DVD1XN1X_VersionHistory_E

DVD1XN1X Ver.22.
20-00
<Applicable to S/N> <Release Date> JP: Ver.22.20-00
Refer to ECR 322G056 February 2023 EU: Ver.22.20-00
AP: Ver.22.20-00
<Parts Information> AM: Ver.22.20-00
CG723992: CDR_ASSY NO.532(DVD1XN1X(22.20-00)) CN: Ver.22.08.08-00
AN616770: CDR_ASSY NO.478(DVD1XN2J(22.08.08-00)) (For China market only)
<FDS File Name>

P_XNSWSTAL_22200001.cab (Including installer)
P_XNSWSTAL_22200000.cab (VHD only)
Changed Specifications
1 Now GP Customize function can be used in BB mode.
2 GDI function has been expanded.
3 A service setting has been added to prevent the message "Aspiration Sensor is OFF" from being
displayed when the blood aspiration sensor is not used.
4 Platelet CHECK Level2 has been removed from QC list. (EU market only)
5 In XN BB mode, Ret ch information which is not displayed as QC measurement result has been
removed from browser display. (EU market only)
6 Now XN CAL can be used for WBC calibration in the BB mode.
7 WBC calibration formula in BB mode has been changed.
8 Decision of RET Abn Scattergram has beefed up.
9 Decision of PLT Abn Scattergram has beefed up.
10 When a new stain cartridge is loaded, the opening date is written on the RFID, but this process
overlaps with writing the number of remaining tests, which can cause the analyzer to aberrate.
Therefore, the software has been modified to prevent double writing to RFID.
11 In Ver.22.19-00, service settings to use barcode reader F-100 were added. In addition to these
settings, adoption logic for sample ID read by barcode reader has been added to further increase the
reading rate of low quality labels. New barcode reader setting below has also been added in service
menu.
Barcode reader setting (1) Barcode reader setting (2)

Resolved Program issues
1 Resolved the issue that the suspended sampler measurement could not be resumed when the mode
switch was pressed to switch to the sampler measurement mode after the manual measurement was
completed only when SA-01 was used as the sampler.
2 The UI list of Brazilian Portuguese has been corrected.
Remarks
Module Version
[IPU] 00-22 Build205
[Device Control Manager] 00-22 Build205
[Analysis] 00-22 Build89
[Analyzer Sequencer] 00-22 Build205
[Sampler Sequencer] 00-22 Build205
Sequence Program Version

[Analyzer] 00-69
[Sampler] 00-16
ECR 322G056
DVD1XN1X Ver.22.19-00
Refer to ECR 322B052 September 2022 EU: Ver.22.19-00
AP: Ver.22.19-00
CQ759907: CDR_ASSY NO.525(DVD1XN1X(22.19-00)) CN: Ver.22.08.07-00
<FDS File Name>

1 IPU now works in an environment with Firewall Function enabled.
2 As SNCS integrates into Caresphere, IPU no longer uses the word "SNCS".
3 New service setting "Analysis interval for Exchange Piercer" to change the number of measurements
before piercer replacement message occurs has been added.
4 The default value for the service setting "Barcode reader type" has been changed.
Was Is
NFT-7175 (OPTOELECTRONICS) BL-185 (KEYENCE)
5 Add the new service setting to use barcode reader F-100 (OPTOELECTRONICS). (Each analyzer
system settings)
・Number of barcode reader decode matches
・Minimum reading digits for barcode reader
6 Norwegian and Swedish have been added as display languages in IPU. (for EU market only)
1 Resolved the issue that log off history would not be kept if Windows exited before writing log off
history to the database in the shutdown process.
2 Resolved the issue that some of the conditions in rule 1 of PLT-I/PLT-O switching were incorrect and
could not be switched when MicroR was 5.0%.
3 Resolved the issue that the management range can not be set correctly when QC file is restored and
QC limit setting is set as "%".
4 Resolved the issue that cleaning operation can not be performed properly when 2 units are started
simultaneously to be cleaned by CELLCLEAN AUTO on XN-9100/XR-9000 with BT-50 in the
configuration.
5 Resolved the issue that grade value of Q-Flag does not become blank when measurement result is
blank data.
6 Resolved the issue that inability to restore older versions of smp files in Ver.22-18-00.
Remarks
Module Version

[Analyzer] 00-68
[Sampler] 00-16
ECR 322B052
Refer to ECR 321A036 March 2022 EU: Ver.22.18-00
AP: Ver.22.18-00
AK910980: CDR_ASSY NO.504 (DVD1XN1X(22.18-00)) CN: Ver.22.10.00-00
<FDS File Name>

1 XR can now control XR-9000 in which BT-50 is included in the configuration.
2 Users who do not have the right to change settings can now switch the reagent from RU to
CELLPACK DCL.
3 A service setting has been added to set the number of tests to be taken before performing the "Drain
RBC Isolation Chamber". (Setting name: Analysis interval for drain RBC Isolation Chamber,
Execution timing: During startup sequence at next startup)
4 The determination of the WBC Abn Scattergram has been enhanced when the fluorescence
intensity (SFL) of the WBC decreased.
1 Resolved the issue that IPU stops when shutdown is complete when the host computer is
turned off during shutdown.
2 Resolved the issue that the screen lock is re-activated when the screen is not operated after the
screen lock is released by IC card.
3 Resolved the issue that expiration date of reagent is not displayed correctly if the analyzer is
shutdown without measurement after staining solution replacement.
4 The classification algorithm has been modified so that MN and PMN could be correctly classified
when measuring the sample that the population of multinucleated cells appear in area with high
fluorescence intensity (SFL) in BF mode. (An algorithm is added to detect the misclassification of a
part of PMN as MN in the macrophage region.)
5 The classification algorithm has been modified so that LYMPH and MONO could be correctly
classified when measuring the sample with aberration cells appearing in area with high fluorescence
sensitivity in WB mode.
6 Resolved the issue that NRBC is not calculated correctly (false high or false low) due to a problem of
NRBC classification algorithm.
Remarks
Module Version

[Analyzer] 00-67
[Sampler] 00-16
ECR 321A036
DVD1XN1X Ver.22.17-00 Upgrade Procedure
<Applicable to S/N> <Release Date>
Refer to ECR 321A035 November 2021
<Part No./Name> Module Version

CJ770053: [IPU] 00-22 Build176
CDR_ASSY NO.501 (DVD1XN1X(22.17-00)) [Device Control Manager] 00-22 Build176
<FDS File Name> Sequence Program Version
P_XNSWSTAL_22170001.cab (including installer) [Analyzer] 00-66
P_XNSWSTAL_22170000.cab (vhd only) [Sampler] 00-16
1 The classification algorithm has been changed for the residual RBC measurement in BB (Blood Bank)
mode as a countermeasure for false high in residual RBC.
2 The QC parameters for BB mode can be output to the external QC via online.
3 The RBC-O parameters, displayed as “RBC” in “BB Res Control Level1” and “BB Res Control Level2”
materials, are deleted from the QC parameters for BB mode.
4 The QC functions in BB mode become available for European and Asia Pacific markets.
5 For North American markets, WBC(BB) is changed from the research parameters to the reportable
parameters.
1 Even if the analysis mode was set to “Normal” after a “Precision Check” analysis was performed in
any analysis modes other than “Normal” in the Service mode setting, the analysis mode stayed the
same as it was.
This issue has been resolved. The “Precision Check” analysis can now be performed correctly even
after the analysis mode is switched from other modes than “Normal”.
2 The classification algorithm for WBC and NRBC has been changed to resolve the following 3 issues.
(1) NRBC could be false low if abnormal nucleated RBCs interfered with the WBC region on WNRch
and this caused incorrect WBC/NRBC classification.
(2) NRBC could be false high if unknown particles interfered with the TNC region on WNRch.
(3) NRBC could be false low when nucleated RBCs did not appear in the expected position on
WNRch and this caused incorrect NRBC classification.
After this change, the following operation are performed when the algorithm decides that the
classification cannot be performed normally.
(1) The NRBC+WBC cluster is grayed out.
(2) The WBC related items are masked.
(3) The “WBC Abn Scattergram” message is output.
3 When “RBC Abn Distribution”, indicating the possibility of abnormality on RBCch, was output, the low
reliability mark [*] was appended to the RET%, IRF, LFR, MFR, HFR, and RET-He items calculated
only in RETch.
This issue has been resolved, and the low reliability mark is not appended to the RET%, IRF, LFR,
MFR, HFR, and RET-He items when “RBC Abn Distribution” is output.
4 When the system was XN-9000 configuration, it was possible that the XN analyzers and CV-50 would
adopt sample numbers read by BT-40 instead of those read by the XN analyzer after BT-40 read the
sample barcodes. This would cause adopting incorrect sample numbers if user changed sample
position in the sample rack.
This issue has been resolved, and sample numbers read by XN analyzers are adopted at the time of
measurement.
5 Units for some parameters were not output correctly when measurement items were output via GDI.
This issue has been resolved.
Remarks
ECR 321A035
Refer to ECR 320B032 February 2021

BM496971: [IPU] 00-22 Build164
[Analyzer] 00-65
[Sampler] 00-16
1 Assay value for PLT CHECK can be used when accessing “Read Assay File” in QC registration
screen, so that it can use PLT CHECK with barcode reading in BB mode.
2 Outputting QC comment in each plot in QC chart to a HOST computer is supported.
(ASTM format only)
QC Comment
3 WBC(BB) parameter has been changed from reportable parameter to research parameter.
(For North America market only)
4 Canceling the database optimization process has been supported.
[Cancel] button
5 “RE-MONO” has been added as a service parameter and they can be output to the host computer.
Parameters listed below are output as service parameter to host computer. (Not displayed in IPU)
(1) RE-MONO#
(2) RE-MONO%
(3) RE-MONO%M
This function is supported in ASTM format and Standard format only.
6 Adding service setting “Sensitivity adjustment of the PLT-F channel in QC analysis”. Plotting position
of PLT cluster on PLT-F ch can be adjusted by this setting. (Setting range is 0-14 and default value is
0)
7 Message displayed when reagent supply source is changed between RU and DCL has been
changed. Previously when RU-20 has any problem and reagent source is changed to DCL, and then
changed back to RU-20 again, at that time the message displayed was confusing and customer can
connect DST directly. To address the issue, message has been changed.
Ver.22.15-00 and before Ver.22.16-00
8 Memory size IPU can use has been changed from 2GB to 4GB. (Only for Windows10 64bit OS)
Previously there was “Out of Memory” error can occur because IPU can access up to 2GB of memory.
The memory size that IPU can access is extended to address this issue.
9 When display language is changed from English to local language, some wordings have been
changed to local language.
10 QC data is no longer written directly to the folder accessed by Support Manager.
QC data was directly written to the folder monitored by Support Manager.
However, to prevent zero byte (no content) of data from being sent to the SNCS server, QC data is no
longer written directly to the folder monitored by Support Manager now.
11 Previously when starting the “GP customize” program there was a possibility to have “.NET
Framework error” in the region where comma is used as decimal point. This issue is solved.
1 The classification algorithm of AS-LYMPH has been improved.

In previous version, AS-LYMPH can be zero when there are many plots around normal LYMPH
cluster area even though there are AS-LYMPH plots at high SFL area. Now classification algorithm of
AS-LYMPH has been improved to count AS-LYMPH accurately.
Position of AS-LYMPH cluster
2 In APD Parameter Setting menu, service engineers could not input voltage value as they intended.
3 Some of functionalities could not be used such as reagent replacement, measurement mode change,
when logging on to the IPU using an IC card while the power of the main unit is turned on.
4 WBC count could become 1/3 when analyzing a whole blood sample in the LW mode if following
steps below are taken. This issue has been resolved.
(1) Select Low WBC mode, and click OK to close the dialog.
(2) Input sample No, check “Query to Host” and close the dialog by clicking [OK] button.
(3) Receive analysis order for LW mode from host computer.
(4) In “Change Measurement Mode” select Whole Blood..
(5) Press start switch to run a sample, without accessing “Manual Analysis” dialog.
5 With the configuration that there are two main units are used (i.e XN-2000) there was a possibility not
to show restart button after shutdown. This issue has been resolved.
In case that left analyzer is turned OFF and right analyzer is turned ON, restart button could not be
displayed when shutting down the analyzer with CELLCLEAN on rack. This issue has been resolved.
6 In BF mode, the sum of WBC was not 100% in some specific cases. This issue has been resolved.
Remarks
ECR 320B032
S/N: Not fixed yet March 2020

CS661128: [IPU] 00-22 Build157
[Analyzer] 00-65
[Sampler] 00-16
1 The versions of VisualStudio and Microsoft SQLServer have been changed. The installed applications
depend on Windows OS.
The service life for previous versions of Visual Studio and Microsoft SQL Server will end before the
end of the sales of XN analyzers. To resolve the situation, the versions of Visual Studio and Microsoft
SQL Server for Windows 10 have been changed.
Before change After change

VisualStudio2008 -> VisualStudio2017
SQLServer2014 Express SP2 SQLServer2016 Express SP2
The new VisualStudio and SQLServer are installed automatically when the installer runs. .NET
Framework4.7.2 is installed as well.
Note:
(1) Once upgraded to Ver.22.15-00, downgrading to previous versions cannot
be performed.
(2) On Windows7, VisualStudio2017 is installed. However, SQL Server 2016 is
not installed.
2 The “Blood Bank (BB) mode (IVD)” whose analysis parameters are “reportable” has been added for
XN-10 and XN-20 only. *License is required.
The BB mode (IVD) can be applied to only XN-10 and XN-20 analyzers with the PLT-F channel such
as XN-10 [B1] and XN-20 [A1] in the XN-1000 or XN-2000 configuration.
Note:
(1) In case that BB mode (RUO) has been used in previous versions
(Ver.22.09-00 thru Ver.22.13-00) and the BB mode (IVD) is introduced, the
IPU program needs to be re-installed. And then, the license key for the BB
mode (IVD) needs to be entered.
(2) In case of the XN-2000 configuration, 2 licenses for both analyzers are
required to use the BB mode (IVD).
1 When WBC aggregation occurred on the WNR ch, “BASO#” and “BASO%” research parameters
were not masked. This has been changed so that those parameters are now masked.
2 When the data form is “0.XXXX” on the “Target/Limit Setting” screen, the data could be input only to
three decimal places and could not be input to the four decimal places. This issue has been resolved.
This issue occurred on the following items:
Measurement Mode Item and unit name

WB “10^6/uL” for RET#
WB “10^12/L” for RET#
WB “L/L” for PCT
WB “Ratio” for PCT
BB (PLT pack) “10^6/uL” for RBC
BB (PLT pack) “10^12/L” for RBC
3 After the QC file whose QC file number had been deleted was registered with different lot number, the
QC file could not be deleted. This issue has been resolved.
4 When a manual measurement was performed in BB mode, the QC sample taken into the analyzer
could not be taken out and the analyzer would not start measurement until restarting.
5 When starting the IPU program, mounting VHD could fail and “MountError” would occur. This issue
has been resolved.
6 The French and Spanish messages have been modified.
7 The stability of WBC classification function has been improved for the BB mode quality control.
8 On Windows10, there was a case that an error dialogue appeared and IPU locked up when the SNCS
router was connected. This issue has been resolved.
9 On Windows 10, the execution of DB restoration tool could fail when upgrading from Ver.22.11-00 or
earlier. This issue has been resolved.
10 When SA-01 was used on the XN-1000 configuration, the internal error could occur after performing
the followings:
(1) Sample measurement started on the sampler mode.
(2) After the analyzer picked up and mixed a sample tube, the mode switch was pressed and
switched to the manual measurement mode.
(3) After the analyzer returned the sample tube to the rack, the rack was removed by hand.
(3) The mode switch was pressed again to change to the sampler measurement mode.
(5) The rack removed on the previous step was entered again and the measurement started.
(6) The internal error occurred when the analyzer detected the first sample tube.
11 Error messages displayed on XN IPU for the RU-20 pressure errors were incorrect. This issue has
been resolved so that the same messages as shown in the IFU will now appear.
12 Previously, analysis results for WBC related parameters were not masked, depending on the “Mask of
analysis result with misclassification for WBC differentials” service setting, when NRBC interference
to WBC area was detected and “WBC Abn Scattergram” was output. This issue has been resolved
and WBC related parameters are now masked.
Applicable parameters
NEUT#, NEUT%, LYMPH#, LYMPH%, MONO#, MONO%, EO#, EO%, BASO#,
BASO%, NRBC#, NRBC%, IG#, IG%, WBC-N, WBC-D, WBC-P, HFLC#, HFLC%,
NEUT#&, NEUT%&, BA-N#, BA-N%, BA-D#, BA-D%
13 When the “Limit Setting” was set as “Ratio(%) for the “QC Setting” and QC lot was registered, “Limit
range(%)” for sensitivity items (WNR-X, WNR-Y, WNR-Z etc.) were 100%. However, normal users
cannot change the sensitivity items and the limit were not managed properly. (Only the “Service” user
can change the sensitivity items)
This issue has been resolved by using “Differential(#)” regardless if limit is set to “Ratio(%)” or
“Differential (#)” for sensitivity items.
14 After the “Positive ID check error” occurred, SP did not make smear when the rack with error was re-
entered. This issue has been resolved.
15 On XN-2000 configuration, if only one of 2 analyzers performs measurement repeatedly, the piercer
mechanism unit in the other analyzer did not return to the initial position and continually moved to
right. This issue has been resolved.
On analyzers with Ver.22.09-00 or later, the piercer mechanism unit moved to right when the
pneumatic unit turned to “Sleep” after the instrument status changed from “Working” to “Ready”.
However, initialization of the piercer mechanism unit was not performed until starting measurement.
Therefore, if the instrument status changed from “Working” to “Ready” without performing
measurement repeatedly, the piercer mechanism unit continually moved to right.
To resolve this issue, initialization of the piercer mechanism unit is now performed when the
pneumatic unit turns to “Sleep”.
In addition, the piercer mechanism unit does not move to right when the “Parts information KIT
NO.458” setting value is set as “Not Installed” in the “NVram” setting.
16 When the “Blasts/Abn Lympho?” Q-Flag positive level was set as 90 and “Blasts?” and “Abn
Lympho?” are set as default value (100), there was a case that the “Abn Lympho?” Q-flag was
incorrectly judged as “Positive” though the Q-Flag value of the measurement result for “Abn
Lympho?” was 90.
This issue has been resolved and the Q-Flag judgment is always performed based on the positive
level configured in “Service Settings”.
Remarks
ECR 319E046
(North American Markets only)
S/N: Not fixed yet December 2019

N/A [IPU] 00-22 Build135
[Analyzer] 00-63
[Sampler] 00-16
1 The following changes have been made for “BB mode”.
(1) Plasma measurement function has been deleted.
(2) The “RUO” warning message has been deleted.
(3) The following BB mode parameters now become reportable.
- RBC(BB)
- HGB (BB)
- HCT (BB)
- PLT (BB)
- WBC (BB)
(4) Quality control for BB mode can now be performed.

(5) Auto-validate and auto-output can now be performed on BB mode.
(6) BB mode analysis results can now be output to the host computer.
(7) Graphic print can now be performed for BB mode analysis results.
(8) List print can now be performed for BB mode analysis results.
(9) The layout for data browser has been changed.
(10) For North American markets, BB mode background check result will not appear on the "Explorer"
screen.
(11) For North American markets, the tabs for BB mode now appear on the "Explorer" screen.
(12) “Normal range” does not appear on histogram for BB mode analysis results.
(13) The format for CSV output has been changed.
(14) Abnormality notification functions have been added.
(15) WDFch performance for BB mode has been improved.
(16) The linearity range for reportable parameters has now been set.
None
Remarks
This program is only for BB-mode evaluation in the North American markets.
ECR 319F015
S/N: Not fixed yet August 2019

BW605994: [IPU] 00-22 Build123
CDR_ASSY NO.422 (DVD1XN1X(22.12-00) [Device Control Manager] 00-22 Build123
[Analyzer] 00-63
[Sampler] 00-16
1 A message displayed on “Aspiration Sensor Cal” has been changed.
Before change Execute Aspiration Sensor Calibration after Aspiration Sensor was
executed.
After change Execute Aspiration Sensor Calibration after Aspiration Sensor
Adjustment was executed.
2 For instruments with the “EU” destination, judgment calculation algorithms for “Blast?”, “Abn
Lympho?”, and “Blasts/Abn Lympho?” Q-flags have been changed. In addition, a service setting has
been added to decide whether the changed algorithms are used.
Setting name Setting value Default value

Select Q-Flag grade value algorithm of WBC IP 0: Ver.22.11 1: Ver.22.12
messages 1: Ver.22.12
1 When the number of measured samples exceeded 100,000 after installation, data bacame
fragmented and database volume unintendedly increased. When the size of database exceeded 4
GB, new measurement results could not be added. To resolve this issue, the following measure has
been implemented.
(1) IPU will perform the database defragmentation (optimization) as soon as the database uses the
specified volume. When the optimization is being performed, the following progress bar appears:
(2) A setting to select frequency for database optimization from High, Middle, and Low has been
added to “System” in “IPU Setting”. The frequency depends on the setting value and the number
of samples per day. The rough indication is as follows:
Frequency of optimization
Setting Required
value 600 analyses 400 analyses 200 analyses time
per day per day per day
High Every 12 days Every 19 days Every 37 days 10 minutes
Middle Every 37 days Every 56 days Every 112 days 15 minutes
Low Every 87 days Every 131 days Every 262 days 25 minutes
In addition, a database optimization tool (DBDefrag.exe) to defragment database manually and a
database repair tool (XN_DatabaseRepairer.exe) have been added to “C:\Program
Files\Sysmex\Tools” folder.
Note:
To execute DBDefrag.exe and XN_DatabaseRepairer.exe, logon as Windows administrator
is necessary.
2 On the PLT-F ch, particles which were not PLT were mistakenly counted as PLT, resulting in falsely
high PLT. To resolve this issue, when the abnormal scattergram appears, re-classification will be
performed and the “PLT Abn Scattergram” IP message will be shown. In addition, the low reliability
marks will be placed next to the PLT related parameters.
PLT related parameters

PLT, PLT-F, PLT-F2, IPF, IPF#, H-IPF
Examples of abnormal PLT scattergram

3 Backup files containing comma “,” and square bracket “[” could not be restored. This issue has been
resolved. With this change, the version for QC backup files has been upgraded to Ver.1.2.
Caution:
The QC backup files obtained on XN with Ver.22.12-00 cannot be restored on XN with
Ver.22.11-00 or lower. In addition, backup files obtained on XN with Ver.22.11-00 or lower
cannot be restored on XN with Ver.22.12-00 if the QC comment contains comma “,”.
4 When opening database failed at startup, thresholds for all Q-Flags were 0 since thresholds for Q-
Flags could not be read. If measurement was performed with this condition, all Q-Flag results were
“Positive”. To resolve this issue, when opening database failed, retrial is executed. If retrial failed, the
following message box appears and measurements cannot be performed until restarting IPU.
Massage box
5 On Ver.22.09-00 thru Ver.22.11-00, all logon names displayed on the “Audit Log” screen was
"(Logoff)”. This issue has been resolved.
6 On Ver.22.10-00 and Ver.22.11-00, a click of the [Left] button on the “Piercer Adjustment” screen
moved the piercer 4 pulses although the screen changed by only 1 pulse. This issue has been
resolved.
Remarks
None
ECR 319C033
DVD1XN2J Ver.22.08 (22.08.01-00) Upgrade Procedure
(For China market only)
Refer to ECR 321I017 October 2021

AN616770: [IPU] 00-22 Build124
CDR_ASSY NO.478 (DVD1XN2J) [Device Control Manager] 00-22 Build124
<FDS File Name> [Analyzer Sequencer] 00-22 Build124
P_XNSWSTCN_22080100.cab [Sampler Sequencer] 00-22 Build124
[Analyzer] 00-63
[Sampler] 00-16
Same contents as DVD1XN1X Ver.22.12-00.
Same contents as DVD1XN1X Ver.22.12-00.
Remarks
None
ECR 321I017
S/N: Not fixed yet June 2019

BJ766337: [IPU] 00-22 Build110
[Analyzer] 00-62
[Sampler] 00-16
1 To improve NEUT/ EO differentiation, the following changes have been made.
(1) The NEUT/ EO differentiation algorithm has been changed so that NEUT and EO values in EO
false low samples can be calculated correctly.
(2) The NEUT/ EO differentiation algorithm has been changed so that NEUT and EO values in EO
false high samples can be calculated correctly.
(3) The judgment conditions for the “WBC ABn Scattergram” flagging used to retest EO and the
“Confirm eosinophil” action message have been changed to improve the specificities.
None
Remarks
None
ECR 318J049

BN892486: [IPU] 00-22 Build103
[Analyzer] 00-62
[Sampler] 00-16
1 The logon function using an IC card reader has been added only for Windows 10.
2 The GDI interface has been added. In addition, the GDI activation service setting has been added.

GDI activation 0: Do Not Activate 0: Do Not
1: Activate Activate
3 A service setting for the smart indicator (SI-14) has been added.

External indicator light 0: SI-10/11/12/13 1: SI-14 (In case
1: SI-14 of upgrading, the
default is “0”)
4 An adjustment function for MiniCollect microtube has been added.
5 Detail codes are now output for “Cannot recognize Fluorocell --- information” errors to parameters for
error history screen, error history list printing, error history CSV output, and SNCS error report.
Following errors are scope of this change:
- Cannot recognize Fluorocell WNR information
- Cannot recognize Fluorocell WDF information
- Cannot recognize Fluorocell WPC information
- Cannot recognize Fluorocell RET information
- Cannot recognize Fluorocell PLT information
Detail codes to be output are as follows:
Param1 Param2
Top 2byte Bottom 2byte 4byte
Error occurrence Error type Error status
position
01: Sequencer 01: Discrepancy on decrypted 0001: REAGENT_ERROR_UID
side UID at an event other than
startup check
02: Different tag being read 0001: REAGENT_ERROR_UID
from the tag read previously
03: Unregistered third party 0001: REAGENT_ERROR_UID
reagent tag being read
04: Failure on password 0002: REAGENT_ERROR_PASS
authentication
05: ISO15963 error -
occurrence
02: DCM side 06: Discrepancy on remaining 0003: REAGENT_ERROR_COUNT
test count in UID existing in
record
07: Expired (Sysmex genuine 0006:
reagent) REAGENT_ERROR_EXPIR_GENUINE
07: Expired (Registered third 0007:
party reagents whose coded REAGENT_ERROR_EXPIR_REGISTER
UID and UID matches) ED
07: Expired (Registered third 0008:
party reagents whose coded REAGENT_ERROR_EXPIR_THIRDPART
UID and UID do not match) Y
08: SLIX2 authentication 0004: REAGENT_ERROR_AUTHE
failure (signature verification
error)
08: SLIX2 authentication 0005: REAGENT_ERROR_MANU
failure (manufacturer error)
09: Registered third party -
reagent being set again
6 The configuration including CV-55 can now be selected in “ConfigTool”.

7 A service setting has been added to select whether or not the low reliability mark is output for “Giant
Platelet?”.

Mark of analysis result in case of 0: Do Not Mark 1: Mark (In case
“Giant Platelet?” 1: Mark of upgrading, the
default is “1” as
well)
Affected PLT parameters

PDW, MPV, P-LCR, PCT, PLT, PLT-I, PLT-O, IPT_F, IPT_F_A, PLTF2
8 The “Blast/AbnLympho?” flagging specificity has been improved.

9 Improvements of Q-flagging judgment value calculation for “Blast?”, “AbnLympho?”, and “Blast/
AbnLympho?”, which were made in Ver.21.11-00 (for European markets only), have been applied to
the other markets, AM, JP, AP, and CN.
10 McAfee Ver.7 can now be used on Windows 7.
11 Messages displayed in Russian, Greek, German, and Italian have been improved.
1 In XN-1500, there was a possibility that a sample tube was not returned to the sample rack when
performing sampler analysis after correcting an error categorized as “Sampler Analysis Stop 3”, which
is errors relating to the analysis line such as a rack move error. This issue has been resolved.
2 When SA-01 was used, there was a possibility that a background check would not finish and the
instrument status did not become “Ready” if there was a lot of files (more than 5000 data files). This
issue has been resolved.
3 “Low count error” and “PLT sampling error” can now be output correctly.
4 The classification function for WNR ch has been improved for low RBC.
5 The motor operation on RBT aspiration has been improved since there was a possibility of a potential
motor failure.
6 The following issues on Ver.22.09-00 have been resolved.
(1) The “No Analysis Orders” error did not occur.
(2) Sample tubes were not transferred to the SP.
(3) The “Aspiration Sensor is OFF” error occurred though “Aspiration Sensor” setting was set with
“Use”.
7 If the birth date was not registered in the “Register Patient Information” dialogue, the current date was
registered as the birth date. This issue has been resolved and the patient birth date is no set if the
birth date is left blank. Additionally, the usability has been improved.
8 When replacing reagents on XN-2000 or etc., instrument status could not become “Ready” if the
mode was switched between registering new reagents and executing replacement. This issue has
been resolved.
9 When Hypo-he became high, a false low could occur in rare cases. This issue has been resolved.
10 Q-Flag judgment values could show 100 although flagging judgment result was “Negative”. This issue
has been resolved so that judgment values are calculated correctly.
The affected flags are as follows:
- RBC Agglutination?
- Turbidity/HGB Interf?
- Iron Deficiency?
- HGB Defect?
- Fragments?
Correct Incorrect
11 When SA-01 was used and following steps were performed, removing blood on bottom surface of the
tube cap could not be performed. This issue has been resolved.
(1) Sample was measured in the “Manual” mode with “Cap Open”.
(2) Sample was measured in the “Sampler” mode.
Remarks
None
ECR 318H059
S/N: Not fixed yet October 2018

CP687800: [IPU] 00-22 Build89
[Analyzer] 00-61
[Sampler] 00-16
1 For Chinese markets only, the XN-1590 configuration has been added.
2 The analysis channel, used as adopted PLT and WBC result (“switching”), can now be displayed on
“Cumulative” and HPC screen.
Adopted channels (performed “switching”) can be identified with a marking starting with”&” on the
screen as follows.
These markings are displayed on “Numerical”, “Graph” screen, and printed results for “Cumulative”
and “HPC”.
Markings added to the result indicate the channel. The explanation is as follows.
Meaning Mark
Adopted result on WBC-D &D
Adopted result on PLT-O &O
Adopted result on PLT-F &F
2 The blood bank mode (Research Use Only) has been added. (To activate the blood bank mode,
license key is required.)
License keys to activate the blood bank mode can be only applied to XN-1000 or XN-2000
configuration whose XN-10 and XN-20 analyzer(s) have PLT-F channel.
1 In the XN-1500 configuration, if the following steps were performed, SA-21 could not be used. This
(1) XN was powered on by powering SP-50 ON with WOL.
(2) XN IPU was shutdown.
(3) Although SP-50 was being used, XN IPU was powered OFF and SA-21 could not be used.
2 Previously, due to the failure of IPU startup process, the IPU program could fail to start normally and a
Mounter.exe termination error could occur. This issue has been resolved.
3 When a new sample ID was read while multiple samples were selected on “Worklist”, a lot of
additional samples could be selected erroneously and IPU operation could be slow. This issue has
been resolved.
4 The “Aspiration unit left-right motor error” could occur on XN analyzers which has a countermeasure
kit against erroneous high HGB. This issue has been resolved.
5 Previously, Q-Flag value “0” was not displayed (left blank) for Q-Flag even though parameters are
judged as “Negative”. This issue has been resolved and Q-Flag value “0” is now displayed.
6 On WNRch, WBC could erroneously be differentiated as NRBC. This issue has been resolved.
7 BASO result measured on WDFch is now adopted if BASO result measured on WNRch is found
abnormal.
8 The sum of WBC was not 100% in some specific cases. This issue has been resolved.
9 When using XN MemTool (initialization tool for XN analyzers and samplers) for the SA-21, rack feed-
out pulse value for the SA-30 was set instead. This issue has been resolved.
10 When “Auto output” configuration was set and analysis result was automatically sent to the host
computer, the action messages for the result of delta check could not be sent to the host computer.
Remarks
None
ECR 318C064
S/N: Not fixed yet August 2018

BH076050: [IPU] 00-22 Build72
[Analyzer] 00-60
[Sampler] 00-16
None
1 With program version 22.07, RFID tag issue had been addressed, however when upgrading the
device driver was not updated and the countermeasure was not activated. This issue has been
resolved.
2 When viewing IFU in the IPU, the application program has been changed from Acrobat to “PDF
viewer” with version 22.05 and “PDF viewer” installation program was added. However, at version up,
that program was not registered in the “White List” for McAfee and error message “IPU.exe has
stopped working….” appeared and IPU program did not start up at next power on. This issue has
been resolved.
3 With the Rerun/Reflex/Comment Rule, when Retest:Eo was judged as “True” (means “Retest:Eo”
appears on the screen), Retest: PLT was also judged as “True” and Action that was set in rule screen
was applied. This issue has been resolved.
Remarks
None
ECR 318E043
DVD1XN1X Ver.22.07-00 Upgrade Procedure Upgrade Procedure
(FileDeliverySystem)
S/N: Not fixed yet April 2018

CU372078: [IPU] 00-22 Build63
[Analyzer] 00-60
[Sampler] 00-16
None

1 In WB mode only: differentiation algorithm of neutrophils and eosinophils has been changed for cases
of eosinophil abnormalities.
With this change, an action message “Confirm eosinophil and neutrophil count by other methods” and
two service settings have been added to notify users of possible falsely-low of eosinophil or
eosinophil abnormality.
(1) An action message “Confirm eosinophil and neutrophil count by other methods” and a service
setting “Use ‘Confirm eosinophil’ action message” have been added.
When a service setting “Use ‘Confirm eosinophil’ action message” is set as “1: Use” and if the
analysis result is judged as a possible false-low caused by eosinophil abnormality, a message
“Confirm eosinophil and neutrophil count by other methods” is output and the low reliability mark is
applied to NEUT#, NEUT%, EO#, and EO%.
In addition, a message “Confirm eosinophil and neutrophil count by other methods” appears on
“Action” field in “Main” tab and on “List Box” in “User”, “Lab. Only”, and “Lab. Only(RUO) tabs.

Use “Confirm eosinophil” action 0: Do Not Use 0: Do Not Use
message 1: Use
Added service settings and their default value
“Use ‘Confirm eosinophil’ action message” setting screen

(2) A service setting “Add the rule for ‘WBC Abn Scattergram’ not to miss eosinophilia” has been
added.
When a service setting “Add the rule for ‘WBC Abn Scattergram’ not to miss eosinophilia” is set as
“1: Add” and if the analysis result is judged as possible eosinophil false-low, a message “WBC
Abn Scattergram” is output and the low reliability mark is applied to NEUT#, NEUT%, EO#, and
EO%.

Add the rule for “WBC Abn 0: Do Not Add 1: Add
Scattergram” not to miss eosinophilia 1: Add
“Add the rule for ‘WBC Abn Scattergram’ not to miss eosinophilia” setting screen
(3) A service setting “Display conditions of the analysis results for NEUT and EO” is no longer
displayed on “Service settings” screen.
(4) New action message “Confirm eosinophil and neutrophil count by other methods” has been added
to host output function.
(5) A pull-down menu option [Retest:Eo] has been added to “Action Message(s)” on “Register Rerun/
Reflex/Comment Rule” screen as a function for “ActionMessageDetail”.
“Register Rerun/Reflex/Comment Rule” screen
2 A retry process for “Fluorocell RFID tag error”, which occurred due to writing failure, has been added.
Remarks
ECR 318D005

AG702998: [IPU] 00-22 Build56
[Analyzer] 00-60
[Sampler] 00-16
1 On XN-1500 and XN-3100 (standalone), two service settings, “Query to host wait time” and “Query
host computer for Rerun/Reflex analysis”, have been added.Therefore in ASTM format, using results
of initial or Rerun/Reflex analysis, the XN analyzer inquires the host computer for Rerun/Reflex
analysis and/or SP orders.

Query to host wait time Input wait time in seconds 10 [seconds]
Query host computer for Rerun/Reflex 0: Do Not Query 0: Do Not Query
analysis 1: Query
2: Query Using QueryToHost
function in Rule Screen
“Query to host wait time” setting screen
“Query host computer for Rerun/Reflex analysis” setting screen
(1) Each time when “Query host computer for Rerun/Reflex analysis” setting value is changed, rule
expression will be evaluated and rule supplementary explanation will be changed.
(2) When the SA-01 is used in XN-1000 system, setting menus, “Query to host wait time” and “Query
host computer for Rerun/Reflex analysis”, do not appear as the SA-01 does not have a function to
perform reanalysis.
(3) On XN-3100(standalone), the rack is not fed out until XN receives analysis result because if the
rack is fed out, reanalysis cannot be performed when reanalysis is required as a result of
QueryToHost.
(4) On XN-1500, if XN received the order which cannot be measured, both XN and SP skip the
sample aspiration.
(5) Depending on “Query host computer for Rerun/Reflex analysis” setting value (0 through 2),
contents displayed on IPU screen and SP order adopted when preparing smear differ.
1) When “Query host computer for Rerun/Reflex analysis” setting value is 0. (Do Not Query) (XN
behaves same as previous versions)
(a) SP rule is executed.
(b) The SP rule flow chart and tab appear on the rule screen.
Rule screen when the setting value is “0”
(c) The SP rule check box appears on rule “Initialize” screen box.
“Initialize” screen when the setting value is “0”
2) When “Query host computer for Rerun/Reflex analysis” setting value is 1 (Query) or 2 (Query
Using QueryToHost function in Rule Screen)
(a) SP rule is not executed.
Orders which are sent back to SP, corresponding to inquiry from SP, are prioritized as follows:
1. QueryToHost orders at reanalysis
2. QueryToHost orders at initial analysis
3. Orders registered manually
The order sent is eventually adopted as SP order.
(b) The SP rule flow chart and tab does not appear on the rule screen
Rule screen when the setting value is “1” or “2”

(c) The SP rule check box does not appear on rule “Initialize” screen box
“Initialize” screen when the setting value is “1” or “2”

(d) “SP Rule Setting” and “Default SP Order Setting” are not printed.
These settings are not included in master settings, backup, and restoration file as well.
(e) XN receives values for “User Field No.1” in the messages sent from the host computer. (For
XN-1500 and XN-3100 (standalone) only)
If the message sent to the XN contains SMEAR order, XN orders SP-50 the value in “User Field
No.1”. If the message sent to the XN does not contains SMEAR order, XN ignores the values in
“User Field No.1”. For detail of “User Field No.1”, refer to the XN series ASTM Host Interface
Specifications.
(f) A menu “Specify by SP” can be selected in “Regist Order” and “Modify Order” screens for
“Number of slide”.
“Regist Order” screen when the setting value is “1” or “2”

(g) “SP” appears on “Work List” at the time of list printing if “Number of slide” is configured as
“Specify by SP”.
(h) The number of slide to be prepared is 0 if “Number of slide” is configured as “Specify by SP”,
when “Query host computer for Rerun/Reflex analysis” setting value is changed from “1” or “2”
to “0”.
(i) if “Number of slide” is configured as “Specify by SP”, “Number of slide” is unchanged from
“Specify by SP” even after “Query host computer for Rerun/Reflex analysis” setting value is
changed from “1” or “2” to “0” and then changed back from “0” to “1” or “2” again unless the
order is modified.
(j) An action item “QueryToHost” appears on “Register Rerun/Reflex/Comment Rule” screen for
“Action” when “Query host computer for Rerun/Reflex analysis” setting value is “2”.
“Register Rerun/Reflex/Comment Rule” screen when the setting value is “2”
(k) If SP order exists on Work List at the time of reanalysis, the result of QueryToHost is prioritized
and the order is sent to SP.
(l) Two Settings “SP Rule Setting” and “Default SP Order” do not appear on “Analysis Settings”
screen for “SP Setting”.
“Analyzer Settings” screen for SP setting when the setting value is “1” or “2”
2 On XN-9100 system without BT, a service setting “System behavior when RET is ordered in the
system in which RET cannot be analyzed” has been added. When this setting is configured as “1:
Skip”, sample analysis will be skipped if its order includes parameters which an XN analyzer cannot
analyze. Then, the sample will be transported to another XN analyzer which can analyze the
parameter.
Previously, if order containing RET was sent to an XN analyzer which could not analyze RET, the XN
analyzed parameters except for RET. After this change, either one of settings can be selected from
“analyzing sample without RET” or “skipping sample analysis”. When upgrading from previous
versions, the setting value is “0: Analyzer without RET discrete”. (The XN behaves as same as before
this change.)
In addition, to enable this setting, a service setting “ASTM exception order setting” needs to be “1:
Use”. Therefore, default value for “ASTM exception order setting” has been changed to “1”.

System behavior when RET is 0: Analyze without RET discrete 1: Skip
ordered in the system in which RET 1: Skip
cannot be analyzed
ASTM exception order setting 0: Do Not Use 1: Use
1: Use
Added and changed service settings and their default value
“System behavior when RET is ordered in the system in which RET cannot be analyzed”
setting screen
3 IPU settings, analyzer settings, service settings, and backup file for rules are now output to
RemoteMaintenance in SNCS folder when a service setting “Output report file” is configured as “1:
Output”.
4 A service setting “Send reagent information to the host computer has been added. When this setting
is configured as “1: Send”, reagent information used for analysis is sent to the host computer.

Send reagent information 0: Do Not Send 1: Send
1: Send
Added service setting and its default value
“Send reagent information” setting screen

5 Software version description displayed on “Version Information” screen has been changed.

Ver.xx.xx-xx Ver.xx (xx.xx-xx)
(If Ver.22.06-00, Ver.22(22.06-00) is displayed)
6 For EMEA markets, judgment for WBC IP messages has been modified, such as Blast/Abn Lympho
and others.
7 From Ver.22.04-00, WRP CHECK EX can be used. With this change, related error messages have
been changed as well.

Unable to correctly identify RANGE Unable to correctly identify WRP CHECK
CHECK X III. EX.
Check Measurement Mode(RANGE Check Measurement Mode(WRP CHECK
CHECK X III) EX)

1 Previously there was a possibility that DeviceControlManager.exe abnormally stopped during analysis
and analysis could not be performed. This issue has been resolved.
2 During sampler analysis, after aspiration of 10th sample in the rack was finished, sampler analysis
abnormally stopped and analyzer needed to be restarted if the following conditions were met. This
(1) XN was powered ON while the host computer was OFF.
(2) XN measured 2 QC samples.
(3) A dialogue “Unable to establish TCP/IP connection with host computer” appeared.
(4) The host computer was powered ON.
(5) A dialogue “Unable to establish TCP/IP connection with host computer” on IPU screen was
closed.
(6) Sampler analysis was started.
(7) Aspiration for sample which was in the position numbered 10 of the rack was finished and sample
tube was returned to the rack.
3 If the following conditions were met, analyzer could abnormally stop. This issue has been resolved.
(1) A body fluid sample was analyzed.
(2) After aspiration was complete and the sample tube holder was ejected, the mode switch was
pressed.
(3) An error “Analysis result is high” occurred.
(4) [Execute] button was pressed on the help screen.
(5) The software abnormally stopped.
4 From Ver.22.06-00, the low reliability mark [*] is now applied to PLT related parameters for samples
which were judged as positive for an IP message “Giant Platelet?” as the mark should have been
applied.
Applicable parameters
PLT, PDW, MPV, P-LCR, PCT
Remarks
ECR 317H098
S/N: Not applicable January 2018

- [IPU] 00-22 Build51
[Analyzer] 00-60
[Sampler] 00-16
1 The XN IPU program can now run on Windows 10 PC.

None
Remarks
Application of Ver.22.05-00 to the field has been skipped.
ECR 317H098
(For North American Markets Only) (FileDeliverySystem)

S/N: Not fixed yet October 2018

CV667602: [IPU] 00-22E Build2
CDR_ASSY NO.374 (DVD1XN1X(22.04-10)) [Device Control Manager] 00-22E Build1
[Analysis] 00-22E Build1
[Analyzer Sequencer] 00-22E Build1
[Sampler Sequencer] 00-22E Build1
[Analyzer] 00-60
[Sampler] 00-16
None
1 In WB mode only: differentiation algorithm of neutrophils and eosinophils has been changed for cases
of eosinophil abnormalities.
With this change, an action message “Confirm eosinophil and neutrophil count by other methods” and
two service settings have been added to notify users of possible falsely-low of eosinophil or
eosinophil abnormality.
(1) An action message “Confirm eosinophil and neutrophil count by other methods” and a service
setting “Use ‘Confirm eosinophil’ action message” have been added.
When a service setting “Use ‘Confirm eosinophil’ action message” is set as “1: Use” and if the
analysis result is judged as a possible false-low caused by eosinophil abnormality, a message
“Confirm eosinophil and neutrophil count by other methods” is output and the low reliability mark is
applied to NEUT#, NEUT%, EO#, and EO%.
In addition, a message “Confirm eosinophil and neutrophil count by other methods” appears on
“Action” field in “Main” tab and on “List Box” in “User”, “Lab. Only”, and “Lab. Only(RUO) tabs.

Use “Confirm eosinophil” action 0: Do Not Use 0: Do Not Use
message 1: Use
“Use ‘Confirm eosinophil’ action message” setting screen

(2) A service setting “Add the rule for ‘WBC Abn Scattergram’ not to miss eosinophilia” has been
added.
When a service setting “Add the rule for ‘WBC Abn Scattergram’ not to miss eosinophilia” is set as
“1: Add” and if the analysis result is judged as possible eosinophil false-low, a message “WBC
Abn Scattergram” is output and the low reliability mark is applied to NEUT#, NEUT%, EO#, and
EO%.

Add the rule for “WBC Abn 0: Do Not Add 1: Add
Scattergram” not to miss eosinophilia 1: Add
“Add the rule for ‘WBC Abn Scattergram’ not to miss eosinophilia” setting screen
(3) A service setting “Display conditions of the analysis results for NEUT and EO” is no longer
displayed on “Service settings” screen.
(4) New action message “Confirm eosinophil and neutrophil count by other methods” has been added
to host output function.
(5) A pull-down menu option [Retest:Eo] has been added to “Action Message(s)” on “Register Rerun/
Reflex/Comment Rule” screen as a function for “ActionMessageDetail”.
“Register Rerun/Reflex/Comment Rule” screen
2 A retry process for “Fluorocell RFID tag error”, which occurred due to writing failure, has been added.
Remarks
None
ECR 318D063
S/N: Not fixed yet November 2017

AA927601: [IPU] 00-22 Build47
[Analyzer] 00-60
[Sampler] 00-16
1 The name of flag for infection has been changed from “pRBC” to “iRBC”.
・pRBC includes the meaning of “Parasite” which may emphasizes “Malaria infection”.
Therefore, it has been changed to iRBC (inclusion RBC) to be easily accepted by users.
[Influenced parameter]
pRBC(R), pRBC-WNR#, pRBC-WDF#
2 WRP CHECK EX has become available.
・With the discontinuation for “RANGE CHECK X”, a linearity check product “WRP CHECK EX” has
become available as a replacement.
3 In the body fluid analysis mode, the error massage indicating “there is no sample tube on the sample
holder” has been added.
・In the body fluid analysis mode, if there is neither normal nor micro sample tube on the sample
holder, the Error Message “No tubes are in tube holder” will be displayed.
This update is only applicable to the XN-series with a SENSOR_ASSY NO.11 [AS261366], which
was applied by ECR 315F082.
Changes:
Check box “Tube Sensor” has been added on the screen at manual analysis mode (body fluid).
Default value of the check box is “checked” and will be initialized for individual sample.
In case that there is neither normal nor micro sample tube on the sample holder with check box is
“checked”, measurement can not be performed and the Error Massage “No tubes are in tube holder”
is displayed.
4 In the case of configuration including five or more CV-55, the error recovery method of XN analyzers
has been changed.
5 The countermeasure against a writing failure for the number of remaining tests to RFID tag in the
case of emergency stop has been added.
・When emergency stop occurs while writing the number of remaining tests into genuine reagent
RFID tag, the information of the remaining tests could not be written into the tag and a genuine
reagent was incorrectly recognized as an ingenuine rseagent.
Program has been changed to prevent this malfunction even in the state of emergency stop.
6 Writing function of the number of remaining tests to RFID tag has been enhanced.
・There were cases that genuine reagent was incorrectly recognized as ingenuine regent because the
actual remaining amount of fluorocell did not match with the number of remaining tests written in
RFID.
To resolve this issue, the number of times using fluorocell in the service menu mode (Diaphragm
Pump) has been written into RFID tag.
1 Differentiation algorithm of neutrophils and eosinophils in case there are degranulated eosinophils
has been changed.
・In the case of degranulated eosinophils, there are cases that eosinophil cluster is too close or
overlap to neutrophil cluster that causes false-classified as neutrophil.
To solve this issue, differentiation algorithm program has been changed.
2 The issue that the measurement can not be performed as order in the manual analysis mode has
been resolved.
・There was a possibility that the measurement could not be performed as host order when opening
the manual analysis mode display to order the next sample before absorbing.
Program has been changed to resolve this issue.
3 The countermeasure against “Fluorocell RFID tag error” which is frequently occurred when using new
RFID tag on Fluorocell bottles has been added.
Remarks
None
ECR 317G030
XN-10 S/N: 32971 and thereafter October 2017
XN-20 S/N: 13958 and thereafter
XN-1000 Supply Parts S/N: Not applicable
XN-IPU S/N: Not applicable

AY810988: [IPU] 00-22 Build41
CDR_ASSY NO.325(DVD1XN1X(22.03-00)) [Device Control Manager] 00-22 Build41
[Analyzer] 00-59
[Sampler] 00-16
1 The monitoring method for “Abnormal pressure loss” has been changed.
(During startup of pneumatic unit, “Abnormal pressure loss” error is monitored.)
2 Previously, in ASTM communication, when an unavailable parameter (IPF: Research parameter)
order was received from the host computer, XN output this parameter erroneously as “0”. (The XN’s
action when receiving unavailable parameter was not clearly defined in the XN.) In order to resolve
this situation, the XN's action when receiving unavailable order, which is not described in “ASTM Host
Interface Specifications”, has been added in service setting.
•“ASTM exception order setting”: Setting whether recognizing measurement order or not when
receiving undescribed order in Specifications. The initial value is “0: Do Not Use”.
This setting action is same as before updating program. This means that when IPF order is received
from the host computer, IPF result will be “0”. When “1” is selected, only ordered parameters*
described in the specifications will be measured. The other parameters will be excluded and not be
measured.
(Refer to Service Manual Chapter 5 Service Program.)
* Refer to “Table 4.3.3.4.2: List of Analysis Parameters Ordered” (page 29: “Automated Hematology
Analyzer XN series ASTM Host Interface Specifications”).
3 (For North American market only) (RUO) IFU for RU-21 can now be viewed on Built-in IFU.
4 Previously, restarting sampler analysis was not possible after recovering from “Rack removed” error
on SP-50 in XN-1500 configuration. The XN-1500 can now restart sampler analysis after recovering
from SP-50 “Rack removed” error.
5 The logging function has been enhanced so that the log can be recorded in detail when “Internal
Error” occurs*. (In order to get detailed information when a rare error occurs.)
* Internal Error occurs in following sequence error
• Unit activated twice
• Unit controlled illegally
• Motor activated twice
Log file Information

• location: C:\Program Files\Sysmex\Log\YYYYMMDD
• Created “.SMT”, “.SEQ” files
• YYYYMMDD means instrument startup date. When instrument runs overnight, the log will be saved
in the same folder (previous date). (Storage period: 60 days)
6 Previously, if XN-3000/3100 received smear order when “Command not to aspirate” was checked in
“Analysis Stop Setting” in standalone mode, a “Invalid analysis item is specified” error occurred. In
order to resolve this situation, sampler analysis will be stopped when “Command not to aspirate” was
checked.
1 Previously, SP rule was not applied when measuring samples with raised bottom tube or Sarstedt
tube. As a result, smear was not prepared. This was because only normal sample tube was objective
sample tube. This has been resolved by adding raised bottom tube or Sarstedt tube as objective
sample tube.
2 Previously, there was a possibility that “Mount Error” (Windows error) occurred while starting up IPU
program. This has been resolved by extending monitoring time for starting up IPU program from 60
sec to 300 sec.
3 Countermeasures for false high WBC (-N) count have been made.
Symptom: WBC related parameters result became high.
Cause: Not specified
Countermeasures:
1 “Detection of falsely high WBC-N” algorithm* has been added to service setting. ([0: Do Not Use, 1:
Use] Initial value for EU destination is [1: Use]. The other markets are [0: Do Not Use].
2 A service setting to set the threshold of “Detection of the falsely high WBC-N” algorithm is added.
3 When falsely high WBC is detected, an action message “Suspect sample, check the sample.” is
displayed. Low reliability mark (*) is also attached to the WBC related item (WBC, NRBC#,
NRBC%).
* This algorithm is detected by comparing LC-I and TNC-N. (LC-I is obtained from counted particles
in higher channels of RBC ch.)
• Reference: Service Manual Chapter 5 Service Program
4 Previously, “Total Number of Blocks” was “2” regardless if outputting research parameters on DPS
host communication. In order to resolve this situation, “Total Number of Blocks” has been changed as
follows.
• Total Number of Blocks: “01” when outputting without research parameters.
• Total Number of Blocks: “02” when outputting with research parameters.
Remarks
None
ECR 317C001
S/N not applicable August 2017

BC531574: [IPU] 00-22 Build34
[Analyzer] 00-59
[Sampler] 00-16
1 Failure prediction function has been enhanced.
Data for items listed below has been monitored via SNCS to predict instrument failure.
- Draining time in startup sequence
- Values of each pressure in startup sequence
2 The performance of blood aspiration sensor has been improved.
To support market requests to increase the aspiration sensor stability, the calibration of blood aspira-
tion sensor has been added to correct the difference between discrete modes.
*Caution)
From Ver.22.02-00, blood aspiration sensor calibration is required when Service Engineer performs
actions like those shown below.
- Changing piercer or rinse cup
- Changing PCB NO.30001 (Refer to Service Manual Chapter 3)
3 Contents of files sent via SNCS have been changed.
4 Service setting for output of FCS file (used mainly for lab research) has been added to secure
additional HDD space.
- Setting value “0”: Not output FCS file (Default)
- Setting value “1”: Output FCS file
5 When lymphocyte is incorrectly discriminated as monocyte, lymphocyte shows falsely low value. To
resolve this issue, discrimination algorithm has been improved. (This algorithm has been adopted on
XN-L series as Ver.00-14)
6 Detecting condition has been modified to display “PLT-F channel error” when instrument detects lot
failure of Fluorosell PLT. (Refer to Service manual Chapter 6 "PLT-F channel error")
7 (For Chinese market only) SystemConfig has been revised so that XN-2800 can be installed.
8 Reagent management function has been improved.
- In order not to restart sample analysis on the instrument with simplified sampler, sampler analysis
method has been changed so that the restarting sampler analysis will not start while authenticating
stain tag (RFID tag). (Sampler analysis starts after completing authentication.)
9 When neutrophilic cells are incorrectly discriminated as eosinocyte, eosinocyte shows falsely high
value. To resolve this issue, discrimination algorithm has been improved.
10 As there was unnecessary movement of solenoid valve, the sequence has been revised so that WPC
homolyzer charging is executed only during WPC measurement sequence.
1 On XN-1000 SA-01 model, lockup when skipping sample aspiration has been resolved.
2 Lockup when suspending measurement while waiting for analysis order has been resolved.
3 Lockup when recovering from sleep mode has been resolved.
4 Lockup when detecting a Micro tube while reagent is depleted during manual measurement has been
resolved.
5 Error detecting function has been improved.
There was a possibility that residual waste liquid remained in RBC/HGB chamber due to a partial
clog. To detect residual waste liquid in the chamber, detect timing of the chamber draining has been
revised to move the timing ahead by 0.2 sec.
6 “WBC Abn Sct.” is an error message which is displayed when WBC discrimination is not performed
correctly due to low fluorescence signal. However, there were cases where this message was not
displayed even though WBC discrimination was not performed correctly. To resolve this issue, WBC
discrimination algorithm has been improved.
Remarks
None
ECR 316J044
S/N not applicable April 2017

AW002660: [IPU] 00-22 Build22
[Analyzer] 00-58
[Sampler] 00-16
1 Analysis algorithm for North American markets has been developed. (North American markets only)
• For North American markets, the setting range to select PLT Clumps algorithm has been set to “0 to
1”. For other markets, the setting range has been set to “0 to 2”.
0: Type A [Algorithm by program version 00-17 or lower]

1: Type B [Algorithm by program version 00-18]
2: Type C [Algorithm by program version 00-21 or higher]
• For North American markets, the setting value for “Use "Giant Platelet?" IP message” has been
changed to [0: Do Not Use].
2 Program has been changed to add settings for the AP markets.
• From version 22.01-00, market location “Asia Pacific” can be selected. When upgrading to program
version 22.01-00 or higher, AP users must select Asia Pacific in the following dialog box.
• Program downgrade is also possible with version 22.01-00 or higher.

3 Previously, two “Auto output of a sample on which a barcode read error occurred” settings were
displayed in Service Settings. The program has now been changed to display only one “Auto output of
a sample on which a barcode read error occurred” setting.
4 Previously, it took about 15 minutes to display SystemConfig when the IPU was started up for the first
time. By displaying SystemConfig faster, IPU start-up process speed has been improved.
1 Previously, when printing was done using GP Customize, the Russian language changed to the Latin
language in some regions. This issue has now been resolved.
2 Previously, there were some cases where the instrument stopped abnormally during startup. This
issue has now been resolved.
3 Previously, the analysis result of a sample number that starts with “QC” was not displayed if the lot
has not been registered. This issue has now been resolved.
Remarks
None
ECR 316I050
DVD1XN1X Ver.22.00-00 (Skipped)
S/N not applicable April 2017

N/A [IPU] 00-22
[Device Control Manager] 00-22
[Analysis] 00-21
[Analyzer Sequencer] 00-22
[Sampler Sequencer] 00-22
[Analyzer] 00-58
[Sampler] 00-16
1 As for Sysmex user password on the IPU program, it is now possible to select between a one-day
password or a service-defined password, to prevent an unauthorized user from accessing the service
mode.
• When logged on as service user, “sysmex” will be displayed as “Logon Name”. The initial password
is “c9.0”. “sysmex” is displayed in “Logon Name” column, “Service” is displayed in “Operator Name”
column and “Build-in-User” is displayed in “Operator Info.” column.
• “Password Mode” has been added to Service Settings. The default setting is “Service defined”.
2 “Replace Piercer” has been moved from the User menu to the Service menu.
• Removed [Replace Piercer] from the Maintenance menu button and added it to the Service menu.
3 As countermeasures against use of reagents not authorized by Sysmex, the following changes have
been made.
• It is now possible to use ICODE SLIX2 RFID tags, which feature increased security.
• A message box will now be displayed to inform users if an unauthorized reagent has been set in the
instrument.
• The name of manufacturer and the place of production read from the RFID tag will now be saved in
the IPU database and displayed in the archives.
4 To support the RU-20 Upgrade Kit, the following changes have been made.
• Four analyzers can be connected with the RU-20.
• To connect four analyzers with the RU-20, the preparation volume of 9L/h is not sufficient.
Therefore, it is now possible to select between 9L/h and 12L/h in SystemConfig.
NOTE: The selection radio buttons will not be displayed when the RU-21 is selected.
<If 12L/h is selected>

(1) “0.09MPa pressure error” message may be received from the RU-20.
(2) “0.09MPa pressure error” will be displayed in the RU history screen and output to a SNCS file.
(3) If 12L/h is selected in SystemConfig, 0.09MPa will be displayed in the status display.
(4) If “0.09MPa pressure error” occurs, it is possible to jump to the on-line IFU’s troubleshooting
page.
<If 9L/h is selected>
(1) “0.07MPa pressure error” message may be received from the RU-20.
(2) “0.07MPa pressure error” will be displayed in the RU history screen and output to a SNCS file.
(3) If 9L/h is selected in SystemConfig, 0.07MPa will be displayed in the status display.
(4) If “0.07MPa pressure error” occurs, it is possible to jump to the on-line IFU’s troubleshooting
page.
• If the RU is connected with two IPUs, SNCS files will not be sent.
If two IPUs are connected with one RU unit, the two IPUs may receive the same error from that RU
unit. Therefore, “Output RU report file” and “Output RU report file when error occurs” have been
added to Service Settings. The default settings are 1 for both settings.
5 To support the SP-50, the following changes have been made.
(1) In SystemConfig’s initial setup wizard screen, “XN-3000” was changed to “XN-3000/XN-3100”,
and the radio buttons were changed to a combo box. In the combo box, either SP-50(Host
mode), SP-50(Standalone mode), SP-10(Host mode) or SP-10(Standalone mode) can be
selected. The default setting is SP-50(Host mode).
(2) Between XN-2000 and XN-1000 in the initial setup wizard screen, “XN-1500” has been added.
The analyzer to connect can be selected via a combo box. XN-20 or XN-10 can be selected in
the combo box. The default setting is XN-20.
Initial setup wizard screen (new)
(3) If XN-3100 or XN-1500 is selected in the initial setup wizard screen, the following screen will
be displayed and instrument ID will be stored.
If XN-3100 is selected
If XN-1500 is selected
(4) It is now possible to select connection with DIA (Digital Image Analyzer) if the system
configuration is XN-1500, XN-3000 (Standalone) or XN-3100 (Standalone), or when upgrading
the system.
Only when XN-1500, XN-3000 (Standalone) or XN-3000 (Stand alone) system configuration is
selected, “Connecting the DIA” button will be displayed in the System Configurator screen.
(5) When the IPU starts up on the XN-1500, the SP-50 will start up together with the analyzer. As
for XN-1500, “SP-50 connection settings” button will be displayed in the System Configurator
screen. (Refer to the picture in (4) listed above.
6 The speed of copying files during program upgrade has been increased.

1 Previously, there were some cases where bookmarks in on-line IFUs were not displayed correctly
when a text-search was done. This issue has now been resolved.
2 Previously, there were cases where the IPU stopped abnormally when the SP and the IPU were being
connected in the XN-3000 (Standalone) mode. This issue has now been resolved.
3 Previously, [Asc.] radio button was not displayed properly in the [Sort] dialog box. This issue has now
been resolved.
4 Previously, when a sample was switched on the XN-9000, patient information was replaced by that of
another patient. This issue has now been resolved.
Remarks
None
ECR 316I050
DVD1XN1X Ver.21.12-00 (European Upgrade Procedure Upgrade Procedure
markets only) (FileDeliverySystem)

XN-1000 SUPPLY PARTS(EU) S/N: A9203 November 2016
and thereafter
XN-1000 SUPPLY PARTS (SA-01_EU) S/N:
A9203 and thereafter
XN-2000 SUPPLY PARTS(EU) S/N: A2890
and thereafter
XN-9000 SUPPLY PARTS(XN-11/XN-21)
S/N: Not fixed
and thereafter
XN-9100(1) SUPPLY PARTS(EU) S/N:
XN-9100(1) SUPPLY PARTS(XN-11/XN-21)
S/N: A1026 and thereafter

AF632243: [IPU] 00-21 build11
CDR_ASSY NO.293(DVD1XN1X(21.12-00)) [Device Control Manager] 00-21 build11
[Analysis] 00-21 build16
[Analyzer Sequencer] 00-21 build9
[Sampler Sequencer] 00-21 build9
[Analyzer] 11-57
[Sampler] 00-16
None
1 Previously, when a sample was switched, patient information was replaced by that of another patient
as follows.
This issue has now been resolved.
Previously, on the XN-9000, patient information was replaced by that of another patient when the user
performed the following operations. This issue has now been resolved.
1) The user placed sample A (Sample No. A and patient ID is A) in position 1 of a sample rack and
performed a system analysis. Sample No. was read on the BT-40.
2) After the sample rack passed through the BT-40, the user moved Sample A from position 1 to a
different position on the same sample rack. The user then placed Sample B in position 1 (Samples
were switched).
3) When samples were switched (as mentioned in item 2 above), analysis information (i.e. analysis
order and patient information) on Sample B was not registered to the host computer.
4) Sample A's patient information was linked to both samples A and B, i.e. both samples A and B had
the same patient information originally recorded for sample A.
2 Previously, the analysis results of a sample number that starts with "QC" could not be displayed. This
With program versions 00-20 or lower, analysis results which were analyzed in the QC mode were
displayed if a sample has a sample No. that starts "QC" and a lot has not been registered on the
sample.
However, with version 21.00-00, analysis results of such sample were not displayed.
Remarks
None
ECR 316G033
market only) (FileDeliverySystem)

S/N: Not fixed yet September 2016
<Part No./Name> [IPU]

BD501411: (Device Control Manager): Ver.00-21
CDR_ASSY NO.282(DVD1XN1X(21.11-00)) (Analysis): Ver.00-21
(Analyzer Sequencer): Ver.00-21
(Sampler Sequencer): Ver.00-21
[Sequence Program Version]

(Analyzer): Ver.11-57
(Sampler): Ver. 00-16
1 "Blast" flagging sensitivity has been improved. When there are many blasts in the blood, Lymphocyte
might have been classified as Monocyte which lead to missing "Blast?" flag.
"Atypical Lympho" flag has now better classification. In WDF channel when location of Lymphocyte
cluster and Monocyte cluster is very close, there is a possibility to classify Lymphocyte as Monocyte
and generate false "Atypical Lympho?" flag.
"Blast/Abn Lympho?" Q-flag calculation algorithm has been optimized.
1 Previously "Aspiration unit up-down motor error" occurs when running auto rinse after performing QC
measurement by customers or using control mode / calibrator mode in service program. This issue
has been corrected.
Remarks
None
ECR316F086
DVD1XN1X Ver.21.10-00 (patch Upgrade Procedure
program) (European market only)
S/N: Not fixed yet May 2016

CD503528: CDR_ASSY (Device Control Manager): Ver.00-21
NO.274(DVD11XN1X) (Analysis): Ver.00-21

Resolved issues
1 It has been found that “Aspiration unit up-down motor error" error occurred when auto-rinse is
performed right after running QC on the instrument with program version 00-21. This has been
resolved.
market only) (FileDeliverySystem)


BM390236: CDR_ASSY (Device Control Manager): Ver.00-21
NO.269(DVD1XN1X(21.10-00)) (Analysis): Ver.00-21

1 "error code", "parameter 1" and "parameter 2" can now be displayed on IPU RU error history and can
also be output to SNCS.
2 Priority code has been added to IPU setting.
Set input-output setting of priority code. [0: Do Not Input or Output (Default), 1: Only Input, 2: Only
Output, 3: Input and Output]: (Service Manual P. 5-53)
3 The following data has been added for SNCS.
-Outputting service data and target limits on QC
-Outputting analyzed data for calibration
- Outputting NVRAM data
4 Result with barcode read error can now be performed Auto Validate.
(Service Manual P. 5-60)
5 Mark for “outside of linearity” in PD mode has been changed as follows.
WBC: 4400×10^2/uL
PLT: 500×10^4/uL
PLT-I: 500×10^4/uL
PLT-O: 500×10^4/uL
PLT-F: 500×10^4/uL
WBC-N: 4400×10^2/uL
WBC-D: 4400×10^2/uL
6 Exponential and logarithm formula have been added to rule function.
7 WC1 draining on startup monitoring time has been changed from 0.1 sec to 0.5 sec after starting WC1
draining.
8 Generating and outputting of scattergram for HPC on HPC mode is now available.
9 Infection parameters (AS-LYMP#, AS-LYMP%, RE-LYMP#, RE-LYMP%) can now be masked when
IP message "Blast/Abn.Lympho?" and "Blast?" appear.
10 Action message "Suspect Sample?" can now be turned off in manual mode by service setting.
Service Setting can be changed to "Used" or "Not Used". Default: "Used"
11 Specifications for sampling error have been changed as follows.
Currently, sampling error judgment is performed on first sampling time. It has been changed to
perform during every sampling time.
12 Information for connected reagent can now be output.
13 "Giant Platelet?" flag can be added by changing "PLT Clumps?" algorithm.
Following settings can be changed as follows.
Type A: (Same as version 00-17, High specific, Not judge "Giant Platelet?" )
Type B: (Same as version 00-18, High sensitivity, Not judge "Giant Platelet?" (default))
Type C: (Added by 21-00, Balanced with type A and B, judge "Giant Platelet?")
14 Flag judgment for "Dimorphic Population" has been improved.
15 "CELLPACK DFL" has been added to filter function of reagent replacment screen.
16 Notation for program version has been changed as follows.
"##. %%-&&"
##: Incremented when major functional change.
%%: Incremented when major problems are fixed.
&&: Assigned unique number for special order.
17 Previously, there was a possibility that NRBC became falsely high by affecting lipid particles. In order
to resolve this situation, lipid particles can now be discriminated as Ghost when lipid particles are
detected.
18 Previously, there was a possibility that NRBC was included in WBC even when NRBC appeared. In
order to resolve this situation, "WBC Abnormal Scattergram" flag is output and related parameters are
masked with hyphen when NRBC is interfered in WBC area.
19 Previously, there was a possibility that Lymphocyte became falsely low by detecting Lymphocyte was
falsely discriminated as monocyte. This has been resolved.
20 Following issues have been resolved.
- IG became falsely high when NEUT clusters divided into more than two. This has been resolved.
- IG became falsely low when IG cluster is divied from NEUT clusters. This has been resolved.
21 Following parameters have been added as reportable parameters.
"Delta-He", "RBC-He", "HYPO-He", "HYPER-He", "MicroR" and "MacroR".
Following parameters have been added according to licenses.
"RE-LYMP#" and "RE-LYMP%" (reportable parameter)
"AS-LYMP%L" and "RE-LYMP%L" (research parameter)
22 Grade Value for "Atypical Lympho?" calculation algorithm has been added. Setting can be changed
as follows.
Type A (default)
Type B (added calculation algorithm)
23 RE-Lymp discrimination algorithm has been changed by adding fixed gate.
Type A (Automatic gate) (default)
Type B (Fixed gate) (default for EU market)
24 Some characters in Brazilian Portuguese have been fixed.
25 IP message "Giant Platelet?" is now selectable.
Resolved issues
1 Previously, there was a possibility that piercer was damaged as tube holder was moved before
monitoring piercer ascending. In order to resolve this situation, sequence of piercer has been
changed to ascend before moving tube holder.
2 Previously, there was a report that result of PLT-O and RBC-O became low by 20%, caused by
lowering of FCM charging DP dispensing volume due to DP dirt. In order to resolve this situation,
cleaning FCM charging DP has been improved by applying CELLCLEAN cleaning for longer time at
shutdown and cleaning sequences.
3 Previously, piercer adjustment screen could not close even when "CLOSE" button was pressed. This
has been resolved.
4 Previously, lot registration information was not inherited when program was updated. This has been
resolved.
5 Previously, there was a possibility that the air gap was not correctly generated on PD mode. In order
to resolve this situation, position of air gaps for changing PD mode have been lowered by 1.4 mm
from the current position.
Remarks
None
ECR: 315G054

AH689045: CDR_ASSY (Device Control Manager): Ver.00-21
NO.256(DVD1XN1X(21.00-00)) (Analysis): Ver.00-21

1 "error code", "parameter 1" and "parameter 2" can now be displayed on IPU RU error history and can
also be output to SNCS.
2 Priority code has been added to IPU setting.
Set input-output setting of priority code. [0: Do Not Input or Output (Default), 1: Only Input, 2: Only
Output, 3: Input and Output]: (Service Manual P. 5-53)
3 The following data has been added for SNCS.
-Outputting service data and target limits on QC
-Outputting analyzed data for calibration
- Outputting NVRAM data
4 Result with barcode read error can now be performed Auto Validate.
5 Mark for “outside of linearity” in PD mode has been changed as follows.
WBC: 4400×10^2/uL
PLT: 500×10^4/uL
PLT-I: 500×10^4/uL
PLT-O: 500×10^4/uL
PLT-F: 500×10^4/uL
WBC-N: 4400×10^2/uL
WBC-D: 4400×10^2/uL
6 Exponential and logarithm formula have been added to rule function.
7 WC1 draining on startup monitoring time has been changed from 0.1 sec to 0.5 sec after starting WC1
draining.
8 Generating and outputting of scattergram for HPC on HPC mode is now available.
9 Infection parameters (AS-LYMP#, AS-LYMP%, RE-LYMP#, RE-LYMP%) can now be masked when
IP message "Blast/Abn.Lympho?" and "Blast?" appear.
10 Action message "Suspect Sample?" can now be turned off in manual mode by service setting.
Service Setting can be changed to "Used" or "Not Used". Default: "Used"
11 Specifications for sampling error have been changed as follows.
Currently, sampling error judgment is performed on first sampling time. It has been changed to
perform during every sampling time.
12 Information for connected reagent can now be output.
13 "Giant Platelet?" flag can be added by changing "PLT Clumps?" algorithm.
Following settings can be changed as follows.
Type A: (Same as version 00-17, High specific, Not judge "Giant Platelet?")
Type B: (Same as version 00-18, High sensitivity, Not judge "Giant Platelet?" (default))
Type C: (Added by 21-00, Balanced with type A and B, judge "Giant Platelet?")
14 Flag judgment for "Dimorphic Population" has been improved.
15 "CELLPACK DFL" has been added to filter function of reagent replacment screen.
16 Notation for program version has been changed as follows.
"##. %%-&&"
##: Incremented when major functional change.
%%: Incremented when major problems are fixed.
&&: Assigned unique number for special order.
17 Previously, there was a possibility that NRBC became falsely high by affecting lipid particles. In order
to resolve this situation, lipid particles can now be discriminated as Ghost when lipid particles are
detected.
18 Previously, there was a possibility that NRBC was included in WBC even when NRBC appeared. In
order to resolve this situation, "WBC Abnormal Scattergram" flag is output and related parameters are
masked with hyphen when NRBC is interfered in WBC area.
19 Previously, there was a possibility that Lymphocyte became falsely low by detecting Lymphocyte was
falsely discriminated as monocyte. This has been resolved.
20 Following issues have been resolved.
- IG became falsely high when NEUT clusters divided into more than two. This has been resolved.
- IG became falsely low when IG cluster is divied from NEUT clusters. This has been resolved.
Resolved issues
1 Previously, there was a possibility that piercer was damaged as tube holder was moved before
monitoring piercer ascending. In order to resolve this situation, sequence of piercer has been
changed to ascend before moving tube holder.
2 Previously, there was a report that result of PLT-O and RBC-O became low by 20%, caused by
lowering of FCM charging DP dispensing volume due to DP dirt. In order to resolve this situation,
cleaning FCM charging DP has been improved by applying CELLCLEAN cleaning for longer time at
shutdown and cleaning sequences.
3 Previously, piercer adjustment screen could not close even when "CLOSE" button was pressed. This
has been resolved.
4 Previously, lot registration information was not inherited when program was updated. This has been
resolved.
5 Previously, there was a possibility that the air gap was not correctly generated on PD mode. In order
to resolve this situation, position of air gaps for changing PD mode have been lowered by 1.4 mm
from the current position.
Remarks
None
ECR: 316G057
DVD1XN1X Ver.00-20 build 10 Upgrade Procedure Upgrade Procedure
(SAP markets only) (FileDeliverySystem)

None October 2017

None [IPU] 00-20 build10
[Device Control Manager] 00-20 build10
[Analyzer] 00-55
[Sampler] 00-15
1 Differentiation algorithm of neutrophil and eosinocyte in case there are degranulated eosinocytes has
been changed.
* Degranulated eosinocytes could be false-classified as neutrophil.
In addition, a new setting “Display conditions of the analysis results for NEUT and EO” is added in
service settings. The setting enables to set result display setting and low-reliability mark setting.
Degranulated eosinocytes are

false-classified as neutrophil
Resolved issues
None
Remarks
For XN-10/20
ECR 317H094
DVD1XN1X Ver.00-20 build9 Upgrade Procedure Upgrade Procedure
and thereafter
XN-1000 SUPPLY PARTS(CHN) S/N: A9203
and thereafter
XN-1000 SUPPLY PARTS (SA-01_CHN)
and thereafter
and thereafter
XN-9000 SUPPLY PARTS(EXP) S/N: A2422
and thereafter
XN-9000 SUPPLY PARTS(US) S/N: A2422
and thereafter
and thereafter
S/N: Not fixed
and thereafter
and thereafter
XN-9100(1) SUPPLY PARTS(US) S/N:
XN-9100(1) SUPPLY PARTS(CHN) S/N:

BG024779: [IPU ]00-20 build9
CDR_ASSY NO.296(DVD1XN1X(00-20 B9)) [Device Control Manager] 00-20 build9
[Analysis ] 00-20 build6
[Analyzer] 00-55
[Sampler] 00-15
None
Resolved issues
as follows.
were switched).
Remarks
ECR 316G033
DVD1XN1X Ver.00-20 Upgrade Procedure Upgrade Procedure
S/N: Not fixed yet November 2015

CY363761: CDR_ASSY (Device Control Manager): Ver.00-20
NO.227(DVD1XN1X(00-20)) (Analysis): Ver.00-20

1 Windows fixed password for "sysmex" account can now be changed.

2 Error detection method for "Cannot recognize Fluorocell XXX information" has been changed. (XXX
stands for Dye parameters.)
3 Previously, a user with QC performance access right could delete QC data. In order to prevent
deleting of QC data, a user with only QC performance has been added.
4 Previously, even though the aspiration of CELLCLEAN AUTO was completed in 7 minutes, rack
conveyor line was stopped for 14 minutes and only manual mode could be performed. Sampler
analysis can now be started 7 minutes earlier by returning the CELLCLEAN tube to sample set unit
and feeding out rack.
5 Cycle counts for Repeat, Reflex and Rerun are now included in shutdown report for SNCS.
6 Action messages for reagent replenish errors have been changed.
7 Analysis data including sample number with forbidden character codes for windows (\/:*?"<>|) can
now be output in FCS format.
8 IP message "pRBC?(R)" can now be output to DP.
9 When IP message "pRBC?(R)" is output, a flag "Morph" can now be attached to the result.
10 As a countermeasure against ribosome interference, when instrument judges a ribosome appearance
sample, the following processes can now be performed.
- Outputting WBC Abnormal Scattergram flag
- Attaching low reliable mark to WBC related parameters
- WBC re-discrimination
11 "PLT Clumps?" judging algorithm can now be selected for ver. 00-17 or ver. 00-18.
Resolved issues
1 Previously, QC barcodes could not be read if the sample number digit length setting was changed.
This has been resolved.
2 Mis-calculation for NEUT-RI and NEUT-GI has been resolved.
3 Incorrect malaria particle number in the scattergram has been corrected.
4 Previously, there was a possibility that giant platelets became falsely high value when these particles
interfered with WBC on WNR-ch. This has been resolved.
5 Previously, when analysis mode was changed to sampler mode after using micro sample tube,
sampler analysis could not be performed. This has been resolved.
6 Previously, when analysis mode was changed to sampler mode after using micro sample tube,
sampler analysis cannot be performed. This has been resolved.
7 Previously, "Blood aspiration sensor is OFF" message appeared, even when blood aspiration sensor
was ON and service mode setting screen was closed. This has been resolved.
Remarks
None
ECR:315A030
DVD1XN1X Ver.00-19D build 16 Upgrade Procedure Upgrade Procedure
(SAI markets only) (FileDeliverySystem)

None February 2018

None [IPU] 00-19D Build16
[Device Control Manager] 00-19D Build13
[Analyzer Sequencer] 00-19D Build12
[Sampler Sequencer] 00-19D Build12
[Analyzer] 10-55
[Sampler] 00-16
1 Differentiation algorithm of neutrophil and eosinophil has been changed for the two cases shown
below.
[Case1]
In case of eosinophilia (especially in case of degranulated eosinophil) and the cluster appears nearby
neutrophil cluster, the analyzer falsely classifies the eosinophil cluster as neutrophil cluster.
Therefore, differentiation algorithm has been changed to avoid this false-classification.
[Case2]
In WDFch main scattergram, there is a possibility that the analyzer falsely classifies debris (unknown
particle shown in low-range of SFL) as eosinophil cluster. In this case, Re-differentiation algorithm
does not work correctly.
Therefore, differentiation algorithm has also been improved to avoid this false-classification.
Resolved issues
None
Remarks
For XN-10/20
ECR 318B011
(SAI markets only) (FileDeliverySystem)

None October 2017

None [IPU] 00-19D build15
[Device Control Manager] 00-19D build15
[Analyzer] 00-55
[Sampler] 00-15
been changed.
service settings. The setting enables to set result display setting and low-reliability mark setting.

Resolved issues
None
Remarks
For XN-10/20
ECR 317H094
(North America markets only) (FileDeliverySystem)

XN-9000 SUPPLY PARTS(US) S/N: A2422 November 2016
and thereafter
S/N: Not fixed

AY591900: [IPU] 00-19D build13
CDR_ASSY NO.290(DVD1XN1X(00- [Device Control Manager] 00-19D build13
19DB13)) [Analysis ] 00-19 build15
[Analyzer] 00-55
[Sampler] 00-15
None
Resolved issues
as follows.
were switched).
Remarks
For XN-10/20
ECR 316G033
DVD1XN1X Ver.00-19D (North Upgrade Procedure Upgrade Procedure
America markets only) (FileDeliverySystem)

S/N: Not fixed yet. June 2016
<Part No./Name> [IPU]: Ver.00-19D

BP592752: CDR_ASSY NO.276 (Device Control Manager): Ver.00-19D
(DVD1XN1X(00-19D)) (Analysis): Ver.00-19
(Analyzer Sequencer): Ver.00-19D
(Sampler Sequencer): Ver.00-19D

Initial version
This program is based on DVD1XN1X(00-19) and added modifications.
1 XN-9100 (CV-55) connection is now possible.
2 12L/h setting on the RU-20 is now available.
Resolved issues
1 Previously, the PDF files bookmarks for built-in IFUs could not be read properly. This has been
resolved.
2 Previously, the IPU for XN-3000 could abnormally shut down in stand-alone mode. This has been
resolved.
3 There was a case that the IPU sent an incorrect communication massage to Host.
4 Previously, the sampler analysis could not be performed by switching to sampler mode after
microtubes had been used. This has been resolved.
5 Previously, piercer adjustment screen could not be closed. This issue has been resolved.
Remarks
For XN-10/20
ECR:316D038
DVD1XN1X Ver.00-19E build 5 Upgrade Procedure Upgrade Procedure
(SCH market only) (FileDeliverySystem)

None November 2017

None [IPU] 00-19E build5
[Device Control Manager] 00-19E build5
[Analysis] 00-19E build2
[Analyzer] 01-55
[Sampler] 00-15
None
Resolved issues
been changed.
service settings. The setting enables to set result display setting and low-reliability flag setting.

2 The countermeasure against “Fluorocell RFID tag error” which is frequently occurred when using new
RFID tag on Fluorocell bottles has been added.
Remarks
For XN-10/20
ECR 317K046
DVD1XN1X Ver.00-19E build Upgrade Procedure Upgrade Procedure
3(Chinese market only) (FileDeliverySystem)

XN-1000 SUPPLY PARTS(CHN) S/N: A9203 November 2016
and thereafter
and thereafter
and thereafter
S/N: Not fixed
and thereafter

AP098873: CDR_ASSY [IPU] 00-19E build3
NO.294(DVD1XN1X(00-19EB3)) [Device Control Manager] 00-19E build3
[Analysis ] 00-19E build1
[Analyzer] 00-55
[Sampler] 00-15
None
Resolved issues
as follows.
were switched).
Remarks
None
ECR 316G033
DVD7XN1J Ver.00-19E build 2 (Only Upgrade Procedure Upgrade Procedure
Chinese market) (FileDeliverySystem)

S/N: Not applicable. PM parts registration May 2016
only.
<Part No./Name> [IPU]: Ver.00-19E

BM741264: CDR_ASSY (Device Control Ma8ager): Ver.00-19E build2
NO.252(DVD7XN1J(00-19E))) (Analysis): Ver.00-19E build2

Resolved issues
1 Previously, output function for reagent information to SNCS when starting up instrument and replacing
reagent has been added, however instrument ID and reagent information were not output correctly.
Remarks
None
ECR:316C110
DVD5XN1X Ver.00-19C (Patch Upgrade Procedure Upgrade Procedure
Program) (FileDeliverySystem)

XN-1000 Supply Parts S/N: A5946 and October 2015
thereafter
XN-1000 Supply Parts (AP) S/N: A6317 and
thereafter
XN-2000 Supply Parts S/N: A6317 and
thereafter
thereafter
XN-11 S/N: A1052 and thereafter

BX080595: CDR_ASSY (Device Control Ma8ager): Ver.00-19C
NO.235(DVD5XN1X(SP2)) (Analysis): Ver.00-19

Resolved issues
1 It was observed that XN/XN-L sent incorrect data to Host Computer when special conditions were
met. This has been resolved.
Remarks
None
ECR:315G028
DVD1XN1X Ver.00-19C build2 Upgrade Procedure Upgrade Procedure
and thereafter
and thereafter
and thereafter
and thereafter
XN-9000 SUPPLY PARTS(EXP) S/N: A2422
and thereafter
XN-9000 SUPPLY PARTS(US) S/N: A2422
and thereafter
and thereafter
S/N: Not fixed
and thereafter
and thereafter

AX051886: [IPU] 00-19C build2
CDR_ASSY NO.295(DVD1XN1X(00-19C [Device Control Manager] 00-19C build2
B2)) [Analysis ] 00-19 build15
[Analyzer] 00-55
[Sampler] 00-15
None
Resolved issues
as follows.
were switched).
Remarks
ECR 316G033
S/N: Not fixed yet April 2015

BA988785: CDR_ASSY (Device Control Manager): Ver.00-19

1 ICIS related parameters are now reportable. (AS-LYMPH? (For EU Market)

2 Priority of @ and * mark of analysis can now be changed.
3 Temporary switching from RU-20 to CELLPACK DCL function has been added.
4 XbarM calculation criteria has been changed to include plots used on XE and XE.
5 In twin instrument, when one instrument fails and the other instrument operates normally, sampler
analysis now can be operated without stopping sampler analysis.
6 WBC now has "*" (asterisk) when there is a channel difference between WBC-N and WBC-D.
7 Default analysis discrete can now be set. (Previously, full discrete was default in sampler analysis.
8 Warning function when aspiration sensor turns OFF.
9 Reagent remaining counters can now be turned off for Chinese market.
10 IP v6 can now be used for host communication
11 New parameter WBC-N (SSC-FSC) can now be available. (For Chinese markets only.)
12 Output function for off line SNCS has been added
13 Remaining stain quantity can be stored in data base.
14 Adding low reliability mark to PLT-I, PLT-O, PLT-F, PLT and related parameters when PLT Clumps is
judged can now be available
15 dRBC (R) flag has been added.
16 On XN-2000/3000, function for re-analysis on another analyzer other than first analyzed instrument
by host computer inquiry has been added
17 Anemia flag judgment will be performed regardless of RBC analysis order.
18 PLT-O scattergram can now be turned off by service setting.
19 Action message when short sample error appears has been changed.
20 Displaying warning message when receiving "Command not to aspirate" order from host computer
has been added.
21 Reagent lot number will now be added to results in CSV file.
22 IPF# and HPC% have been changed to reportable parameters. (IPF#: EU, AM; HPC%: EU)
23 Grade value will now be described as space when Blast/Abn-Ly flag is not judged by stability
judgment rule.
24 Fail safe function preventing mixing of rinsing solution to micro sample test tube when rinse cup
malfunctioned has been added.
25 AFLAS flagging rule has been improved.
26 Threshold value for WBC aggregation (WBC Abn Sct) can now be adjusted.
27 NEUT will not now become "0" when PMN is low on hsA mode.
Resolved issues
1 WBC eliminating area malfunction on Malaria analysis algorithm has been revised.
2 Not reflecting target values for QC file registration has been revised.
3 Output values for WPC-GR#, WPC-MO# and WPC-LY# which are calculated from WPC ch have
been revised.
4 Brazil Portuguese wording has been revised.
5 Previously, RBC low value and HGB low value samples were regarded as blank samples. This has
been resolved.
6 Previously, unnecessary flag messages were displayed when ID read error occurred on reanalysis.
7 Previously, short sample occurred even when sample was sufficient volume. This has been resolved
8 Previously, XN with SA-01 responded that wrong sample No. Attribute was sent to host computer.
Remarks
None
ECR:313L045
DVD5XN1X Ver.00-18B (Patch Upgrade Procedure Upgrade Procedure

thereafter
thereafter
thereafter
thereafter

BX080595: CDR_ASSY (Device Control Ma8ager): Ver.00-18B

Resolved issues
Remarks
None
ECR:315G028
S/N: Not fixed yet October 8, 2014

AR508733: CDR_ASSY (Device Control Manager): Ver.00-18

1 Previously, there was a possibility that the False Negative (FN) ratio for judgment of “PLT Clumps?”
on low PLT sample may be high when PLT-F ch or WDF ch are not used on CBC measurement. In
order to resolve this, the algorithm has been enhanced.
2 Research parameters and reportable parameters will now be displayed in separate screens. (North
American markets only)
When “Display research use only parameters” check box is selected in IPU setting, “Lab Only (RUO)”
tab is added to the main screen.
1 Research Use Only Parameters

列1 2
テキスト Display
Display research
research use
use only
only parameters
parameters
テキスト
Lab Only (RUO)

Analysis CSV output has been changed as follows.
[General users]
When a general user outputs data in CSV format, only reportable parameters will be saved (output).
[Users with ”Display and Output of Research Items” authorization]

When a user, who has ”Display and Output of Research Items” authorization, outputs data in CSV
format, only research parameters (reportable parameters and service parameters are not included)
will be saved (output).
[Service Users (sysmex]

When a user, who logged in “sysmex”, outputs data in CSV format, research parameters and service
parameters (reportable parameters are not included) will be saved (output).
[Outputting Research parameters to host computer]

When “Display research use only parameters” check box is selected in IPU setting, research
parameters will be output to host computer with “~” attached to research parameter’s name. (ASTM
format)
[Outputting Research parameters to SNCS and SysmexInsight]

Research parameters will output SNCS and SysmexInsght with “~” attached to research parameter’s
name.
Resolved issues
1 Previously, there was a possibility that the “Aged sample?” was displayed instead of “Blast/Abnormal
Lymp” even when the “Aged sample?” setting was not used. This has been resolved.
Remarks
None
ECR:314E078
DVD5XN1X Ver.00-17C (Patch Upgrade Procedure Upgrade Procedure

thereafter
thereafter
thereafter
thereafter

BX080595: CDR_ASSY (Device Control Manager): Ver.00-17C

Resolved issues
Remarks
None
ECR:315G028
DVD5XN1X Ver.00-17B (Patch Upgrade Procedure Upgrade Procedure

thereafter
thereafter
thereafter
thereafter

BX080595: CDR_ASSY (Device Control Manager): Ver.00-17B

Resolved issues
Remarks
None
ECR:315G028
DVD1XN1X Ver.00-17A Upgrade Procedure Upgrade Procedure
S/N: Not fixed yet November 27, 2014

BH063799: CDR_ASSY (Device Control Manager): Ver.00-17
NO.203(DVD6XN1X(00-17A)) (Analysis): Ver.00-17A

1 The following function for “PLT Clumps?” in version 00-17 has been enhanced in program version 00-
17A.
Previously, there was a possibility that the PLT coagulated sample was missed in CBC mode or
CBC+DIFF mode. In order to resolve this, the algorithm has been enhanced.
2 Channel for Discrete test and “PLT Clumps?” flagging judgment has been changed as follows.
CBC + DIFF + WNR + WDF
Resolved issues
Remarks
None
ECR:314J042
S/N: Not fixed yet July 28, 2014

CW784474: CDR_ASSY (Device Control Manager): Ver.00-17

1 Suspect flagging performance on WPC ch has been improved.

2 Cord blood WBC discrimination performance when RBC value is very low has been improved.
Program has improved WNR analysis program when running cord blood after processing with
PrepaCyte..
3 Service setting for RET Abnormal Scattergram rule criteria has been added.
4 Function of displaying action message "Aged Sample?" has been added. (Service setting)
5 Discrimination performance has been improved for Eosinophil and Neutrophil when analyzing some
abnormal samples. Neutrophil and Eosinophil are detected with two clusters and discriminated. When
abnormal Neutrophil appeared (especially hypersegmentation), Neutrophil may detected with two
clusters and one of the two clusters are regarded as Eosinophil. In order to resolve this situation, the
discrimination program was improved so that the cluster is detected as false Eosinophil and re-
discriminated as Neutrophil.
6 For EU markets, "RBC-He", "Delta-He", "NEUT-GI" and "NEUT-RI" as reportable parameters, and
"RE-LYMP#" and "RE-LYMP%" as research parameters have been added when Extended
inflammation parameters license is active.
7 CBC process performance for RBT has been improved. When using normal test tubes, throughput for
CBC analysis and CBC+DIFF analysis are equal. However when using RBT, the CBC analysis
throughput was lowered because a “termination process” (one of processes used during lapped
analysis) was always performed. In order to resolve this, the sequence was changed so that the
“termination process” is no longer performed when using RBT.
8 Piercing shifting movement for Hemogard (BD) has been added. (Shifting 1.2 mm to the right.)
(Service setting)
9 Calibrator Calibration function has been improved when performing calibration of RBC and HCT at
the same time. HCT calibration value is now calculated using new RBC calibration value. RBC and
HCT calibrator calibration input screen is now divided into two screens.
10 On ASTM format, switching function for last name and first name order has been added.
11 SMP file automatic backup function has been added. (Service Setting)
13 Default on-board rule will be installed automatically, when the IPU program is newly installed.
13 Action message when detecting insufficient mixed sample has been changed to "Suspect sample,
check the sample.
Resolved issues
1 Previously, there was a possibility that the "Out of XX (reagent)" error occurred erroneously for DCL.
In order to resolve this situation, bubble sensor setting has been changed for Cellpack DCL
2 Previously, there was a possibility that the QC data was abnormal on radar chart even the QC data
was normal on QC Chart. This has been resolved. Program changed bubble count threshold from 6 to
12 bubbles.
3 Previously, there was a possibility that the edge of the micro tube holder was erroneously detected as
micro tube body. In order to resolve this situation, micro tube detecting sequence has been changed.
4 Previously, there was a possibility that blood aspiration sensors were adjusted incorrectly, as some
blood sample for sensor adjusting was erroneously drained. In order to resolve this situation, blood
sensor adjustment sequence has been changed. Program now discards current blood (2 uL) and
uses the next 2 uL for adjusting.
Remarks
None
ECR:313I003
S/N: Not fixed yet March 17, 2014

BX564945: CDR_ASSY NO.68 (Device Control Manager): Ver.00-16
(Analysis): Ver.00-16

1 Analysis algorithm for HPC Mode has been improved for Europe and China specifications. (This
modification was applied for North America market with ver] 00-15.)
2 Switching from WBC-N to WBC-D has been applied when specific WBC aggregation occurred.
3 Action message "Sample Mixing Failure" for the sample insufficient mixing has been added.
4 Display and output in Portuguese has been added to Europe and North America specifications.
5 "PRBC" flag has been changed to "pRBC."
6 Not using Folder sharing setting has been added for the method of image data output in ASTM
format. (Service Setting)
7 PNG file format setting has been added for the method of image data output in DPS format. (Service
Setting)
8 Sub scattergram has been added when outputing in CSV output.
9 Low reliability mark will not be attached to the sample with the sample with low TNC value.
10 Built-in IFU has been applied to AP specifications.
Resolved issues
1 Previously, SP-10 built-in IFU was not functioned properly. This has been resolved.
2 Previously, scattergrams and histogram could not viewed in host computer when the data included
"\","/", ":", "<", ">" and "|" in ASTM format. This has been resolved.
3 Previously, background check for BF mode or hsA mode was performed when Autorinse was
performed in sampler analysis. This has been resolved.
4 Previously, there was a possibility that blood sample splattered when removing blood sample from
back side of test tube cap. This has been resolved by not performing this process when open mode.
5 Previously, there was a possibility that WC2 was overflown on PD mode. This has been resolved.
6 Previsouly, there was a possibility that remaining lyse solution could not detected on RR-10. This has
been resolved.
7 Previously, there was a possibility that blood sample was aspirated to rinse cup when rinsing the
piercer before analyzing RET-ch and PLT-F ch. As a result, RBC-O and PLT-O became lower and
calibration could not be performed.
8 Previously, incorrect data was transmitted when outputing histogram data in DPS format. This has
been resolved.
9 Previously, there was a possibility that output marks for host computer did not disappear when
outputting to host comuter. This has been resolved.
Remarks
None
ECR:313G047
S/N: Not fixed yet November 5, 2013


1 Raised Bottom Sample Tube(*1) is supported.

2 QC analysis function for HPC mode has been added. (for American markets only.)
3 "HPC%" has been added as a reportable parameter (for American markets only.)
4 "Delta-HGB" and "MCHC-O" have been added as research parameters.
5 DIA feed out function has been added to enable feed out slide glasses on XN-3000 stand-alone
mode.
6 XN-9000 (XN-20[A2], XN-10[B3], XN-10[B4]) have been added as components to connect to an IPU
computer.(For European markets only.)
7 SNCS files that are output at shutdown will be output at the time of cleaning as well.
8 Support Manager can now output SNCS file.
9 To remind customers that reagent supply will be stopped during reagent replenishment and drain on
RU-20, a message is now displayed when executing reagent replenishment and reagent drain.
10 Analysis algorithms for HPC mode have been improved. (for American markets only.)
11 At WNRch, WBC Abnormal Scattergram has been flagged when specifically-hemagglutinate is
recognized.
12 The accuracy of WBC counting for aged samples has been improved.
13 Logic has been added to judge if the PLT value is "low reliability" when RBC invades PLT area.
Resolved issues
1 There was a possibility that WBC-N value might be falsely low. This problem has been corrected.
2 There was a possibility that the sample aspiration sensor could not detect short sample error and the
result was falsely low. To resolve this situation, the judgment condition has been changed.
3 There was a possibility that the IPU program could not start if setting file was corrupt. This problem
has been corrected.
4 The function to highlight the analysis mode field in the explorer screen when "Analysis result is high"
error occurs was not implemented. This is now being implemented.
5 There was a possibility that text including apostrophe (') could not be properly registered on IPU
program. This problem has been corrected.
6 Previously, "WBC Abn Scattergram" flagging for BASO# did not work in HPC mode. To resolve this
situation, this function has been implemented.
Remarks
None
ECR:313B037
S/N: Not fixed yet. April 18, 2013
XN-1000 SUPPLY PARTS (EU) S/N: A1305 and thereafter

XN-1000 SUPPLY PARTS (AP) S/N: A1253 and thereafter
XN-1000 SUPPLY PARTS (CHN) S/N: A1321 and thereafter
XN-3000 SUPPLY PARTS (AP) S/N:
XN-3000 SUPPLY PARTS (CHN) S/N:
XN-3000 SUPPLY PARTS (EU) S/N:
XN-3000 SUPPLY PARTS (US) S/N:
XN-9000 SUPPLY PARTS (EXP) S/N: A1246 and thereafter


1 Discrimination performance for NRBC high value sample on WDF channel has been improved.
2 Discrimination for Neutrophil and Eosinophil has been improved.
3 Service setting for removing "PLT Abnormal Distribution" in PLT-F analysis has been added.
4 Service setting for changing PLT judgment criteria of Action message and PLT switching has been
added.
5 Service setting to add SNCS file for X-barM QC plot has been added. (When performing "saved as
SNCS format" or when Auto Output is set, the file is saved as
"XbarM_[AnalyzerID][PlotDateTime]_[Channel].txt under the location of "C:\Program
Files\Sysmex\SNCS\SendFolder\XbarM\".)
6 When discrimination error occurred for WBC scattergram, Service setting for masking related
parameter has been added.
7 Reagent remaining volume indicator for DCL has been applied with the countermeasure against the
HGB unexpected high value.
8 In order to prevent from fluctuation of dye solution volume caused by air bubbles on DP, Setting
sequence has been improved.

1 Previously, IPU screen did not display properly when IPU PC was turned ON without display power
already ON (the display was turned ON after running the IPU program.) This has been resolved.
2 Previously, the analyzer quit unexpectedly when PD mode and WB mode were performed in RAP
analysis. This has been resolved.
3 Previously, the sample ID was incremented even when "Auto Increment Function" was turned off.
4 Previously, the piercer was inserted between piston and inner surface of the test tube when using
Sartstedt test tube. In order to resolve this. the piercer moves to the right by 1.2 mm when aspirating
blood sample. (This sequence only applies when setting to Sartstedt for the test tube setting.)
Remarks
None
ECR: 312J024
S/N: Not fixed yet. February 18, 2013


(Sampler): Ver.00-15
1 The color of Abnormal Lympho area on WPC scattergram has been changed from red to gray when
"Abn Lympho?" is not flagged.
2 Malaria detection function has been added.
3 hsA Mode (High Sensitivity Analysis) has been added.
4 Data can be stored as FCS format (Flow Cytometry Data File Format Standards).
5 Positive/Negative judgment level criteria change for PLT Clumps is available by channels by service
setting.
6 When there are specification differences are between left main unit and right main unit on XN-2000 or
XN-3000, the retest judgment and PLT-I/O switching judgment will be performed to be equal between
left and right main units.
7 MCHC criteria for "Turbidity/HGB Interference?" has been added to service setting.
8 "*****000 10^6/L" has been added to RBC-BF unit setting.
9 On SNCS remote maintenance output function, outputting "reagent electric conductivity calibration"
has been added.
10 Initial value for "NRBC low count correction" has been changed to "0: Do Not Correct."
11 MicroR >= 10% of PLT low reliability judgment has been changed to MicroR >= 5%.
<NOTE>As for item 2 and 3 above, those functions become available when license registration is
completed.

1 Previously, there was a possibility that "Instrument communication error" occurred even though there
was no communication problems between IPU and RU-20. (The error occurred because the resource
was insufficient when the "System Restore Point" of Windows was active. In order to resolve this
situation, the "System Restore Point" of Windows has been disabled when the program is installed or
upgraded.)
2 WBC differential parameters can be reported incorrectly when the following three conditions occur.
(Neut% is calculated incorrectly ending up with a total % of differential parameters being more than
100% )
1) Service Setting is set to 6-part differential. (Refer to XN-1000/2000 Service Manual page 5-57.)
2) A sample with abnormal cells (ex. abnormal lymphocyte) is measured.
3) "WBC Abnormal Scattergram" (Judged by the classification between Baso area and non-Baso
area) is flagged.
3 Previously, application error could occur when cursor movement by keyboard and cursor movement
by software are conflicted on Explorer screen or Browser screen. This has been resolved.
4 Previously on SA-01, if "Ejection table is full" error and "Rack not placed on feed-in table" error
occurred simultaneously, "Ejection table is full" could not cleared. This has been resolved.
5 Previously on SA-01, when "Sampler analysis stop error occurred", sampler analysis could not be re-
started. This has been resolved.
6 Previously on SA-01, rack feed-in error occurred. This has been resolved.
7 Previously, there were no escape process performed for special characters "|","\","^","&" on ASTM
format. This has been resolved.
8 Previously, there was a possibility when patient information was received from host computer without
doctor name and ward field, IPU program stored incorrect doctor names and ward names. This has
been resolved.
9 Previously, incorrect records were printed, valid characters were printed. This has been resolved.
10 Previously, IPU program unexpectedly quit when BF mode data was printed on DP. This has been
resolved.
11 Previously, lines on table and picture were shifted when customized lines table picture were printed.
12 Previously, result for SP judging rule was not reflected to the work list when results were output to
host computer on XN-3000 standalone mode.
Remarks
None
ECR: 312I007
January 18, 2013


1 Flagging for "Blasts/Abn Lymph?" has been improved.
2 Discrimination performance for WBC/NRBC on WNR ch has been improved.

1 Rinsing function has been improved as a countermeasure against HGB unexpected high value.
Remarks
None
ECR: 312I006
September 24, 2012


1 Discrimination for HFLC particles has been improved when particles appear in high florescent area on
WDF channel.
2 Discrimination for "Atypical Lymph?" on WDF channel has been improved.
3 In order to improve reliability for PLT-F, a rule for "PLT Abn Scattergram" has been added.
4 Previously, there was a possibility that BASO# became falsely high by invading lymphocyte particles
into BASO area when analyzing CLL or DLBCL samples. In order to resolve this situation, "WBC Abn
Scattergram" will be notified in such a case.
5 The program now supports XN-3000 Standalone mode. (In XN-3000 Standalone mode, only ASTM
format will be supported.)
6 A research parameter "PLT-F2" has been added. (A parameter which has one more digit than PLT-F
and has high reproducibility with low values.)
7 Previously, when Rerun and Reflex are judged at the same time, only Rerun was performed. In order
to resolve this situation, the priority of the rule action has been modified.
8 Previously, there was a possibility that Hgb value was incorrect when analyzing high bilirubin sample
due to SLS capability. In order to resolve this situation, a research parameter "HGB-O" analyzing with
FCM has been added.
9 BCR5342H (NEC made) barcode reader is now supported. (Only for software. Hardware modification
will be available.)
10 An Analysis Stop Setting, when an order inquiry was set for a parameter which would be analyzed on
defective analyzer only, has been added.
11 Some instrument configurations have been added so that more combinations with B1, B3 and B4 can
be connected to IPU. (EU market only)
12 A service setting has been added to enable connecting with CELLPACK DCL temporarily when
installing analyzer or RU-20 is defective.
13 For printing list, a white color background screen can now be selected.

1 An option for removing blood on sample tube cap with service setting has been added. (A hardware
modification is necessary when this option is applied. An ECR will be issued for this modification.)
2 In order to prevent leakage from rinse cup, the sequence program has been changed by performing
draining WC2 before turning off the pneumatic unit.
3 Previously, there was a possibility that the MCH and MCHC became zero. It has been resolved.
4 Previously, the IPU program quit unexpectedly when analyzing a sample with abnormal scattergram.
5 Previously, there was a possibility that a WPC Channel Error erroneously occurred on HPC Mode.
6 Previously, there was a possibility that the Patelite remained in red even though replacing reagent.
7 Previously, there was a possibility that the IPU program quit unexpectedly, when entering expiration
date with keyboard without using reagent code. This has been resolved.
8 Previously, valves for rinsing FCM/RBC syringes remained open after performing "Shipping1" and
"Shipping3." As a result, the liquid flowed back from the WC2. This has been resolved.
Remarks
None
ECR: 312G038
DVD1XN1X Ver.00-10 Upgrade Procedure
XN-1000 SUPPLY PARTS (EU) S/N: June 23, 2012
Not fixed yet.
Not fixed yet.
Not fixed yet.
Not fixed yet.
Not fixed yet.
Not fixed yet.


1 When low specific gravity eosinophil appeared on WDF ch, position of neutrophil cluster and
eosinophil cluster were very close. As a result, eosinophil was discriminated as neutrophil. This
discrimination has been improved.
2 There was a possibility that reticulocyte count was affected by appearing RBC with Howell-Jolly body.
In order to resolve this, rules to judge as "RET Abnormal Scattergram.".
3 Changing PLT Clumps rule as follows
- To improve flag detection, CBC rule for PLT Clumps was removed when WDF channel or PLT
channel was used.
- Previously, PLT Clumps was judged by PLT-F rule when PLT-F channel and WDF channel were
used. To improve flag detection for PLT aggregation, WDF channel rule has been added.
4 The discrimination between WBC cluster and NRBC cluster when lots of tumorous lymphocytes were
observed like CLL sample has been improved.
5 Instrument's configuration has been changed so that additional instruments can connect to IPU.
6 Up to three analyzers can now be connected to RU-20.
7 Display digit for HGB on XN-21 or XN-11 can be selected with SystemConfigurator as follows.
- Current display digit for HGB: ***.* [g/dL] or **** [g/L]
- Added display digit for HGB: ***.** [g/dL] or **** .*[g/L]
8 IFU for XN-21/XN-11 will now be displayed as a built-in manual on XN-21/XN-11.
9 BL-180/185 (KEYENCE made) barcode reader is now supported. (Only for software. Hardware
modification will be available.)
10 Scattergram and histogram research parameters can now be output in ASTM Format.
11 Registered user number has been changed from 20 to 100.
12 Specifications for HPC Mode have been changed as follows.
- HPC Mode results will not be used for delta check.
- PLT has been added to numeric value and graph on HPC tab.
- HPC# will now be displayed when analysis mode is "Control" even not in QC mode.
13 The status of Feed-in arm left position sensor will now be displayed on Sampler status screen. (The
SNS213 sensor status will be displayed as No.13 on sensor status screen.
14 The Mixing method of PLT-F channel sample has been streamlined as a countermeasure against
PLT-F high value on QC.
15 The following sequences have been changed.
- Previously, piercer needle pierced into bottom of sample tube. As a result, sample tubes came up
when piercer ascends. In order to resolve this, on open mode, piercer will ascend with closing tube
clamp.
- Previously, Syringe was not in limit position after completing Shipping 1. In order to resolve this,
syringe will return to its limit position when shipping sequences 1, 2 or 3 are completed.

1 Previously, a registered user may not be logged on as IPU distinguished upper case characters and
lower case characters. This has been resolved.
2 Previously, the analyzer unexpectedly quit when pressing start switch and starting sampler analysis
were performed simultaneously. This has been resolved.
3 Previously, raw data for header was erroneously stored when measurement skip occurred. This has
been resolved.
4 A border line in PLT-F channel was added with program version 00-09. However, some part of the
border line was not output to ASTM format. This has been resolved.
5 When both WPC and PLT-F were analyzed, ItemOrdered([WPC]) and ItemOrdered ([PLT-F])
registered in rule screen did not worked properly. As a result, rule judgment was not performed.
(Example: When Rerun was set by ItemOrdered([WPC]), the concerned sample was not re-
analyzed.)
6 The color of the WDF Channel scattergram on BF mode became same color with WB mode.
7 Previously, in PD mode, upper limit of the linearity range for WBC, WBC-N and WBC-D were
4400.0×10^2/μL. They should be 1000.0×10^2/μL. This has been resolved.
8 Previously, HGB value was entered by (10^(-1)mmol/L) in unit for the condition equation with only
HGB (g/L). As a result, the judgment of delta check was incorrect. This has been resolved.
Remarks
None
ECR: 312D066
XN-1000 SUPPLY PARTS (EU) S/N: June 11, 2012


1 The judgment rule of PLT Channel Error has been changed to eliminate poor detection of PLT
channel abnormality.
2 A border line has been added between two particles areas at PLT-Fch.
3 WBC classification accuracy of sample that shows high NRBC value has been improved.
4 A compensation function for NRBC false high value has been added when NRBC shows exceedingly
low value.
5 Some instrument configurations have been added so that more combination with B3 and B4 can be
connected to IPU.
6 The specification has been changed so that PLT-I is applied as PLT regardless of switching condition
on Analyzer A2/B3 that operate PLT-I/O switching.
7 A service setting has been added so that parameter unit settings on IPU are matched with the ASTM
format.
8 A function has been added so that only a specific barcode can be read in case multiple barcode labels
are attached on a sample tube. (Unset barcode symbol in the IPU will be ignored.)
9 SysmexInsight function has been implemented. (Only for U.S. markets)
10 Air bubble draining in Whole Blood Aspiration syringe during priming sequence has been improved.
11 Sent pulse at fine adjustment of optic axis has been reduced by changing adjustment time from 29
sec to 24 sec.
12 SD bar has been displayed on Whole Blood parameters of browser main screen of HPC mode
analysis data.
13 The color of patelite status has been standardized as follows. Green: Normal status Red: Abnormal status.
14 The specifications of LED lighting of XN-1000 (SA-01) have been standardized with XN-1000. XN-
2000. XN-3000 and XN-9000.
15 The usability of GP customize function has been changed to match to the general operation method
of draw tools.
16 Error monitoring timing and detailed information of sheath motor error have been added.
17 The condition of [Cleaning is required.] and [Cleaning is required (Warning).] has been changed.
18 The program has been changed so that the compressor will be stopped regardless of error
occurrence when analyzer has not been operated for a specified time.
19 Adobe plug-in has been removed from the IPU PC.
20 Progress status information will now be displayed during program upgrading process.
21 Non-translated messages have been translated into multiple languages.
22 A message will now be displayed in case of the parameter DB loading is failed during IPU start up.
23 Residual pulses at initialization of WB Asp. Motor, RBC sheath motor and FCM sheath motor will now
be stored.

1 The possibility that analysis result is not masked when FCM sheath motor stops abnormally has been
resolved.
2 The possibility that low reliability flag was not added on PLT when "PLT Clumps?" has been resolved.
3 The problem that IPU does not send order inquiry to host during sampler measurement has been
resolved.
4 The problem that software keyboard does not work properly when users log in to Windows via
Remote Desktop has been fixed.
5 A possibility of that PLT-O switching doesn't work correctly under following conditions occurred at the
same time has been resolved. - RDW-SD was not calculated.- RDW-CV was calculated.- PLT
histogram was abnormal.
6 The problem that flag status turn to "discrete" when the result of "PLT Clumps?" judgment doesn't
meet prerequisite has been fixed.
7 CELLCLEAN AUTO is mis-aspirated during sampler analysis in XN-9000 stand alone mode has been
fixed.
8 The problem that rack could not be back into sampler when "Sampler Analysis Stop 3" error occurred
during Sampler initializing on XN-3000 has been fixed.
9 The problem that [Rack ejection error] occurred at unintended timing on XN-1000 (SA-01) has been fixed.
10 The problem that power was turned off while hand placed at the lower position when instrument was
shut down by CELLCLEAN AUTO has been fixed.
11 The problem that [Positive ID abnormality] error could occur despite correct sample was detected has
been fixed.
12 The display of [HPC#] in Control analysis has been corrected.
13 The problem that IPU program was abnormally closed if QC file that has the expiration period is NULL
or date format is not covered by IPU was operated has been fixed.
14 Terminate record was output twice on OnlineQC. When an output plot was re-output during
OnlineQC, the record was overwritten on the same file. There was a possibility that the previous
record was remained on the file. This has been fixed.
15 The defect that the expiration message was not displayed even if the expiration period after opening
the lid was overdue when reagent code that already input had been re-entered has been fixed.
16 The problem about display of compressor operation time and laser oscillation time has been fixed.
(ex. In case cumulative time is 26:21:15, 02:21:15 was displayed.)
17 The problem that Analyzer or IPU was abnormally quitted has been fixed.
18 The problem that IPU display was not updated has been fixed.
19 Displaying erratum has been corrected.
20 The problem that FCM sheath motor error occurred during lap analysis on Low WBC mode or other
modes has been fixed.
21 Program has been changed to fix the problem that sampler analysis is suspended regardless of the
suspend conditions when error occurrence related to blood asp. error.
Remarks
None
ECR: 311L057
XN-1000 SUPPLY PARTS (EU) S/N: February 15, 2012


Added Functions
1 The program now supports CELLCLEAN AUTO.
2 The program now supports HPC mode.
3 The program now supports XN-21/XN-11 models.
4 The program now supports SA-01 sampler.
5 The program now supports output for RU-20 SNCS as follows.
-Adding shutdown report
-Adding event history
-Adding error report
6 Action message "Difference between PLT and PLT-F. Check the results." has been added.
7 Revised some messages in German program.
8 The program now supports color sensor.
1 Rule for the "PLT channel error" has been changed.
2 The algorithm for IPF/WBC discrimination on PLT/F channel has been added.
3 "PLT Clumps?" rules have been changed. (Added for American market Only. Already available in
other markets by earlier version.)
4 Ghost discrimination algorithm for PLT-F channel has been changed. (Added for American market
Only. Already available in other markets by earlier version.)
5 The algorithm for improving NEUT/EO discrimination on WDF channel has been added. Added for
American market Only. Already available in other markets by earlier version.)
6 Shutdown and cleaning are now recorded individually on maintenance record.
7 To prevent rinse cup drain line clogging, improved cleaning after measurement and before entering
sleep mode status have been implemented.
8 Error detection method for "FCM sheath motor error" and "RBC sheath motor error" has been
changed by checking remaining pulse number.
9 Explorer now will no longer store dummy results when detecting a sample without blood sample
detect on sampler L-J QC.
10 Cumulative tab setting on the Data Browser Screen has been changed to show all data or last data.
11 Setting for monitor leakage sensor has been added as follows.
- Adding not monitoring sensor
- If a "Water leak" error appears as yellow in the status (warning) screen in service mode, the error
continues and the error will be cleared once the error is recovered. If the error appears as red in
status screen, the error can only be cleared by turning off the instrument to resolve.
12 Combination of XN modules connected to one IPU has been expanded.
13 Conditions for stopping alarm have been changed if error occurs while logging ON. To stop alarm, IPU
screen can be touched using touch panel function or clicking with mouse.

1 A Falsely low result of HF-BF% computed by erroneous calculation (divided by 100) has been
resolved.
2 Previously, the "WBC Abn Sct." was flagged even when the WBC<5/ul on BF mode had been
resolved. (For American markets only. This issue was resolved by program version 00-07 in other
markets.)
3 Previously, the assay value could not read when registering XN-CHECK BF.
4 Previously, the confirmation dialog did not appear when receiving invalid orders on inquiry download
function has been resolved.
5 Previously, the control menu did not accept screen touching due to calendar control failure.
6 Previously, the older order was applied when receiving new order reducing the needed number of
parameters. This has been resolved.
7 Previously, the downloading inquiry order stopped if inquiring an order which was not registered in the
host computer. This has been resolved.
8 Previously, discrete parameters which were not licensed were not displayed. This has been resolved.
9 Previously, parameters which were not selected as available on the instrument were not printed
anyway, This has been resolved.
10 Previously, changing of the IPU settings should be reflected only after the next logging ON to the IPU.
However, the changes were reflected right after the setting was changed. This has been resolved.
11 The following issues when connected with XN-9000 have been resolved.
- Rack position LED did not light when a feeding error occurred on XN stand alone.
- Updating CT-90 status screen was delayed when main unit status was changed.
12 Previously, the data format for SNCS was set according to the IPU setting. The date format has been
fixed as "YYYYMMDD".
13 Previously, the 5 differential parameters that are masked on IPU were not masked on the host
computer output. This has been resolved.
14 Previously, when the order inquiry was performed from main unit on mode B, a scattergram on
unmeasured channel was displayed. This has been resolved.
15 Previously, when the order inquiry was performed from main unit on mode B, the blood aspiration
sensor was not used. This has been resolved.
16 Previously, two login dialogs could not start when starting up the IPU. This has been resolved.
17 Previously, the IPU application could abnormally terminate when shutting down the IPU. This has
been resolved.
18 Previously, the Auto rinse could be started before coming to a ready status and instrument locked up.
19 Previously, the rack and edge of the measurement line touched when performing Sampler Positions
Adjustments under the following conditions. This has been resolved.
When the current screen is moved to "Tube rotor position" or "Tube pickup position."
When "Pulse Entry" button is pressed to display Pulse Entry screen and "OK" button is pressed.
20 Previously, "Out of Fluocell XXX" occurred, which was unlicensed, while setting sequence was
performing. This has been resolved.
21 Previously, re-occurring saving error of RU history occurred on the instrument connecting with RU.
Remarks
None
ECR: 311J096
XN-1000 SUPPLY PARTS (EU) S/N: December 8, 2011


Added Functions
1 A copy / paste function has been added, on a record basis, for Rerun/Reflex/Comment Rule,
Validation Rule and Output Rule on the Rule screen.
2 The program now supports traditional Chinese and Korean languages.
3 Backup and restore tools for the IPU have now been loaded.
4 Service settings have been added to enable a sample number to be modified when a barcode is read
as follows:
- Suppress/Padding setting for specified digits
- Fetching setting for specified digits
5 An open/close button has been added on the top right corner of Rule screen to allow users to hide a
flow chart (Rule Execution Order). Displaying of the Rule Execution order chart will be toggled with a
click of the button.
6 The program now supports Windows 7 SP1.
7 When outputting in CSV format, users can now select outputting scattergrams in white background.
8 A service setting has been added to allow users to select the letter size for printing.
9 The program now supports the function of transmitting CELLPACK DST reagent information to WAM
IF.
10 The specifications have been changed to display a progress dialogue box when "GP Customize" icon
is clicked in the Menu screen.
11 Previously, if the IPU computer is switched OFF abruptly, the layout setting files for IPU screens may
be corrupted, and if these files are read, there was a possibility that the IPU could not be started. In
order to resolve this, the program has been changed to show the initial screen if the layout setting file
is corrupted.
1 To make more user friendly, the layout for the Instructions For Use screen has been changed.
2 The functions for RU icons have been changed to make more user friendly as follows:
- The reagent replacement screen is now displayed when clicking the Reagent icon.
- The reagent replacing icon is now displayed while replacing reagent on the RU.
3 To prompt users to enter a reagent code, a caption has been added to the screen displayed when
reagent is replaced on the RU.
4 As there is a time lag between when the Execute button is pressed in the Reagent Replacement
screen and when reagent replacement is started, users are unable to tell whether reagent
replacement is in progress or not. To resolve this, the message of reagent replacement in progress
and its display method have been changed.
5 To make more user friendly, the following changes have been made to the manual analysis screen:
Previously, when the OK button is pressed even once in the manual analysis screen, it was
impossible to return to the barcode reading mode. To resolve this, a barcode read setting checkbox
has been added to allow users to return to the barcode reading mode.
The checked status of checkboxes in the manual analysis screen will remain unchanged even after
the IPU program is closed.
To encourage users to remove caps from the sample tubes before performing an analysis, the icon for
the manual analysis button in the control menu has been changed to the image of an uncapped
sample tube, flashing in white color.
6 If set to not allow users to edit rules in Service Mode Settings, [Register Rule], [Modify Rule] and
[Delete Rule] icons in the Rule screen will be hidden, not disabled.
7 The following errors have been deleted from the Repeat Rule screen, as sampler analysis would be
stopped if any of the errors occurs.
41°C reagent heater thermistor error

34°C reagent heater thermistor error
41°C FCM reaction chamber thermistor error
34°C FCM reaction chamber thermistor error
FCM detector thermistor error
FCM sheath thermistor error
Environment temperature thermistor error
APD thermistor error
Laser output error
"Failed to read sample number during manual analysis" error has been deleted from the Repeat Rule
screen.
8 Color of the status indicator LED when the analyzer is being restarted has been changed from green
to red.
9 The rule for "PLT Clumps?" flag has been changed. (Except for the North America region.)
10 The order of IP messages for Data Printer (DP) printing format settings in IPU Setting have been
modified to match the order in the analysis data list window.
11 Chinese screen display has been changed based on requests from local offices.
12 An icon showing required sample volume or cap open/close has been added to the manual analysis
screen for the Body Fluid mode.
13 Previously, errors that do not occur due to the configuration of the instrument were displayed in gray
in Repeat Rule tab in the Rule screen. The specification has now been changed to hide those errors.
14 Previously, when one reagent was shared by multiple instruments (XN-2000, XN-3000 or XN-9000), if
one of the instruments was in the sleep status and reagent replacement was to be performed in
another instrument, reagent was not replaced until the sleep status was canceled. It has been
changed to automatically cancel the sleep status for all instruments to replace reagent.
15 To make more user friendly, the positions of display switching buttons are now stored in the IPU and
will be restored when the IPU is restarted.
16 The specifications for WAM IF material records have been changed as follows:
- "The starting date of using reagent" has been changed to "The starting date and time of using
reagent".
- "The opened date of reagent" has been changed to "Installed date of reagent".
17 Error messages for when Fluorocell reagents have run out have been changed as follows:
- "Replace Fluorocell" message is deleted .
- "Out of Fluorocell" message is now displayed when replacement is needed.
18 In XN-2000 and XN-3000, when the analysis module on the right-hand side was switched OFF, the
tube grabber came in contact with the sample tube detection unit of the sampler module. In order to
resolve this, the sequence program has been changed to not lower the tube grabber to the lowest
position when the instrument is being shut down; by forwarding the sample set unit a little to hook the
tube grabber.
19 The sequence program has been changed to prevent syringes from getting stuck, by increasing motor
driving current.
20 The sequence program has been changed to prevent false tube detection errors at home position by
chattering of signal.

1 In body fluid analysis, there were cases where "WBC Abn Scattergram" was flagged even when WBC
was less than 5/uL. This issue has now been resolved (Except for the North America region).
2 Previously, when the IPU was restarted after the width of the list view columns had been changed to
the maximum, the horizontal scroll bar was not displayed correctly. This issue has been resolved.
3 Some inadequate performance of GP customize tools have now been resolved.
4 Previously, some text was cut off due to layout changes and multi-language support. This issue has
now been resolved.
5 Corrections have been made to prevent the names of axes in scattergram from being cut off.
6 Previously, the dialogue box displayed when printing settings from IPU Setting and Analyzer Setting
did not contain a progress bar. A progress bar is now displayed in the dialogue box.
7 Previously, when an on-screen keyboard was used, the keyboard was not closed even after the
screen area outside of the edit box had been clicked. This issue has now been resolved.
8 Previously the DGH output field in the Sample Explorer screen was cleared even if outputting results
[Data Printer, Graphic Printer (GP) or Host Computer (HC)] was not successful. This issue has been
resolved.
9 When only the XN-10 was connected to the IPU, an unwanted black frame was displayed in the
temperature field of the Analyzer Sensor Display. This issue has been resolved.
10 Previously, the setting of the printing language was not properly reflected. The problems have now
been resolved.
11 When printing QC analysis data to a graphic printer, the color of plotted point was incorrect. The issue
has now been resolved.
12 The following problems with screen displays when orders are received from the host computer have
now been resolved.
- The message of "The inquiry is accepted" was displayed even though the inquired order was
registered when incorrect order was sent from the host computer.
- New registered ward name and doctor name were not displayed in the patient registration screen.
13 When the analyzer was restarted, there was a possibility that "Reagent Replenishment" could be
displayed in the control menu. This issue has been resolved.
14 There was a possibility that what had been entered could not be displayed in the input field in the
Reagent Replenishment screen. This issue has been resolved.
15 When querying the host, analysis is performed with an unintended combination of analysis mode,
discrete tests and analysis parameters. This issue has been resolved.
16 Reagent code entry screen was incorrectly displayed. This issue has now been resolved.
17 When communicating with the host computer, there was a possibility that error messages could not
be displayed even if errors occurred. This issue has been resolved.
18 If "Ejection table is full" error occurred while the instrument was entered in Service Mode and "Error
Ignore" settings were selected, errors could not be cleared. This issue has now been resolved.
19 If a new user is set as Auto Logon user immediately after the user was added in IPU Setting, settings
could not be printed properly. This issue has been resolved.
20 Previously, when "Body fluid" analysis data was output in CSV format, data for "PLT" and "WBC" were
output even though PLT and WBC parameters were not analyzed. This issue has been resolved.
21 The reagent lot information for analysis results differed from that for the discreet test performed. This
22 Images on the IPU screen were distorted on rare occasions. This issue has now been resolved.
23 Previously, when the mode switch (the switch to open/close Tube holder) was pressed immediately
after the pneumatic unit had stopped, it could take more than 10 seconds for the mechanical section
to start. A change has been made so that the mechanical section will start immediately after the mode
switch is pressed.
24 Previously, in cases where multiple units are connected and two instruments shut down at the same
time when the IPU Shutdown setting was set to OFF, on rare occasions, the Restart icon was not
displayed, making it impossible to restart the analyzers. This issue has now been resolved.
25 Previously, when comparing records on the IPU program, upper-case letters and lower-case letters
were differentiated. A correction has been made not to differentiate upper-case letters and lower-case
letters.
26 Previously, when L-J Control was executed using sampler analysis when on twin model, the recorded
date for QC analysis results could be incorrect. This issue has now been resolved.
27 Previously, when Alt and F4 keys are pressed at the same time when displaying the Analyzer menu,
the screen was closed. This issue has now been resolved.
28 Previously, there was a possibility that the Rule could be changed without verifying the action by the
IPU program. This issue has now been resolved.
29 Previously, a blank measurement could be performed even if reagent had run out. This issue has now
been resolved.
30 The OK button was not enabled in the manual analysis screen even if a sample number had already
been entered when an error occurred, on rare occasions. This issue has now been resolved.
31 If reagent is shared with multiple analyzers, there was a possibility that unintended reagent
replenishment could be carried out. This issue has now been resolved.
32 Previously, in sampler analysis, sample tubes were transferred to the analyzer waiting to be restarted.
33 There was a problem that the selection button disappeared when the up/down scroll bar buttons were
clicked. The problem has now been fixed.
34 Previously, the expiry date for reagent was not displayed depending on the date format. This issue
35 Previously, on rare occasions, all buttons remained disabled in the sampler position adjustment
screen and it was not possible to close the screen. This issue has now been resolved.
36 Previously, positive ID check error occurred when L-J sampler analysis was performed with QC file
number on twin model. This issue has now been resolved.
37 Previously, the sampler number became "1" when an analyzer BR test is performed in the sampler
mode. A correction has been made to display the correct sample number.
38 Previously, when an order was modified in the Register Order dialog box of the Work List screen with
the "Rack unit registration" box ticked off, changes made in the dialog box were not registered
correctly. This issue has now been resolved.
39 Previously, on rare occasions, an analyzer locked up when it was returning from a 12 hour sleep
status. This issue has now been resolved.
40 Previously, when replacing CELLPACK DST for RU-20, if the barcode of reagent other than
CELLPACK DST was read, the IPU unexpectedly quit. This issue has now been resolved.
41 Previously, Order Type for performing analysis using micro collection tubes was "Manual". This has
been changed from "Manual" to "Manual (Open)".
42 Previously, errors displayed in the Repeat Rule screen in accordance with RET and PLT-F licenses
were incorrect. (RET related errors were displayed on the instrument without RET license.) This issue
43 Previously, on rare occasions, RFID tag errors occurred with unexpected timing. This issue has now
been resolved.
44 In an SNCS start-up report, the time that pressure reaches the specified value was always output as
"0". A correction has been made to output the accurate time.
45 Previously, a sample number could not be entered when a hand-held barcode reader was used on
rare occasions. This issue has now been resolved.
46 In WAM IF, output texts were different from the specifications. This issue has now been resolved.
47 In Greek language, the system language node for SNCS model information output file was incorrectly
output as "POR". This has now been changed to "GRE".
48 Previously, when erroneous patient information was received in ASTM format, it was used as the
patient information. This issue has now been resolved.
49 Previously, in the IPU screen, the dilution mode was erroneously described as "Dilution". The word
"Dilution" has all been changed to "Pre-Dilution".
50 Previously, when a dye ran out during the initial rinsing and was replaced subsequently, the analyzer
locked up when the initial rinsing completed. This issue has now been resolved.
51 Previously, when Ward Name and Doctor Name combo boxes were de-selected in any of the dialog
boxes below, combo boxes could not be changed by keyboard operations. This issue has now been
resolved.
* Register Patient Information dialog box
* Modify Patient Information dialog box
* Register Order dialog box
* Modify Order dialog box
52 Previously, when "Environment temperature is high" error occurred while the analyzer was operating
and the error could not be cleared even after the temperature reached the specified temperature. This
53 Previously, on rare occasions, analysis was skipped unexpectedly during sampler analysis in
Operation Mode B. This issue has now been resolved.
54 Previously, when IPU.exe was started while the IPU was running, the same IPU program was started
simultaneously (two IPU programs running). As a result, communication with the analyzer was
disconnected. This issue has now been resolved.
55 Previously, when querying the host computer in ASTM format, if the host computer replied "no patient
comment" and "sample comment exists", the sample comment was used as "patient comment". This
56 Previously, although text received from the host computer did not meet specifications (such as two
byte characters); the IPU used the data from the message. This issue has now been resolved.
57 Previously, when analysis data was output in ASTM format, on rare occasions, rule numbers and rule
name were not output even though they fell under Rerun/Reflex Rule. This issue has now been
resolved.
58 Previously, the layout of the browser screen could not be changed even by a user who has the
authority to modify settings. This issue has now been resolved.
59 Previously, when outputting log files in SNCS, files with extensions "seq", "sns", "bar", "mmb" could
not be overwritten. This issue has now been resolved.
60 Previously, there was a possibility that parameters were blank in the Analyzer Sensor Display dialog
box when Analyzer Sensor Display is opened while the analyzer is running. This issue has now been
resolved.
61 Previously, when querying an order using the compatible format of existing models (XE-5000, XE-
2100, XT-4000i, XT-2000i), patient comment was not registered correctly. This issue has now been
resolved.
62 Previously, when "Download" button is clicked in the Work List screen and text with blank patient ID is
received, a data base error message was displayed. This issue has now been resolved.
63 Previously, when querying an order using the compatible format of an existing model, the text sent
was not correct according to the communication specifications because the text length exceeded the
compatible format of the existing model. This issue has now been resolved.
64 Previously, when querying an order using the compatible format of an existing model, analysis of
WPCch and PLT-Fch was performed even though no order was given to perform analysis of these
channels. This issue has now been resolved.
65 When performing sampler analysis with XN-9000, there was a possibility that analysis could be
skipped regardless of the sample type or order. This issue has now been resolved.
66 Samples with discrimination error values are displayed on the IPU. However, masked data could be
output to the host computer. A correction has been made so that data on the IPU will be output to the
host computer.
Remarks
None
ECR: 311E068
XN-1000 SUPPLY PARTS (US) S/N: September 1, 2011

(Sampler Sequence): Ver.00-06

1 Calendar Control is now supported using a touch panel.
2 "NRBC-X" and "NRBC-Y" have been added to the browser screen service tabs.
3 Algorithm for WDF channel NEUT/EO discretion has been improved. (Exclude for American Markets)

1 If a "Hand Up/Down Error" occurred while switching modes, an application error occurred. This has
been resolved.
2 In WDF (EXT) screen, color of SFL particles was same as ghost (blue) even though it must be WDF-
BF color when XN CHECK BF was analyzed. This has been resolved.
3 Leakage occurred from a drain chamber while performing setting sequence. This has been resolved.
Remarks
None
ECR: 311E067
DVD1XN1X Ver.00-05 Upgrade Procedure Upgrade Procedure (NA)
XN-1000 SUPPLY PARTS (US) S/N: August 8, 2011


1 Reagent replacement function for Argentina has been added.
2 XN-3000 has been added to SystemConfig tool.
3 Conforms to PeteLite.
4 Zero padding/zero suppress function has been added when reading barcode label.
5 Inverse rotation function for barcode reading (Retrying barcode reading with inverse rotation on
barcode read error.) has been added. (This function can be set by service setting.)
6 Nicknames for XN-9000 analyzers have been set as "XN-9000-1", "XN-9000-2", "XN-9000-3" from
the right to left order.
7 Text in screens for Italian and Portuguese have been revised.
8 Open mode is now set as default mode when switching to BF mode. (Non-open mode is the default
mode when switching to Whole blood mode or Low WBC mode.)
9 Required sample volume is now displayed on manual analysis screen for BF mode.
10 "uL" has been added to WBC-BF unit setting.
11 The plot data of X-BarM is now included in the SNCS output.
12 The error reports are no longer output to SNCS when logging on with Sysmex user.
13 Preparation process is now performed when switching from non-PD mode to PD mode.
14 Initial focus (initial mouse pointer position) in now positioned out of edit box.
15 All characters in the edit box are now selected when edit box for numbers are selected when using
software keyboard.
16 Shortcut key assigns which are not supported by IPU program (Ctrl+W, Ctrl+Alt+ arrow key,
Ctrl*shift+B, Ctrl+Shift+C) are now invalid.
17 Some screen designs (scroll bar, radio button, check box or tab) have been changed.
18 All targets/limits are now loaded regardless of analyzer type when reading QC assay value.
19 Backup and restore of patient information can now be performed after shutting down the analyzer.
20 Encodes and languages on CSV output are now followed by OS locale.
21 Supply related error messages for Reservoir Tank have been deleted.
22 WPC related error messages (WPC sampling error, WPC channel error) that appear on Repeat rule
screen are now displayed under the RET and PLT-F related error messages.
23 Particles in SSC-FL and SSC-FSC areas on WPC channel scattergram are now displayed in red
color.
24 Ghost discrimination algorithm for PLT-F channel has been changed. (excludes North American
markets)
25 In order to improve barcode reading performance, number of matching scans on barcode read has
been changed to two times.
26 Some parts of the "PLT Clumps?" rule have been changed. (excludes North American markets)
27 Condition of PLT channel error has been changed.

1 Previously, time for displaying QC file screen could become extremely long when QC file numbers
became high. This has been resolved.
2 Some characters of SD values were cut on BF mode QC chart, when the SD values of WBC-BF,
PWN# and MN# exceed 7 digits.
3 Masked results could be printed out with "+++++" or "-----" when the masked result was 5 digits.
4 The order of filter dialog in Explorer screen was not matched with XE/XT/XS. This has been resolved.
5 Previously, filter condition was displayed as "Filter: all" on RU history screen even when only one RU
was connected. Filter condition is no longer displayed on RU history screen when only one RU is
connected.
6 Previously, screen keyboard did not disappear when focus (mouse pointer) was out of edit control.
7 Previously, research parameter in additional discrete was not analyzed on Reflex analysis. All
parameters with order in additional discrete will now be analyzed.
8 Previously, PLT-I was analyzed in BF mode. PLT-I is no longer analyzed in BF mode.
9 Previously, RBC(FSC) graphic data was output on CSV output even though the RET discrete analysis
was not performed. RBC(FSC) graphic data is now output when RET discrete analysis was
performed.
10 Previously, changing for DP setting was not reflected until changing print format or restarting IPU
program. Program has been changed to reflect the change of DP setting immediately.
11 Previously, the analyzer locked up when resuming from sleep status while displaying manual analysis
screen. This has been resolved.
12 Previously, error parameter in error log became blank when an error occurred while analysis was
processing. This has been resolved.
13 Previously, Fluorocell PLT was not displayed on reagent tab in Explorer. This has been resolved.
14 Previously, the analyzer status of lighting or blinking on IPU could be changed depending on the
sampler status. This has been resolved.
15 Previously, reagent lot number on reagent replacement screen was left aligned. This has been
resolved.
16 Previously, "Check Analysis Mode" could be displayed on QC analysis even though analysis mode
was correct. This has been resolved.
17 Previously, when all Fluorocell reagents are expired and analysis was performed logging on with
sysmex user, "Service Mode Setting" screen did not appear. This has been resolved.
18 Previously, blank grids were displayed in the data display area which were not applicable parameters
on Calibrator Calibration, Precision Check screens. Blanks are now displayed in the Calibrator
Calibration, Precision Check screens for the parameters which are not targeted.
19 Previously, the order of sampler IDs in Sequence Program Version was "Left instrument" > "Right
Instrument" > "Center Instrument". They are now displayed as "Left Instrument" > "Center Instrument"
> "Right Instrument."
20 The analyzer locked up when barcode read test was performed while starting up process of the
analyzer was suspended due to running out of a reagent. This has been resolved.
21 Previously, the CSV format was not output on Work List when the cursor was off the screen. This has
been resolved.
22 Previously, on GP customize function, FieldID list was not updated or width/height value became "0"
for the fix objects. This has been resolved.
23 Previously, values after the decimal point for the reagent volume were omitted when reading reagent
barcode label for reagent replacement. Reagent volume information is now correctly registered when
reading reagent barcode label.
24 Previously, analyzer menu screen was erroneously closed when "Alt + F4" was pressed. The key
input of "Alt +F4" is now rejected on analyzer menu screen.
25 Previously, the analyzer locked up when manual analysis was started after performing barcode read
test twice. This has been resolved.
26 Previously, the order of the error messages on Browser screen and what GP printed out were
different. This has been resolved.
27 Previously, the IPU locked up when printing setting values without installing printer driver. This has
been resolved.
28 The problem of settings for "Display and output for Research parameters" not being printed has been
resolved.
29 The problem of parameters for PLT-F-RBC-X not being displayed correctly has been resolved.
30 Previously, service settings were erroneously set as "0: Check, 1: Do Not Check" for "Check order key
matching" and "0: Suppress Zeros, 1: Do Not Suppress Zeros" for "Suppress zeros in sample
numbers". The settings are now corrected as "0: Do Not Check, 1: Check" for "Check order key
matching" and "0: Do Not Suppress Zeros, 1: Suppress Zeros" for "Suppress zeros in sample
numbers".
31 Previously, the analyzer locked up while re-starting the analyzer just when closing the Slider Assy No.
9 after shutting down. This has been resolved.
32 The problem of sample being aspirated even though the sample was ordered not to aspirate has been
resolved.
33 The problem of rack collecting on conveyor coming late when the sample was ordered to not aspirate
for Rerun/Reflex analysis on XN-9000 has been resolved.
34 Previously, remaining volume was displayed at maximum volume box when replacing used but
remaining reagent. Indicated volume on the reagent package is now displayed at maximum volume
box.
35 The problem that reagent information was not updated when replacing reagents with un-authorized
supplier's reagent has been resolved.
36 The problem that the overwrite confirmation dialog was hidden when other screen was clicked while
CSV was outputting has been resolved.
37 The problem that the hard copy could not perform has been fixed.
38 Previously, the default rule of A1 instrument included action of Reflex (RET) record. The action of
Reflex (RET) record has been removed from the default rule of A1 instrument.
Remarks
None
ECR: 311E066
DVD1XN1X Ver.00-04
S/N: Not fixed yet.


Remarks
This is the initial version released to the markets.

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DVD1XN1X Ver.22.

<FDS File Name>

Barcode reader setting (1) Barcode reader setting (2)

Sequence Program Version

<FDS File Name>

Resolved Program issues

Sequence Program Version

<FDS File Name>

Resolved Program issues

Sequence Program Version

<Part No./Name> Module Version

Resolved Program issues

<Part No./Name> Module Version

Ver.22.15-00 and before Ver.22.16-00

Resolved Program issues

1 The classification algorithm of AS-LYMPH has been improved.

Position of AS-LYMPH cluster

<Part No./Name> Module Version

Before change After change

Resolved Program issues

Measurement Mode Item and unit name

<Part No./Name> Module Version

(4) Quality control for BB mode can now be performed.

Resolved Program issues

<Part No./Name> Module Version

Setting name Setting value Default value

Resolved Program issues

PLT related parameters

Examples of abnormal PLT scattergram

<Part No./Name> Module Version

Resolved Program issues

Same contents as DVD1XN1X Ver.22.12-00.

<Part No./Name> Module Version

Resolved Program issues

<Part No./Name> Module Version

Setting name Setting value Default value

Setting name Setting value Default value

6 The configuration including CV-55 can now be selected in “ConfigTool”.

Setting name Setting value Default value

Affected PLT parameters

8 The “Blast/AbnLympho?” flagging specificity has been improved.

Resolved Program issues

<Part No./Name> Module Version

Resolved Program issues

<Part No./Name> Module Version

Resolved Program issues

<Part No./Name> Module Version

Resolved Program issues

Setting name Setting value Default value

“Use ‘Confirm eosinophil’ action message” setting screen

Setting name Setting value Default value

“Register Rerun/Reflex/Comment Rule” screen

<Part No./Name> Module Version

Setting name Setting value Default value

“Query to host wait time” setting screen

“Query host computer for Rerun/Reflex analysis” setting screen

Rule screen when the setting value is “0”

“Initialize” screen when the setting value is “0”

Rule screen when the setting value is “1” or “2”

“Initialize” screen when the setting value is “1” or “2”

“Regist Order” screen when the setting value is “1” or “2”

“Register Rerun/Reflex/Comment Rule” screen when the setting value is “2”

Setting name Setting value Default value

Setting name Setting value Default value