. Maintenance and Inspection Log ····················································· 5-1

6. Maintenance and Inspection Manual ················································ 6-1

Table of Contents-1
7. Parts Replacement ········································································· 7-1

7.1 List of parts to be maintained and replaced ······················································· 7-2


7.2 Parts replacement during maintenance····························································· 7-6
7.3 Miscellaneous part ······················································································· 7-46
7.4 Powder Bicarbonate Assy (option) ··································································· 7-48

8. Terminology ·················································································· 8-1

9. Other Adjustments ········································································· 9-1

9.1 Zero compensation of the blood leak detector (BLD-01) ······································· 9-2
9.2 Adjustment of Overload Sensitivity in Heparin Pump Assembly ····························· 9-5
9.3 Adjustment of Concentration and Conductivity ··················································· 9-6
9.4 Blood pump: Switching to the line with a small diameter tube ································ 9-13

Table of Contents-2
1. Installation Environment

1.1. Surrounding environment ················································································ 1-2


1.2. Workspace required ························································································ 1-2
1.3. Electric power equipment················································································ 1-3
1.3.1. For the 230V (AC) unit ·············································································· 1-3
1.3.2. For the 110V (AC) unit ·············································································· 1-3
1.4. Water supply and drainage requirements······················································ 1-3
1.4.1. Water supply pressure ·············································································· 1-3
1.4.2. Water supply flow ······················································································ 1-3
1.4.3. Water supply temperature ········································································· 1-4
1.4.4. Drainage ···································································································· 1-4

1-1
The following conditions are required for the installation environment in order to use this
equipment safely and properly.

1.1. Surrounding environment

Storage and shipping Storage and shipping


During operation
(with internal fluid) (without internal fluid)

Surrounding temperature (°C) 15 to 35 5 to 50 -10 to 50


Surrounding humidity (%) 35 to 80
35 to 85 (non condensing)
(non condensing)
Air pressure (hPa) 795 to 1062

NOTE
 Do not expose this equipment to direct sunlight.

1.2. Workspace required

Prepare a space larger than 5cm, 10cm, and 20cm


above, each side, and back of the equipment,
respectively, with respect to the outside demension.
For ventilation, use a ventilation opening of larger than
φ20cm in diameter or avoid placing an object next to at
least one of the 5 open sides of the equipment.

Outside demension of the equipment

Top 280 mm
W
Wheel part 490 mm

D Wheel part 440 mm

Excluding the infusion stand 1365 mm


H
Including the infusion stand 1930 mm

Figure 1-1 Outside dimensions of


the equipment

1-2
1.3. Electric power equipment

1.3.1. For the 230V (AC) unit

The unit requires an 230 V (AC) ±10%, 50/60 Hz power source for proper operation.
A power outlet of 230 V (AC), 15 A or larger with protective earth is required for the machine.
Be sure to connect the power plug properly.

1.3.2. For the 110V (AC) unit

The unit requires an 110 V (AC) ±10%, 50/60 Hz power source for proper operation.
A power outlet of 110 V (AC), 20 A or larger with protective earth is required for the machine.
Be sure to connect the power plug properly.

! WARNING
 Do not use an AC power plug or adaptor that requires protective earth removal.
 Do not use an adaptor for the equipment plug when connecting to the power outlet.
 For any problem with the electric power equipment, contact an authorized electrician to check
the wiring.

1.4. Water supply and drainage requirements

Check the following to ensure the proper equipment operation.

1.4.1. Water supply pressure

The normal pressure between 0.05 and 0.74 MPa (0.5 to 7.5 kgf/cm2) is required.

1.4.2. Water supply flow

The water supply flow must be 900mL/min or higher.

1-3
1.4.3. Water supply temperature

A range of 14 to 30°C is necessary. (4 to 30°C with the Heat Exchanger option)


The water supply temperature is minimum 5°C lower than the preset temperature of
dialysate.

1.4.4. Drainage

Drainage flow must be 1500 mL/min or higher.


Keep the drainage tube 3 m or shorter.
The maximum height of the drain tube is 60 cm, with free outlet to avoid contamination.

Figure 1-2 Drainage

1-4
2. Precautions for Maintenance

2.1. Precautions before handling ··········································································· 2-2


2.1.1. Service technician ···················································································· 2-2
2.1.2. Well-planned maintenance········································································ 2-2
2.1.3. Clothes ······································································································ 2-2
2.2. Handling the equipment ·················································································· 2-2
2.3. Replacement parts ·························································································· 2-2
2.4. Liability for readjustment and repair ······························································· 2-2

2-1
2.1. Precautions to be taken before handling

! CAUTION
 Do not connect the equipment to a patient during maintenance.

2.1.1. Service technician

Only Service technicians who received a technical training of dialysis machines from Nipro, are
allowed to maintain the machine.
Otherwise, a person who is being supervised by a trained technician , is allowed to maintain the
equipment.

2.1.2. Well-planned maintenance

Use of the equipment without planning maintenance, can decrease work efficiency and cause
injury, accident, and errors. It can also interfere with the original purpose, maintenance.
Schedule the time to maintain the equipment, and prepare necessary tools, parts, testing
equipment, and documents in advance.

2.1.3. Clothes

Try to minimize injury and accident by wearing appropriate clothes to work on the equipment.
Select clothes that do not attract a lot of electrostatics. Avoid exposing skin even if the
surrounding temperature is high.

2.2. Handling the equipment

Work in accordance with the instructions.


Read the attached Instruction Manual carefully.
Transport and handle the equipment in accordance with the Manual.
Be sure to check the electric power line, water supply/drainage line, and other connection lines
before working on the equipment.

2.3. Replacement parts

Use the parts specified by the manufacturer.

2.4. Liability for readjustment and repair

A person who readjusted or repaired is liable for consequential events.

2-2
3. Daily Inspection

3.1 Daily inspection by operator ··········································································· 3-2


3.2 Monthly inspection ··························································································· 3-2
3.3 Maintenance and inspection by service technician······································· 3-2
3.4 Maintenance by service technician ································································ 3-2
3.5 Inspection after a long-term storage ······························································ 3-2

3-1
! CAUTION
 Do not connect the equipment to a patient during maintenance.

3.1. Daily inspection by operator

Check the following items before and after using the equipment on the same day.
Ensure normal operation of the equipment.
Abnormality, such as leakage around the equipment.
Check loosening of clamps for the water supply opening and drainage opening hoses.
(1) There not being residual chemical solution.
(2) Residual quantities of disinfection or acetic acid solution being enough.
(3) Consumption of disinfection or acetic acid solution being reasonable.
(4) The real concentration of dialysate being reasonable.
(5) There not being abnormal sound, a bad smell, over heat.
(6) The filter of the fan not having blocking.
(7) Foreign substance such as disinfectant stain on the equipment exterior.
(8) Dialysate stain on the equipment. A dialysate stain can cause rust. Wipe it off
immediately.
(9) Abnormality when the start-up test is performed.
(10) If the equipment will be in operation overnight, ensure that the coupler is fit firmly on the
coupler holder.
(11) Confirm that the equipment detects the coupler switch signal.
(12) The syringe must be filled with the preset infusing volume.

3.2. Monthly inspection

Clean the air filter of the fan. (See 7.3.1., 7.3.2.)

3.3. Maintenance and inspection by service technician

Check the working hours. Perform a periodical inspection every 5000 hours or every 6 months.
See “5. Maintenance and Inspection Log” for items to be inspected.

3.4. Maintenance by service technician

Check the working hours. The service technician should maintain the hydrauric line and electrical
board every 5000 hours or every 6 months.

3.5. Inspection after long-term storage

Before starting dialysis treatment after more than 1 month of storage, a disinfection and a water
rinse of minimum 1 hour is required.
Also maintain and inspect the equipment in accordance with “4. Maintenance and Inspection
Instructions.”

3-2
4. Maintenance and Inspection Instructions

4.1. Maintenance and inspection instructions ······················································· 4-2


4.2. Instructions on the maintenance and inspection log ····································· 4-3

4-1
! CAUTION
 Do not connect the equipment to a patient during maintenance.

4.1. Maintenance and inspection instructions

The maintenance and inspection log shown in the next chapter is provided to record and keep
the results of maintenance and inspection. The log will help for the future maintenance and
management of the equipment. See “6. Maintenance and Inspection Manual” for the
maintenance and inspection methods. The person who maintains and inspects ( a service
technician or NIPRO personnel ) must record the results in accordance with the instructions
described in 4.2. Make a copy of this form before logging.

4-2
4.2. Instructions on the maintenance and inspection log

(1) When to maintain and inspect


● Items with the “6□” symbol should be inspected every 6 months.
● Items with the “6□+□” symbol should be inspected every 12 months.
(2) Record the model of the equipment.
(3) Record the serial number of the equipment.
(4) Record the duration of the equipment operation.
(5) Record the date when the equipment was installed.
(6) Record the date when the equipment was inspected.
(7) Record the name of the person who inspected.
(8) Enter the results of inspection into the boxes next to the inspection items, using the
following symbols:
Symbol Results of inspection Recording priority
√ No abnormalities found
Required disassembly for

inspection
X Exchanged 1
A Adjusted 2
T Tightened 3
C Cleaned 4
L Lubricated 5
●If two or more maintenance works are performed per item, refer to the above table and use
the symbol with higher priority.
EXAMPLE) When an item is adjusted (A) and cleaned (C), enter “A” into the corresponding
box.
●If inspection of an item requires disassembly, draw a circle around the symbol.
(9) Use the “Observation and Notes” column to write information, such as the part exchanged
during maintenance and inspection, when necessary.

NOTE
● Execute maintenance and inspection, make sure to keep the maintenance record, and store the
record properly.

! CAUTION
● Dialysate and body fluid can cause infection. Never exchange parts before rinsing the hydraulic
lines.

4-3
4-4
5. Maintenance and Inspection Log

5-1
5-2

Maintenance and Inspection: 6-month inspection => 6□ 12-month inspection => 6□+□
Equipment model: Serial No. of the equipment: Duration of equipment operation:
Date of equipment installation: / / Date of inspection: / / Inspector:
Inspector’s signature:
Results of inspection (Inspected: √, Disassembled: ○, Exchanged: X, Adjusted: A, Tightened: T, Cleaned: C, Lubricated: L)

1.Externals, connection tubes, and cables 6.Heparin pump area 9.Other items to inspect
6 Conditions of connection tubes (bending, etc.) 6 Movement of the heparin pump 6 Bending, leakage, staining, etc of tubes
6 Connection to the drain pipe 6 Loosening of the heparin pump pulley 6 Abnormal sound/smell
6 Presence of damage and connection of cables Consistency between displayed and infused volumes (STANDBY, DIALYSIS, RINSING)
6 Conditions of the grounding conductor 6 Presence of air bubbles in the hydraulic line
6 Damage/deformation that interfere with functions 7.Movements of monitoring and indication alarms 6 Leakage from the hydraulic line
6 Conditions of the light indicator 6 Temperature-related alarms 6 Filling flow rate (970 to 1034 mL/min)
(calibration of temperature indication) 6 Filling complete pressure
2
2.Water supply, concentrate feeder, and drainage areas 6 Dialysate concentration alarm 0.098 to 0.108 MPa (1.0 to 1.1 kgf/cm )
6 Conditions of tubes (bending, etc.) (calibration of concentration indication) 6 Dialysate flow rate
6 Movement of the solenoid valve 6 Venous pressure alarm Tightening the terminal block
6 Movement of the reducing valve (calibration of the venous pressure gauge)
6 Check of the degassing part 6 Arterial pressure alarm 10.Powder Bicarbonate Assy (Option)
6 Movement of the AS2 (calibration of the arterial pressure gauge) 6 Movement of the solenoid valve
6 Conditions of rinse ports 6 Dialysate pressure alarm 6 Bending, leakage, staining, etc of tubes
Stain, leakage, or blockage in filters (calibration of the dialysate pressure gauge) 6 Damage/deformation that interfere with functions
6 Blood leak alarm Stain, leakage, or blockage in filters
3.Closed line area (movement of the blood leak detector)
6 Movement of the solenoid valve 6 Tube error alarm
6 Flow meter display (movement of the air bubble detector)
6 Movement and leakage in concentrates/UF pumps 6 Insufficient water supply
6 Movement during gas purge 6 Alarm buzzer
6 Movement and adjustment during BYPASS Blood leak alarm (calibration for blood-leak detection)

4.Disinfectant/acid solution (option) feeder areas 8.Electric tests


6 Movement of the solenoid valve 6 Short circuit breaker operation Observation and Notes
6 Residual disinfectant/acid solution (option) 6 Battery capacity for power failure backup
6 Conditions of the tube (bending, etc.) Leakage current
Conditions of the equipment with grounding
5.Blood pump area
6 Loosening and abnormal sound in the rotating part
Consistency between displayed and actual flow volumes
6. Maintenance and Inspection Manual

6-1
6-2

Inspection item Inspection method Criteria Note

1. Externals, connection tubes, and cables

(1) Conditions of connection tubes. (1) Visual inspection. (1) OK if the equipment functions normally (1) The water supply opening / Drainage
(bending, etc.) opening and dialyzer coupler must
be closed with a metallic band and
binding band, respectively.

(2) Connection to the drain pipe. (2) Visual inspection. (2) OK if the equipment functions normally (2) Length of the drain tube: <3 m
Height at the tip of the drain tube:
<60 cm.
(3) Presence of damage and connection (3) Visual inspection. (3) Must not be damaged
of cables.

(4) Conditions of the grounding conductor. (4) Visual inspection. (4) Must be connected to a 3P outlet

(5) Damage/deformation that interfere with (5) Visual inspection. (5) Must not be damaged/deformed
functions.

(6) Conditions of the light indicator. (6) Visual inspection. (6) Must light / blinking under the following (6) The criteria is applied when the light
conditions indicator movements is preset to “1”.
Red: lights during the alarm emergence
Yellow: blinking during the standby
process
Green: blinking during the rinse process
Blue: blinking when timer comp

2. Water supply, concentrate feeder, and


drainage areas

(1) Conditions of tubes. (Bending, etc.) (1) Visual inspection. (1) OK if the equipment functions normally (1) Exchange the tube with leakage

(2) Movement of the solenoid valve. (2) Check the movement from MAINTE4. (2) Must have the movement sound
Inspection item Inspection method Criteria Note

(3) Movement of the reducing valve. (3) While water is supplied to the equipment, (3) Must be 0.034 to 0.038 MPa (257 to
turn on V1, V4, V10 and (V35) from 287 mmHg)
MAINTE4. Leave them for approx. 30 sec
and turn OFF V4. Measure the pressure
between the reducing valve and V1.

(4) Check of the degassing part. (4) Collect the dialysate from the sample port (4) Must be the PO2 specified
in the standby process.

(5) Movement of the AS2. (5) Visual inspection during the standby (5) Water should not exit from the air side
process.

(6) Conditions of rinse ports. (6) Visual inspection during the rinse process. (6) No fluid leakage

(7) Stain, leakage, or blockage in filters. (7) Visual inspection. (7) Must have no stain, leakage, or
blockage

3. Closed circuit area

(1) Movement of the solenoid valve. (1) Operate the equipment manually from (1) Movement sound must be audible
MAINTE4.

(2) Movement and leakage in (2) Perform UF and inspect visually. (2) Pumps rotate smoothly
concentrates/UF pumps.

(3) Movement during gas purge. (3) Short line the FSW connector during the (3) Dialysate pressure must be 10 to 50
standby process and operate gas purge. mmHg
6-3
6-4

Inspection item Inspection method Criteria Note

4. Disinfectant/acid solution (option) feeder


areas

(1) Movement of the solenoid valve. (1) Operate the equipment manually from (1) Movement sound must be audible.
MAINTE4.

(2) Residual disinfectant/acid solution. (2) Collect a sample from the drain opening 5 (2) Residual chlorine must be <0.1 ppm.
(option) min before the water rinse ends in the
disinfection process.

(3) Conditions of the tube. (bending, etc.) (3) Visual inspection. (3) OK if the equipment functions normally.

5. Blood pump area

(1) Loosening and abnormal sound in the (1) Check the externals and sound. (1) The rotating part should not be loose or
rotating part. have abnormal sound.

(2) Consistency between displayed and (2) Measure the actual flow volume using the (2) When the display is 140, actual flow (2) Use water and measure the flow
actual flow volumes. blood line. volume must be 126 to 154 mL/min. volume per min with an electric
When the display is 330, the actual flow balance.
volume must be 297 to 363 mL/min.

6. Heparin pump area

(1) Movement of the heparin pump. (1) Push the pusher manually to free the (1) Must move smoothly. (1) Apply grease on the feed screw part.
system. Grease No.: MOLYKOTE
BR2 Plus Grease (Dow Corning)
(2) Loosening of the heparin pump pulley. (2) Tighten the set screw on the pulley. (2) OK if not loose.

(3) Consistency between displayed and (3) Install a syringe pump with filled with water (3) The difference between the actual and (3) Adjust from MAINTE6 “Syringe
infused volumes. and operate at 9.9 mL/hr for 60 min. preset infusing volumes must be <10%. Diameter Size,” if the difference is
larger.
Inspection item Inspection method Criteria Note

7. Movements of monitoring and indication


alarms

(1) Temperature-related alarms. (1) Compare preset and displayed (1) Difference must be <±0.5 C.
(calibration of temperature indication) temperatures in the preparation process.

(2) Dialysate concentration alarm. (2) Compare displayed and actual (2) Difference must be <2 mEq/L.
(calibration of concentration indication) concentration in the preparation
process.
(3) Venous pressure alarm. (3) Change the alarm range manually in (3) Alarm is active when the current level is
(calibration of the venous pressure gauge) Dialysis waiting process. out of range.

(4) Arterial pressure alarm. (4) Change the alarm range manually in (4) Alarm is active when the current level is
(calibration of the arterial pressure gauge) Dialysis waiting process. out of range.

(5) Dialysate pressure alarm. (5) Change the alarm range manually in (5) Alarm is active when the current level is
(calibration of the dialysate pressure gauge) Dialysis waiting process. out of range.

(6) Blood leak alarm. (6) Set the temperature to 36.5 °C in the (6)Real Blood leak value must be < 30.
(movement of the blood leak detector) preparation process. Read the Real blood
leak value in MAINTE MODE1.

(7) Tube error alarm. (7) Remove the tube from the air bubble (7) Alarm is active.
(movement of the air bubble detector) detector. Turn on the BUBBLE
DETECTOR switch.

(8) Insufficient water supply. (8) Operate the equipment after decreasing (8) Alarm is active
the water supply to an insufficient level.

(9) Alarm buzzer. (9) Check the buzzer sound. (9) OK if buzzer sound is normal.

(10) Blood leak alarm. (10) Install a simulated blood leak filter. Read (10) The Real blood leak value is the total
(calibration of blood-leak detection) the Real blood leak value in MAINTE1. of the specified value of the dummy
simulated filters ±80 ppm.
6-5
6-6

Inspection item Inspection method Criteria Note

8. Electric tests

(1) Short circuit breaker operation. (1) Operate the switch to check the short (1) OK if power supply shuts off.
circuit breaker.

(2) Battery capacity for power failure (2) Attach the blood line on the blood pump (2) The blood pump and heparin pump (2) Set the blood pump flow at 150
backup. and air bubble detector. Turn on the must operate for >20 min. mL/min.
BLOOD PUMP, HEPARIN PUMP and NOTE: It must operate for 20 min, Set the heparin pump flow at 2.0
BUBBLE DETECTOR switches. Turn off considering the time it takes to mL/h.
the equipment breaker. complete blood collection in case of Start after charging for 48 hrs.
power failure. This time frame may A new battery allows approx. 30 min
Mute the buzzer by pressing the vary, depending on the age of the of operation with full charge. The
MUTE/RESET switch. battery. Exchange the battery if battery gradually deteriorates
necessary. although there is no power failure.

At the same time, check: Check the following function:


· Air bubble detector · Air bubble detector is on
Remove the blood line from the air bubble The blood pump must stop when the
detector. sensor detects air bubbles.

(3) Leakage current. (3) Connect the jig to measure leakage (3) OK if < 5mA. (3) The jig to measure leakage current is
current to the equipment. Measure the necessary.
current in the protective earth conductor The standard of the jig must be in
(the grounding conductor of the power accordance with IEC60601-1.
plug) during normal operation.

(4) Conditions of the equipment with (4) Use a tester to measure the resistance (4) OK if < 10. (4) The power breaker must be turned
grounding. between each heater body and the OFF.
grounding terminal.
Inspection item Inspection method Criteria Note

9. Other items to inspect

(1) Bending, leakage, staining, etc. of (1) Visual inspection. (1) OK if the equipment functions normally. (1) Exchange the tube with leakage.
tubes.

(2) Abnormal sound/smell. (STANDBY, (2) Check sounds and smells. (2) OK if no abnormal sounds / smell are
DIALYSIS, RINSING) present.

(3) Presence of air bubbles in the (3) Visual inspection during the STANDBY (3) No air bubbles in the hydraulic line
hydraulic line. process.

(4) Leakage from the hydraulic line. (4) Perform the start-up test or the CHECK (4) Test must be completed without a
operation from MAINTE7. problem.

(5) Filling flow rate. (5) In the standby process, measure the (5) The system should complete filling
drainage flow rate after installing the flow within 5.8 to 6.2 sec.
gauge onto the drainage line.
(Dialysate flow rate: 500 mL/min)

(6) Filling complete pressure. (6) Measure the pressure on the (6) The pressure must be 0.098 to 0.108
2
P4-discharge side. (FS1-OUT side) Mpa (1.0 to 1.1 kgf/cm ) when filling is
complete.

(7) Dialysate flow rate. (7) Measure the MAX dialysate flow rate. (7) The MAX dialysat flow must be
800 mL/min.

(8) Tightening the terminal block. (8) Check the tightening. (8) OK if not loose. (8) The power breaker must be turned
OFF.
6-7
6-8

Inspection item Inspection method Criteria Note

10. Powder Bicarbonate Assy (Option)

(1) Movement of the solenoid valve. (1) Check the movement from MAINTE4. (1) Must have the movement sound

(2) Bending, leakage, staining, etc. of (2) Visual inspection. (2) OK if the equipment functions normally. (2) Exchange the tube with leakage.
tubes.

(3) Damage/deformation that interfere with (3) Visual inspection. (3) Must not be damaged/deformed
functions.

(4) Stain, leakage, or blockage in filters. (4) Visual inspection. (4) Must have no stain, leakage, or
blockage
7. Parts Replacement

7 Parts Replacement ······································································· 7-1


7.1 List of parts to be maintained and replaced ········································ 7-2
7.2 Parts replacement during maintenance ············································· 7-6
7.2.1. Water supply filter Assy (F1) ····················································· 7-6
7.2.2. Two-way solenoid valve (V46) ··················································· 7-7
7.2.3. Two-way solenoid valve (V9a, V9b, V19, V34, V35) ······················ 7-8
7.2.4. Two-way solenoid valve
(V1, V5a, V5b, V6a, V6b, V7a, V7b, V8a, V8b, V55) ····················· 7-9
7.2.5. Two-way solenoid valve
(V4,V10,V11,V21,V27,V28,V29,V30,V31,V43,V56,V57)················· 7-10
7.2.6. Two-way solenoid valve (V33) ··················································· 7-11
7.2.7. Two-way solenoid valve (V12,V17,V24,V45) ································ 7-12
7.2.8. Temperature sensor Assy (T1, T2, T3, T4, T5, T6, T7) ··················· 7-13
7.2.9. Dialysate pressure sensor Assy (PD)·········································· 7-14
7.2.10. Conductivity sensor Assy (CD1, CD2, CD3) ································· 7-15
7.2.11. Degassing tank Assy (AS1) ······················································ 7-17
7.2.12. Air elimination tank Assy (AS2) ················································· 7-18
7.2.13. Buffer tank Assy ····································································· 7-20
7.2.14. Magnet gear pump (P1, P2) ····················································· 7-21
7.2.15. Heparin pump Assy (HP)·························································· 7-22
7.2.16. Blood pump Assy (BP)····························································· 7-25
7.2.17. Sample port Assy (SL) ····························································· 7-26
7.2.18. Rinse port ············································································· 7-27
7.2.19. Joint of concentrate tank ·························································· 7-28
7.2.20. Flow sensor Assy (FS1) ··························································· 7-30
7.2.21. Flow sensor Assy (FS2) ··························································· 7-31
7.2.22. Coupler Assy ········································································· 7-32
7.2.23. Blood leak detector Assy (BLD) ················································· 7-33
7.2.24. Chamber Assy (Ca,Cb) ···························································· 7-34
7.2.25. Ultrafiltration pump Assy (UFP) ················································· 7-36
7.2.26. Pump for A concentrate Assy (P3)·············································· 7-38
7.2.27. Pump for B concentrate Assy (P4) ············································· 7-40
7.2.28. Relief valve Assy (RV) ····························································· 7-42
7.2.29. Clamp Assy (CLV) ·································································· 7-43
7.2.30. Other hydraulic components ····················································· 7-45

7.3 Miscellaneous part ········································································ 7-46


7.3.1. Air filter ················································································ 7-46
7.3.2. Air filter 2 ·············································································· 7-47

7.4 Powder Bicarbonate Assy (option) ··················································· 7-48


7.4.1 Powder Bicarbonate Cartridge Holder Assy ································· 7-48

7-1
7.1. List of parts to be maintained and replaced

Approximate time to
Code Name of ASSY/Part Model No. Code No. qty replace Note
2 yr Ad libitum
Water supply filter
SAS-16001 0-501-307 1
Assy
F1
1) Filter FI116ATERP265A00 0-201-213 1
2) Packing 01931500108 0-501-305 1 I.D.16mm
Two-way solenoid valve SV2-322-S 2-006-008 1
V46 1) Diaphragm D3A540 0-501-117 1 Best if replace yearly.
2) Valve body D3B2041 0-704-099 1
Two-way solenoid valve SV2-422-S 0-501-120 5
V9a 1) Diaphragm D4A350 0-501-121 5 Best if replace yearly.
V9b
V19
V34 2) Valve body D4B1081 0-704-103 5
V35

V1 Two-way solenoid valve SV2-422-SHP 0-501-125 10


V5a 1) Diaphragm D4A350 0-501-121 10 Best if replace yearly.
V5b
V6a
V6b
V7a
V7b 2) Valve body D4B1081 0-704-103 10
V8a
V8b
V55
V4 Two-way solenoid valve SV2-322-SHW 0-501-294 12
V10 1) Diaphragm D3A540 0-501-117 12 Best if replace yearly.
V11
V21
V27
V28
V29
V30 2) Valve body D3B2041 0-704-099 12
V31
V43
V56
V57
Relief solenoid valve SV2-322S13-SRHW 0-501-127 1
V33 1) Diaphragm D3A540 0-501-117 1 Best if replace yearly.
2) Valve body D3B2041 0-704-099 1
V12 Mixing solenoid valve SV2-322MX5-S 0-704-101 4
V17 1) Diaphragm D3A540 0-501-117 4 Best if replace yearly.
V24
V45 2) Valve body D3B1590 0-704-100 4
*1) Powder Bicarbonate Assy : <P>
*2) Acid-Rinsing Port Assy : <A>
*3) CF flashing unit : <C>

7-2
Approximate time to
Code Name of ASSY/Part Model No. Code No. qty replace Note
2 yr Ad libitum
SAS-15041 0-701-739 1 T1
T1 SAS-15042 0-701-740 1 T2
T2 SAS-15043 0-701-741 1 T3
T3 Temperature sensor
SAS-15044 0-701-742 1 T4
T4 Assy
T5 SAS-15045 0-701-743 1 T5
T6 SAS-15046 0-701-744 1 T6
T7 SAS-15047 0-701-745 1 T7
1) O-ring P4 0-701-750 7
Dialysate pressure
PD-02-650 0-701-170 1
sensor Assy
PD
1) O-ring S-16 0-504-026 1 Replace when disassembled
2) Manifold 93882911 0-504-025 1
Conductivity sensor
SAS-12007 0-701-015 3
Assy
CD1 1) O-ring P2 0-701-011 9
CD2
2) Sensor holder A 01931100191 0-701-008 6
CD3
3) Sensor holder B 01931100192 0-701-010 3
4) O-ring P9 0-701-009 6
Degassing tank Assy 90612300 0-501-273 1
AS1
1) O-ring G50 9-001-121 1 Replace when disassembled
Air elimination tank Assy 90612400100 0-701-726 1
1) Float OLV-5(Special) 0-501-153 1 Best if replace yearly.
AS2
2) O-ring G50 9-001-121 1
3) Packing 01930200088 0-201-016 1
BTW Assy 90733500 0-701-775 1
BTW
1) O-ring G70 9-001-123 1 Replace when disassembled
BTD Assy 90733500 0-701-775 1
BTD
1) O-ring G70 9-001-123 1 Replace when disassembled
BTB Assy 90574400 0-501-309 1
BTB
1) Packing 90364413001 0-501-161 1 Replace when disassembled
Magnet gear pump MDG-R3SD24V-01 4-070-014 1 For P1 with P1 harness
P1
1) Pump body set MDG-R3SD24V-01B 4-070-012 1
Magnet gear pump MDG-R3SD24V-01 0-701-702 1 For P2 with P2 harness
P2
1) Pump body set MDG-R3SD24V-01B 4-070-012 1
Heparin pump Assy 93896500 0-504-035 1 – –
HP
1) Half nut 91936519 0-504-070 1
Blood pump Assy MRP22-011 0-504-215 1
BP
1) Rotor Assy AS49898-01 0-504-179 1
Sample port Assy 90403400 0-501-179 1
SL
1) Packing (B) 01939800472 0-000-060 1
*1) Powder Bicarbonate Assy : <P>
*2) Acid-Rinsing Port Assy : <A>
*3) CF flashing unit : <C>

7-3
Approximate time to
Code Name of ASSY/Part Model No. Code No. qty replace Note
2 yr Ad libitum
Rinse port SAS-08016 0-501-200 1 For A concentrate
(For concentrate) SAS-08017 0-501-201 1 For B concentrate

1) O-ring 01931200030 0-501-261 2
2) Gasket 01931200031 0-501-262 2
Rinse port
SAS-08018 0-501-095 1
(For disinfectant)

1)Tube connector S 93663311001 0-501-096 1
2) Packing (A) 91936944004 2-002-066 1
Joint of concentrate SAS-08013 0-501-189 1 For A concentrate
tank (Side of the
dialysate) SAS-08014 0-501-190 1 For B concentrate

1) O-ring 01931200030 0-501-261 2
2) Gasket 01931200031 0-501-262 2
Joint of concentrate SAS-17004 1 Disinfectant
– tank (Side of the Acid
disinfectant) SAS-17005 1
Option<A>
Flow sensor Assy SAS-12017 0-701-021 1
FS1
1) Packing 93614615100 0-501-295 2
Flow sensor Assy SAS-16002 0-701-759 1
FS2
1) Packing 93614615100 0-501-295 2
SAS-08033 0-501-206 1 Red
Coupler Assy
– SAS-08034 0-501-207 1 Blue
1) Packing 90363014001 0-501-209 2
Blood leak detector Assy BLD-01 4-030-078 1
BLD
1) Cartridge holder 93444823100 0-504-034 1
Ca Chamber Assy 90611000 0-803-003 1
Cb 1) Membrene 90351014100 0-703-003 2
*1) Powder Bicarbonate Assy : <P>
*2) Acid-Rinsing Port Assy : <A>
*3) CF flashing unit : <C>

7-4
Approximate time to
Code Name of ASSY/Part Model No. Code No. qty replace Note
2 yr Ad libitum
Ultrafiltration pump
V-10AUM-P1H 0-501-168 1
Assy
UFP
1) Back sheet 1615001500 0-501-049 1
2) Lip seal 1615003300 0-501-050 3
Pump for A
V-10AFP06-XP-43 0-701-028 1
concentrate Assy
P3
1) Back sheet 1615001500 0-501-049 1
2) Lip seal 1615003300 0-501-050 3
Pump for B
V-10AUM-P3BH 0-501-172 1
concentrate Assy
P4
1) Back sheet 1615001500 0-501-049 1
2) Lip seal 1615003300 0-501-050 3
Powder Bicarbonate
Cartridge Holder 90579300105 0-507-080 (1) Option<P>
Assy
– 1)Check valve 90369326001 0-507-020 (1)
2)Nozzle packing 90369324100 0-507-053 (2)
3)Packing 90369323001 0-507-024 (2)
Other hydraulic
– – – – –
component
1) Coupler line filter 90404111001 0-501-218 1
2) Concentrate
90403323001 0-501-219 (4) Option <P><A>
line filter
3) Filter 93663321100 0-501-217 3 (2) Option <P><A>
4) T-shaped
93663916100 0-501-220 3(3)
connector S
5) T-shaped
93613911100 0-501-114 23(4)
connector
6) Reducer hose
90403911 0-501-115 1(7)
– connector
7) Hose
01930600070 0-501-116 (2) Option<HE>
connector
8) Plug 93893020004 0-501-216 1
30m of Silicon tube
has been used per
9) Silicone tube ø5×ø11 9-004-038 – one machine.
If you change whole
tube, you need 30m.
6.5m of Silicon tube
has been used per
10) Silicone tube ø3 ×ø6 2-002-071 – one machine.
If you change whole
tube, you need 6.5m.
Use something which
Lithium battery CR2032 0-502-220 1 has no conductivity for
– removal.
Ni-cd battery 20KR-CH(3AH) 0-502-085 1
*1) Powder Bicarbonate Assy : <P>
*2) Acid-Rinsing Port Assy : <A>
*3) Heat Exchanger Assy : <HE>

NOTE 1) This list doesn’t guarantee the performance of parts within the indicated time frame.
The time to exchange parts, is especially depending on the used concentration of disinfectants.
2) This list shows approximate time when parts have to be replaced except for electric components.

7-5
7.2. Parts replacement during maintenance

7.2.1. Water supply filter Assy (F1)

7.2.1.1. Overall configuration

6 Assy

7.2.1.2. List of components

No. Name Model No. Code No. Note


1 Cap 93619318101 0-501-304 Blue cap
2 Hose connector 93619319 0-201-212
3 Packing 01931500108 0-501-305 I.D.16mm
4 Filter FI116ATERP265A00 0-201-213
5 Body 93619320101 0-501-306
6 Water supply filter Assy SAS-16001 0-501-307

7.2.1.3. How to replace parts


(1) Disassemble the Water supply filter Assy by turning the cap 1 counterclockwise.
(2) Replace the filter 4 and packing 3 .
(3) Reassemble by turning the cap 1 clockwise.

7-6
7.2.2. Two-way solenoid valve (V46)

7.2.2.1. Overall configuration

11 Assy

7.2.2.2. List of components

No. Name Model No. Code No. Note


1 Actuator Assy – –
2 Core – –
3 Pacless pipe – –
4 Sound damp sheet – –
5 Spring – –
6 Plunger – –
7 Diaphragm support – –
8 Diaphragm D3A540 0-501-117
9 Valve body D3B2041 0-704-099
10 Screw M3×45P2 0-501-119
11 Two-way solenoid Valve SV2-322-S 2-006-008

7.2.2.3. How to replace parts


(1) Unscrew the 2 screws 10
. to remove the valve body 9 .
(2) Remove the diaphragm 8 from the plunger 6 .
(3) Replace the diaphragm 8 and valve body 9 . (Enchase the diaphragm 8 firmly to the
plunger 6 .)
(4) Reassemble and tighten the screws ( 10 ) to the torque of 0.69 N.m (7 kgf.cm).

7-7
7.2.3. Two-way solenoid valve (V9a, V9b, V19, V34, V35)

7.2.3.1. Overall configuration

12 Assy

7.2.3.2. List of components

No. Name Model No. Code No. Note


1 Actuator Assy – –
2 Core – –
3 Pacless pipe – –
4 Sound damp sheet – –
5 Spring – –
6 Plunger – –
7 Diaphragm support – –
8 Diaphragm D4A350 0-501-121
9 Ring – –
10 Valve body D4B1081 0-704-103
11 Screw – –
12 Two-way solenoid Valve SV2-422-S 0-501-120

7.2.3.3. How to replace parts


11 10
(1) Unscrew the 2 screws to remove the valve body .
(2) Remove the diaphragm 8 from the plunger 6 .
(3) Replace the diaphragm 8 and valve body 10 . (Enchase the diaphragm 8 firmly to the
plunger 6 .)
11
(4) Reassemble and tighten the screws to the torque of 0.69 N.m (7 kgf.cm).

7-8
7.2.4. Two-way solenoid valve (V1, V5a, V5b, V6a, V6b, V7a, V7b, V8a, V8b, V55)

7.2.4.1. Overall configuration

12 Assy

7.2.4.2. List of components

No. Name Model No. Code No. Note


1 Actuator Assy – –
2 Core – –
3 Pacless pipe – –
4 Sound damp sheet – –
5 Spring – –
6 Plunger – –
7 Diaphragm support – –
8 Diaphragm D4A350 0-501-121
9 Ring – –
10 Valve body D4B1081 0-704-103
11 Screw – –
12 Two-way solenoid Valve SV2-422-SHP 0-501-125

7.2.4.3. How to replace parts


11 10
(1) Unscrew the 2 screws to remove the valve body .
(2) Remove the diaphragm 8 from the plunger 6 .
(3) Replace the diaphragm 8 and valve body 10 . (Enchase the diaphragm 8 firmly to the
plunger 6 .)
11
(4) Reassemble and tighten the screws to the torque of 0.69 N.m (7 kgf.cm).

7-9
7.2.5. Two-way solenoid valve
(V4,V10,V11,V21,V27,V28,V29,V30,V31,V43,V56,V57)

7.2.5.1. Overall configuration

11 Assy

7.2.5.2. List of components

No. Name Model No. Code No. Note


1 Actuator Assy – –
2 Core – –
3 Pacless pipe – –
4 Sound damp sheet – –
5 Spring – –
6 Plunger – –
7 Diaphragm support – –
8 Diaphragm D3A540 0-501-117
9 Valve body D3B2041 0-704-099
10 Screw – –
11 Two-way solenoid Valve SV2-322-SHW 0-501-294

7.2.5.3. How to replace parts


10 9
(1) Unscrew the 2 screws to remove the valve body .
(2) Remove the diaphragm 8 from the plunger 6 .
(3) Replace the diaphragm 8 and valve body 9 . (Enchase the diaphragm 8 firmly to the
plunger 6 .)
10
(4) Reassemble and tighten the screws to the torque of 0.69 N.m (7 kgf.cm).

7-10
7.2.6. Relief solenoid valve (V33)

7.2.6.1. Overall configuration

11 Assy

7.2.6.2. List of components

No. Name Model No. Code No. Note


1 Actuator Assy – –
2 Core – –
3 Pacless pipe – –
4 Sound damp sheet – –
5 Spring – –
6 Plunger – –
7 Diaphragm support – –
8 Diaphragm D3A540 0-501-117
9 Valve body D3B2041 0-704-099
10 Screw – –
11 Relief solenoid Valve SV2-322S13-SRHW 0-501-127

7.2.6.3. How to replace parts


(1) Unscrew the 2 screws 10
to remove the valve body 9 .
(2) Remove the diaphragm 8 from the plunger 6 .
(3) Replace the diaphragm 8 and valve body 9 . (Enchase the diaphragm 8 firmly to the
plunger 6 .)
10
(4) Reassemble and tighten the screws to the torque of 0.69 N.m (7 kgf.cm).

7-11
7.2.7. Mixing solenoid valve (V12,V17,V24,V45)

7.2.7.1. Overall configuration

7.2.7.2. List of components

No. Name Model No. Code No. Note


1 Actuator Assy - -
2 Core - -
3 Pack-less pipe - -
4 Sound damp sheet - -
5 Spring - -
6 Plunger - -
7 Diaphragm support - -
8 Diaphragm D3A540 0-501-117
9 Valve body D3B1950 0-704-100
10 Screw - -
11 Mixing solenoid valve SV2-322MX5-S 0-704-101

7.2.7.3. How to replace parts


(1) Unscrew the 2 screws 10
to remove the valve body 9 .
(2) Remove the diaphragm 8 from the plunger 6 .
(3) Replace the diaphragm 8 and valve body 9 . (Enchase the diaphragm 8 firmly to the
plunger 6 .)
10
(4) Reassemble and tighten the screws to the torque of 0.69 N.m (7 kgf.cm).

7-12
7.2.8. Temperature sensor Assy (T1,T2,T3,T4,T5,T6,T7)

7.2.8.1. Overall configuration

7.2.8.2. List of components


No. Name Model No. Code No. Note
1 Sensor holder 90732511004 0-701-747
2 O-ring P4 0-701-750 Viton
3 Backup ring BE002 0-701-751
4 Thermistor E3M-42D-S36 0-702-082 With T1 harness
0-702-083 With T2 harness
0-702-084 With T3 harness
0-702-085 With T4 harness
0-702-086 With T5 harness
0-702-087 With T6 harness
0-702-088 With T7 harness
5 Support plate 01931500006 0-701-749
6 Clip 90732512004 0-701-748
7 Temperature sensor SAS-15041 0-701-739 T1
Assy SAS-15042 0-701-740 T2
SAS-15043 0-701-741 T3
SAS-15044 0-701-742 T4
SAS-15045 0-701-743 T5
SAS-15046 0-701-744 T6
SAS-15047 0-701-745 T7

7.2.8.3. How to replace parts


See the figure on the right. O-ring
Sensor holder
(1) Pull out the clip. Backup ring
(2) Remove Support plate, thermistor, Backup ring, Support plate Thermistor
O-ring.
(3) Replace O-ring.
(4) Attach O-ring, Backup ring, thermistor, Suppor
plate.
(5) Attach clip. Clip

7-13
7.2.9. Dialysate pressure sensor Assy (PD)

7.2.9.1. Overall configuration

9 Assy

7.2.9.2. List of components

No. Name Model No. Code No. Note


1 Manifold 93882911 0-504-025
2 O-ring S-16 0-504-026
3 Pressure transducer – –
4 Base plate – –
5 Spacer – –
6 Dialysate pressure – –
sensor board
7 Screw M3×12 0-504-031 With a plain washer and
a spring lock washer
8 Board cover 93882914 0-504-032
9 Dialysate pressure PD-02-650 0-701-170
sensor Assy

7.2.9.3. How to replace parts


! CAUTION
 Do not touch the surface of the pressure transducer of the dialysate pressure sensor. It can
cause malfunction.

(1) Remove the board cover 8 .


(2) Unscrew the 2 screws 7 .
(3) Remove the pressure transducer 3 from the manifold 1 , using a precision flathead
screwdriver, etc.
(4) Replace the manifold 1 and O-ring 2 .
(5) Reassemble and tighten the screws 7 to the torque of 0.69 N.m (7 kgf.cm).

7-14
7.2.10. Conductivity sensor Assy (CD1,CD2,CD3)

7.2.10.1. Overall configuration

7.2.10.2. List of components

No. Name Model No. Code No. Note


1 Sensor holder A 01931100191 0-701-008
2 O-ring P9 0-701-009 Silicone rubber
3 Sensor holder B 01931100192 0-701-010
4 O-ring P2 0-701-011 Silicone rubber
5 Pin 01931000386 0-701-012
6 Screw M3×35 0-701-013 SUS
7 Nut For M3 0-701-014 SUS
8 Plain washer For M3 0-701-189 SUS
9 Screw M3×8 0-204-067 SUS
10 Conductivity sensor Assy SAS-12007 0-701-015

7-15
7.2.10.3. How to replace parts

Remove the six screws (9).


Draw out the pin (6).
Remove the O-ring(7) from the pin(6), and replace it.
Remove the two screws (4).
Remove the O-ring(3) from the sensor holder B(6), and
replace it.
Assemble the parts in the reverse order of the disassembly
procedure.
Tightening torque for the screw(4) and screw(9) shall be
0.39N・m (4kgf・cm) at assembling them.
! CAUTION
When installing the O-ring(7) to the pin(6), make sure to put some
water on the O-ring to make it more slippery. Any damage or twist on
the O-ring(7) may cause liquid leakage.

7-16
7.2.11. Degassing tank Assy (AS1)

7.2.11.1. Overall configuration

7.2.11.2. List of components


No. Name Model No. Code No. Note
1 AS Case 90352311100 –
2 Wire net 91933015002 0-201-013
3 AS plate 90352314101 –
4 O-ring G50 9-001-121 Viton
5 Float 93898213100 0-501-143
6 AS1 Case 90352312100 –
7 Screw M4x15 SUS304
8 AS Bracket 90612311001 –
9 Steel ball Grade28 spare1/8 SUS316
10 Stopper 90402316001
11 Degassing tank Assy 90612300

7.2.11.3. How to replace parts


(1) Unscrew the 4 screws 7 .
(2) Replace the 2 O-ring 3 .
(3) Reassemble in the reverse order.

7-17
7.2.12. Air elimination tank Assy (AS2)

7.2.12.1. Overall configuration

7.2.12.2. List of components


No. Name Model No. Code No. Note
1 AS Case –
2 Wire net 91933015002 0-201-013
3 AS Plate 90352314101 –
4 O-ring G50 9-001-121
5 Ring –
6 Float –
7 Float switch shaft –
8 Mesh 90352417100 0-501-283
9 Packing 01930200088 0-201-016
10 AS2 Case –
11 Nut –
12 Screw M4x15 –
13 AS Bracket –
14 Tube –
15 Pin –
16 Connector –
17 Air elimination tank Assy 90612400100 -
18 Float switch Assy OLV-5(Special) 0-501-153 (5),(6),(7),(11)

7-18
7.2.12.3. How to replace parts
(1) Unscrew the 4 screws 12 .
(2) Remove the ring 5 and float 6 .
(3) Replace the float 6 and 2 O-rings 3 .
(4) Reassemble in the reverse order.

7-19
7.2.13. Buffer tank Assy

7.2.13.1. Overall configuration

7 Assembly

7.2.13.2. List of components


No. Name Model No. Code No. Note
1 Upper tank (1) 93283512002 0-501-167
2 O-ring G70 9-001-123 Viton
3 Lower tank 93283511001 0-501-166
4 Nut For M4 0-201-127
5 Plain washer For M4 0-201-132
6 Screw M4×20-3P 0-201-133
7 BTW Assy 90733500 0-701-775
BTD Assy

7.2.13.3. How to replace parts


(1) Unscrew the 4 screws (6).
(2) Replace the O-ring (2).
(3) Reassemble in the reverse order.

7-20
7.2.14. Magnet gear pump (P1,P2)

7.2.14.1. Overall configuration

7.2.14.2. List of components

No. Name Model No. Code No. Note


1 Pump body set MDG-R3SD24V-01B 4-070-012
2 Magnet gear pump MDG-R3SD24V-01 4-070-014 For P1 With P1 harness
0-701-702 For P2 With P2 harness
3 Pump bracket 90572611001
4 Rubber sheet 93141036001
5 Rubber cushion KA-12
6 Plain washer For M5
7 Spring washer For M5
8 Nut For M5
9 Screw M4x8 –

7.2.14.3. How to replace parts


(1) Unscrew the 4 screws.
(2) Replace the Pump body set 1 .
(3) Reassemble in the reverse order.

7-21
7.2.15. Heparin pump Assy (HP)

7.2.15.1. Overall configuration

50 Assy

7.2.15.2. List of components

No. Name Model No. Code No Note


1 Pusher E 93896511 0-504-036
2 Button 93896538 0-504-037
3 Coil spring No.1043 0-504-038
4 Pin 93896537 0-704-091
5 Screw M3×8 0-201-081 With a plain washer and
a spring rock washer
6 Metal fitting 93896533 0-504-041
7 Harness holder B 93886530 0-504-042
8 Screw M3×10 0-701-181 With a plain washer and
a spring rock washer
9 Sensor blacket 93886536 0-504-044
10 Limit switch SS-01 0-504-045
11 Screw M2.3×12 0-201-096 With a plain washer and
a spring rock washer
12 Screw M3×8 0-201-081 With a plain washer and
a spring rock washer
13 Syringe holder 93886513 0-504-048
14 Shaft A 93896524 0-504-049
15 Screw M4×8 0-504-050

7-22
No. Name Model No. Code No Note
16 Coil spring No.1145 0-504-051
17 Stopper 93886535 0-504-052
18 Screw M3×8 0-201-081 With a plain washer and
a spring rock washer
19 Syringe base 93896532 0-504-054
20 Packing φ1 –
21 Screw M4×16 0-504-056 With a spring rock
washer
22 Chassis 93886514 0-504-057
23 Motor plate 93886515 0-504-058
24 Screw M4×8 0-201-071 With a plain washer and
a spring rock washer
25 Stepping motor KT42JM4-004 4-028-013
26 Screw M3×8 0-201-081 With a plain washer and
a spring rock washer
27 Timing pulley 10XL037 0-504-062
28 Timing pulley 12XL037 0-504-063
29 Timing belt 70-XL-025U 0-204-043
30 Setscrew M4×4 0-701-079
31 Screw M3×8 0-804-076
32 Plate 93886520 0-504-067
33 Plate 2 93886529 0-504-068
34 Shaft 93896519 0-504-069
35 Half nut 91936519 0-504-070
36 Clutch spring 91936523 0-504-071
37 Spring case 93146521 0-504-072
38 Screw M3×6 0-701-180 With a plain washer and
a spring rock washer
39 Rotation detection – –
sensor
40 Dog 93896534 0-504-075
41 Bearing RF-1450ZZ 0-504-076
42 Feed screw 93896517 0-504-077
43 Housing 93896516 0-504-078
44 Guide shaft 93896518 0-504-079
45 Limit switch SS-01 0-504-045
46 Screw M2.3×12 0-201-096 With a plain washer and
a spring rock washer
47 Nut 93886523 0-504-082
48 Lever 91936927 0-504-083
49 O.L spring 01930600121 0-504-084
50 Heparin pump Assy 93896500 0-504-035

7-23
7.2.15.3. How to replace parts
(1) Loosen the setscrews 30 (4 in total). Remove the pulley 28 from the feed screw 42 and the
pulley 27 from the stepping motor 25 .
(2) Unscrew the 4 screws 24 and disassemble into chassis 22 , motor plate 23 , and housing 43 .
(3) Push the shaft 34 in the housing 43 part to remove the feed screw 42 .
(4) Unscrew the 4 screws 31 .
(5) Open a space between the lever 48 (resin part) and the metal part of the housing 43 part by
inserting a flathead screw driver, etc. Insert a screwdriver, etc. while pressing and squeezing
the spring inside the housing by hand.
(6) Rotate the shaft 34 by 90 degrees, and replace the half nut 35 .
(7) Reassemble in the reverse order.

7-24
7.2.16. Blood pump Assy (BP)

7.2.16.1. Overall configuration

6 Assy
7.2.16.2. List of components

No. Name Model No. Code No. Note


1 Housing Assy AR02672-01 0-504-178
2 Rotor Assy AS49898-01 0-504-179 Rotational handle built-in
With a plain washer and
3 Screw M5×10 0-504-180
a spring rock washer
4 BP cover Assy SAS-08035 0-504-190 With pin
5 Motor FY6PF6G-303 0-504-191
6 Blood pump Assy MRP22-011 0-504-215

7.2.16.3. How to replace parts


[How to replace Rotor Assy]
(1) Pull open the handle of the Rotor Assy 2 .
(2) Remove the Hex socket head cap screw with captive washer 3 .
(3) Pull out the Rotor Assy 2 .
(4) Reverse above procedure when mounting parts.
(5) [How to replace BP cover Assy]
(6) Remove carefully the pin 4 to upper side (the knurling side of the pin) of the BP cover Assy.
(7) Insert the pin 4 (the knurling side is upper) when mounting the BP cover Assy.

! CAUTION
 Replace maximum 3 times the BP cover Assy to prevent a decline of fixed power of the pin.
 Remove the pin very carefully because holes of the Housing are sometimes transformed when
the pin is removed by force.

7-25
7.2.17. Sample port Assy (SL)

7.2.17.1. Overall configuration

6 Assy

7.2.17.2. List of components

No. Name Model No. Code No. Note


1 Body 01930400069 0-201-044
2 Spring 919388670041 2-002-063
3 Valve 90403411001 0-201-043
4 Packing (B) 01939800472 0-000-060
5 Syringe holder 01930400085 0-201-042
6 Sample port Assy 90403400 0-501-179

7-26
7.2.18. Rinse port

7.2.18.1. Overall configuration

10 Socket

7.2.18.2. List of components

No. Name Model No. Code No. Note


1 Plug S 90403311001 0-501-202 For A concentrate
Plug L 90403312001 0-501-203 For B concentrate
2 SAS-08009 0-501-191 For A concentrate
Body
SAS-08010 0-501-192 For B concentrate
3 O-ring 01931200030 0-501-261 Silicone rubber ( black )
4 Washer 90403321001 0-501-193
5 Gasket 01931200031 0-501-262 Silicone rubber ( black )
6 Valve 90403317001 0-501-204
7 Cone spring 90403348001 0-501-205
8 Adapter A 90403313001 0-501-194
9 Nut 90403318001 0-501-195
10 Socket SAS-08016 0-501-200 For A concentrate,
Consists of 2 to 9
SAS-08017 0-501-201 For B concentrate,
Consists of 2 to 9
Note) Be aware of the direction of the notch during the parts replacement of 4 .

7-27
7.2.19. Joint of concentrate tank

7.2.19.1. Side of the dialysate

7.2.19.1.1. Overall configuration

9 Socket

7.2.19.1.2. List of components

No. Name Model No. Code No. Note


1 Body SAS-08009 0-501-191 For A concentrate
SAS-08010 0-501-192 For B concentrate
2 Washer 90403321001 0-501-193
3 Gasket 01931200031 0-501-262 Silicone rubber ( black )
4 Adapter A 90403313001 0-501-194
5 Nut 90403318001 0-501-195
6 Silicone tube ø5×ø11×L35 –
7 Pure chlorofluorocarbon TF185 –
FEP tube
8 Washer 90403321001 0-501-193
9 Socket SAS-08011 0-501-196 For A concentrate,
Consists of 1 to 6
SAS-08012 0-501-197 For B concentrate,
Consists of 1 to 6
10 Joint of concentrate tank SAS-08013 0-501-189 For A concentrate,
(Side of the dialysate) Consists of 7 , 8 , 9
SAS-08014 0-501-190 For B concentrate,
Consists of 7 , 8 , 9
Note) Be aware of the direction of the notch during the parts replacement of 3 .

7-28
7.2.19.2. Side of the disinfectant

7.2.19.2.1. Overall configuration

7.2.19.2.2. List of components


No. Name Model No. Code No. Note
Cap Y 90354011 0-701-159 Yellow
1
Cap GS 90579015 Gray
2 FEP tube TF145 - L=390mm
3 Silicone tube φ5×φ11 - L=30mm
Disinfectant tank joint Assy SAS-17004
4
Acid tank joint Assy SAS-17005 OPTION

7-29
7.2.20. Flow sensor Assy (FS1)

7.2.20.1. Overall configuration

7.2.20.2. List of components

No. Name Model No. Code No. Note


1 FS bracket 90334611003 0-504-213
2 Photo sensor EE-SPX303N 0-504-201
3 Block 01931200024 0-701-017
4 Packing 93614615100 0-501-295 FKM
5 Pipe 93614617 0-504-121
6 Teflon ball Spare 1/4
0-504-122
(precision 50μ)
7 Bolt M4×10 0-201-128 SS
8 Screw M3×16-3P 0-201-090 SS
9 Nut For M4 0-201-127 SUS
10 Hexagon bolt M4×12 0-504-130 SUS
11 Flow sensor Assy SAS-12017 0-701-021 FS1
12 Bolt M4×8 0-201-071 SS

7-30
7.2.21. Flow sensor Assy (FS2)

7.2.21.1. Overall configuration

7.2.21.2. List of components

No. Name Model No. Code No. Note


1 FS bracket 90334611003 0-504-213
2 Photo sensor EE-SPX303N 0-504-201
3 Block 01931200024 0-701-017
4 Packing 93614615100 0-501-295 FKM
5 Taper pipe TP-6572TM 0-501-317
6 Teflon ball Spare 1/4
0-504-122
(precision 50μ)
7 Bolt M4×10 0-201-128 SS
8 Screw M3×16-3P 0-201-090 SS
9 Nut For M4 0-201-127 SUS
10 Hexagon bolt M4×12 0-504-130 SUS
11 Flow sensor Assy SAS-16002 0-701-759 FS2
12 Bolt M4×8 0-201-071 SS

7-31
7.2.22. Coupler Assy

7.2.22.1. Overall configuration

7 Assy

7.2.22.2. List of components

No. Name Model No. Code No. Note


1 Socket 90363011001 0-501-208
2 Packing 90363014001 0-501-209
3 Slider R 90363013001 0-501-210 Red
Slider B 90363012001 0-501-211 Blue
4 Spring 91933314001 0-701-378
5 Steel ball MDM-3006 0-701-385
6 Stop ring 91933312001 0-701-377
7 Coupler Assy SAS-08033 0-501-206 Red
SAS-08034 0-501-207 Blue

7-32
7.2.23. Blood leak detector Assy (BLD)

7.2.23.1. Overall configuration

4 Assy

7.2.23.2. List of components

No. Name Model No. Code No. Note


1 Body – –
2 Cartridge 93444823100 0-504-034
3 Screw – – With a plain washer and
a spring lock washer
4 Blood leak detector BLD-01 4-030-078
Assy

7-33
7.2.24. Chamber Assy (Ca,Cb)

7.2.24.1. Overall configuration

14 Assy

7-34
7.2.24.2. List of components

No. Name Model No. Code No. Note


1 – – – None
2 Two-way solenoid valve SV2-422-SHP 0-501-125
3 Case R 90351011100 0-703-002
4 Case L 90351012100 0-703-004
5 Membrane 90351014100 0-703-003
6 Nut plate A 90351015100 0-703-005
7 Nut plate B 90351016100 0-703-006
8 Bolt M5x25 0-703-012 4.91N・m(50kgf・cm)
9 Chamber flame A 90571022100 0-501-286
10 Chamber flame B 90571023100 0-501-287
11 Rubber sheet T1 01931000096 0-703-011
12 Bolt M4×10 0-201-128 1.18N・m(12kgf・cm)
13 Bolt M4×8 0-201-071 1.18N・m(12kgf・cm)
14 Chamber Assy 90611000 0-803-003

7-35
7.2.25. Ultrafiltration pump Assy (UFP)

7.2.25.1. Overall configuration

10 Assy
7.2.25.2. List of components

No. Name Model No. Code.No Note


1 3-phase Stepping motor – –
2 Drive joint – –
3 Back sheet 1615001500 0-501-049 For φ10
4 Lip seal 1615003300 0-501-050 For φ10
5 Hexagon cap nut – –
6 Pump head Assy – – 3 , 4 , 5 included
7 Fixed screw – –
8 Fixed plate – –
9 Set screw – –
10 Ultrafiltration pump Assy V-10AUM-P1H 0-501-168
(Piston pump)

7-36
7.2.25.3. How to replace Lip Seal and Back Sheet
(1) Unscrew the set screw 9 .
(2) Unscrew the fixed screw 7 and remove the fixed plate 8 .
(3) Remove the body of the pump head Assy 6 from the drive joint 2 .
(4) Remove the hexagon cap nut 5 and replace the back sheet 3 and lip seal 4 .
(5) Reassemble in the opposite procedure. Hold the lip seals 4 in the direction as the diagram
below indicates, and insert them carefully into back of the plunger one by one turning around
slightly.
(6) Note. 1) Do not bend or damage the lip seals 4 .
(7) 2) After attaching the lip seals 4 , wipe the plunger off with alcohol, etc. so that any adhesion of
finger trace or dust does not remain.
(8) When fixing the pump head Assy 6 , in the case of Ultrafiltration pump, fasten set screw 9

so that angle of A measurement in the figure becomes approximately 20°.


(9) After the reassemble, the discharge rate of the pump should be confirmed to be
7.5 mL/10 rev±3 % in the case of Ultrafiltration pump.
(10) If the discharge rate is out of the rage, adjust the angle of the pump head Assy 6 of (6).

Plunger

Back sheet

Lip seals

Fitting

Hexagon cap nut

7-37
7.2.26. Pump for A concentrate Assy (P3)

7.2.26.1. Overall configuration

(Right-side projected×2)
(Left-side projected×1)

Details of section B

11 Assy
7.2.26.2. List of components

No. Name Model No. Code No. Note


1 3-phase Stepping motor – –
2 Drive joint – –
3 Back sheet 1640450500 0-501-049 For φ10
4 Lip seal 1640450400 0-501-050 For φ10
5 Coned disk spring – –
6 Hexagon cap nut – –
7 Pump head Assy – – 3 , 4 , 5 , 6 included
8 Fixed screw – –
9 Fixed plate – –
10 Set screw – –
11 Pump for A concentrate V-10AFP06-XP-43 0-701-028
Assy (Piston pump)

7-38
7.2.26.3. How to replace Lip Seal and Back Sheet
10
(1) Unscrew the set screw .
(2) Unscrew the fixed screw 8 and remove the fixed plate 9 .
(3) Remove the body of the pump head Assy 7 from the drive joint 2 .
(4) Remove the hexagon cap nut 6 and the coned disk spring 5 , and replace the back sheet
3 and lip seal 4 .
(5) Reassemble in the opposite direction. Hold the lip seals 4 in the direction as the diagram
below indicates, and insert them carefully into the back of the plunger one by one, turning
slightly around .
(6) Note. 1) Do not bend or damage the lip seals 4 .
(7) 2) After attaching the lip seals 4 , wipe the plunger off with alcohol, etc. so that any adhesion of
finger trace or dust does not remain.
(8) When fixing the pump head Assy 7 , in the case of pump for A concentrate, fasten set screw
10
so that angle of A measurement in the figure becomes approximately 9.7°.
(9) After the reassemble, the discharge rate of the pump should be confirmed to be 1.3 mL/
10 rev±7 % in the case of pump for A concentrate.
(10) If the discharge rate is out of the rage, adjust the angle of the pump head Assy 7 of (6).

Plunger

Back sheet

Lip seals

Fitting
Hexagon cap nut

7-39
7.2.27. Pump for B concentrate Assy (P4)

7.2.27.1. Overall configuration

(Right-side projected×2)
(Left-side projected×1)

Details of section B

11 Assy

7.2.27.2. List of components

No. Name Model No. Code No. Note


1 3-phase Stepping motor – –
2 Drive joint – –
3 Back sheet 1615001500 0-501-049 For φ10
4 Lip seal 1615003300 0-501-050 For φ10
5 Coned disk spring – –
6 Hexagon cap nut – –
7 Pump head Assy – – 3 , 4 , 5 , 6 included
8 Fixed screw – –
9 Fixed plate – –
10 Set screw – –
11 Pump for B concentrate
V-10AUM-P3BH 0-501-172 0.30mL/rev
Assy (Piston pump)

7-40
7.2.27.3. How to replace Lip Seal and Back Sheet
10
(1) Unscrew the set screw .
(2) Unscrew the fixed screw 8 and remove the fixed plate 9 .
(3) Remove the body of the pump head Assy 7 from the drive joint 2 .
(4) Remove the hexagon cap nut 6 and the coned disk spring 5 , and replace the back sheet
3 and lip seal 4 .
(5) Reassemble in the opposite direction. Hold the lip seals 4 in the direction as the diagram
below indicates, and insert them carefully into the back of the plunger one by one turning
around slightly.
(6) Note. 1) Do not bend or damage the lip seals 4 .
(7) 2) After attaching the lip seals 4 , wipe the plunger off with alcohol, etc. so that any adhesion of
finger trace or dust does not remain.
(8) When fixing the pump head Assy 7 , in the case of pump for B concentrate, fasten set screw
10
so that angle of A measurement in the figure becomes approximately 7.9°.
(9) After the reassemble, the discharge rate of the pump should be confirmed to be
3.0 mL/10 rev±7 % in the case of pump for B concentrate.
(10) If the discharge rate is out of the rage, adjust the angle of the pump head Assy 7 of (6).

Plunger

Back sheet

Lip seals

Fitting
Hexagon cap nut

7-41
7.2.28. Relief valve Assy (RV)

7.2.28.1. Overall configuration

9 Assy
7.2.28.2. List of components

No. Name Model No. Code No. Note


1 Valve body ACB220 –
2 Seat – –
3 Packing ACL040 –
4 Seat holder – –
5 Spring ACK340 –
6 Lock nut – –
7 Case – –
8 Number Plate – –
9 Relief valve Assy AC-3200-63H-PA 0-101-104

7-42
7.2.29. Clamp Assy (CLV)

7.2.29.1. Overall configuration

23 Assy

7.2.29.2. List of components

No. Name Model No. Code No. Note


1 Solenoid 7SC AWG.25X3X4 long life 0-504-094
2 Solenoid BKT 9389 6211 0-504-095
3 Cooling plate 9389 6214 0-504-096
4 Screw M3×4 0-701-079
5 Nut For M6 0-504-098 With spring rock /
plain washers
6 Spring BKT 9389 6213 0-504-099
7 Sensor BKT 9389 6218 0-504-100
8 Micro limit SW SS-01GL13 0-504-101
9 Spring No.4068 0-704-073
10 O-ring P10 4-023-027
11 Lod 9389 6217 0-504-104
12 Seat 9389 6220 0-504-105
13 Fan EUDC24B8S 0-502-164
14 Nut For M6 0-504-098 With spring rock washer
15 Head 9389 6215 0-504-108
16 Flange bush 80F-1212 0-504-109

7-43
No. Name Model No. Code No. Note
17 Solenoid base 9389 6212 0-504-110
18 Screw(S tight) M4×8 0-504-111
19 Screw M3×20 0-704-077 With a plain washer and
a spring rock washer
20 Screw M3×6 0-701-180 With a plain washer and
a spring rock washer
21 Screw(S tight) M3×8 0-704-079
22 Screw M2.3×12 0-201-096 With a plain washer and
a spring rock washer
23 Clamp Assy SAS-08003 0-504-093

7-44
7.2.30. Other hydraulic components

7.2.30.1. Overall configuration

7.2.30.2. List of components

No. Name Model No. Code No. Note


1 Coupler line filter 90404111001 0-501-218 F2
2 Concentrate line filter 90403323001 0-501-219 F3, F4
3 Filter 93663321100 0-501-217 F5, F6
4 T-shaped connector 93613911100 0-501-114
5 T-shaped connector S 93663916100 0-501-220
6 Reducer hose connector 90403911 0-501-115
7 Hose connector 01930600070 0-501-116
8 Plug 93893020004 0-501-216
30m of Silicon tube has
– Silicone tube ø5×ø11 9-004-038
been used per one
machine.
If you change whole tube,
you need 30m.
6.5m of Silicon tube has
– Silicone tube ø3×ø6 2-002-071
been used per one
machine.
If you change whole tube,
you need 6.5m.

7-45
7.3. Miscellaneous part
7.3.1. Air filter

7.3.1.1. Overall configuration

7.3.1.2. List of components

No. Name Model No. Code No. Note


1 Guard – –
2 Air filter FLM8 0-505-002
3 Cover – –

7.3.1.3. How to replace parts

! CAUTION
 Turn off the power of this equipment before cleaning the air filter. It can cause injury.

(1) Remove the cover 3 .


(2) Take out the air filter 2 .
(3) To clean the air filter 2 , rinse with water or remove dust. Dry well if it is rinsed with water.
(4) Reassemble in the reverse order.

NOTE
 Air is aspirated into the fan of this equipment.

7-46
7.3.2. Air filter 2

7.3.2.1. Overall configuration

7.3.2.2. List of components

No. Name Model No. Code No. Note


1 Guard – –
2 Air filter F92 filter 0-704-113
3 Cover – –

7.3.2.3. How to replace parts

! CAUTION
 Turn off the power of this equipment before cleaning the air filter. It can cause injury.

(1) Remove the cover 3 .


(2) Take out the air filter 2 .
(3) To clean the air filter 2 , rinse with water or remove dust. Dry well if it is rinsed with water.
(4) Reassemble in the reverse order.

NOTE
 Air is aspirated into the fan of this equipment.

7-47
7.4. Powder Bicarbonate Assy (option)

7.4.1. Powder Bicarbonate Cartridge Holder Assy

7.4.1.1. Overall configuration

34 Assy

7-48
7.4.1.2. List of components

No. Name Model No. Code No. Note


1 Base BKT 90579311100 *
2 Base 90369312100 0-507-051
3 Arm A 90369313001 0-507-010
4 Arm B 90369314001 0-507-011
5 Arm A cover 90369315001 0-507-012 With a magnet
6 Arm B cover 90369316001 0-507-013 With a magnet
7 Button 90369317001 0-507-014
8 Nozzle A 90369319001 0-507-015
9 Nozzle B2 01931100123 0-701-121
10 Case 90369321001 0-507-017
11 Sealing ring 90369322001 0-507-018
12 Nozzle support 90369325001 0-507-019
13 Check valve 90369326001 0-507-020
14 Stopper 90369318100 0-507-052
15 Shaft 90369327001 0-507-022
16 Nozzle packing 90369324100 0-507-053
17 Packing 90369323001 0-507-024
18 Spring 90369330 0-701-122
19 Spring 5626 0-507-026
20 Screw M2.5×5 0-701-176 SUS
21 Screw M6×10 0-507-028 SUS
22 Plain washer For M8 0-701-190
23 C type retaining ring C-8 0-701-298
24 Hexagon socket head M2×6 0-507-032 SUS
cap screws
25 proximity sensor RS-902S-500 0-502-279 LS7b
0-502-277 LS7a
26 Sensor bracket 90369328001 0-507-034
27 Nut plate 90333016001 0-507-035
28 P tite M3×8 0-507-036
29 screw M4×8 0-201-071 With a plain washer and
a spring lock washer.
30 Silicone tube ø3×ø6 – L=145mm
31 Silicone tube ø3×ø6 – L=150mm
32 BC hose connector 01931100182 0-701-117
33 Insulok T18R – L=100mm, W=2.5mm
34 Powder Bicarbonate 90579300105 0-507-080
Cartridge Holder Assy

7-49
7-50
8. Terminology

8-1
1 3P outlet:
AC outlet with a grounding terminal

2 Gas purge:
Removes air that accumulates in the air elimination tank (AS2) in a closed line

3 Filling line:
The hydraulic line between a water supply inlet and a chamber

4 Filling complete pressure:


The liquid pressure in the filling line that is observed after a chamber is filled with liquid

5 Filling flow rate:


The rate of water flown into a chamber

6 Air elimination tank:


A part that eliminates air inside a closed line

7 Chamber:
Space where a certain volume of dialysate is collected, which is a part of the closed circuit.
A chamber is a part of a dialyzer , to store a set volume of dialysate and to supply it into the
dialyzer section. It also stores a set volume of used dialysate that is sent from a dialyzer, and
drains it into the drainage line.

8 Concentrate pump:
The pump that controls infusion volume of dialysate concentrate and B concentrate.

9 UF pump:
The pump that controls ultrafiltration

10 Closed line:
A closed line consists of a chamber, dialyzer, charging pump, coupler line, etc.

11 MAINTE screen:
The screen to display and change the equipment status, values detected by a sensor, various
settings, etc.

8-2
9. Other Adjustments

9.1 Zero compensation of the blood leak detector (BLD-01) ································ 9-2
9.1.1 How to perform a zero compensation ····················································· 9-2
9.1.2 Checking the REAL blood leak value by using a simulated filter ············· 9-3
9.1.3 Adjusting the REAL blood leak value ······················································ 9-4
9.2 Adjustment of Overload Sensitivity in Heparin Pump Assembly ····················· 9-5
9.2.1 Adjustment of Procedure········································································· 9-5
9.3 Adjustment of Concentration and Conductivity ··············································· 9-6
9.3.1 Calibration of Actual Concentration of “Water + Stock Solution A ··········· 9-6
9.3.2 Calibration of Actual Concentration of “Water + Stock Solutions A + B” ·· 9-8
9.3.3 Calibration of CD2 and CD3 Conductivities ··········································· 9-10
9.3.4 Calibration of CD1 Conductivity ······························································ 9-11
9.4 Blood pump: Switching to the line with a small diameter tube ························ 9-13
9.4.1 How to switch ·························································································· 9-13

9-1
9.1. Zero compensation of the blood leak detector (BLD-01)

Perform a zero compensation when the REAL blood leak value is 150 ppm or higher. (Check the
REAL blood leak value in MAINTE1.)

! CAUTION
 Blood leak detection can fail with a presence of foreign substance. Remove foreign substance
that may be present. Use water and disinfectant before checking the REAL blood leak value.

9.1.1. How to perform a zero compensation

Operate the blood leak detector in the standby mode after completing the cleaning process.
After operating the detector for 5 min or longer in the standby process, turn the adjustment
volume 1 of the blood leak detector to the left. Adjust the REAL blood leak value in the range of 30
to 40 ppm.

Note 1: Make sure that no air bubbles are inside the cartridge of the blood leak detector.
Note 2: When the adjustment volume 1 is turned excessively, the displayed value is slightly
lower than the actual value.

Blood leak detector

Adjustment volume 1 Adjustment volume 2

Make sure that the REAL blood leak value is 80 ppm or lower.

9-2
9.1.2. Checking the REAL blood leak value by using a simulated filter

Following the zero compensation, attach the simulated filter on the detector. Check if the
simulated blood leak value is displayed.

After energizing the unit for 5 min or longer, remove the cartridge of the blood leak detector in
accordance with the following diagram. (Install the cartridge for a zero compensation first.)

Loosen one screw


to remove the
cartridge.

Note: Pipework of the tube is not


necessary.

Read the REAL blood leak value after installing the cartridge for a zero compensation. ··· (A)
Next, install the cartridge with a simulated blood leak filter and read the REAL blood leak value.
··· (B)

Calculate the values (B)-(A). It is acceptable if (B)-(A) is within “the specification labeled on the
simulated blood leak filter ± 80 ppm or lower.”

Readjustment is necessary if it is out of the range. See “9.2.3. Adjusting a REAL blood leak
value” for readjustment.

Cartridge for a zero compensation Cartridge with a simulated blood leak filter

Cartridge for a
zero Cartridge
compensation with a filter

9-3
9.1.3. Adjusting the REAL blood leak value

As shown in 9.1.2. Checking the REAL blood leak value by using a simulated blood leak filter.
Readjustment is necessary if the REAL blood leak value that is measured with a simulated blood leak
filter, is out of range. Follow the adjustment procedure below. (Check the REAL blood leak value in
MAINTE1.)

1. Attach the cartridge for a zero compensation.


Important: Check if no air bubbles are present in the cartridge.

2. Turn the adjustment volume 2 , to adjust the REAL blood leak


value in a range of 80±10 ppm.
Important: Turn to the right, to increase the value.
And turn to the left, to decrease the value.

3. Attach the cartridge with a simulated blood leak filter.


Important: Check if no air bubbles are present in the cartridge.

4. Adjust the REAL blood leak value to the specified value


labeled on the simulated blood leak filter + 80”±10 ppm.

5. Repeat steps 1 to 4 until the REAL blood leak values in 2 and 4 will fit within the ranges.

6. After the values achieve the ranges, leave the cartridge with the simulated blood leak filter on
the system and decrease the REAL blood leak value by turning the adjustment volume 1. Adjust
the value until the system achieves the value of: “the REAL blood leak value in 4.” subtracted by
“the REAL blood leak value in 2.” Tolerance here is±8 ppm.

EXAMPLE) If the blood leak REAL value in 4 is 430 ppm and


the value in 2 is 80 ppm, 430 – 80 = 350±8 ppm is applied.
Turn the adjustment volume 1 to the left until 350±8 ppm.

7. Remove the cartridge with a simulated blood leak filter from the blood leak detector.

8. Attach the cartridge of the original blood leak detector and run the system for 5 min or longer in
the standby process. Subsequently, adjust the REAL blood leak value to 30 to 40 ppm by turning
the adjustment volume 1.
Important: Make sure that no air bubbles are mixed inside the cartridge.
Important: If the REAL blood leak value is >41 ppm, turn the adjustment volume 1 to the left.
Important: If the REAL blood leak value is <29 ppm, turn the adjustment volume 1 to the right.

9-4
9.2. Adjustment of Overload Sensitivity in Heparin Pump Assembly

9.2.1. Adjustment of Procedure

(1) Attach a syringe in the heparin pump.


(2) Adjust the syringe, using a nut, so that the syringe overload alarm is active when a pressure of
about 0.086MPa (500 to 800mmHg) is applied. (Refer to “7.2.11 Heparin Pump”.)
The syringe overload sensitivity changes by about 3.0N (0.3kgf) per rotation of the nut.

9-5
9.3. Adjustment of Concentration and Conductivity

9.3.1. Calibration of Actual Concentration of “Water + Stock Solution A”

Connect stock solution A of dialysate to be calibrated to the connector for


stock solution A, and connect water to the connector for stock solution B in
order to start the standby process (for dialysate creation).

Stock solution A
Water

Fig. 8-1 Connection of Stock Solution A and Water

9.3.1.1. Offset Adjustment


(1) Display the Bic. concentration setting window of the dialysis screen or CONC. SET screen.
(2) Change the Bic. concentration higher than the base concentration by 20mEq/L. By this
change, the setting concentration of A becomes lower than the base concentration by
20mEq/L.
(3) After approx. 10 min when the concentration stabilizes, collect sample dialysate from the
sample port and measure the actual concentration.
(4) Display the MAINTE 5 screen.
(5) Calculate an offset value based on a difference between the stock solution A setting
concentration and the actual concentration.
Offset value = “Setting concentration [mEq/L]” – “Actual concentration [mEq/L]“
(6) Select the A chamber side (upper side) of “water + A offset”.
(7) Change the offset value.
Value after the change = “Value before the change” + “Calculation value of (5)”
(8) Select the B chamber side (lower side) of “water + A offset”.
(9) Change the offset value in the same procedure as (7).
(10) After approx. 5 minutes when the concentration stabilizes again, collect sample fluid from the
sample port and measure the actual concentration. Check that the setting and actual
concentrations are the same. (If not, repeat the procedure from (5).)

9.3.1.2. Gain Adjustment


(1) Display the Bic. concentration setting window of the dialysis screen or CONC. SET screen.
(2) Change the Bic. concentration lower than the base concentration by 20mEq/L. By this
change, the setting concentration of A becomes higher than the base concentration by
20mEq/L.
(3) After approx. 5 min when the concentration stabilizes, collect sample dialysate from the

9-6
sample port and measure the actual concentration.
(4) Display the MAINTE 6 screen.
(5) Calculate the input value of P3 FLOW.
Input value = Actual concentration ÷ Setting concentration of A x Setting value of P3

Example) When the system is operated while the concentration of A is set to 130mEq/L,
actual concentration is 127mEq/L and 0.180 is input at P3 FLOW:

Input value = 127 ÷130×0.180=0.1758 → 0.176 by rounding off to three decimal places

Change the setting of P3 FLOW on the MAINTE 6 screen to 0.176.

(6) After approx. 5 minutes when the concentration stabilizes again, collect sample fluid from the
sample port and measure the actual concentration. Check that a difference between the
setting and actual concentrations is within ±2mEq/L. (If not, repeat the procedure from (5).)

9-7
9.3.2. Calibration of Actual Concentration of “Water + Stock Solutions A + B”

Continue from the procedure described in “9.3.1”.

Disconnect the connector for stock solution B from the connected water and
connect to the stock solution B of dialysate to be calibrated.

Stock solution A
Stock solution B

Fig. 8-2 Connection of Stock Solutions A and B

9.3.2.1. Offset Adjustment


(1) Display the Bic. concentration setting window of the dialysis screen or CONC. SET screen.
(2) Change the Bic. concentration lower than the base concentration by 10mEq/L. Also change
the dialysate concentration lower than the base concentration by 10mEq/L.
(3) After approx. 5 min when the concentration stabilizes, collect sample dialysate from the
sample port and measure the actual concentration.
(4) Display the MAINTE 5 screen.
(5) Calculate an offset value based on a difference between the dialysate setting concentration
and the actual concentration.
Offset value = “Setting concentration [mEq/L]” – “Actual concentration [mEq/L]”
(6) Select the A chamber side (upper side) of “water + A + B offset”.
(7) Change the offset value.
Value after the change = “Value before the change” + “Calculation value of (5)”
(8) Select the B chamber side (lower side) of “water + A + B offset”.
(9) Change the offset value in the same procedure as (7).
(10) After approx. 5 minutes when the concentration stabilizes again, collect sample dialysate from
the sample port and measure the actual concentration. Check that the setting and actual
concentrations are the same. (If not, repeat the procedure from (5).)

9.3.2.2.Gain Adjustment
(1) Display the Bic. concentration setting window of the dialysis screen or CONC. SET screen.
(2) Change the Bic. concentration higher than the base concentration by 10mEq/L. Also change
the dialysate concentration higher than the base concentration by 10mEq/L.
(3) After approx. 5 min when the concentration stabilizes, collect sample dialysate from the
sample port and measure the actual concentration.
(4) Display the MAINTE 6 screen.

9-8
(5) Calculate the input value of P4 FLOW.
Input value = (Actual concentration – A setting concentration) ÷ Setting concentration of B x
Setting value of P4

Example) When the system is operated while the concentration of A is set to 110mEq/L,
concentration of B is set to 40mEq/L, actual concentration is 153mEq/L and 0.30 is
input at P4 FLOW:

Input value =(153-110)÷40×0.30=0.322 → 0.32 by rounding off to two decimal places

Change the setting of P4 FLOW on the MAINTE 6 screen to 0.32

(6) After approx. 5 minutes when the concentration stabilizes again, collect sample dialysate from
the sample port and measure the actual concentration. Check that a difference between the
setting and actual concentrations is within ±2mEq/L. (If not, repeat the procedure from (5).)

9-9
9.3.3. Calibration of CD2 and CD3 Conductivities

Calibrate the indications of the B conductivity sensors CD2 and CD3. (CD3 is applicable only for
the machine equipped with an optional B powder cartridge.)

(1) Insert a conductivity meter into downstream side of CD2 and D3 each of the system to
circulate water. (Refer to the figure below.)
・CD2 or 3 does not need to be dismounted from the system. (Leave the harness
connected to the main unit.)
・Check that no air is trapped in the circuit.

CD2 CD3 Conductivity


meter

Water

Circulation
pump

(2) Display the SET 4 (Display correction of conductivity) screen.

(3) Add stock solution B to water until the conductivity becomes approx. 1mS/cm (within the
range of 0.7 – 1.3mS/cm). (The mixing ratio of water and solution B is “1000mL : 12mL”.)
(4) When the value on the conductivity meter stabilizes, input a REAL value of CD2 (CD3) at
INPUT (1) ((3)) and input a conductivity value of conductivity meter at BASE (1) ((3)). (As
a REAL value of CD2 (CD3), input a value displayed on the above screen.) (NOTE: Do
not press “MEMORY” displayed at this time. Press it only after the step (6) is finished.)
(5) Add stock solution B (about 36mL) until the conductivity becomes approx. 4mS/cm (within
the range of 3.7 – 4.3mS/cm).
(6) When the value on the conductivity meter stabilizes, input a REAL value of CD2 (CD3) at
INPUT (2) ((4)) and input a conductivity value of conductivity meter at BASE (2) ((4)). (As
a REAL value of CD2 (CD3), input a value displayed on the above screen.)
(7) Press “MEMORY”. Software offset is completed as soon as “MEMORY” disappears.

9-10
(8) Add water until the conductivity becomes approx. 2.5mS/cm (within the range of 2.2 –
2.8mS/cm).
(9) When the value on the conductivity meter stabilizes, check that a difference between the
displayed CD2 (CD3) and the conductivity is within ±2%.

! CAUTION
 For measurement of the conductivity, always use calibrated measuring instruments.

9.3.4. Calibration of CD1 Conductivity

Calibrate the indication on the dialysate conductivity sensor CD1.

(1) Insert a conductivity meter into downstream side of CD1 of the system to circulate water.
(Refer to the figure below.)
・CD1 does not need to be dismounted from the system. (Leave the harness connected
to the main unit.)
・Check that no air is trapped in the circuit.

CD1 Conductivity
meter

Water

Circulation
pump

(2) Dismount the electric console side cover on the right when viewed from the system front
side.
(3) Display the SET 4 (Display correction of conductivity) screen.

9-11
(4) Add stock solution A to water until the conductivity becomes approx. 16mS/cm (within the
range of 15 – 17mS/cm). (The mixing ratio of water and solution A is “1000mL : 42mL”.)
(5) When the value on the conductivity meter stabilizes, change the value input at “CD1:
PARAM” on the “Display correction of conductivity” screen until CD1 and the conductivity
meter indicate the same value.
(6) Add water (about 400mL) until the conductivity becomes approx. 12mS/cm (within the
range of 11 – 13mS/cm).
(7) When the value on the conductivity meter stabilizes, adjust the VR2 for the CD1 sensor of
the analog board until the CD1 of the system and the conductivity meter indicate the same
value.

(8) Add stock solution A until the conductivity becomes approx. 14mS/cm (within the range of
13 – 15mS/cm).
(9) When the value on the conductivity meter stabilizes, check that a difference between the
displayed CD1 and conductivity is within ±2%.

! CAUTION
 For measurement of the conductivity, always use calibrated measuring instruments

9-12
9.4. Blood pump: Switching to the line with a small diameter tube

9.4.1 How to switch

(1) Set the maximum flow rate for the blood pump (BP).
a. Display the MAINTE6 screen.
b. Set the rate from “BP MAX FLOW RATE”.

NOTE
 Set "blood pump MAX flow rate" under 300mL/min when using small diameter blood line.
 Set "blood pump MAX flow rate" under 600mL/min when using large diameter blood line.
 For type of blood line, refer to “21.7. Blood Lines” described in the instruction manual.

(2) Adjust the flow rate.


a. Remove the right upper side cover of the machine and cover of electrical BOX.
b. Adjust the VR3 on the I/O board.
Run the blood pump, and then adjust VR3 as actual flow rate is within ±10% of
displayed flow rate.

NOTE
 Current actual rotation speed [rpm] of blood pump can be confirmed by "BP REAL" display in
MAINTE4 screen.
 When the tube diameter is φ6.35×φ9.75±0.15mm, rotation speed of blood pump is
approximately 33.3 rpm when the blood pump flow rate is 200mL/min.
 When the tube diameter is φ8.00×φ12.00±0.15mm, rotation speed of blood pump is
approximately 23.4 rpm when the blood pump flow rate is 200mL/min.

! CAUTION
 After switching to a small diameter line, check the actual flow rate, and ensure that the precision
of ultrafiltration is not changed.

9-13
9-14
Nipro Corporation
3-9-3, Honjo-Nishi, Kita-ku, Osaka 531-8510, JAPAN
Phone +81-6-6372-2331

Nipro Europe N.V.


Weihoek 3 H 1930 Zaventem BELGIUM
Phone +32-(0)2 725 55 33

CX1213-1709-ENG0 (25 Sep. 2017)

0123

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