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Chapter 4 Adjustment

4.1 Piercer Position Adjustment ................................................................................................................1


4.1.1 Initial Position.....................................................................................................................2
4.1.2 Aspiration Position .............................................................................................................2
4.1.3 RBC/HGB Chamber...........................................................................................................4
4.1.4 WNR Chamber...................................................................................................................5
4.1.5 WPC Chamber (Only for XN-20)........................................................................................6
4.1.6 Other Sample Tube Aspiration Position Adjustment ..........................................................8

4.2 Tube Holder Position Adjustment ........................................................................................................9


4.2.1 Aspiration Position .............................................................................................................9
4.2.2 Sampler Set Position .......................................................................................................10
4.2.3 Manual Position ...............................................................................................................11
4.2.4 ID Reader Position...........................................................................................................12

4.3 Hand Position Adjustment .................................................................................................................14


4.3.1 Preparation ......................................................................................................................14
4.3.2 Hand Height Position Adjustment (Rack Position) ..........................................................14
4.3.3 Hand Tilt Adjustment........................................................................................................15
4.3.4 Hand Clipper Front/Back Position Adjustment .................................................................22

4.4 Sampler Position Adjustment ............................................................................................................23


4.4.1 Preparation ......................................................................................................................23
4.4.2 Rack Feed-in Position......................................................................................................23
4.4.3 Rack Feed-out Position....................................................................................................24
4.4.4 Tube pickup Position (Hand clipper left/right position) .....................................................26

4.5 Barcode Reader Position Adjustment................................................................................................28


4.5.1 Main Unit Barcode Reader Adjustment............................................................................28
4.5.2 Sampler Barcode Reader Position Adjustment................................................................30

4.6 Laser Power Adjustment ...................................................................................................................33


4.6.1 Remove Covers ...............................................................................................................33
4.6.2. Laser Power Adjustment.................................................................................................35
4.6.3 Install Covers ...................................................................................................................35

4.7 Laser Power Threshold Adjustment ..................................................................................................36

4.8 Optical Alignment ..............................................................................................................................37


4.8.1 Remove Covers ...............................................................................................................37
4.8.2 Analyzer Preparation .......................................................................................................41
4.8.3 Laser Diode Angle Adjustment ........................................................................................41
4.8.4 FSC Detector Left/Right Position .....................................................................................43
4.8.5 Adjust Flowcell Angle.......................................................................................................46
4.8.6 FSC Collector Unit and Laser Diode Focus .....................................................................47
4.8.7 Initial Position...................................................................................................................49
4.8.8 Latex Preparation.............................................................................................................50
4.8.9 Oscilloscope Preparation .................................................................................................50

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4.8.10 Optical Alignment Rough ...............................................................................................51
4.8.11 Optical Alignment Fine ...................................................................................................60
4.8.12 Front Scatter DC confirmation .......................................................................................62
4.8.13 Optical Alignment Rough Confirmation..........................................................................62
4.8.14 Checking Optical Axis ....................................................................................................63
4.8.15 Fixing Screws.................................................................................................................63
4.8.16 Final Confirmation..........................................................................................................66
4.8.17 Apply Lock Tight.............................................................................................................68
4.8.18 Install CHASSIS_ASSY NO.24 ......................................................................................70
4.8.19 Install Covers .................................................................................................................71

4.9 RBC Clog Level Adjustment ..............................................................................................................73

4.10 HGB Zero Adjustment .....................................................................................................................74

4.11 Blood Aspiration Sensor Adjustment ...............................................................................................75


4.11.1 Aspiration Sensor Blank .................................................................................................75
4.11.2 Aspiration Sensor Span..................................................................................................76
4.11.3 Blood Sensor..................................................................................................................71

4.12 Sensitivity Adjustment .....................................................................................................................79

4.13 Whole Blood Calibration ..................................................................................................................87


4.13.1 Measurement .................................................................................................................87
4.13.2 Data Verification .............................................................................................................88
4.13.3 Read Target ...................................................................................................................88
4.13.4 Calibration......................................................................................................................89
4.13.5 Calibration for RBC-He and RET-He at Customer side .................................................91
4.13.6 Calibration Confirmation ................................................................................................92

4.14 Whole Blood PF Calibration ............................................................................................................93


4.14.1 Measurement .................................................................................................................93
4.14.2 Data Verification .............................................................................................................94
4.14.3 Read Target ...................................................................................................................94
4.14.4 Calibration......................................................................................................................95
4.14.5 Calibration confirmation .................................................................................................96

4.15 PD Mode Data Adjustment ..............................................................................................................97


4.15.1 Measurement Setting.....................................................................................................97
4.15.2 Enter Calibration Value ..................................................................................................98
4.15.3 Calibration Confirmation ................................................................................................99

4.16 PD Mode PF Data Adjustment ......................................................................................................100


4.16.1 Measurement Setting...................................................................................................100
4.16.2 Enter Calibration Value ................................................................................................101
4.16.3 Calibration Confirmation ..............................................................................................102

4.17 Body Fluid Mode Data Adjustment ................................................................................................103


4.17.1 Measurement Setting...................................................................................................103
4.17.2 Enter Calibration Value ................................................................................................104

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4.17.3 Calibration Confirmation ..............................................................................................105

4.18 Blood sensor..................................................................................................................................106

4.19 Raised Bottom Sample Tube setting procedure ............................................................................108


4.19.1 Setting on IPU program ...............................................................................................108
4.19.2 Piercer position adjustment for RBT and operation check (Target: XN-10/XN-20) ......109
4.19.3 Checking for related program versions before using RBT ........................................... 111

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Chapter 4 Adjustment
4.1 Piercer Position Adjustment
1. Loosen start switch fixed with 3 screws and move it lower by sliding along the rail.

2. Click ”SERVICE MENU”


3. Select “Piercer Adjustment”

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4.1.1 Initial Position

Caution:
When Sarstedt test tube is not used, make sure that the Container type is "Normal.”
Make sure again that the Container type is normal after adjusting. When adjusting
Sarstedt test tube, adjust the position by referring to "4.1.6 Other Sample Tube
Aspiration Position Adjustment." If the Container type is Sarstedt when using test
tube type other than Sarstedt, aspiration error may occur.

1. Select “Normal” on Container Type.


2. Select “Int.Position”.
3. Adjust the piercer position by clicking "Up" and "Down" so that the piercer tip and the bottom
face of Rinse cup are same level. And then, click "Up" 3 more times to move upward for narrow
portion of rinse cup.
4. After adjustment, click “save” to save the setting value.

Piercer

Narrow Portion

Rinse Cup
Piercer Tip

4.1.2 Aspiration Position


Caution:
When Sarstedt test tube is not used, make sure that the Container type is "Normal.”
Make sure again that the Container type is normal after adjusting. When adjusting
Sarstedt test tube, adjust the position by referring to "4.1.6 Other Sample Tube
Aspiration Position Adjustment." If the Container type is Sarstedt when using test
tube type other than Sarstedt, aspiration error may occur.

1. Select “Aspiration Position”


2. Using “Up” or “Down” button, adjust the piercer position so that piercer tip is at the same height
of the sample holder top surface. Using “Left” and “Right” button, also adjust piercer position so
that piercer tip is at center of the sample holder by viewing from front.
3. After adjustment is completed, click “Save” to save the setting value.

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4. Record “Up & Down pulse” value. (It will be used in 4.1.6 other sample tube aspiration position
adjustment)

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4.1.3 RBC/HGB Chamber
1. Remove cover of CHAMBER_ASSY NO.19 by loosening one fixing screw.

2. Select “RBC/HGB Chamber”


3. Using “Up” or “Down” button, adjust the piercer position so that the piercer tip is at the same
height of RBC/HGB chamber top surface. Using “Left” and “Right” button, also adjust the piercer
position so that the piercer tip is at the center of RBC/HGB chamber by viewing from front.

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4. After adjustment is completed, click “Save”
5. Put back the cover to CHAMBER_ASSY NO.19

4.1.4 WNR Chamber


1. Select “WNR Chamber”
2. Using “Up” or Down” button, adjust the piercer position so that the piercer tip is at the same
height of WNR chamber top surface which is middle of three chambers. Using “Left” and “Right”
button, also adjust the piercer position so that piercer tip is at the center of WPC chamber by
viewing from front.

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3. After adjustment is completed, click “Save”

4.1.5 WPC Chamber (Only for XN-20)


1. Select “WPC Chamber”
2. Using “Up” or “Down” button, adjust the piercer position so that the piercer tip is at the same
height of WPC chamber top surface. Using “Left” and “Right” button, also adjust the piercer
position so that piercer tip is at the center of WPC chamber by viewing from front.

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3. After adjustment is completed, click “Save”

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4.1.6 Other Sample Tube Aspiration Position Adjustment

Caution:
This adjustment is for using Sarstedt. When using test tupe type other than Sarstedt,
this adjustment is not necessary.

<When using Sarstedt sample tube>


1. Change Container type to “Sarstedt”

2. Using “Up” or “Down” button, adjust “Up & Down pulse” to be same as recorded value in step
4.1.2.
3. After adjustment is completed, click “Save”

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4.2 Tube Holder Position Adjustment

4.2.1 Aspiration Position


1. Click “SERVICE MENU”
2. Select “Tube Holder Adjustment”

3. Click “Aspiration Position”


4. Adjustment tube holder position using “back” or “Front” button so that the distance between arm
unit of HOLDER_ASSY NO.151 and front surface of the tube holder is 0.5mm ± 0.5 as shown.
5. Click “Save”

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4.2.2 Sampler Set Position
1. Click “Sampler Set Position”
2. Adjust tube holder position using “Back” or “Front” button so that the distance between front
surface of the FEEDER_ASSY NO.113 and the front surface of the tube holder is 8mm ± 0.5 as
shown.
3. Click “Save”

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4.2.3 Manual Position
1. Click “Manual Position”
2. Adjust tube holder position using “Back” or “Front” button so that the distance between the front
surface of the SLIDER_ASSY NO.9 and the front surface of FEEDER_ASSY NO.113 is 167mm
± 1 as shown.
3. Click “Save”

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4.2.4 ID Reader Position
1. Click “ID Reader Position”
2. Adjust tube holder position using “Back” or “Front” button so that the distance between front
surface of the chassis of DRIVE MECH_ASSY NO.23 and front surface of the tube holder is
2mm ± 0.5 as shown.
3. Click “Save”

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4.3 Hand Position Adjustment

4.3.1 Preparation
Note: Tube pickup Left/Right position will be adjusted in 4.4.3 sampler profile adjustment.

1. This adjustment starts from main unit to sampler. Turn off sampler until main unit adjustment is
completed. If sampler rack needs to be moved, move sampler rack manually.
2. Open main unit cover and de-activate cover sensor using small piece of paper as shown below.

4.3.2 Hand Height Position Adjustment (Rack Position)


1. Select “Hand Adjustment” > “Rack Position” on “SERVICE MENU”
2. Click “Catch” to close hand clipper.
3. Place an empty sampler rack under hand clipper. Using “Up” and “Down” button, adjust hand
clipper height so that space between the sampler rack top surface and lower surface of the hand
clipper tip is 2.5mm ± 0.5mm.
4. After adjustment is completed, click “Send”

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5. Click “Close” to close “Hand Adjustment” screen.

4.3.3 Hand Tilt Adjustment


1. Select “SV test” on “SERVICE MENU”
2. Click SV NO.80 to close hand clipper.

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3. Place an empty rack under hand clipper, and confirm that the space between sampler rack top
surface and lower surface of hand clipper is 2.5mm. If the space is not 2.5mm, adjust hand up/
down adjustment position by moving hand up/down mechanism belt.

4. Click SV NO.80 on SV test to open hand clipper.


5. Place a sample tube on first position of the sampler rack, and move sampler rack by hand to
align hand clipper center with the sample tube left/right center position.
Note: If hand clipper front/back position is not aligned, then it will be adjusted in 4.3.4 Hand front/back
position adjustment.

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6.Click SV NO.80 to clamp the sample tube by closing hand clipper.

7. Move up hand clipper manually.


8. After hand clipper is moved up, confirm hand clipper left/right position is at center position. If
hand clipper left/right position is not at center, follow steps below.

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<Hand Clipper Left/Right Tilt Adjustment>
a. Loosen fixing screw A.
b. Move STOPPER NO.483 to touch magnet plate to magnet.
c. While touching magnet plate to magnet, adjust hand clipper left/right position
d. Tighten fixing screw A.
e. Confirm hand left/right position is at center, while moving hand clipper up/down.

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9. Move up hand clipper manually to confirm hand clipper front/back position is at center. If hand
clipper front/back position is not at center, adjust as follows.
Note: Confirm front/back position by moving up/down hand clipper. If front/back position is not proper at
center in both hand clipper lower and hand clipper upper positions, adjust 4.3.4 Hand Clipper Front/
Back Position Adjustment.

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<Hand Clipper Front/Back Tilt Adjustment>
a. Loosen fixing screws B and C.
b. Rotate hand clipper front/back.
c.Tighten fixing screw B and C.
d. While move up/down hand clipper, confirm hand front/back position is centered.

10. After adjusting hand clipper front/back tilt adjustment, adjust the followings.

<Sample Set Position Adjustment>


a. Select “Tube Holder Adjustment” > “Sample Set Position” in “SERVICE MENU”
b. Place a sample tube on tube holder and then click “Down”
c. Using “Back” and “Front” button, adjust sample set position so that difference between
sample tube center and tube holder center is minimized.
d. After adjustment is completed, click “Save”
e. Click “Close” to close “Tube Holder Adjustment”screen

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11. Click SV NO.80 on SV test to open hand clipper and then remove sample tube.
12. Click “Close” to close SV test screen.

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4.3.4 Hand Clipper Front/Back Position Adjustment
Note: Hand front/back tilt adjustment might be shifted this adjustment. Check 4.3.2 Hand clipper tilt
adjustment after this adjustment again.

1. Loosen fixing screws D and E.


2. Place a sample tube on first position of sampler rack. Using the sampler rack, adjust hand
clipper front/back position so that hand clipper center is aligned with sample tube center on
sampler rack.

3. After hand clipper front/back adjustment is adjusted, the following steps must be performed.

<Sample Set Position>


a. Select “Tube Holder Adjustment” > “Sample Set Position” in “SERVICE MENU”
b. Place a sample tube on tube holder, and then click “Down”
c. Using “Back” and “Front” button, adjust sample set position so that difference between
sample tube center and tube holder center is minimized.
d. Click “Save” after adjustment is completed.
e. Click “Close” to close “Tube Holder Adjustment” screen.

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4.4 Sampler Position Adjustment
Note: Before this adjustment, 4.3 Hand Adjustment must be completed.

4.4.1 Preparation
1. Turn on sampler power and change mode to sampler mode.
2. Confirm sample rack is interfered with left and right profiles (positioning pin on the rack shifting
belt that push sample rack shifting) in both feed-in and feed-out positions.
*If sample rack is interfered with left and right profiles on both front side belt and back side belt or
spaces between profile and rack is right and left positions are much different, record pulse for
4.4.2 Rack Feed-in Position and 4.4.3 Rack Feed-out Position.

4.4.2 Rack Feed-in Position


1. Turn on sampler power and change mode to sampler mode.

2. Click “Front side”


3. Left and right profiles must not be positioned interfering with the movement in the rack feed-in
position. If profiles interfere the movement of the rack feed-in, adjust profile positions using “Left”
or “Right” button.
4. Place sample rack in rack set position and click “Feed-in” to confirm profiles are not interfere
sample rack movement. If profiles interfere the sample rack movement, adjust profile positions
using “Left” or “Right” button.
5. After adjustment is completed, click “Save”
6. Select “Rack feed-out position” and remove sample rack.
7. Select “Close” to close “Sampler Pos. Adjustnment.”
8. Select “Sampler Pos. Adjustnment” again to initialize the movment.
7. Click “Back side” and adjust profile position in the same manner.

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4.4.3 Rack Feed-out Position
1. Select “Sample Pos. Adjustment” > “Front side” in “SERVICE MENU”

2. Click “Front side”


3. Left and right profiles must not be positioned interfering with the movement in the rack feed-in
position. If profiles interfere the movement of the rack feed-in, adjust profile positions using “Left”
or “Right” button.
4. Click “Rack feed-in position”
5. Place sampler rack in sampler set position and click “Feed-in” to move sampler rack.
6. Click “Rack feed-out position” again.

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7. Click “Feed-out” and confirm profile position does not interfere sampler rack movement.
8. After adjustment is completed, click “Save”
9. Select “Rack feed-out position” to remove sampler rack.
10. Select “Close” to close “Sampler Pos. Adjustnment.”
11. Select “Sampler Pos. Adjustnment” again to initialize the movment.
12. Click “Back side” and adjust profile position in the same manner.

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4.4.4 Tube pickup Position (Hand clipper left/right position)
1. Select “Sampler Pos. Adjustment” > “Front side” in “SERVICE MENU”
2. Place sampler rack on sampler rack set position and “Rack feed-in position”
3. Click “Feed-in” to move sampler rack.

4. Click “Tube pickup position.” When system is XN-2000, select “Left” or “Right” on Analyzer to
select instrument to be adjusted.
5. Adjust sampler rack Left/Right position using “left” and “Right” button so that center of hand
clipper is aligned with center of first sample position on sampler rack.
6. After adjustment is completed, click “Save”
7. Select “Rack feed-out position” to remove sampler rack
8. Select “Close” to close “Sampler Pos. Adjustnment.”
9. Select “Sampler Pos. Adjustnment” again to initialize the movment.
10. Click “Back side” and adjust profile position in the same manner.
11. After both “Front side” and “Backside” adjustments are completed, click “Close” to close
“Sampler Pos. Adjustment” window.
12. Measure some samples in normal sampler mode to confirm both profiles, hand clipper and
sampler rack position are adjusted appropriately.
Note: In case of XN-2000, need to adjust both analyzers after switching “Left/Right” on Analyzer.

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4.5 Barcode Reader Position Adjustment

4.5.1 Main Unit Barcode Reader Adjustment


Barcode Reader Position Adjustment JIG

JIG_ASSY (PM) NO. 5 (BR XN SERIES)(P/N: AY109325)*


* Part above includes following parts.
JIG_ASSY NO.203
JIG_ASSY NO.204

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1. Click mode switch button (Gray color) to move sample set adaptor toward you.
2. Place JIG_ASSY NO.203 on front side adaptor, as shown below.

3. Select “Tube Holder Adjustment” in “SERVICE MENU”


4. Click ID Reader Position” and click “Start” to start ID Reader reading.

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5. While barcode reader is reading barcode, adjust barcode reader position so that LED of barcode
reader light and small beep sounds in regular interval.

6. Click “Stop” and then click “Close” to remove JIG_ASSY NO.203.

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4.5.2 Sampler Barcode Reader Position Adjustment
1. Click “Sampler Pos.Adjustment” in “SERVICE MENU”
2. Select “Rack feed-in position” and confirm that the “Back side” is selected.

3. Place JIG_ASSY NO.205 on first position of sampler rack. When sample tube holder is attached
on sample rack, remove sample tube holder.
4. Place a sampler rack installed JIG_ASSY NO.204 on sample rack set position.

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5. Click “Feed-in” to move the sampler rack.

6. Select “Tube rotor position” to move the sampler rack to the barcode reading position.
7. Barcode reading starts by clicking “Start” button on “Tube Rotation”
8. Loosen fixing screws to adjust barcode reader position so that barcode reader can read barcode
properly. After adjustment is completed, tighten fixing screws.
9. Confirm barcode reader can read barcode properly after tightening fixing screws. When barcode
reader reads barcode properly, barcode LED light green and small beep sounds.

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10. After adjustment is completed, click “Stop” to stop barcode reading.

11. Select “Rack feed-out position” to remove sample rack.


12. Select “Front side” and adjust the bar code reader position by performing step 3 through step
11.
12. Click “Close” to close screen.

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4.6 Laser Power Adjustment
Caution: Make sure that you are wearing laser protection glasses (wave length: 633nm) when
adjusting laser related adjustment.

The following adjustment is mandatory after laser diode replacement. When laser diode is
replaced, optical adjustment is necessary as well as laser power adjustment.

Required Tools for Laser Power


Phillips screwdriver

Ceramic Flat Blade Screwdriver

Laser Power Meter

4.6.1 Remove Covers


1. Remove FCM_BLOCK_ASSY NO.15 covers. Screws do not need to be removed completely.

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2. Put tape on cover switch.

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4.6.2. Laser Power Adjustment
1. Set up laser power meter as follows.
630nm/AUTO/μW (Approx. 1200μW)
Note: Laser power meter should be set to not 639nm but 633nm.

2. Using plastic flat-blade screwdriver, turn VR1 to counter clockwise completely.


3. Select “Laser Power” in “SERVICE MENU” to turn on laser.
4. Using plastic flat-blade screwdriver, turn VR 1 to clockwise so that laser power is increased.

4.6.3 Install Covers


1. Put back covers to FCM BLOCK_ASSY NO.15.

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4.7 Laser Power Threshold Adjustment
This adjustment must be done when laser diode is replaced.
Note: This adjustment must NOT be done when laser diode is NOT replaced.

1. Click “SERVICE MENU.”


2. Click “Laser Setting” > “Execute.”

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4.8 Optical Alignment
Caution: Make sure that you are wearing laser protection glasses (wave length: 633nm) when
adjusting laser related adjustment.

Required Tools for Optical Alignment


Required Tools for Optical Alignment
Hex Wrench (1.5mm, 2.5mm)

Phillips Screwdriver

Oscilloscope

FSC Latex 4207A (P/N:CX472678)

SFL Latex A-7312 (P/N: 521-8653-6)

JIG_ASSY No.200 (P/N: BT570864)

4.8.1 Remove Covers


1. Remove FCM BLOCK_ASSY NO.15 covers. Screws don’t need to be removed completely.

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2. Remove THERMISTOR NO.48_ASSY from flowcell.

3. Loosen two screws and remove FLOWCELL_ASSY NO.2. If screws are covered by base loosen
Screw F and adjust base position using adjustment screw 3.

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4. To prevent FLOWCELL_ASSY NO.2 from damage, cover rubber cup on flowcell, or fix flowcell to
safety position.

5. Fix Cover Switch with tape.

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Adjustment Screw Location

Laser Diode (Optical axis direction (front / FSC collector unit (Optical axis direction (front/
1 6
back)) back))

2 Laser Diode (Left/right) 7 SFL detector (APD) (up/down)

SSC collector unit (Optical axis direction


3 8 SFL detector (APD) (left/right)
(front/back))

4 FSC detector (right/left) 9 SSC detector (left/right)

5 FSC detector (up / down) 10 Beam stopper (left/right)

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4.8.2 Analyzer Preparation
1. To change to manual mode, press mode switch (gray) button if analyzer is sampler mode. When
analyzer is manual mode, sample set holder comes out.

2. Select sensor from maintenance menu on IPU, and confirm FCM detector heater temperature is
40°C ± 1°C.
Note: Wait for heating temperature.

3. When temperature is within the range, close the screen.

4.8.3 Laser Diode Angle Adjustment


1. Remove LENS_ASSY NO.2.
2. Fix JIG_ASSY NO.200 on LENS_ASSY NO.2 position with use of two sets of Screw M2 x 15
which are used for LENS_ASSY NO.2.
Note: When fixing JIG_ASSY NO.200, push it to edge of base. Do not tighten screw too strong.

3. Loosen two screws for laser diode plate spring.


Note: Do not loosen screws too much. If screws are loosen too much, there is a gap between
screws and laser diode.

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4. Confirm that adjustment screw 1 moves smoothly.

5. Loosen two screws for laser diode.

6. Select “Laser Power” on “SERVICE MENU” to turn on laser.


7. Place hex wrench in between laser diode and JIG_ASSY NO.200. Adjust laser diode angle so
that the reflected light and laser light are one line.
8. After adjustment, tighten two screws for laser diode.
9. Turn off laser from laser power screen.

10. Remove JIG_ASSY NO.200.

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4.8.4 FSC Detector Left/Right Position
1. Confirm beam stopper on LENS_ASSY NO.2 moves smoothly, and fix it to original position.
When beam stopper doesn’t move smoothly, loosen screw behind LENS_ASSY NO.2.
2. Rotate adjustment screw 10 of LENS_ASSY NO.2 counter clockwise to move beam stopper out
of laser beam path completely.

3. Confirm two screws are tighten with approx. 4cN/m (0.4kgf/cm) torque on the following figure.
4. Confirm there are no gaps between laser diode base and FCM block base.

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5. Loosen fixing screws from CHASSIS_ASSY NO.24.

6. Loosen screws A and B.

7. Adjust left/right and up/down position on PHOTO DETECTOR_ASSY NO.1 is at the center with
use of Adjustment screw 4 and 5.

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8. Loosen screw “H”.

9. Select “Laser Power” on “SERVICE MENU” to turn on laser.


10. Adjust laser diode left/right position so that laser beam is aligned on PHOTO
DETECTOR_ASSY NO.1 pinhole by adjustment screw 2.
11. If height of pin hole is not adjusted well, adjust up/down position by adjustment screw 5.
12. Turn off laser.

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4.8.5 Adjust Flowcell Angle
1. Insert FLOWCELL_ASSY NO.2 from bottom of FCM detector block.
2. Tighten temporary flowcell two hex-socket bolts.

3. Install THERMISTOR NO.48 carefully.

XN-1000/2000 S/M 4-46 April 2015


4. Select “Optical Axis Adj. (Fine)” on “SERVICE MENU.”

5. Press start switch without sample to fill CELLPACK inside the flowcell by performing optical axis
adjustment measurement.
6. Close “Optical Axis Adj.(Fine)” and run one blank measurement. (without sample)
7. Select “Laser Power” on “SERVICE MENU” to turn laser on.
8. Adjust flowcell angle so that laser beam is aligned with PHOTO DETECTOR_ASSY NO.1
pinhole, and fix FLOWCELL_ASSY NO.2 by two hex socket bolts.

4.8.6 FSC Collector Unit and Laser Diode Focus


1. Loosen screws C.

XN-1000/2000 S/M 4-47 April 2015


2. Move LENS_ASSY NO.2 position farthest from flowcell (to direction of blue arrow) by turning
screw 6.
3. Center pinhole to shadows of flowcell sample path line (in red arrow direction) by adjustment
screw 2. (Figure A)

* When flowcell sample path lines are unclear, take the following steps.
a. Remove LENS_ASSY NO.2 to observe shadow.
b. Put frosted tape between laser diode and flowcell to view shadow clearly.

3. Install LENS_ASSY NO.2 and center beam stopper shadow on pinhole by adjusting adjustment
screw 10.
* When flowcell sample path line is unclear, take the following steps.
a. Put frosted tape between laser diode and flowcell to view shadow clearly.

XN-1000/2000 S/M 4-48 April 2015


4.8.7 Initial Position
1. Confirm screws C are loosen. When not loosen, loosen them.

2. Adjust adjustment screw 3 and 6 so that edge of LENS_ASSY NO.3 becomes one line with edge
of LENS_ASSY NO.2.
3. Adjust adjustment screw 1 so that chamfered corner of laser diode (cylinder) aligns with the
block surface.

XN-1000/2000 S/M 4-49 April 2015


4.8.8 Latex Preparation
1. Prepare latex material.
FSC latex: CELLPACK DCL 3ml + DUKE 4207A 6 Drops

SFL latex: CELLPACK DCL 4ml + LATEX A-7312 2 Drops

• Since undiluted latex is easy to coagulate, shake it enough and add to CELLPACK DCL.
• Use latex material within 3 hours after making.
• Do not add raw latex to diluted latex.

4.8.9 Oscilloscope Preparation


1. Connect oscilloscope probe to the following test points on PCB.30001.
TP1
FSC_L Oscilloscope CH1
5

TP9 SFL Oscilloscope CH2

TP1 Not connect now. (Oscilloscope CH1 will be


SSC
1 connected later)

TP7 A.GND-F Oscilloscope CH1 and CH2 grand

2. Set up oscilloscope as follows:


FSC: 0.2V/DIV

VOLTS/DIV SFL: 50mV/ DIV

SSC: 20mV/DIV

Time 0.5μs/DIV

VARIABLE Turn clockwise completely

XN-1000/2000 S/M 4-50 April 2015


3. Select in Slope.
Select “AUTO” in Mode.
Turn INVERT of CH2 off.
Select x1 in probe.

4.8.10 Optical Alignment Rough


1.Set trigger source to CH1 on oscilloscope.(FSC)

XN-1000/2000 S/M 4-51 April 2015


2. Select “Optical Axis Adj.(Rough)” in “SERVICE MENU” on IPU.
3. Confirm FSC, SFL, SSC gain on “Optical Axis Adjustment (Rough)” screen as follows.
When gain values are different with the following values, enter values and click “Send.”

FSC:70 x 8, SFL: 30 x 4, SSC: 230 x 16

4. Mix diluted FSC latex well and place it on sample set position.
5. Press start switch to measure.

6. Switch to CH1.
7. Perform the following steps so that FSC signal on oscilloscope is higher than 0.5V. If no signal
displays, use adjustment screw 10 so that beam will be split on FSC detector.

XN-1000/2000 S/M 4-52 April 2015


a. Adjust the following order
FSC collector unit laser beam direction (Adjustment screw 6) > FSC collector unit left/right
direction (Adjustment screw 4) > FSC detector up/ down direction (Adjustment screw 5)
b. If 0.5V is not possible, adjust laser diode laser beam direction. (Adjustment screw 1)

Note: Do not use Adjustment screw 2 at this time

8. Switch to CH2.
9. Mix diluted SFL latex well and place it on sample set position and press start switch to measure.
10. Perform the following steps so that SFL signal on oscilloscope is higher than 0.5V.
a. Loosen screws E and D.

b. Adjust the following order:


SSC collector unit laser beam direction (Adjustment screw 3) > APD up/down direction
(Adjustment screw 7) > APD left/right direction (Adjustment screw 8)

XN-1000/2000 S/M 4-53 April 2015


c. At this time, adjust SSC collector unit position in laser beam direction (Adjustment screw 3)
to maximize the waveform.

d. As wave height increase, change oscilloscope gain CH2: SFL VOLTS/DIV from 50V to 0.5V
stepwise.
e. Using SFL latex, adjust steps above until waveform height is higher than 0.5V and
maximized.

11. Set trigger/ SOURCE to CH2 (SFL).

12. Mix diluted SFL latex well and place it on sample set position, and press start switch to
measure.
13. Perform the following steps so that SFL signal on oscilloscope is higher than 1.3V:
a. Adjust laser diode position in laser beam direction (Adjustment screw 1) to maximize
waveform height.
b. Adjust the following order to make waveform height higher than 1.3V:
SSC collector unit laser beam direction (Adjustment screw 3) > APD up/down direction
(Adjustment screw 7) > APD left/right direction (Adjustment screw 8)

XN-1000/2000 S/M 4-54 April 2015


c. Adjust laser diode left/right direction (Adjustment screw 2) so that wave is highest and
uniformed.

* When wave is uniformed, SFL (w) on IPU display will become lower than approx.0.150.

14. Connect CH1 probe from FSC(TP15) to SSC (TP11).


15. Set VOLT/DIV to 20mV/DIV on oscilloscope.

16. Analyze SFL latex and perform the following steps so that SSC signal is higher than 40mV.
a. Loosen two screws (Adjustment screw 9), and adjust left/right position of PHOTO
DETECTOR_ASSY NO.8 (SSC detector) to make the waveform height higher than 40mV.
Target of SSC (w) on IPU screen: lower than 0.250
Note: Cover detector with a palm or cover from light during
adjustment.

XN-1000/2000 S/M 4-55 April 2015


b. After adjustment is completed, tighten Adjustment screw 9 completely.

c. Put back cover and analyze SFL latex to confirm SSC signal is within the following ranges.

SSC Signal (waveform) Higher than 40mV

SSC(w) on IPU screen lower than 0.250

17. Connect oscilloscope CH1 probe from SSC(TP11) to FSC (TP15).


18. Set oscilloscope Trigger/SOURCE to SH1.(FSC)

XN-1000/2000 S/M 4-56 April 2015


19. Set CH1 VOLTS/DIV to 0.2V.

20. Mix diluted FSC latex well and place it on sample set position, and press start switch to
measure.
21. Analyze FSC latex and perform the following steps so that FSC signal is higher than 0.7V:
FSC collector unit laser direction (Adjustment screw 6) > FSC detector up/down direction
(Adjustment screw 5) > FSC detector left/right direction (Adjustment screw 4) to make the
waveform height is higher than 0.7V.

XN-1000/2000 S/M 4-57 April 2015


22. Analyze FSC latex and perform the following steps so that FSC signal is uniformed and lowest:
a. Adjust beam stopper position (Adjustment screw 10) to one direction.
b. When signal disappears, rotate counter direction.

23. Change oscilloscope CH1 from AC to DC. Set oscilloscope to 0.5V range.

24. Analyze FSC latex and perform the following steps so that FSC signal height maintains and
base line is lowest.
a. Adjust beam stopper position (Adjustment screw 10) to one direction.
b. When signal disappears, rotate counter direction.

25. Change oscilloscope CH1 from DC to AC. Set oscilloscope to 0.2V range.

XN-1000/2000 S/M 4-58 April 2015


26. Analyze FSC latex and perform the following steps so that FSC signal is uniformed and lowest.
a. Adjust beam stopper position (adjustment screw 10) to one direction.
b. When signal disappears, rotate counter direction.

27. Change oscilloscope CH1 from AC to DC. Set oscilloscope to 0.5V range.
28. Analyze FSC latex and perform the following steps so that FSC signal height maintains and
base line is lowest.

29. Change oscilloscope CH1 from DC to AC. Set oscilloscope to 0.2V range.

XN-1000/2000 S/M 4-59 April 2015


30. Analyze FSC latex and confirm FSC signal is higher than 0.7V.

31. Close “Optical Axis Adj. (Rough) on IPU.

4.8.11 Optical Alignment Fine

Caution:
- The last half of the sampling data will be decreased as shown below. This
is a normal behaivier for the optical alignment fine.

1. Connect oscilloscope CH1 probe form FSC (TP15) to SSC(TP11)

XN-1000/2000 S/M 4-60 April 2015


2. Set oscilloscope Trigger/SOURCE to CH2 (SFL)

3. Select “Optical Adjustment (fine)” of “SERVICE MENU” on IPU.


4. Put back cover.
5. Mix diluted SFL latex well and place it on sample set position, and press start switch to measure.
6. Adjust laser diode position in left/right direction (Adjustment screw 2) to make SFL signal is
uniformed and highest.
7. Analyze SFL latex and confirm signal is within the following target ranges.
SFL (w): lower than 0.200

SSC signal: higher than 30mV SSC (w): lower than 0.250

If signal is out of range, perform the following steps: 312L031


a. Adjust APD position in left/right direction (Adjustment screw 8) and APD position in up/down
direction (Adjustment screw 7)
B. Re-analyze SFL latex, and confirm signal is within above range.

8. Connect oscilloscope CH1 probe from SSC (TP11) to FSC (TP15)


9. Set oscilloscope Trigger/SOURCE to CH1 (FSC)

10. Set CH1 VOLTS/DIV to 0.2V.

XN-1000/2000 S/M 4-61 April 2015


11. Adjust beam stopper position (Adjustment screw 10) to meet the following range.

FSC signal curve does not have to be a single peak. (Bimodal peaks will not
affect the results.)

201435
FSC signal: higher than 0.7V FSC(w): lower than 0.150

*If signal is out of range, adjust FSC collector position in laser direction (Adjustment screw 6)

12. Close “Optical Adjustment (fine)” on IPU.

4.8.12 Front Scatter DC confirmation


1. Set digital voltmeter to DC Volt.
2. Connect positive probe to FSC test point (TP15)
3. Connect negative probe to GND test point (TP7)
4. Turn on and off laser power and confirm difference is lower than 0.2V
Example: (Laser power ON: 2.750V) - (Laser power OFF: 2.646V) = 0.104V

4.8.13 Optical Alignment Rough Confirmation


1. Place cover on FCM BLOCK_ASSY NO.15.
2. Select “Optical Axis Adj. (Rough)” of “SERVICE MENU” on IPU.
3. Mix diluted FSC latex well and place it on sample set position, and press start switch to measure.
4. Verify FSC signal is within the following range:
FSC Signal: higher than 0.7V FSC(w): lower than 0.150

FSC signal curve does not have to be a single peak. (Bimodal peaks will not
affect the results.)

5. Close “Optical Axis Adj.(Rough)” on IPU.


201435

XN-1000/2000 S/M 4-62 April 2015


4.8.14 Checking Optical Axis
Adjust sensitivity (4.12 Sensitivity Adjustment) and check that WDF-Y ch SFL Gain is within the
following range.

Lower limit: 1216 (=76 x 16) Upper limit: 2256 (=141 x 16)

4.8.15 Fixing Screws


1. Select “Optical Axis Adj.(Fine)” in “SERVICE MENU” on IPU.
2. Loosen CHASSIS_ASSY NO.24 fixing screws.

3. Mix diluted FSC latex well and place it on sample set position and press start switch to measure.
While checking FSC signal of oscilloscope, FSC (x) and FSC (w) on IPU, tighten the following
screws.

XN-1000/2000 S/M 4-63 April 2015


a. Tighten FSC detector left/right (A) and up/down (B) 4 screws equally.
b. Tighten FSC collector unit (C) 2 screws equally.

4. If waveform becomes bad after fixing screws, loosen screws A, B, C and readjust by adjustment
screws 4, 5, 6.

5.Mix diluted SFL latex well and place it on sample set position, and press start switch to measure.
While checking SFL signal of oscilloscope, SFL (x), and SFL(W) on IPU, fixing the following
screws.
a. APD left/right direction (D) and up/down direction (E) 4 screws equally.
b. SSC collector unit (F) 2 screws are torqued to approx. 30cN/m (3kgf/cm)

6. If waveform becomes bad after fixing screws, loosen screws D, E, F and readjust by Adjustment
screw 3, 7, 8.
* If SFL signal is getting lower by loosing screw F, perform steps in the following order:
a. Loosen D, E, F screws.

XN-1000/2000 S/M 4-64 April 2015


b. Tighten F screw with approx. 10cN/m torque.
c. Adjust by Adjustment screw 3, 7, 8.
d. Tighten F screw with approx. 30cN/m torque.

7. Mix diluted FSC latex well and place it on sample set position and press start switch to measure.
While checking FSC signal of oscilloscope, FSC (x) and FSC (W) on IPU, fixing the following
screws.
a. Tighten laser diode (G) 4 screws with approx.10cN/m (1kgf/cm) torque.
b. Tighten laser diode left/right direction (H) 2 screws with approx. 30cN/m (3kgf/cm) torque.
c. Tighten laser diode (G) 4 screws with approx. 30cN/m (3kgf/cm) torque.
d. Tighten beam stopper (I).

8. If waveform becomes bad after fixing screws, check the situation in the following order.
a. Loosen G, H, I screws and confirm waveform become good.
b. When waveform becomes good, identify which screws cause bad waveform while
analyzing FSC latex.

XN-1000/2000 S/M 4-65 April 2015


c. Tighten screws carefully. At this time, confirm there is no gap between laser diode base and
FCM base.

9. If waveform becomes bad after fixing screw H, check the situation in the following order.
a. Tighten screw H.
b. Analyze SFL latex and adjust adjustment screw 2 so that SFL signal is uniformed.
c. Confirm waveform is within specified range with FSC latex.
d. Fix screw H.
Note: If waveform becomes bad by above steps, try tightening while pushing heater down.
Recommend to wear gloves.

9. Close “Optical Axis Adj.(Fine)” on IPU.

4.8.16 Final Confirmation


1. After installing cover on FCM BLOCK_ASSY NO.15 and instument outer cover, confirm all
values are within the range by the following steps:
Optical Alignment Spec
FSC(X)Rough FSC(W)Rough FSC(X)Fine FSC(W)Fine
Target 94 0.075 86 0.100

Upper
<130 <0.150 <110 <0.150
Limit

Lower
>66 - >60 -
Limit

Gain 70 x 8 70 x 8

2014124

XN-1000/2000 S/M 4-66 April 2015


SFL(X)Fine SFL(W)Fine SSC(X)Fine SSC(W)Fine
Target 65 0.150 68 0.180

Upper
- <0.200 - <0.250
Limit

Lower
>46 - >48 -
Limit

Gain 30 x 4 230 x 16

FSC-DC Volume (mv)


Target 63

Upper Limit <200

Lower Limit >10

Gain -

Optical Alignment Rough


a. Select “Optical Adjustment (rough)” of “SERVICE MENU” on IPU.
b. Mix diluted FSC latex well and place it on sample set position, and press start switch to
measure.
c. Confirm FSC (X) and FSC(W) are within the following ranges.
FSC (X) higher than 66, lower than 130 (66 - 130)

FSC(W) lower than 0.150

FSC signal curve does not have to be a single peak. (Bimodal peaks will not
affect the results.)

201435

d. Close “Optical Adjustment (rough)” on IPU.


Optical Alignment Fine
a. Select “optical Adjustment (fine)” of “SERVICE MENU” on IPU.
b. Mix diluted FSC latex well and place it on sample set position, and press start switch to
measure.
c. Confirm FSC(X) and FSC(W) are within the following ranges.
FSC (X) higher than 60, lower than 110 (60 - 110)

FSC(W) lower than 0.150

FSC signal curve does not have to be a single peak. (Bimodal peaks will not
affect the results.)

201435

XN-1000/2000 S/M 4-67 April 2015


d. Mix diluted SFL latex well and place it on sample set position, and press start switch to
measure.
e. Confirm SFL(X) and SFL(W) are within the following ranges.
SFL (X) higher than 46

SFL (W) lower than 0.200

f. Confirm SSC(X) and SSC(W) are within the following ranges.


FSC (X) higher than 48

FSC(W) lower than 0.250

g. Close “Optical Adjustment (Fine)” on IPU.


A: 201218

Front Scatter DC Confirmation


a. Set digital voltmeter to DC Volt.
b. Connect positive probe to FSC test point (TP15)
c. Connect negative probe to GND test point (TP7)
d. Turn on and off laser power and confirm difference is lower than 0.2V.
*Example: (Laser Power ON: 2.750V) - (Laser Power OFF: 2.646V) = 0.104V

4.8.17 Apply Lock Tight


Apply lock tight the following red screws.

XN-1000/2000 S/M 4-68 April 2015


XN-1000/2000 S/M 4-69 April 2015
4.8.18 Install CHASSIS_ASSY NO.24
Put back CHASSIS_ASSY NO.24.

XN-1000/2000 S/M 4-70 April 2015


4.8.19 Install Covers
1. Remove tape from cover switch.

2. Put back covers to FCM BLOCK_ASSY NO.15.

XN-1000/2000 S/M 4-71 April 2015


3.Tie up tubes with tie wrap.

XN-1000/2000 S/M 4-72 April 2015


4.9 RBC Clog Level Adjustment
1. Click “SERVICE MENU”
2. Select “RBC Clogs”
3. Enter “100” on Target and click “Calc”. A gain value is automatically calculated. Then click
“Send”
4. Click “Continue”
5. Confirm RBC Clog value is 100 ± 1. If it is not within the range, repeat RBC clog level
adjustment.

XN-1000/2000 S/M 4-73 April 2015


4.10 HGB Zero Adjustment
1. Click “SERVICE MENU”
2. Select “Sensitivity”
3. Select “HGB” from “Channel” menu.
4. Enter some values on “Blank Gain” of “HGB” and click “Send” so that Blank gain value is “5000 ±
200”
*Repeat step 4 to reach Blank gain to “5000 ± 200” as shown in the procedure below.

<Procedure>
Enter the following value and then click “Send”
HB Blank Gain: 0 - 255
Switching: x1, x2, x4

XN-1000/2000 S/M 4-74 April 2015


4.11 Blood Aspiration Sensor Adjustment
Required Tools or Jig
XN-CHECK Level 2

4.11.1 Aspiration Sensor Blank


1. Click “SERVICE MENU”
2. Click “Aspiration Sensor”

3. Unmark use box of “Blood Aspiration Sensor” on “Analyzer Setting” and measure blank. (Press
start switch without a sample.) Wait 10 minutes to stabilize LED light.
4. Select “Aspiration Sensor” in “SERVICE MENU”. Enter “125” on Span and click “Send.”

5. Select “Sensitivity” on “SERVICE MENU” and “HGB” on pull-down menu.


6. Enter some blank gain values so that Asp. Blank convert is “5000 ± 200” as procedure below.
201392

XN-1000/2000 S/M 4-75 April 2015


<Procedure>
Enter the following value, and then click “Send”
a. Asp. blank gain 1: 0 - 255
b. Switching: x1, x2, x4

4.11.2 Aspiration Sensor Span


1. Select “Aspiration Sensor” in “SERVICE MENU”
2. Place an XN-CHECK Level 2 on sample adaptor and start measurement.
3. After checking value (sample-blank), enter some Span values so that value (sample-blank) is
“6500 ± 500” as procedure below.
<Procedure>
Enter the following value and then click “Send” If the result is out of range, measure XN-CHECK
Level 2 again.
Span: 0 - 255

XN-1000/2000 S/M 4-76 April 2015


4. Check use box of “Blood Aspiration Sensor” is unmarked and measure blank. (Press start switch
without a sample.) Confirm blank gain adjustment again. If blank gain is out of range, adjust it
referring to 4.11.1 Aspiration Sensor Blank.
* Blank gain value might be changed by span adjustment.
5. Mark “aspiration sensor” to put back to previous setting.

4.11.3 Blood Sensor


1. Click Blood sensor from service program.

2. Blood sensor adjustment screen appears.

XN-1000/2000 S/M 4-77 April 2015


3. Place a rack having two plastic sample tubes which outer diameter is from 12mm to 12.5mm.
Empty sample tube is placed in first position, and sample tube filled with 2ml water (Approx.
more than half of sample tube) is placed in second position.

4. Click Execute.

5. Automatically the rack is shifted to blood sensor position. After adjustment the rack is come out
to the left table.
6. Click close.

XN-1000/2000 S/M 4-78 April 2015


4.12 Sensitivity Adjustment
Sensitivity Adjustment Necessary Tool
XN-CAL

Note:
a. Adjust sensitivity after registering reagent information.
b. Aspiration sensor and HGB blank adjustment must be completed before
sensitivity adjustment.

1. Select “Mode” > “Calibrator” in “SERVICE MENU”


2. Place well-mixed XN-CAL on sample set position, and click start switch to measure it once.
3. Click “Sensitivity” from “SERVICE MENU”
4. Enter each assay sheet value into “Target”, and click “Calc” button.
*For each parameter detailed procedure, see each the following parameter adjustment procedure.
Note: Sensitivity adjustment parameters differ depending on the analyzer type.

5. After entering all values, click “Send”

6. Click “Close”
7. Place XN-CAL and press start switch.
8. After measurement is completed, click “Sensitivity” to confirm all parameters are within Assay
sheet targets.

XN-1000/2000 S/M 4-79 April 2015


<WNR>
1. Confirm values are within the following ranges. If they are within ranges, close the screen.
WNR-X: XN-CAL Target Value ± 2

WNR-Y: XN-CAL Target Value ± 2

WNY-Z: XN-CAL Target Value ± 2

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click send)
3. After adjustment is completed, confirm that the data is within ranges, scattergram is normal and
gains are within the following ranges.
Gain

WNR-X 82 - 210

WNR-Y 100 - 255

WNR-Z 100 - 255

<WDF>
1. Confirm values are within the following ranges. When they are within ranges, close the screen.
WDF-X: XN-CAL Target Value ± 2

WDF-Y: XN-CAL Target Value ± 3

WDF-Z: XN-CAL Target Value ± 2

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click “Send”)

XN-1000/2000 S/M 4-80 April 2015


3. After adjustment is completed, confirm that the data is within ranges, scattergram is normal and
gain is within the following ranges.

Gain

WDF-X: 100 - 255

WDF-Y: 74 - 194

WDF-Z: 100 - 255

Adjust sensitivity (4.12 Sensitivity Adjustment) and check that WDF-Y ch SFL Gain is within the
following range.
Lower limit: 1216 (=76 x 16) Upper limit: 2256 (=141 x 16)

XN-1000/2000 S/M 4-81 April 2015


<RET>
1. Confirm values are within the following ranges. When they are within the ranges, close the
screen.
RBC-X: XN-CAL Target Value ± 1

RBC-Y: XN-CAL Target Value ± 3

RBC-Z: XN-CAL Target Value ± 3

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click “Send”)
3. After adjustment is completed, confirm that the data is within ranges, scattergram is normal and
gain is within the following ranges.

Gain

RBC-X: 98 - 244

RBC-Y: 100 - 255

RBC-Z: 100 - 255

<WPC> (Only for XN-20)


1.Confirm values are within the following ranges. When they are within the ranges, close the
screen.
WPC-X: XN-CAL Target Value ± 3

WPC-Y: XN-CAL Target Value ± 2

WPC-Z: XN-CAL Target Value ± 2

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click “Send”)
3. After adjustment is completed, confirm that the data is within ranges, scattergram is normal and
gain is within the following ranges.

XN-1000/2000 S/M 4-82 April 2015


Gain

WPC-X: 100 - 255

WPC-Y: 98 - 244

WPC-Z: 100 - 255

<PLT-F>
Note: Use XN-CAL for the following adjustment

1. Confirm that values are within the following ranges. When they are within the ranges, close the
screen.
PLT-F-RBC-X: XN-CAL Target Value ± 2

PLT-F-RBC-Y: XN-CAL Target Value ± 3

PLT-F-Z: XN-CAL Target Value ± 3

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click “Send”)
3. After adjustment is completed, confirm that the data is within ranges, scattergram is normal and
gain is within the following ranges.

Gain

PLT-F-RBC-X: 87 - 220

PLT-F-RBC-Y: 100 - 255

PLT-F-Z: 100 - 255

XN-1000/2000 S/M 4-83 April 2015


<RBC/PLT>
1. Confirm values are within the following ranges. When they are within the ranges, close the
screen.
MCV: XN-cal Target Value ± 2

MPV: XN-cal Target Value ± 1

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click “Send”)
3. After adjustment is completed, confirm that the data is within ranges, scattergram is normal and
gain is within the following ranges.
4. Confirm data on “Main” from “Browser”

XN-1000/2000 S/M 4-84 April 2015


<HGB>
1.Confirm value is within the following range. If it is within the range, close the screen.
HGB: XN-CAL Target ± 0.2g/dL

2. If values are out of ranges, adjust the parameters which are out of ranges with the following
adjustment procedure. (Enter target and click “Send”)

3. After adjustment is completed, click “Send”


4. Confirm data on “RBC/PLT” of “SERVICE MENU” from “Browser”

XN-1000/2000 S/M 4-85 April 2015


XN-1000/2000 S/M 4-86 April 2015
4.13 Whole Blood Calibration
Whole Blood Calibration Necessary Tool

XN-CAL

Note: Calibration parameters are different depending on analyzer type

4.13.1 Measurement
1. Change mode to manual and whole blood mode on analyzer.
2. Select “Calibration” > “Calibrator Calibration” in Control Menu.

3. Mix XN-CAL, and place it in the sample tube holder. Press the start switch.
4. Analyzer performs 11 times measurement automatically.

XN-1000/2000 S/M 4-87 April 2015


4.13.2 Data Verification
1. By clicking “Next” and “Back”, confirm all results in No.2 to No.11 are displayed without masking
and all calibration parameters are within the limit. If re-analyze the sample due to abnormal data,
select the analysis number with abnormal data and press manual start switch. After
measurement is completed, the sample number result will be automatically replaced by the new
result.
2. After data verification is completed, click “Calibration” and then calibration data screen appears.

4.13.3 Read Target


1. Press “Read” button to read target value. If analyzer is not connected to SNCS, need to read the
data from the media provided in XN-CAL or input manually.

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4.13.4 Calibration
1.After verifying all calibration value, click “OK”
[Before 00-16 or lower]

[After 00-17 or higher]

Current New Current New


Rate(%) Rate(%) Rate(%) Rate(%)

WBC-N 100.0 100.0 Modify HCT 105 114.7 Modify

WBC-D 100.0 99.9 Modify

WBC-P 100.0 99.9 Modify

RBC 110.0 104.7 Modify

HGB 100.0 100.0 Modify

PLT 100.0 100.0 Modify

RET% 100.0 99.9 Modify

RBC-0 100.0 100.0 Modify

PLT-O 100.0 100.0 Modify

< > < >


Cancel OK Cancel

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2. By checking calibrator parameter check box, select calibration parameters which need to be
modified. If calibration parameter does not meet the following condition, the check box for modify
cannot be checked.

80% ≤ New Calibration Value ≤ 120%

New Calibration Value - Current Calibration Value ≤ ±5%

Range Value ≤ Max Range

Acceptable Limit ≤ Delta Percent ≤ Service Limit


3. If auto calculated calibration value needs to be modified, check the check box and enter new
calibration value manually.
4. Click “OK”
Note: If new calibration value is significantly changed, analyzer might be something wrong. Therefore,
verify the analyzer condition again before calibration.

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4.13.5 Calibration for RBC-He and RET-He at Customer side
Note: Before the calibration for RBC-He and RET-He, calibration for RBC-Y, HGB, and RBC has to
have been completed.
1. Run XN CAL five times consecutively, and calculate mean for RBC-He and RET-He.

(for RBC-He)
2. Verify whether the deference between the mean for RBC-He and the target value in the assay
sheet is within ±0.5pg.
3. If the mean for RBC-He exceed the range above, perform the calibration by “NVRAM RBC-He”.
4. After performing the calibration, run XN CAL again (repeat step 1 - 2).
5. Verify that the data are within the above range. If it fails, repeat the steps until it falls within the
range.

(for RET-He)
6. Verify whether the deference between the Mean for RET-He and the target value on the assay
sheet is within ±1.0pg.
7. If the Mean for RET-He exceeds the range, perform the calibration by “NVRAM RET-He”.
8. After performing the calibration, run XN CAL again (repeat step 1, 6).
9. Verify that the data are within the above range. If it fails, repeat the steps until it falls within the
range.

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XN-1000/2000 S/M 4-91 April 2015


4.13.6 Calibration Confirmation
Confirm that the CAL results are within the specified range as follows.
<<Specified range: 1000+/-200>>
Parameters: RBC_CAL, PLT_CAL, WBC_CAL, WDF_CAL, WPC_CAL, RBCO_CAL, PLTO_CAL
<<Specified range: 1000+/-500>>
Parameters: RET_CAL
Confirm that the XN CAL values fall within the acceptable limits after performing calibration.
Re-calibrate if the result exceeds the limit.
Acceptable limit means that assay values multiplied by Acceptable limit (%).

Calibration
Acceptable Limit (%) Calibration parameter Acceptable Limit (%)
parameter
WBC 2.87 PLT-I 4.16
WBC-D 2.27 RET% 15.25
RBC 1.25 PLT-O 5.16
HGB 0.78 RBC-O 5.89
HCT 2.64 WBC-P 3.02

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XN-1000/2000 S/M 4-92 April 2015


4.14 Whole Blood PF Calibration
Whole Blood PF Calibration Necessary Tool

XN-CAL (PF)

Note: When analyzer does not have PLT-F parameter, the following calibration is not required.

4.14.1 Measurement
1. Change mode to manual and whole blood mode on analyzer.
2. Select “Calibration” > “Calibrator Calibration (PLT-F)” in control menu.

3. Mix XN-CAL (PF), and place it in the sample tube holder. Press the start switch.
4. Analyzer performs 11 times measurement automatically.

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4.14.2 Data Verification
1. By clicking “Next” and “Back”, confirm all results in No.2 to No.11 are displayed without masking
and all calibration parameters are within the limit. If re-analyze the sample due to abnormal data,
select the analysis number with abnormal data and press manual start switch. After
measurement is completed, the sample number result will be automatically replaced by the new
result.
2. After data verification, click “Calibration” and then calibration data screen displays.

4.14.3 Read Target


1. Press “Read” button to read target value. If analyzer is not connected to SNCS, need to read the
data from the media provided in XN-CAL or input manually.

XN-1000/2000 S/M 4-94 April 2015


4.14.4 Calibration
1. After verifying all calibration values, click “OK”

2. By checking calibrator parameter check box, select calibration parameters which need to be
modified. When calibration parameter does not meet the following condition, the check box for
modify cannot be checked.

80% ≤ New Calibration Value ≤ 120%

New Calibration Value - Current Calibration Value ≤ ±5%

Range Value ≤ Max Range

Acceptable Limit ≤ Delta Percent ≤ Service Limit

3. If auto calculated calibration value needs to be changed, check the check box and enter new
calibration value manually.
4. Click “OK”
Note: If new calibration value is significantly changed, analyzer might be something wrong. Therefore, verify the
analyzer condition again before calibration.

XN-1000/2000 S/M 4-95 April 2015


4.14.5 Calibration confirmation
Confirm that the CAL results are within the specified range as follows.
<<Specified range: 1000+/-500>>
Parameters: PLT F_CAL
Confirm that the XN CAL PF values fall within the acceptable limits after performing calibration.
Re-calibrate if the result exceeds the limit.
Acceptable limit means that assay values multiplied by Acceptable limit (%).

Calibration parameter Acceptable Limit (%)


PLT-F 1.80

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XN-1000/2000 S/M 4-96 April 2015


4.15 PD Mode Data Adjustment
PD Mode Data Adjustment Necessary Tool

XN-CAL

4.15.1 Measurement Setting


1. Click “Mode” > “Calibrator” in “SERVICE MENU”
2. Switch to Pre Dilute (PD) mode.
3. Press manual measurement button.
Note: Discrete is each analyzer’s full discreet except for PLT-F.

a. Enter sample ID.


b. Discrete: CBC / DIFF / RET / WPC
c. Dilution PD: ON
d. Aspiration Sensor: ON
4. Click “OK”

5. Dilute XN-CAL 500µL by CELLPACK DCL 3ml(1:6 dilution), and measure diluted XN-CAL 10
times. When measuring it, remove XN-CAL cap.
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Note: Mix sample each measurement

XN-1000/2000 S/M 4-97 April 2015


4.15.2 Enter Calibration Value
1. Calculate calibration value by comparing average value with 5 times measurement and assay
value for the following parameters.
Parameters: RBC_PD_CAL / PLT_PD_CAL / HGB_PD_CAL / WBC_PD_CAL /
WDF_PD_CAL / RET_PD_CAL. RBCO_PD_CAL / PLTO_PD_CAL
*Parameters numbers might be changed depending on analyzer type.
Calculation Formula:
Calibration Value(%) = “Assay Value” / “5 times measurement average” x 100 x “Current Calibration Value”

<Adjustment Range: 1000±200>


Parameters: RBC_PD_CAL / PLT_PD_CAL / HGB_PD_CAL / WBC_PD_CAL /
WDF_PD_CAL / RET_PD_CAL. RBCO_PD_CAL / PLTO_PD_CAL
2. Click “NVRAM”
3. Enter calculated calibration value to each parameter of CAL file.
*Example: In case of 98.65%, enter “987” (Round on two places of decimals))
RBC_PD_CAL 1000 PLT_PD_CAL 1000

HGB_PD_CAL 1000 WBC_PD_CAL 1000

WDF_PD_CAL 1000 RET_PD_CAL 1000

RBCO_PD_CAL 1000 PLTO_PD_CAL 1000

4. When calibration values are changed, click “Send”

XN-1000/2000 S/M 4-98 April 2015


4.15.3 Calibration Confirmation
Confirm that the CAL results are within the specified range as follows.
<<Specified range: 1000+/-200>>
Parameters: RBC_PD_CAL, PLT_PD_CAL, WBC_PD_CAL, WDF_PD_CAL, RBCO_PD_CAL, PLTO_PD_CAL
<<Specified range: 1000+/-500>>
ParConfirm that the XN CAL values fall within the acceptable limits after performing calibration.
Re-calibrate if the result exceeds the limit.
Acceptable limit means that assay values multiplied by Acceptable limit (%).

Calibration parameter Acceptable limit (%) Calibration parameter Acceptable limit (%)
WBC 3.76 PLT-I 7.00
WBC-D 2.97 RET% 12.45
RBC 2.10 PLT-O 7.66
HGB 1.31 RBC-O 4.48

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XN-1000/2000 S/M 4-99 April 2015


4.16 PD Mode PF Data Adjustment
PD Mode PF Data Adjustment Necessary Tool

XN-CAL (PF)

4.16.1 Measurement Setting

1. Click “Mode” > “Calibrator PLT-F” in “SERVICE MENU” 201391


2. Switch to Pre Dilute (PD) mode.
3. Press manual measurement button.
4. Enter sample ID.
5. Select discrete: CBC+PLT-F
6. Click “OK”

7. Dilute XN-CAL 500µL by CELLPACK DCL 3ml(1:7 dilution), and measure diluted XN-CAL 10
times. When measuring it, remove XN-CAL cap.
201395
Note: Mix sample each measurement

XN-1000/2000 S/M 4-100 April 2015


4.16.2 Enter Calibration Value
1.Calculate calibration value by comparing average value with 5 times measurement and assay
value for the following parameters.
Parameter: PLT_F_PD_CAL
Calculation Formula:
Calibration Value(%) = “Assay Value” / “5 times measurement average” x 100 x “Current Calibration Value”

<Adjustment Range: 1000 ± 200>


Parameter: PLT_F_PD_CAL
2. Click “NVRAM”
3. Enter calculated calibration value to each parameter of CAL file.
*Example: In case of 98.65%, enter 987 (Round on two places of decimals)
Parameter PLTF_PD_ CAL 1000

4. When calibration values are changed, click “Send”

XN-1000/2000 S/M 4-101 April 2015


4.16.3 Calibration Confirmation
Confirm that the CAL results are within the specified range as follows.
<<Specified range: 1000+/-500>>
Parameters: PLT F_PD_CAL
Confirm that the XN CAL PF values fall within the acceptable limits after performing calibration.
Re-calibrate if the result exceeds the limit.
Acceptable limit means that assay values multiplied by Acceptable limit (%).

Calibration parameter Acceptable limit (%)


PLT-F 2.56

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XN-1000/2000 S/M 4-102 April 2015


4.17 Body Fluid Mode Data Adjustment
Body Fluid Mode Data Adjustment Tool

XN-CAL

4.17.1 Measurement Setting


1. Click “Mode” > “Calibrator” in “SERVICE MENU”
2. Switch to Body Fluid (BF) mode.
3. Enter sample ID.
4. Measure XN-CAL 10 times. When measuring it, remove XN-CAL cap.

Note: Mix sample each measurement.


Do not dilute the XN CAL when analyzing.

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4.17.2 Enter Calibration Value
1. Calculate calibration value by comparing average value with 5 times measurement and XN CAL
assay value for the following parameters

Parameter WBC-BF RBC-BF


Assay value WBC-D RBC

Calibration Formula:
Calibration Value(%) = “Assay Value” / “5 times measurement average” x 100 x “Current Calibration Value”

<Adjustment Range: 1000 ± 200>


Parameter: WBC_BF_CAL / RBC_BF_CAL
2. Click “NVRAM”
3. Enter calculated calibration value to each parameter of CAL file.
*Example: In case of 98.65%, enter 987 (Round on two places of decimals)
WBC_BF_CAL 1000

RBC_BF_CAL 1000

4. When calibration values are changed, click “Send”


Note: Click “Send” when each parameter is selected.

XN-1000/2000 S/M 4-104 April 2015


4.17.3 Calibration Confirmation
Confirm that the CAL results are within the specified range as follows.
<<Specified range: 1000+/-200>>
Parameters: WBC_BF_CAL, RBC_BF_CAL
Confirm that the XN CAL values fall within the acceptable limits after performing calibration.

Do not dilute the XN CAL when analyzing.

Re-calibrate if the result exceeds the limit.


Acceptable limit means that assay values multiplied by Acceptable limit (%).

Calibration parameter Acceptable limit (%) Calibration parameter Acceptable limit (%)
WBC-BF 2.27 RBC-BF 1.25

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XN-1000/2000 S/M 4-105 April 2015


4.18 Blood sensor
1. Click Blood sensor in the service program.

2. Blood sensor adjustment screen appears.

XN-1000/2000 S/M 4-106 April 2015


3. Place a rack with two plastic sample tubes which outer diameter is from 12mm to 12.5mm. Place
an empty sample tube in the first position of the rack, and place a sample tube filled with 2mL
water in the second position.

4. Click Execute.

5. The rack is shifted to blood sensor position automatically. The rack is come to the left table after
the adjustment is completed.
6. Click close.

XN-1000/2000 S/M 4-107 April 2015


4.19 Raised Bottom Sample Tube setting procedure
This procedure describes how to change the settings to use Raised Bottom Sample Tube (Hereafter,
called RBT). This procedure is applicable only for the XN-series program version 00-15 or higher.

4.19.1 Setting on IPU program


(1) Rack Barcode setting (Target: XN-1000/XN-2000/XN-3000)
1) Select [Menu] > [Analyzer Settings] > [Barcode Reader] from IPU program.
2) Check [Rack ID] and click [OK] button.
*This setting is not required on XN-9000 because Rack ID is always used.

(2) Blood Sensor Setting (Target: XN-1000/XN-2000/XN-3000/XN-9000)


1) Select [Menu] > [Analyzer Settings] > [Blood Sensor] from IPU program.
2) Check [Use] and click [OK] button.
*This setting applies to each sampler (CV-50). Therefore, perform this setting to all samplers.

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XN-1000/2000 S/M 4-108 April 2015


4.19.2 Piercer position adjustment for RBT and operation check (Target: XN-10/XN-
20)
(1) Piercer position adjustment for Normal sample tube(or Sarstedt)
1) Perform Piercer position adjustment by referring the installation procedure.
(2) Piercer position adjustment for RBT
1) Select [SERVICE MENU] > [Piercer Adjustment]
2) Change "Container type" to [Raised Bottom Tube]
3) Select "Aspiration. Position"
4) Adjust piercer position so that piercer edge aligns with the upper side of sample set unit by
clicking [Up] or [Down] buttons.
5) Click [Save] button.

2)

3)

Align the edge of piercer to

the center.
4)

5)

6) Change "Container type" to [Normal] or [Sarstedt]


<NOTE>
- When using normal rack, the Container type selected in this step is used. Therefore, select
container type that customer uses daily basis.

- Raise Bottom Tube cannot be allowed to set as standard sample tube. If selecting "Raised
Bottom Tube", Sample Aspiration error will occur due to the difference of piercer aspiration
position.

XN-1000/2000 S/M 4-109 April 2015


7) Click [Save] button
8) Click [Close] button

6) or

7) 8)

(3Operation check after piercer position adjustment


1)Dispense 200uL of sample to 3 RBTs as confirmation samples.
-Human blood or control blood should be used.
<NOTE> Normally, required sample volume is 250uL.

2)Set 3 RBTs on RBT dedicated rack.

3)Set analysis condition as mentioned as listed below.

Analysis mode WB mode


Discrete mode Full mode
Analytical Human blood Normal
mode Control blood Control
* When switching to Control mode, first switch to manual mode, and then switch back to
sampler mode.

4)After analyzing, check the following 2 points.


1.Does not get "Insufficient blood volume (Short Sample?" error.
2.Does not make a hole from piercer on the bottom of RBT

XN-1000/2000 S/M 4-110 April 2015


Ex: Sample of hole from piercer

When both conditions are met, finish operation check.


If either condition is not met successfully, proceed to step 5).

5)Change the piercer Aspiration position.


Perform piercer Aspiration position by referring Step 1-2?Piercer position adjustment for RBT.
As for the moving direction and distance, refer to the following table.
Result at step 4) Direction Distance
When “Insufficient sample volume 1 click
Down (6 pulse :
(Short sample)” error occurred. 0.225mm)
When a piercer hole was found on 1 click
Up (6 pulse :
the bottom of RBT. 0.225mm)
<Note>
Make sure to set "Container type" to [Normal] or [Sarstedt] after position adjustment.

6)Perform step 1) through step 4) again.

4.19.3 Checking for related program versions before using RBT

1.XN-3000 program version


- When using SA-30, the following 2 programs need to be upgraded as below.
SA-30: Ver.00-06
ConfigTool: Ver.00-03

Please verify that both program versions are upgraded as needed.


*When upgrading these programs, first upgrade SA-30 to Ver. 00-06 and then upgrade
ConfigTool to Ver.00-03.

XN-1000/2000 S/M 4-111 April 2015


2. XN-9000 program version
- When using CV-60, the CV-60 program version needs to be upgraded to ver.00-09.
- When using CT-90, the CT-90 program version needs to be upgraded to ver.00-11.
Please check each program version and upgrade as needed.

*When CV-60 connects to VIIT or G8, the settings are the same as SP-10.

XN-1000/2000 S/M 4-112 April 2015

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