56
Adjustment Procedure List <Normal> No. Identification No. Document name Option 1 BHAJ01-001 PV/PA Board Calibration 2 BHAJ01-002 Dialysate Pressure Sensor Calibration 3 BHAJ01-003 Temperature Sensor Calibration①(T2/T3/T7) 4 BHAJ01-004 Temperature Sensor Calibration②(T4/T5/T6) 5 BHAJ01-005 Conductivity Sensor Calibration(CD1/CD2/CD3) 6 BHAJ01-006 Bubble Detector Calibration 7 BHAJ01-007 Blood Leakage Sensor Calibration 8 BHAJ01-008 Shutoff Pressure Adjustment 9 BHAJ01-009 Filling Flow Adjustment 10 BHAJ01-010 RV2 Adjustment 11 BHAJ01-011 P3, P4 Flow Adjustment 12 BHAJ01-012 Clamp Leak Test 13 BHAJ01-013 Syringe Test 14 BHAJ01-014 Blood Pump Shutoff Status Check 15 BHAJ01-015 Blood Pump Flow Adjustment 16 BHAJ01-016 Balance Test 17 BHAJ01-017 UFP Flow Measurement 18 BHAJ01-018 UF Precision Test 1 19 BHAJ01-019 UF Precision Test 2 (during SQHD) 20 BHAJ01-020 Gas Purge Pressure Adjustment 21 BHAJ01-021 Chamber Volumetric Measurement 22 BHAJ01-022 Temperature Sensor Calibration ③ (T1) <Hot disinfection with citric acid ASSY, Dialysate flow ASSY and high flow ASSY> No. Identification No. Document name Option 23 BHAJ00-023 Shutoff Pressure Adjustment 24 BHAJ00-024 Filling Flow Adjustment 25 BHAJ00-025 RV2 Adjustment 26 BHAJ00-026 P3, P4 Flow Adjustment Caution Remove static electricity, using an earth-band when a board is maintained or changed. Do not touch any point other than the mentioned point by a tester when a board is maintained, connecting probes or IC clips of tester. It could be a cause of board breakdown, depending on the touched place. Do not touch any board, electric wiring or terminal except for a maintenance. Do not touch any electric wiring or terminal which is not isolated. Do not touch any board with wet hand. Pull out a power plug from an outlet when the harness is removed from a Terminal block. Use a tester which is “True RMS TYPE” to measure precise alternating current value. * RMS: Root Mean Square

Calibration Manual

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Manuel Calibration

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Page 1: Calibration Manual

Adjustment Procedure List <Normal>

No. Identification No. Document name Option

1 BHAJ01-001 PV/PA Board Calibration

2 BHAJ01-002 Dialysate Pressure Sensor Calibration

3 BHAJ01-003 Temperature Sensor Calibration①(T2/T3/T7)

4 BHAJ01-004 Temperature Sensor Calibration②(T4/T5/T6)

5 BHAJ01-005 Conductivity Sensor Calibration (CD1/CD2/CD3)

6 BHAJ01-006 Bubble Detector Calibration

7 BHAJ01-007 Blood Leakage Sensor Calibration

8 BHAJ01-008 Shutoff Pressure Adjustment

9 BHAJ01-009 Filling Flow Adjustment

10 BHAJ01-010 RV2 Adjustment

11 BHAJ01-011 P3, P4 Flow Adjustment

12 BHAJ01-012 Clamp Leak Test

13 BHAJ01-013 Syringe Test

14 BHAJ01-014 Blood Pump Shutoff Status Check

15 BHAJ01-015 Blood Pump Flow Adjustment

16 BHAJ01-016 Balance Test

17 BHAJ01-017 UFP Flow Measurement

18 BHAJ01-018 UF Precision Test 1

19 BHAJ01-019 UF Precision Test 2 (during SQHD)

20 BHAJ01-020 Gas Purge Pressure Adjustment

21 BHAJ01-021 Chamber Volumetric Measurement

22 BHAJ01-022 Temperature Sensor Calibration ③ (T1)

<Hot disinfection with citric acid ASSY, Dialysate flow ASSY and high flow ASSY>

No. Identification No. Document name Option

23 BHAJ00-023 Shutoff Pressure Adjustment

24 BHAJ00-024 Filling Flow Adjustment

25 BHAJ00-025 RV2 Adjustment

26 BHAJ00-026 P3, P4 Flow Adjustment

Caution ● Remove static electricity, using an earth-band when a board is maintained or changed. ● Do not touch any point other than the mentioned point by a tester when a board is

maintained, connecting probes or IC clips of tester. It could be a cause of board breakdown, depending on the touched place.

● Do not touch any board, electric wiring or terminal except for a maintenance. ● Do not touch any electric wiring or terminal which is not isolated. ● Do not touch any board with wet hand. ● Pull out a power plug from an outlet when the harness is removed from a Terminal block. ● Use a tester which is “True RMS TYPE” to measure precise alternating current value.

* RMS: Root Mean Square

Page 2: Calibration Manual

Dialysate Circuit Flow Chart Flow chart (B Powder Assy)

Page 3: Calibration Manual

Flow chart (B Powder Assy, Hot citric acid disinfection Assy, Dialysate variable control Assy, High-flow compatible Assy)

1-2

Page 4: Calibration Manual

BHAJ01-001

1. PV/PA Board Calibration

Standard Standard During air release :0±2mmHg During air release :0±2mmHg

During pressurization with 300mmHg :300±5mmHg (reference value: -300±30mmHg)During pressurization with 300mmHg :300±5mmHg (reference value: -300±30mmHg)

During self-diagnosis :440±20mmHg During self-diagnosis :440±20mmHg

Required jig Pressure gauge, piping components, pean pincer x 1, ceramic driver for adjustment,

syringe, tester

Purpose To calibrate 2 points of offset and gain if the error is out of range,

comparing device indication and manometer value.

<Illustration> <Procedure>

Remove the cover of the upper left side.

For the two PV/PA placed in a row, the upper one is the

venous pressure sensor board (PV) and the lower is the

arterial pressure sensor board (PA).

Open the screen of Maintenance 1 “Dialysis data display”, “

Pressure.”

【During air-release(offset adjustment)】

Set the pressure port to air-release and adjust the VR2

of the PV/PA board so that the displayed value becomes

0±2mmHg.

CN401

TP1

TP2

VR2

VR3

VR1

【During pressurization with 300mmHg (gain adjustment)】

Pressurize by syringe, and when the pressure gauge value

becomes approximately 300mmHg, shut off the silicon tube

with pean pincers to fix the pressure.

memo

If the pressure tends to be lowered even after

shutting off the silicon tube with pean pincers, fix

at the pressure slightly higher than 300mmHg and wait

until the pressure becomes approximately 300mmHg.

Connection of pressure gauge

1-1

Page 5: Calibration Manual

BHAJ01-001

Adjust the VR1 of the PV/PA board so that the displayed

value of pressure gauge indicates 300±5mmHg when its

actual value is 300mmHg.

CN401

TP1

TP2

VR2

VR3

VR1

Repeat the offset adjustment and gain adjustment until

entering the standard value range.

【Check during pressurization with -300mmHg】

To check the linearity of the sensor output value, when

0mmHg and +300mmHg enter the standard value range, add

-300mmHg with the syringe to the venous (arterial)

pressure and check that the difference between the

indication and displayed value is approximately ±30.

Change the board when the value can not be in this range.

memo

This is only a check, so adjustment

of the difference between indication

and pressure gauge is unnecessary.

If below standard, replace the board.

【Adjustment of self-diagnosed value】

MAINTEBPM

MAINTENANCE MENU Ver1.00

SETTING MAINTE SYSTEM

OPTION ADJUST

● How to display the “Adjustment” menu

To adjust the self-diagnosed value, the “Adjustment

” menu needs to be displayed. Simultaneously press the

two parts indicated with ○ in the left figure for 3

seconds using the maintenance tag and the “ADJUST”

switch is displayed as shown left.

Set the device to the rinse stand by process.

Press the PV (PA) switch at Adjustment 4 “ROM version

display” to simulatingly obtain the output voltage for

self-diagnosis.

memo

During preparation stand by process,

output voltage for self-diagnosis cannot

be obtained.

1-2

Page 6: Calibration Manual

BHAJ01-001

1-3

<Adjustment with voltage>

Connect the tester (+) probe to TP1 on the PV/PA board

and connect the (-) probe to TP2.

Set the tester range to “VDC” and adjust VR3 so that

the measured value for it becomes DC4.70±0.10V.

<Adjustment with display>

When calibrating with the display, adjust VR3 so that the

displayed value becomes 440±20mmHg.

Caution

The “Adjustment”

menu is for the manufacturer to perform adjustment

and contains important

items related to device control. After using it,

be sure to hide it to prevent

uninformed personnel from changing the contents.

How to hide the menu is the same as how to display it.

Page 7: Calibration Manual

BHAJ01-002

2. Dialysate Pressure Sensor Calibration

Standard During air release:0±2mmHg

During pressurization with 300mmHg:300±5mmHg (reference value: -300±30mmHg)

Required jig Pressure gauge, piping components, pean pincer x 3, ceramic driver for adjustment,

syringe

Purpose To calibrate 2 points of offset and gain if the error is out of range,

comparing device indication and manometer value.

<Illustration> <Procedure>

【Draining water in the dialysate pressure sensor】

Caution

Ensure that the breaker is turned off.

Remove the cover for the lower left face.

Referring to BHSM**-019, remove the dialysate pressure

sensor to drain out the dialysate in the dialysate

pressure sensor.

Insert the silicon tube at the lower part into the

dialysate pressure sensor with the tube shut off with the

pean pincer then install the dialysate pressure sensor to

the device.

【During air release (offset adjustment)】

Remove the cover of the dialysate pressure sensor.

Install the connector “PD” to the dialysate pressure

sensor board “CN1”.

Turn on the breaker and I/O switch.

With the Maintenance 6 screen “Device calibration”, set

the dialysate pressure display offset to 0. If the

dialysate pressure display offset is input intentionally,

write down the input value for inputting again after

adjustment.

Open the “Pressure” screen of Maintenance 1 “Displaying

dialysis data.”

TP1

TP2

VR2

VR1

CN1

2-1

Page 8: Calibration Manual

BHAJ01-002

3-2

<Illustration> <Procedure>

Adjust the VR2 of the dialysate pressure sensor board so

that the dialysis pressure displayed value becomes 0±

2mmHg during air release.

【During pressurization with 300mmHg (gain adjustment)】

Connect the piping components to the dialysate pressure

sensor to pressurize with the syringe. At the point where

the pressure gauge value indicates approximately 300mmHg,

shut off the silicon tube with the pean pincer to fix the

pressure.

memo

If the pressure tends to be lowered even after shutting

off the silicon tube with the pean pincer, fix at the

pressure slightly higher than 300mmHg and wait until

the pressure becomes approximately 300mmHg.

Connecting the pressure gauge

TP1

TP2

VR2

VR1

CN1

Adjust the VR1 of the dialysate pressure sensor board

so that the displayed value of pressure gauge indicate

s 300±5mmHg when its actual value is 300mmHg.

Repeat the offset adjustment and gain adjustment until

entering the standard value range.

【Check during pressurization with -300mmHg】

To check the linearity of the sensor output value, when

0mmHg and +300mmHg enter the standard value range, add

-300mmHg with the syringe and check that the difference

between the indication and pressure gauge value is within

±30.

memo

This is only a check, so adjustment of the difference

between indication and pressure gauge is unnecessary.

Page 9: Calibration Manual

BHAJ01-003

3. Temperature Sensor Calibration①(T2/T3/T7)

Standard T2/T3/T7:25℃±0.2℃, 40℃±0.2℃

Required jig Temperature calibration device (Code NO.0-506-001), ceramic driver for adjustment,

Phillips screwdriver

Purpose To calibrate 2 points of offset and gain if the error is out of range,

comparing device indication and manometer value.

<Illustration> <Procedure>

Caution

●Ensure the breaker is turned off.

Remove the cover of the upper right face and the electric

cover.

Remove the connector for the temperature sensor to be

worked on, which is on the I/O board, and install the

temperature calibration device.

* Select based on the temperature sensor to be adjusted.

Temperature sensor Connector name

T2 Heater outlet

temperature CN215

T3 Dialysate

temperature CN216

T7 Coupler

temperature CN246

Temperature calibration device dummy resistance value

Temperature Resistance value

25℃ 8.494±0.024 kΩ

40℃ 8.904±0.024 kΩ

【Configuration of conductivity sensor module board】

Right face of the device Temperature sensor module board

3-1

Page 10: Calibration Manual

BHAJ01-003

3-2

<Illustration> <Procedure>

Turn on the breaker and I/O switch to confirm the

indicated temperature with the Maintenance 1 “Dialysate data display” and “Temperature/concentration.”

【(Gain adjustment) at 25℃】

Adjust the adjustment VR on the temperature sensor

module board so that the indicated temperature becomes

25.0±0.2℃ when the knob of the temperature

calibration device is set to 25℃.

【(Offset adjustment) at 40℃】

Adjust the adjustment VR on the temperature sensor

module board so that the indicated temperature becomes

40.0±0.2℃ when the knob of the temperature

calibration device is set to 40℃.

Repeat【offset adjustment】 and 【gain adjustment】until

entering the standard value range.

VR1

VR2

VR3

VR4

VR5

VR6

* Select based on the temperature sensor to

be adjusted.

* VR is on the temperature sensor module.

Temperature

sensor VR at 25℃ VR at 40℃

T2 VR3 VR4

T3 VR5 VR6

T7 VR1 VR2

VR configuration of temperature sensor

module board

Page 11: Calibration Manual

BHAJ01-004

4. Temperature Sensor Calibration②(T4/T5/T6)

Standard T4/T5/T6: 25℃±0.2℃、40℃±0.2℃

Required jig Temperature calibration device (Code No. 0-506-001), ceramic driver for adjustment,

Phillips screwdriver

Purpose To calibrate 2 points of offset and gain if the error is out of range,

comparing device indication and manometer value.

<Illustration> <Procedure>

Caution

※ Ensure that the breaker is turned off.

Remove the cover of the upper right face and the electric

cover.

Remove the connector for the temperature sensor to be

worked on, which is on the I/O board, install the

temperature calibration device.

* Select based on the temperature sensor to be adjusted.

Temperature sensor Connector name

T4 For CD1 temperature

compensation CN217

T5 For CD2 temperature

compensation CN234

T6 For CD3 temperature

compensation CN239

Temperature calibration device dummy resistance value

Temperature Resistance value

25℃ 8.494±0.024 kΩ

40℃ 4.904±0.024 kΩ

【Configuration of conductivity sensor module board】

Right face of the device CD1 CD2 CD3

4-1

Page 12: Calibration Manual

BHAJ01-004

4-2

<Illustration> <Procedure>

memo

Adjustment VR for T4/T5/T6 is on the conductivity

sensor module board, not on the temperature sensor

module board.

Turn on the breaker and I/O switch to confirm the

indicated temperature with the Maintenance 1 “Dialysate data display” and “Temperature/concentration.”

【(Gain adjustment) at 25℃】

Adjust the adjustment VR on the conductivity sensor

module board so that the indicated temperature becomes

25.0±0.2℃ when the knob of the temperature

calibration device is set to 25℃.

【(Offset adjustment) at 40℃】

Adjust the adjustment VR on the conductivity sensor

module board so that the indicated temperature becomes

40.0±0.2℃ when the knob of the temperature

calibration device is set to 40℃.

Repeat【offset adjustment】 and 【gain adjustment】until

entering the standard value range.

VR1

VR2

VR3

VR4

VR5

* Select based on the temperature sensor to be

adjusted.

* VR is on the temperature sensor module.

Temperature

sensor VR at 25℃ VR at 40℃

T4 (CD1) VR4 VR5

T5 (CD2) VR4 VR5

T6 (CD3) VR4 VR5

VR configuration of

conductivity sensor module board

Page 13: Calibration Manual

BHAJ01-005

5. Conductivity Sensor Calibration (CD/CD2/CD3)

Standard

Standard voltage waveform :100±1.0mVAC

CD1 :2.50±0.02VDC (offset), 5.00±0.02VDC(gain)

CD2/CD3 :0.20±0.02VDC (offset), 1.50±0.02VDC (gain)

Required jig Concentration calibration device (Code No. 0-506-007), ceramic driver for adjustment,

Phillips screwdriver, tester

Purpose To calibrate 2 points of offset and gain if the error is out of range,

comparing device indication and manometer value.

<Illustration> <Procedure>

Caution

Ensure that the breaker is turned off.

Remove the cover of the upper right face and the electric cover for

the right face. Remove the connector for the conductivity sensor to

be worked on, which is on the I/O board, and install the concentration

calibration device.

*Select based on the conductivity sensor to be adjusted.

Conductivity sensor Connector name

CD1 A+B conductivity CN218

CD2 B conductivity (moni) CN233

CD3 B conductivity (cont) CN238

Concentration calibration device dummy resistance value

Cond. sensor Conductivity Resistance value

30mS 133.3±0.1Ω CD1

15mS 266.6±0.1Ω

9mS 444.4±0.1Ω CD2/CD3

1.2mS 3333.3±1.0Ω

【Configuration of conductivity sensor module board】

Right face of the device CD1 CD2 CD3

5-1

Page 14: Calibration Manual

BHAJ01-005

5-2

<Illustration> <Procedure>

Turn on the breaker and I/O switch.

【Adjustment of standard voltage waveform】

Adjust the conductivity sensor to be worked on under the

following conditions.

Set the tester range to “VAC.”

Tester (+) probe Conductivity sensor module board TP2

Tester (-) probe I/O board WJ1

Standard 100±1.0mVAC

Adjustment VR Conductivity sensor module board VR3

【Gain adjustment】

Adjust the adjustment VR on the conductivity sensor

module board so that the tester voltage becomes standard

when the knob of the concentration calibration device

is aligned.(Do not refer to the indicated conductivity

of screen as it’s compensated value by 25 degrees.) 【Offset adjustment】

Adjust the adjustment VR on the conductivity sensor

module board so that the tester voltage becomes standard

when the knob of the concentration calibration device

Is aligned. (Do not refer to the indicated conductivity

of screen as it’s compensated value by 25 degrees.)

Repeat【offset adjustment】 and 【gain adjustment】until

entering the standard value range.

VR1

VR2

VR3

VR4

VR5

TP2

TP4TP3TP1

* Set the tester range to “VDC.”

* Select based on the conductivity sensor to be

adjusted.

Standard

Tester (+) probe Conductivity sensor module board TP1

Tester (-) probe I/O board WJ1

Gain adjustment VR Conductivity sensor module board VR1

Offset adjustment VR Conductivity sensor module board VR2

Conductivity

sensor

Concentration

calibration device

Knob

Standard (VDC)

30mS (gain) 5.00±0.02 CD1

15mS (offset) 2.50±0.02

9mS (gain) 1.50±0.02 CD2/CD3

1.2mS (offset) 0.20±0.02

Configuration of conductivity sensor module board

Page 15: Calibration Manual

BHAJ01-006

6. Bubble Detector Calibration

Standard 3.75±0.25V with the tube installed, 0.2V or less without the tube

Single foam of 0.03mL+0.005 is to be detected.

Required jig Blood circuit, tester, ceramic driver for adjustment, micro syringe

Purpose ・To calibrate output voltage of bubble detector.

・Confirmation of air bubble sensor detection.

<Illustration> <Procedure>

Caution

● Ensure that the breaker is turned off.

Remove the cover of the upper right face and the electric

cover.

Turn on the breaker and I/O switch.

Set the foam detection condition setting of Maintenance

2 “Alarm setting” to “single 10.”

○ Bubble detection condition setting

“Single 10” Single bubble 10μL detected

“1” Integrated bubble 1μL detected.

“50” Integrated bubble 50μL detected.

“100” Integrated bubble 100μL detected.

* Integration mode is based on the integrated amount per

5 minutes.

【Configuration of bubble sensor module board】

Right face of the device Bubble sensor module board

6-1

Page 16: Calibration Manual

BHAJ01-006

6-2

<Illustration> <Procedure>

【Voltage adjustment】

VR1

TP1

Set the standard tube containing the hot water of

approximately 37℃ to the bubble detector.

Set the tester range to “VDC.” Connect the tester (+) probe to TP1 on the bubble sensor

module board.

Connect the tester (-) probe to WJ1 on the I/O board.

Confirm 4.0V or more is obtained when VR1

on the bubble sensor module board is set to MAX.

Configuration of bubble sensor

module board

After confirmation, set to 3.50 to 4.00V again with VR1.

【Detection confirmation】

Set the device to the dialysis stand by process.

(To revolute blood pump)

Rotate the blood pump by 200mL/min. to circulate the hot

water of approximately 37℃ in the blood circuit.

Turn on the bubble detector operation switch and confirm

that the clamp is closed, blood pump stops and “Bubble

alarm” is detected when bubble of 0.03mL is infused

with a micro syringe.

Confirm that the TP1 voltage value becomes 0.2V or less

and “Bubble alarm” is detected when removing the tube

from the bubble sensor.

Set the foam detection condition setting of Maintenance

2 “Alarm setting” to the initial value.

* If ABD does not detect air with above condition,

replace the sensor or the board.

Page 17: Calibration Manual

BHAJ01-007

7. Blood Leakage Sensor Calibration

Standard Standard

【① Confirmation of blood leakage REAL value】:

Self-diagnosis should be acceptable with 150ppm or less.

【① Confirmation of blood leakage REAL value】:

Self-diagnosis should be acceptable with 150ppm or less.

【③ Confirmation with Conf simulation blood leakage filter】:

Blood leakage REAL value after calculation should be not be more than the standard

value ±80ppm described on the simulation blood leakage filter.

【③ Confirmation with Conf simulation blood leakage filter】:

Blood leakage REAL value after calculation should be not be more than the standard

value ±80ppm described on the simulation blood leakage filter.

Required jig Phillips screw driver, ceramic driver for adjustment, BLD-01 calibration cartridge

Purpose To confirm whether blood leak is detected properly or not.

To detect blood leak properly.

【Flow chart】

【①漏血REAL値の確認】

【③擬似漏血フィルタによる確認】

【②ゼロ補正】

・150・自己

ppm以下で自己診断OK

・標

・150

【④漏血REAL値の調整】

ppm以上診断NG

準規格外

・標準規格内

· Self-diagnosis is acceptable with

150ppm or less.【① Confirmation of

blood】

· 150ppm or more

· Self-diagnosis is not

acceptable.

【② Zero calibration】

· Within the standard

【③ Confirmation by

simulation blood leakage

filter】

· Outside the standard

【④ Adjustment of

blood leakage REAL value】

終了Completed

7-1

Page 18: Calibration Manual

BHAJ01-007

<Illustration> <Procedure>

【① Confirmation of blood leakage REAL value】

1. Display Maintenance 1 “Dialysis data display” blood leakage screen.

2. Confirm the blood leakage REAL value with no dirt or bubbles on the

blood leakage cartridge window.

3. Procedure is completed if self-diagnosis is acceptable with 150ppm

or less.

・If self-diagnosis is not acceptable, proceed to

【②Zero calibration】.

・If 150ppm or more, proceed to 【②Zero calibration】.

【②Zero calibration】

Caution

Make adjustment after making sure that no dirt is attached by rinsing with water, disinfenctant and acid.

Compensation with the dirt attached may cause the blood

leakage detection value to deviate.

<Purpose>

Set the blood leakage REAL value to 30 to 40ppm with no

dirt or bubbles on the blood leakage cartridge window when

the blood leakage REAL value is 150ppm or more.

<Reason why the blood leakage REAL value should be

adjusted to 30 to 40ppm, not 0>

No blood leakage REAL values that are 0ppm or less shall

not be indicated, so if it is set to 0ppm, there is no

judging whether it is 0 or under 0. Therefore, 30 to 40ppm,

a little higher, shall be used for adjustment.

1. Operate the device for more than 5 minutes by T WTR

rinsing operation.

2. Remove the front cover.

3. Remove the blood leakage sensor cartridge, confirm

there is no bubble within the cartridge, then return the

cartridge to the original position.

Caution

When removing the blood leakage sensor cartridge, do

7-2

Page 19: Calibration Manual

BHAJ01-007

<Illustration> <Procedure>

not lose O-rings at the both ends. These O-rings prevent

the dialysate from entering the board when there is a

leak on the cartridge.

4. Display Maintenance 1 “Dialysis data display” blood leakage screen.

5. Adjust the adjustment VR1 so that the blood leakage REAL

value becomes 30 to 40ppm.

Caution

Rotate the adjustment VR1 counterclockwise when the

blood leakage REAL value is 41ppm or more.

Rotate the adjustment VR1 clockwise when the blood

leakage REAL value is 29ppm or less.

6. Proceed to【③ Confirmation by the simulation blood

leakage filter】.

【③ Confirmation by the simulation blood leakage filter】

<Purpose>

Adjustment VR2

(GAIN)

Adjustment VR1

(OFFSET)

Make a blood leakage state by the simulation blood leakage

filter, confirm the blood leakage REAL value rises up to

the standard (refer to the followings) in that state, then

confirm the blood leakage sensor detects the leakage

normally.

Caution

If the bubbles remain in the zero compensation

cartridge, remove them by patting or shaking.

1. Remove the cartridge of the blood leakage sensor and

install the zero compensation cartridge.

* The blood leakage REAL value at this time is to be (A).

Caution

If the bubbles remain in the cartridge with simulation

blood leakage filter, remove them by patting or

shaking.

2. Remove the zero compensation cartridge and install the

7-3

Page 20: Calibration Manual

BHAJ01-007

<Illustration> <Procedure>

cartridge with the simulation blood leakage filter.

* The blood leakage REAL value at this time is to

be (B).

3. Confirm the value obtained by (B) – (A) is in the range of ±80ppm from the standard value indicated on the

simulation blood leakage filter.

4. The procedure is completed if

within the standard range.

・If out of the standard range, proceed to 【④ Adjustment

of the blood leakage REAL value】.

【④ Confirmation of blood leakage REAL value】

<Purpose>

Adjust the blood leakage sensor so that it detects the

blood leakage state normally.

“Zero point adjustment” 1. Replace on the zero compensation cartridge with the

same procedure as【③ Confirmation by the simulation

blood leakage filter】

2. Adjust the adjustment VR2 so that the blood leakage REAL

value becomes 80±10ppm.

Caution

Rotate the volume clockwise when the blood leakage REAL value is over the standard value. Rotate the volume

counterclockwise when the blood leakage REAL value is

under the standard value.

“Adjustment by the simulation blood leakage filter” 3. Replace on the cartridge with the simulation blood

leakage filter with the same procedure as

【③ Confirmation by the simulation blood leakage

filter】

Adjustment

VR2 (GAIN)

7-4

Page 21: Calibration Manual

BHAJ01-007

7-5

<Illustration> <Procedure>

4. Adjust the adjustment VR1 so that the blood leakage REAL

value becomes the standard value indicated on the

simulation blood leakage filter +80±10ppm.

5. Repeat the zero point adjustment and the simulation

blood leakage filter adjustment until the blood leakage

REAL value enters in the range.

6. Remove the cartridge with the simulation blood leakage

filter.

7. Install the original cartridge, operates for 5 minutes

by T WTR rinse operation, then adjust VR1 so that the blood

leakage REAL value becomes 30 to 40ppm.

Caution

Ensure that the both ends of the cartridge are

installed with O-rings.

Adjustment VR1

(OFFSET)

Page 22: Calibration Manual

BHAJ01-008

8. Shutoff Pressure Adjustment (Standard model)

Standard Reducing valve:0.034 to 0.038MPa (257 to 287mmHg)

Fill-up pressure:0.088 to 0.098MPa(0.9 to 1.0kgf/cm2)

Required jig Pressure gauge, piping components, pean pincer x 2, hexagon wrench (5mm),

monkey wrench

Purpose Adjustment reducing valve: To make proper secondary pressure.

Adjustment of fill-up pressure: To make a proper pressure in the closed circuit.

<Illustration> <Procedure>

【Adjustment of reducing valve】

Remove the cover of the upper right face and the front

cover.

Set the device to the preparation stand by process.

Attach a pressure gauge to out side of reducing valve.

Turn ON the V1 and V10 manually with Maintenance 4

“Operation status.” Confirm the dialysate pressure value. If it is outside the

range of 0.034 to 0.038MPa (257 to 287mmHg), adjust the

reducing valve with a hexagon wrench of 5mm, aiming at

0.037MPa (280mmHg).

After adjustment, open V4 manually for approximately 2

seconds to let out the pressure contained in the device.

When the reducing valve has been adjusted, repeat the

above-mentioned procedure to confirm the reproductivity

of the pressure value.

【Adjustment of fill-up pressure】

Remove the front cover and the cover for the lower left

face.

Install the piping components and pressure gauge at the

confluence part of the P4 discharge and the mainstream.

Mounting position of pressure gauge

8-1

Page 23: Calibration Manual

BHAJ01-008

8-2

<Illustration> <Procedure>

Pressure gauge is mounted.

Operate the device in the preparation state.

When filling is completed, adjust the relief valve 1 (RV1)

so that the pressure gauge value is within the standard

range (0.088 to 0.098MPa(0.9 to 1.0kgf/cm2)).

Fix the lock nut with a monkey wrench after completing the

RV1 adjustment.

【Configuration of RV1】

Left face RV1 is attached to the OUT side line of AS1.

Page 24: Calibration Manual

BHAJ01-009

9. Filling Flow Adjustment (Standard model)

Standard Filling time must be the range of 45 to 48 seconds when 630 to 680mL/min.

Required jig Flowmeter, flathead screwdriver, stopwatch

Purpose To fill up a chamber of filling side before the liquid of closed circuit side is run

out.

<Illustration> <Procedure>

Remove the front cover.

【Adjustment by stopwatch】

Operate in the preparation process.

Display Maintenance 4 “Operation status.”

Measure with a stopwatch the time from the changeover of

A/B chamber until FS1 is turned on (no dialysate flow).

Adjust the needle valve (NV1) so that the measurement time

is within the standard range (45 to 48 seconds).

【Adjustment by flowmeter】

Install the flowmeter to the drainage line and operate in

the preparation state.

Adjust the needle valve (NV1) so that the reading of the

flowmeter installed on the drainage line is within the

standard range (630 to 680mL/min).

Caution

● Flow rate is different at pump flashing and completion

of filling.

● Note that the reading position of the flow against the

float depends on the manufacturer and type of the

flowmeter. For our genuine flowmeter, top face of the

float is to be the reading point.

9-1

Page 25: Calibration Manual

BHAJ01-010

10. RV2 Adjustment (Standard model)

Standard Maximum dialysate flow: 700mL/min

Bypass flow: 500mL/min

Required jig Flathead screwdriver, monkey wrench, flowmeter, pressure gauge, pean pincer,

piping components

Purpose Adjustment of RV2 : To make a proper pressure in the closed circuit.

Bypass flow : To adjust dialysate flow during bypass.

<Illustration> <Procedure>

【When normal】

Remove the front cover and the cover for the lower left

face.

Fully open NV2 and adjust RV2 so that the dialysate flow

at that time becomes 700mL/min.

NV2

Fix the lock nut with a monkey wrench after completing the

RV2 adjustment.

Adjust NV2 so that the flow rate for using dialysate flow

can be obtained. (Normally 500L/min)

<Bypass flow>

Adjust the flow for bypass to 500mL/min with PC1.

【Configuration of RV2】

Left face

RV2 is attached to the OUT side line of AS2.

10-1

Page 26: Calibration Manual

BHAJ01-010

10-2

<Illustration> <Procedure>

【Bypass flow】

Adjust the flow to 500ml/min when it’s bypass.

After adjustment, apply paste ”1401C” to PC1 to fix

it.

【Configuration of PC1】

Right face

PC1(Bypass flow)

Page 27: Calibration Manual

BHAJ01-011

11. P3, P4 Flow Adjustment

Standard Standard P3 actual flow: 13.3 to 15.3g (per 1 round) P4 actual flow:17.5 to 18.5g (per 1 round)P3 actual flow: 13.3 to 15.3g (per 1 round) P4 actual flow:17.5 to 18.5g (per 1 round)

Required jig Electric scale, container (approximately 2L)

Purpose Measure discharge volume and

calculate the coefficient value, to infuse precise solution.

<Illustration> <Procedure>

Remove the front cover.

To uniform the suction amount of the concentrate solution,

rotate the P3 and P4 spindle to the position shown in the

figure.

Face up the white circle part.

<Configuration of concentration solution pump>

Upper one is P4.

Lower one is P3.

Set the chamber volume of Maintenance 5 “Concentrate calibration” to 500mL for both A and B.

Set the coefficient “P3 flow” and “p4 flow” of Maintenance 6 “Device calibration” to the following values.

○Theoretical figure for each coefficient

P3 flow P4 flow

Normal 0.130 0.60

Normal + B powder 0.130 0.30

11-1

Page 28: Calibration Manual

BHAJ01-011

11-2

<Illustration> <Procedure>

Operate the device in the preparation state.

① Set the container containing water to the electric

scale and perform zero reset.

② Put the A dialysate (P3) concentration solution

connector in the container and measure the suction

amount of the A dialysate for 3 rounds continuously.

③ Take out the A dialysate (P3) concentration solution

connector from the container and read the value on the

electric scale.

Measure the B dialysate (P4) similarly.

Based on the measured value, calculate the coefficient by

the following formula.

P3 = (measured value ÷3)÷P3 theoretical value

P3 = (measured value ÷4)÷P3 theoretical value

P3 theoreti

cal value

P4 theoreti

cal value

Normal 109.846 30

Normal + B powder 109.846 60

Input the obtained coefficient to Maintenance 6 “Device calibration” and measure for 3 rounds each suction amount

again.

Based on the measured value, calculate the coefficient by

the following formula.

Measured value ÷3 = suction amount per 1 round

If the calculation result is within the standard range,

regarded as passed.

If out of standard range, perform measurement again.

Return the chamber volume of Maintenance 5 “Device calibration” to the original value.

Page 29: Calibration Manual

BHAJ01-012

12. Clamp Leak Test

Standard Standard 1mmHg or less/ 2 minutes 1mmHg or less/ 2 minutes

Required jig Pressure gauge, piping components, pean pincer x 2, syringe, stopwatch

Purpose Leak test in clamped state

<Illustration> <Procedure>

Set the pressure gauge, piping components (with no water),

syringe to the clamp.

With bubbles, turn on the bubble detector operation switch

to clamp.

Pressurize with a syringe and fix the pressure gauge value

to 150mmHg with pean pincers.

Pressure can be easily pulled out immediately after

fixation, so leave it for approximately 90 seconds.

The pressure gauge value after leaving for 90 seconds is

to be A.

The pressure gauge value after leaving for another 2

minutes is to be B.

Shut off the adjusting tool for leakage test with a forceps

as in the left figure.

The pressure gauge value after leaving for another 2

minutes is to be C.

The value obtained by (A-B) is to be D.

The value obtained by (B-C) is to be E.

memo

This value E indicates the leakage amount from the piping components.

The value obtained by (D-E) is to be F.

Confirm that the value F is 1mmHg or less.

Remove the adjusting tool for the leakage test to the

original state.

Clamp

Pressure gauge

Clamp

Pressure gauge

Clamp

Pressure gauge

12-1

Page 30: Calibration Manual

BHAJ01-013

13. Syringe Test

Standard Standard Stroke: 0.494 to 0.546mm/min (Syringe ratio:100%), overload: 500 to 800mmHg Stroke: 0.494 to 0.546mm/min (Syringe ratio:100%), overload: 500 to 800mmHg

Required jig Stopwatch, caliper square, calculator, pressure gauge, syringe (20mL), piping

components

Purpose Stroke: For syringe injection rate verification.

Overload: To verify whether the syringe is stopped at the specified pressure or not.

<Illustration> <Procedure>

【Stroke test】

Syringe ratio of Maintenance 6 “Device calibration”

is to be 100%.

Move the pusher of heparin pump to the right end and

measure the position with the caliper square. “Distance A” Press the heparin pump flow display section and set the

HP injection speed to 9.9mL/hour.

Make sure the blood pump is running. (Without blood pump

revolution, the syringe pump does not work.)

Start up time measurement by a stopwatch simultaneously

with turning on the blood pump operation switch.

Memo

The heparin pump operates in conjunction with the blood pump.

Measurement with the actual injection amount is impossible due to individual difference of syringe.

Therefore, normality of the heparin pump injection

amount should be confirmed by obtaining the pusher

travel distance per 1 minute in the stroke test and

confirming the obtained distance is within the

standard range.

Turn OFF the heparin pump operation switch after operation

for 30 minutes then measure the pusher travel distance

with the caliper square.

“Distance B” Travel distance per 1 minute =

Calculate (distance A [mm]-Distance B[mm])÷ operation

time [min].

Confirm the travel distance per 1 minute is 0.494 to

0.546mm/min.

If out of the standard range, refer to BHTS**-003.

13-1

Page 31: Calibration Manual

BHAJ01-013

13-2

Caution

After the test, return the syringe ratio to the original value.

【Overload adjustment】

Remove the cover for the upper left face.

Set the syringe with the pressure gauge installed at the

end.

Turn ON the heparin pump operation switch.

Adjust the nut so that the “E63 syringe overload or injection completion” alarm is detected when long-pressing the heparin pump flow fast-forward switch

and adding pressure of approximately 0.086Mpa (500 to

800mmHg). (For the nut position, refer to BHSM**-003.)

Caution

Overload detection pressure fluctuates due to sliding resistance of the syringe gasket.

O.Rotating in the compressing direction of L spring

rises the overload detection pressure. Rotating in the

extending direction lowers the pressure.

memo

Overload detection value changes approximately 0.022Mpa (160mmHg) per one turn of nut. (Pressure

change is the reference value when the Nipro 20mL is

used.)

* No need to remove the heparin pump for adjustment.

Weak Strong

Front

Page 32: Calibration Manual

BHAJ01-014

14. Blood Pump Shutoff Status Check

Standard Standard Discharge pressure to be 0.1Mpa (1.0kgf/cm2). Discharge pressure to be 0.1Mpa (1.0kgf/cm2).

Required jig Test tools, pressure gauge, blood circuit

Purpose To adjust occlusion.

<Illustration> <Procedure>

Set the test tools to the blood circuit and operate the

blood pump at 350mL/min.

Discharge pressure to be 0.10Mpa (1.0kgf/cm2) or more.

Caution

Specification of the blood circuit set here is as follows. If a blood circuit not complying with the

specification, it will not be covered by the warranty.

φ8.00×φ12.00±0.15mm, L:210mm or more, t=2.00±0.1mm

14-1

Page 33: Calibration Manual

BHAJ01-015

15. Blood Pump Flow Adjustment

Standard Standard Difference between the set flow and actual flow: within 10% Difference between the set flow and actual flow: within 10%

Required jig Blood circuit, electric scale, stopwatch container

Purpose Adjustment of difference between the set flow and actual flow

<Illustration> <Procedure>

Set the blood circuit.

Use the electric scale to measure the actual flow per one

minute by the given flow setting.

Adjust VR3 on the I/O board so that the difference between

the set flow rate and the actual flow rate becomes within

10%.

On Maintenance 4 “Operation status”, the blood pump rotation number “BP REAL value” is displayed. Take it as

a guide to rotate VR3.

After adjustment, use the electric scale again to measure

the actual flow per one minute by the given flow setting

and confirm that it is within the standard.

Caution

Specification of the blood circuit set here is as

follows. If a blood circuit not complying with the

specification, it will not be covered by the warranty.

φ8.00 x φ12.00±0.15mm, L:210mm or more, t=2.00

±0.1mm

15-1

Page 34: Calibration Manual

BHAJ01-016

16. Balance Test

Standard Standard 24 to 60g/h 24 to 60g/h

Required jig Blood circuit, dialyzer, electric scale, container (approximately 2L), stopwatch

Purpose To confirm removed water volume when UF pump is stopped.

<Illustration> <Procedure>

“Dialysate display offset” of Maintenance 6 “Device calibration” is to be 0.

Set the blood circuit and dialyzer and operate them in the

preparation process.

Caution

Ensure that the venous side of the blood circuit is installed with a needle.

Set the blood pump flow so that the dialysate pressure

value becomes 200±10mmHg .

memo

After this, do not change the setting of the blood pump flow adjustment knob.

Wait until the dialysate temperature enters the range of

36.5±0.5℃ with the setting at 36.5℃.

When the dialysate pressure is stabilized at 200±10mmHg,

turn OFF the blood pump operation switch to stop the blood

pump.

16-1

Page 35: Calibration Manual

BHAJ01-016

16-2

<Illustration> <Procedure>

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Place the container on the electrical scale and reset the

weight display to zero.

Put the blood circuit in the container, turn ON the blood

pump operation switch then start up the stopwatch

simultaneously.

After 30 minutes have passed, turn OFF the blood pump

operation switch.

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Read the value on the electric scale and calculate the UF

volume per one hour.

UF volume [g/hour] = (reduced water volume read) [g/30

min.]x2

Set “Dialysate pressure display offset” of Maintenance 6“Device calibration” to the original value.

When the UF volume is not in 24 to 60g/hour, perform the

following adjustment or hermetic type of leakage test

Page 36: Calibration Manual

BHAJ01-016

16-3

<Illustration> <Procedure>

●Shutoff pressure adjustment

Standard model BHAJ**-008

Model with “hot water citric

acid disinfection”. BHAJ**-023

●RV2 adjustment

Standard model BHAJ**-010

Model with “hot water citric

acid disinfection”. BHAJ**-025

Page 37: Calibration Manual

BHAJ01-017

17. UFP Flow Measurement

Standard Standard 0.700 to 0.800mL/STROKE 0.700 to 0.800mL/STROKE

Required jig Blood circuit, dialyzer, electric scale, container (approximately 5L), stopwatch

Purpose Measure discharge volume of pump and

calculate the coefficient value, to execute precise ultra-filtration.

<Illustration> <Procedure>

Set the blood circuit and operate them in the preparation

process.

Caution

Ensure that the venous side of the blood circuit is installed with a needle.

Set the UF speed to 5.00L/h and set the target UF volume

to 2.50L/h or more.

Set the “UF upper limit alarm setting value” of Maintenance 2 “Alarm setting” to 100%. (Default value: 30%)

Change the UFP flow set value of Maintenance 6 to 0.750mL.

Wait until the dialysate temperature enters the range of

36.5±0.5℃ with the setting at 36.5℃.

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Place the container on the electrical scale and reset the

weight display to zero.

Put the blood circuit in the container and operate the

blood pump.

17-1

Page 38: Calibration Manual

BHAJ01-017

<Illustration> <Procedure>

Press the dialysis SW and start up the dialysis operation.

art up the stopwatch simultaneously with the UF start.

y changes from lighting to

St

memo

When the UF speed dot displablinking, the UF starts.

at the dialysate pressure

lue becomes 200±10mmHg .

tion

ocess and turn OFF the pump operation switch.

Set the blood pump flow so th

va

After 30 minutes have passed, press the

preparation/collection switch to enter the collec

pr

Take out the arterial and venous end of the blood circuit

om the container and wait until there is no drop.

nsure that the drops are put in the container.

fr

Caution

E

lectric scale and calculate the UF

lume per one hour.

[g/hour] = (reduced water volume read) [g/30

Read the value on the e

vo

UF volume

min.]x2

om the UF volume per hour and

input it to the device.

Calculate the UFP flow fr

UFP flow rate [ml/STROKE]

= UF volume[g/h]×1.5÷10000

(0.750:5000=UFP flow rate: from [UF volume per hour])

5072×1.5÷10000=0.761[mL/STROKE]

Maintenance 2 “Alarm setting” to the original state.

Example: When UF volume is 5072.6g/h

Set “UF upper alarm set value” of

17-2

Page 39: Calibration Manual

BHAJ01-018

18. UF Precision Test 1

Standard Standard Set value±30g/h or less Set value±30g/h or less

Required jig Blood circuit, dialyzer, electric scale, container (approximately 5L), stopwatch

Purpose Verification of UF precision

<Illustration> <Procedure>

Set the blood circuit and operate it in the preparation

process.

Caution

Ensure that the venous side of the blood circuit is installed with a needle.

Set the UF speed to the given value.

memo

Change the “UF upper limit alarm setting value” of

Maintenance 2 “Alarm setting” when performing with

high UF.

Wait until the dialysate temperature enters the range of

36.5±0.5℃ with the setting at 36.5℃.

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Place the container on the electrical scale and reset the

weight display to zero.

Put the blood circuit in the container and operate the

blood pump.

18-1

Page 40: Calibration Manual

BHAJ01-018

18-2

<Illustration> <Procedure>

Press the dialysis SW and start up the dialysis operation.

Start up the stopwatch simultaneously with the UF start.

memo

When the UF speed dot display changes from lighting to blinking, the UF starts.

The blood pump flow is to be the given value.

After 30 minutes have passed, press the

preparation/collection switch to enter the collection

process and turn OFF the pump operation switch.

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Read the value on the electric scale and calculate the UF

volume per one hour.

UF volume [g/hour] = (reduced water volume read) [g/30

min.]x2

If within the error UF speed per hour±30g, it is regarded

as passed.

Set “UF upper alarm set value” of Maintenance 2 “Alarm setting” to the original state.

If not within the passed range, perform the following

adjustment.

● Balance test: BHAJ**-010

Page 41: Calibration Manual

BHAJ01-019

19. UF Precision Test 2 (during SQHD)

Standard Standard Within set value±30g/h Within set value±30g/h

Required jig Blood circuit, dialyzer, electric scale, container (approximately 5L), stopwatch

Purpose Verification of UF precision during SQHD

<Illustration> <Procedure>

Set the blood circuit and operate it in the preparation

process.

Caution

Ensure that the venous side of the blood circuit is installed with a needle.

Set the UF speed to the given value.

Operate the device in SQHD.

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Place the container on the electrical scale and reset the

weight display to zero.

Put the blood circuit in the container and operate the

blood pump.

19-1

Page 42: Calibration Manual

BHAJ01-019

19-2

<Illustration> <Procedure>

Press the dialysis SW and start up the dialysis operation.

Start up the stopwatch simultaneously with the UF start.

memo

When the UF speed dot display changes from lighting to blinking, the UF starts.

The blood pump flow is to be the given value.

After 30 minutes have passed, press the

preparation/collection switch to enter the collection

process and turn OFF the pump operation switch.

Take out the arterial and venous end of the blood circuit

from the container and wait until there is no drop.

Caution

Ensure that the drops are put in the container.

Example: Input the coefficient b’

When increasing UF by 10g/h

Current value +10

When decreasing UF by 10g/h

Current value -10

Read the value on the electric scale and calculate the UF

volume per one hour.

UF volume [g/hour] = (reduced water volume read) [g/30

min.]x2

Display Maintenance 2 “UF control.”

Input the coefficient b’ so that UF volume per hour is within the set value±30g/h and test again.

If not within the passed range, perform the following

adjustment.

Balance test : BHAJ**-017

UFP flow rate measurement: BHAJ**-018

Page 43: Calibration Manual

BHAJ02-020

20-1

20. Gas Purge Pressure Adjustment Standard -100~0mmHg

Required jig

Purpose To remove air in the closed circuit properly.

<Illustration> <Procedure>

Turn ON the gas purge switch in the Preparation process (after Standby process automatically). And while A or B

chamber is being filled with flesh dialysate (while FS1

is OFF), adjust the pinch cock (PC2) so that the dialysate

pressure at that time becomes -100 to 0 mmHg.

PC2

Left face of the device

After adjustment, apply paste "Three bond 1401C" to PC2

to fix it.

Page 44: Calibration Manual

BHAJ01-021

21. Chamber Volumetric Measurement

Standard Standard 495 to 515mL 495 to 515mL

Required jig Pean pinch, container (approximately 2L), electric scale

Purpose To infuse precise solution.

<Illustration> <Procedure>

Remove the cover for the lower left face.

Operate the device in the preparation process (prepara

tion completion process).

Remove the V21 connector.(*1)

Shut off the silicon tube at the AS1 air vent side with

a pean pinch.

Left face of the device

Sequence step

Measure the drainage volume with the electric scale,

monitoring the Maintenance 4 “Operation status” screen.

Drainage volume obtained when the sequence step is JB(JKB)

is the volume of the A chamber side.

Drainage volume obtained when the sequence step is JA(JKA)

is the volume of the B chamber side.

Perform measurement three times each, and confirm the

average value is 495 to 515ml.

Input the average of the measured values to the chamber

volume of Maintenance 5 “Device calibration.”

<MAINTE4> FLOWCHART(STP)○

○ ○

○ ○ ○

○ ○

○ ○ ○

○ ○

○ ○

BP:

値88.8 88.8rpm rpm設定値 REAL

V1 V9b V28b

V4 V10 V29

V11 V30

V5b V12

V6a V17

V6b V19

V7a V21

V7b V22 H

ONOFF

○ ○ ○P1V27aV8a

○ ○ ○P2V27bV8b

○ ○ ○P3V28aV9a

V5a

V31

V33

V35

V34

○REAL

Value Setting

value

P4

21-1

Page 45: Calibration Manual

BHAJ01-021

21-2

<Illustration> <Procedure>

【Filling time flow chart】

flow

NO flow

Chamber A Chamber B Chamber A

45-48sec

充填時間 ハイセラポンプフラシング時間Hi-ceramic pump flashing time

Filling time

3sec

(*1) Drainage performed one second after the completion

of filling is not included in the chamber volume as

the flushing of UF pump is performed as above. Remove

the V21 connector so as not to perform flushing.

Page 46: Calibration Manual

BHAJ01-022

22. Temperature Sensor Calibration ③(T1)

Standard Standard 25℃±0.2℃, 40℃±0.2℃ 25℃±0.2℃, 40℃±0.2℃

Required jig Temperature calibration device (Code No. 0-506-001), ceramic driver for adjustment,

Phillips screwdriver

Purpose To calibrate 2 points of offset and gain if the error is out of range, comparing device

indication and dummy resistance value.

<Illustration> <Procedure>

Caution

Ensure that the breaker is turned off.

Remove the cover of the upper right face and the electric

cover at the right face.

Remove the connector CN214 for the temperature sensor

to be worked on, which is on the I/O board, and install

the temperature calibration device.

Temperature calibration device dummy resistance value

Temperature Resistance value

25℃ 8.494±0.024 kΩ

40℃ 4.904±0.024 kΩ

Turn on the breaker and I/O switch and confirm the

displayed temperature with Maintenance 1 “Dialysis

data display” and “Temperature/concentration.”

For the position of the adjustment volume VR4 and VR5

on the I/O board, confirm with the BHSM**-101 layout

drawing.

【At 25℃ (gain adjustment)】

Adjust the VR4 on the I/O board so that the displayed

temperature becomes 25.0±0.2℃ when the knob of the

temperature calibration device is set to 25℃.

【At 40℃ (offset adjustment)】

Adjust the VR5 on the I/O board so that the displayed

temperature becomes 40.0±0.2℃ when the knob of the

temperature calibration device is set to 40℃.

Repeat the offset adjustment and gain adjustment until

entering the standard range.

22-1

Page 47: Calibration Manual

BHAJ00-023

23. Shutoff Pressure Adjustment

Standard Standard Reducing valve:0.034 to 0.038MPa (257 to 287mmHg) Reducing valve:0.034 to 0.038MPa (257 to 287mmHg)

Fill-up pressure:0.112 to 0.118MPa(1.15 to 1.2kgf/cm2) Fill-up pressure:0.112 to 0.118MPa(1.15 to 1.2kgf/cm2)

Model with “hot water citric acid disinfection”. Model with “hot water citric acid disinfection”.

Required jig Pressure gauge, piping components, pean pincer x 2, hexagon wrench (5mm),

monkey wrench

Purpose Adjustment reducing valve: To make proper secondary pressure.

Adjustment of fill-up pressure: To make a proper pressure in the closed circuit.

<Illustration> <Procedure>

【Adjustment of reducing valve】

Remove the cover of the bottom right face and the front

cover.

Set the device to the preparation stand by process.

Attach a pressure sensor to the out side of reducing valve.

Turn ON the V1 and V10 manually with Maintenance 4

“Operation status.” Confirm the dialysate pressure value. If it is outside the

range of 0.034 to 0.038MPa (257 to 287mmHg), adjust the

reducing valve with a hexagon wrench of 5mm, aiming at

0.037MPa (280mmHg).

After adjustment, open V4 manually for approximately 2

seconds to let out the pressure contained in the device.

When the reducing valve has been adjusted, repeat the

above-mentioned procedure to confirm the reproductivity

of the pressure value.

【Adjustment of fill-up pressure】

Remove the front cover and the cover for the lower left

face.

Install the piping components and pressure gauge at the

confluence part of the P4 discharge and the mainstream.

Mounting position of pressure gauge

23-1

Page 48: Calibration Manual

BHAJ00-023

23-2

<Illustration> <Procedure>

Pressure gauge is mounted.

Operate the device in the preparation state.

When filling is completed, adjust the relief valve 1 (RV1)

so that the pressure gauge value is within the standard

range (0.112 to 0.118MPa(1.15 to 1.2kgf/cm2)).

Fix the lock nut with a monkey wrench after completing the

RV1 adjustment.

【Configuration of RV1】

Left face RV1 is attached to the OUT side line of AS1.

Page 49: Calibration Manual

BHAJ00-024

24.Filling Flow Adjustment

Standard Standard Filling time must be the range of 32 to 34 seconds when 880 to 950mL/min. Filling time must be the range of 32 to 34 seconds when 880 to 950mL/min.

Model with “hot water citric acid disinfection” Model with “hot water citric acid disinfection”

Required jig Flowmeter, flathead screwdriver, stopwatch

Purpose To fill up a chamber of filling side before the liquid of closed circuit side is run

out.

<Illustration> <Procedure>

Remove the front cover.

【Adjustment by stopwatch】

Operate in the preparation process.

Display Maintenance 4 “Operation status.”

Measure with a stopwatch the time from the changeover of

A/B chamber until FS1 is turned on (no dialysate flow).

Adjust the needle valve (NV1) so that the measurement time

is within the standard range (32 to 34 seconds).

(Concentration pump stops after 30 secs from moving.)

【Adjustment by flowmeter】

Install the flowmeter to the drainage line and operate in

the preparation state.

Adjust the needle valve (NV1) so that the reading of the

flowmeter installed on the drainage line is within the

standard range (880 to 950mL/min).

Caution

● Flow rate is different at pump flashing and completion

of filling.

● Note that the reading position of the flow against the

float depends on the manufacturer and type of the

flowmeter. For our genuine flowmeter, top face of the

float is to be the reading point.

24-1

Page 50: Calibration Manual

BHAJ00-025

25. RV2 Adjustment

Standard Standard

Conversion flow : 300±10mL/min , 800 to 840mL/min Conversion flow : 300±10mL/min , 800 to 840mL/min

Adjustment of PC3 : Conversion flow 300±10mL/min Adjustment of PC3 : Conversion flow 300±10mL/min

Adjustment of RV2 : 0.166 to 0.171 MPa Adjustment of RV2 : 0.166 to 0.171 MPa

Bypass flow : The difference between bypass and UNSETt bypass must be in the range of

±40mL/min.

Model with “hot water citric acid disinfection”

Required jig Flathead screwdriver, monkey wrench, flowmeter, pressure gauge, pean pincer,

piping components

Purpose Adjustment of RV2 : To make a proper pressure in the closed circuit.

Bypass flow : To adjust dialysate flow during bypass.

<Illustration> <Procedure>

【ConfiguratioUNSETf RV2】

RV2 is attached to the OUT side line of AS2.

Left face

Right face

【ConfiguratioUNSETf PC1,PC3】

PC1(Bypass flow)

PC3 (Adjustment at the time of 300mL/min)

25-1

Page 51: Calibration Manual

BHAJ00-025

<Illustration> <Procedure>

○1.Adjustment preparation

Remove the front cover and the cover for the lower left

face.

Install the pressure gauge to “V4” IN side.

MAINTEBPM

MAINTENANCE MENU Ver1.00

SETTING MAINTE SYSTEM

OPTION ADJUST

● How to display the “Adjustment” menu.

To make adjustment, the “Adjustment” menu needs to be displayed. Press the two parts marked with ○ in the

left figure for 3 seconds simultaneously with the

maintenance tag, then the “ADJUST” switch appears as shown left.

8888

<ADJUST 5> DEBUG

流量フィードバック: FS5出力値:

FS5出力値 =

▲ ▼

換算流量: 888

準備時流量: 888

8.8

洗浄時流量: 888

× 電圧値 + 8888

しない 888

P2制御電圧:

(密閉時間:888.8 sec)

Open the page 2 of “Adjustment 5.”

Set the “Flow rate feedback” to “UNSET.”

Input the values indicated on the setting value

stickers to “FS5 output value = coefficient 1 x voltage + coefficient 2.”

Run the device in the process of completed preparation.

Set a dialyzer and a blood line.(Attach the couplers)

Caution

Ensure that the veUNSETus side of the blood circuit is installed with a needle.

Flow rate feedback

FS5 output value

P2 control

voltage

FS5 output value

Voltage

Supply time Reduced Flow

Rinse flowPreparation flow

UNSET

25-2

Page 52: Calibration Manual

BHAJ00-025

<Illustration> <Procedure>

○2. Adjustment at dialysate flow of 300mL/min

8888

<ADJUST 5> DEBUG

流量フィードバック: FS5出力値:

FS5出力値 =

▲ ▼

換算流量: 888

準備時流量: 888

8.8

洗浄時流量: 888

+× 電圧値 8888

しない 888

(密閉時間:888.8 sec)

P2制御電圧:

Set the “P2 control voltage” to 1.2V.

Set the blood pump flow to 0mL/min.

(Flow of dialysate must be dialyzer side. UNSETt

bypass)

Adjust “PC3” so that the CONV FL on the screen (Conversion flow) indicates 300±10mL/min, referring

to the FS5 output. Confirm this value after 2 minutes

from the PC3 is adjusted.

Confirm “FS5 output value” is within 300±15mL/min.

Change the coefficient 2 in the “FS5 output value = coefficient 1 x voltage + coefficient 2” so that the “FS5 output value” is in the range of 300±15mL/min if

it is out of range.

(If deviated to the positive side, input the negative

value. If deviated to the negative side, input the

positive value.)

○ 3. Adjustment preparatioUNSETf RV2

Make dialysate pressure in the range of 200±10mmHg by adjusting blood flow.

Adjust “P2 control voltage” to get the CONV FL

value in the range of 800 to 840 ml/min.

(When it’s around 4.8V, the flow will be 800ml/min.)

When the CONV FL value does UNSETt get more than 800

ml/min (with dialysate flow), adjust RV2 iUNSETrder to get the range.

○ 4.Adjustment of RV2

Display Maintenance 4 “Operation status.”

Adjust “RV2” so that the pressure gauge value indicates 0.166 to 0.171MPa (1.70 to 1.75kgf/cm2) when FS2 is ON

(UNSET dialysate flow.Pink.).

Flow rate feedback UNSET FS5 output value

Voltage FS5 output value

Reduced Flow Supply time

P2 control

voltage

Preparation flow Rinse flow

25-3

Page 53: Calibration Manual

BHAJ00-025

25-4

<Illustration> <Procedure>

Confirm the CONV FL value is in the range of 800 to 840mL/min. Open the page 2 of “Adjustment 5.

Confirm “FS5 output value” is within “CONV FL

value”±40mL/min.

Change the coefficient 1 in the “FS5 output value =

coefficient 1 x voltage + coefficient 2” so that the

“FS5 output value” is in the range of “CONV FL

value”±40mL/min if it is out of range.

(If deviated to the positive side, input the negative

value. If deviated to the negative side, input the

positive value.)

Caution

When the coefficient 1 is changed, confirm the “FS5 output value” at “○2. Adjustment when the

dialysate flow is 300mL/min” too.

Fix the lock nut with a monkey wrench after completing

the RV2 adjustment.

Set the “Flow rate feedback” of “Maintenance 5” to “SET.”

Hide the “Adjustment” menu. Caution

The “Adjustment” menu is for the manufacturer to

make adjustment. It includes important items

concerning device control. After using the “

Adjustment” menu, be sure to hide it to prevent

uninformed personnel from changing the contents.

How to hide it is the same as how to display it.

After adjustment, press the dialysate flow display

sectioUNSETpen the dialysate flow setting window, and

set the value to the usual dialysate flow rate.

After adjustment, apply paste ”1401C” to PC3 to fix it.

Page 54: Calibration Manual

BHAJ00-025

25-5

<Illustration> <Procedure>

<Bypass flow>

Run the device in the process of completed preparation.

Set the “Flow rate feedback” of “Adjustment 5” to “UNSET.”

Adjust “P2 control voltage” to get the CONV FL

value in the range of 800±40 ml/min when it’s UNSETt

bypass.

For the converted flow rate, confirm after passing more than 2 rounds.

Confirm the CONV FL during bypassing and releasing the

bypass. For the CONV FL value, confirm it after passing

more than 2 rounds.

Adjust “PC1” so that the difference becomes±40mL/min,

referring FS5 output.

Set the “Flow rate feedback” of “Maintenance 5” to “SET.”

Hide the “Adjustment” menu. After adjustment, apply paste ”1401C” to PC1 to fix it. Caution

The “Adjustment” menu is for the manufacturer to

make adjustment. It includes important items

concerning device control. After using the “

Adjustment” menu, be sure to hide it to prevent

uninformed personnel from changing the contents.

How to hide it is the same as how to display it.

Page 55: Calibration Manual

BHAJ00-026

26. P3, P4 Flow Adjustment

Standard Standard P3 actual flow: 13.3 to 15.3g (per 1 round) P4 actual flow:17.5 to 18.5g (per 1 round)P3 actual flow: 13.3 to 15.3g (per 1 round) P4 actual flow:17.5 to 18.5g (per 1 round)

Required jig Electric scale, container (approximately 2L)

Purpose Measure discharge volume and

calculate the coefficient value, to infuse precise solution.

<Illustration> <Procedure>

Remove the front cover.

To uniform the suction amount of the concentrate solution,

rotate the P3 and P4 spindle to the position shown in the

figure.

Face up the white circle part.

<Configuration of concentration solution pump>

Upper one is P4.

Lower one is P3.

Set the chamber volume of Maintenance 5 “Concentrate calibration” to 500mL for both A and B.

Set the coefficient “P3 flow” and “p4 flow” of Maintenance 6 “Device calibration” to the following values.

○Theoretical figure for each coefficient

P3 flow P4 flow

Hot water citric acid

disinfection

0.180 0.60

Hot water citric acid

disinfection + B Powder

0.180 0.30

26-1

Page 56: Calibration Manual

BHAJ00-026

26-2

<Illustration> <Procedure>

Operate the device in the preparation state.

① Set the container containing water to the electric

scale and perform zero reset.

② Put the A dialysate (P3) concentration solution

connector in the container and measure the suction

amount of the A dialysate for 3 rounds continuously.

③ Take out the A dialysate (P3) concentration solution

connector from the container and read the value on the

electric scale.

Measure the B dialysate (P4) similarly.

Based on the measured value, calculate the coefficient by

the following formula.

P3 = (measured value ÷3)÷P3 theoretical value

P3 = (measured value ÷4)÷P3 theoretical value

P3 theoreti

cal value

P4 theoreti

cal value

Hot water citric acid

disinfection

79.333 30

Hot water citric acid

disinfection + B powder

79.333 60

Input the obtained coefficient to Maintenance 6 “Device calibration” and measure for 3 rounds each suction amount

again.

Based on the measured value, calculate the coefficient by

the following formula.

Measured value ÷3 = suction amount per 1 round

If the calculation result is within the standard range,

regarded as passed.

If out of standard range, perform measurement again.

Return the chamber volume of Maintenance 5 “Device calibration” to the original value.