DVD1XNVX Version History E

Version History
XN-V Series Program DVD1XNVX

DVD1XNVX: Ver.3.07-00 Upgrade Procedure
<Applicable S/N> <Release Date>
Refer to ECR 321G059 October 2021
<Part No./Name>
BF860669: CDR_ASSY NO.315(DVD1XNVX)
<FDS File Name>

P_XNVSWSTAL_00120001.cab (Including installer)
P_XNVSWSTAL_00120000.cab (VHD file only)
Changed Specifications
1 A new animal species "(022) BoneMarrow" has been added.
2 The logon name at the time of measurement can be confirmed from the measurement result.
3 In the measurement of camel blood, the setting range of PLT CAL in the animal species setting has
been changed to 0.0 ~ 999.9.
When measuring camel blood platelets with RBC/PLTch, normal calibration alone was not sufficient to
measure them correctly, and it was necessary to multiply them by a special factor in the animal
species setting, and an upper limit of 150 was insufficient.
The setting range has been changed to address this issue.
“Service Species CAL” will be displayed in “Animal Species Setting” -> “Service”, if “Service Setting” -
> “IPU settings” -> “Miscellaneous” -> “Enable Species PLTI_CAL” is set to “1: Enable” and IPU is
restarted.
4 Specification changes from XN-Series Ver.22.16-00 have been applied.

(1) “Sensitivity adjustment of the PLT-F channel in QC analysis” has been added to the service settings.
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)
(1) The analysis mode has been changed to allow precision check measurements.
With this change, the convenience in installation and calibration certification procedures are
enhanced.
XN-V Series (E) S/M

Version History
Resolved issues
1 When samples of dogs and cats were measured, the fluorescence intensity of WBC tended to be
higher than the measurement of human blood, and NRBC and WBC were not fractionated correctly.
To resolve this issue, analysis algorithms for WNRch has been changed.
2 When the instrument was shut down without measuring sample after exchanging stain solution, the
expiration date of reagent was not displayed correctly.This problem has been resolved.
Remarks
Module Version
IPU 00-12
Device Control Manager 00-12
Analysis 00-12
Analyzer Sequencer 00-12
Sampler Sequencer 00-12
Analyzer 03-61
Sampler 00-16
ECR: 321G059
XN-V Series (E) S/M

Version History
<Applicable S/N>
Refer to ECR 320C010
<Release Date>
<Part No./Name> February 2021
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.3.06-00, downgrading to previous versions cannot
be performed.
(2) On Windows7, VisualStudio2017 is installed. However, SQL Server 2016 is
not installed.

(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.
XN-V Series (E) S/M

Version History
(1) 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.
(2) 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.
Resolved issues
1 The problem that "0" is output to the measurement data when the measurement item without the
order is printed in GP has been resolved. (When a measurement item with no order is printed in GP,
"Blank" is output to the measurement data.)
2 Resolutions on program issues from XN-Series Ver.22.12-00 have been applied.

(1) 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.
(2) 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

(1) 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
(2) 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.
(3) When starting the IPU program, mounting VHD could fail and “MountError” would occur. This issue
has been resolved.
(4) 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.
XN-V Series (E) S/M

Version History
(5) 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.
(6) 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.
(7) 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.

(1) 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.
(2) 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.
(3) In APD Parameter Setting menu, service engineers could not input voltage value as they intended.
This issue has been resolved.
Remarks
Module Version
IPU 00-11
Analysis 00-11
Analyzer Sequencer 00-11
Sampler Sequencer 00-11
Analyzer 03-61
Sampler 00-16
ECR: 320C010
XN-V Series (E) S/M

Version History
<Applicable S/N>
XN-V series (XN-1000)S/N: Not fixed
<Release Date>
<Part No./Name> March 2020
1 A new animal species "(021) Bird" has been added.
Note:
(1) Measurements for “(021) Bird” can be performed only on analyzers with the “PLT-
F” license.
(2) Measurements for “(021) Bird” can only be performed in WB mode.
The measurement channels and parameters are shown in the table below:
Measurement channels Calculated measurement parameters

PLT-F ch WBC-F, RBC-F, PLT-F, H-RBC
RBC ch RBC-I, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV
PLT ch None. Not used.
WNR ch None. Only used for manual analysis (extended).
WDF ch None. Only used for manual analysis (extended).
RET ch RBC-O
* RBC = RBC-F, WBC = WBC-F, PLT = PLT-F

* RBC ch is totaling of RBC, WBC, and PLT.

(1) 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.
The following errors are included in 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
XN-V Series (E) S/M

Version History
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
(2) The configuration including CV-55 can now be selected in “ConfigTool”.

(3) A service setting has been added to select whether or not the low reliability mark is output for
“Giant Platelet?”. * For (000)Other only
Setting name Setting value Default value

Mark of analysis result in case of 0: Do Not Mark 1: Mark (In case of
“Giant Platelet?” 1: Mark 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
XN-V Series (E) S/M

Version History
(4) “Blast/AbnLympho?” flagging specificity has been improved. * For (000)Other only
(5) Q-flagging judgment value calculations have been improved for “Blast?”, “AbnLympho?”, and
“Blast/AbnLympho?” * For (000)Other only
(6) In addition to Windows 10, McAfee Ver.7 (SECURITY MASTER (3) COMPLETE) can now be used
on Windows 7.
Resolved issues
1 If manual gate on the PLTch was not used, PLTI_CAL worked correctly. However, in case where
analysis with manual gate was performed on PLTch, PLTI_CAL did not work correctly. This issue has
been resolved.

(1) In the XN-1500 configuration, if the following steps were performed, SA-21 could not be used. This
issue has been resolved.
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 an error “Mounter.exe termination” 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) 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.
(5) On WNRch, WBC could erroneously be differentiated as NRBC. This issue has been resolved.
* For (000)Other only
(6) BASO result measured on WDFch is now adopted if BASO result measured on WNRch is found
abnormal.
(7) The sum of WBC was not 100% in some specific cases. This issue has been resolved.

(1) In XN-1500 configuration, if sampler analysis was performed after correcting “Sampler Analysis
Stop 3” errors such as a rack move error, a sample tube was not returned to the sample rack. This
issue has been resolved.
(2) “Low count error” and “PLT sampling error” can now be output correctly.
(3) The classification function for WNR ch has been improved for low RBC.
(4) When replacing reagents, instrument status could not become “Ready” if the mode was switched
between registering new reagents and executing replacement. This issue has been resolved.
XN-V Series (E) S/M

Version History
(5) When Hypo-He became high, a falsely low could occur in rare cases. This issue has been
resolved.
(6) 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
Remarks
Module Version
IPU 00-10
Analysis Module 00-10
Analysis Sequencer Module 00-10
Sampler Sequence 00-10
Analyzer 03-61
Sampler 00-16
ECR:320A022
XN-V Series (E) S/M

Version History

<Applicable S/N>
<Release Date>
<Part No./Name> January 2019
1 Added service setting which calibrates PLT-I for each animal species.
Enable Species PLTI_CAL [0: Disable, 1: Enable]
Factory default setting: [0]
“Service Species CAL” will be displayed in “Species Setting” if “Enable Species PLTI_CAL” is set to
“1: Enable” and IPU is restarted.
2 Added service setting to select Mono calibration mode in two steps for the facility which requires
analysis result of Mono to match with visual inspection.
Select Analysis Mode [0: Mode1, 1: Mode2]
Factory default setting: [0]
A decrease in Mono will result in higher Lymph.

Mode1: “Enable Species MONO_CAL” is applied.
Mode2: “Enable Species MONO_CAL” is applied after following fixed CAL is applied.
(002)Rat: 50.0%,(003)Dog: 60.0%,(004)NHP: 70.0%
* “Enable Species MONO_CAL” had been added by Ver.3.03-00.
3 Applied specification changes from XN-series Ver.22.04-00

(1) Changed name for infectious disease flag from “pRBC” to “iRBC”.
(2) Enabled “WRP CHECK EX”.
(3) Prevented rack from not being ejected due to deadlock during occurrence of error in XN-9100 new
transportation mode.
(4) Changed to write remaining test number on RFID even when the analyzer is on emergency stop.
(5) Enhanced function of RFID tag remaining test number.

(1) It now supports Windows10 OS.
XN-V Series (E) S/M

Version History

(1) Added “Query to host wait time” and “Query host computer for Rerun/Reflex analysis” to XN-1500/
XN-3100(standalone) service setting.
(2) Added service setting to skip samples for which parameter that cannot be measured were
ordered, and transport the sample to other analysis module in the XN-9100 configuration without
BT.
(3) Added “Send reagent info” service setting to send reagent information used for measurement to
host computer.
(4) Changed version description displayed on version information screen.
(5) Changed error message corresponding to WRP CHECK EX which became usable from
Ver.22.04-00.
Resolved issues
1 Corrected issue where buttons for switching displayed sample (Up and Down buttons) will not be
shown when the screen key board is turned ON and manual analysis screen is displayed.
2 Corrected issue where “DeviceContorolManager.exe has stopped working” error message is

displayed and IPU abnormally terminates if samples of animal species other than mammals are
measured by the species mode except for “(020) Dolphin” or “(000) Other”.
3 Corrected issue where SFL(X) histogram shifts to the right when SFL(X) Gain magnification is
measured by [x2], [x4].
4 Corrected issue where IPU abnormally terminates during measurement in following cases.
(1) When measurement is performed under high DB load condition such as XN-9100 configuration.
(2) When multiple measurement results are selected within the explorer in Ver.3.03-00.
5 Corrected issue where analysis module abnormally terminates when analysis module without RET
license is measured using Low Aspiration (LA) mode.
XN-V Series (E) S/M

Version History
6 6 Analysis algorithms for WDFch and RETch have been changed as improvement for classification.
(1) Measure for Dog Neut fake low value, Lymph fake high value
Was Is
(2) Measure for Cat Eo fake high value, Neut fake low value
Was Is
(3) Measure for Cat Mono fake high value, Lymph fake low value
Was Is
(4) Measure for Mouse Neut fake high value, Lymph fake low value
Was Is
XN-V Series (E) S/M

Version History
(5) Measure for RET fake high value
Was Is
7 Corrected issue where species setting backed up in Ver.3.01-00 cannot be restored to Ver.3.03-00
properly.
8 Applied resolved program issues from XN-series Ver.22.04-00

(1) Improved the neutrophil/ eosinophil fractionation algorithm for abnormal eosinophil patterns (only
applied to animal species (000) Other).
(2) Corrected issue where measurements are not performed as specified in the order.

(1) Corrected issue where there were cases which DeviceControlManager.exe stops its operation
during measurement, and measurement cannot be performed.
(2) Corrected issue where there were cases which sampler measurement stops after aspiration of
10th sample during sampler measurement, and analyzer has to be restarted.
(3) Corrected issue where there was possibility that analysis module abnormally terminates if rinsing
is performed by switching the mode after body fluid measurement.
(4) Added low reliability mark which was missing to the PLT related item of the sample whose IP
message “Giant Platelet?” is determined to be positive (only applied to animal species (000)
Other).

(1) Changed the Neut (neutrophil)/ Eo (eosinophil) fractionation algorithm for abnormal eosinophil
pattern in whole blood mode. For this reason, action messages and service settings to notify
eosinophil pseudo low value and the possibility of eosinophil abnormality have been added.
(2) Changed recovery process for the case which program missed to write to RFID and
“FLUOROCELL RFID tag error” occurs, and added retry function.

(1) Corrected issue where the device driver of Ver.22.07 will not be updated and RFID tag measure
implemented in Ver.22.07 could not be applied unless the USB cable is unplugged and plugged
again.
(2) Added PDF viewer to the white list during version upgrade.
(3) Corrected issue in the rule function where “Retest: PLT” also judged to be true when “Retest: Eo”
was judged true, and the set action was executed accordingly (only applied to animal species
(000) Other).
XN-V Series (E) S/M

Version History
Remarks
Module Version
IPU 00-09
Analyzer 03-61
Sampler 00-16
ECR:318F055
XN-V Series (E) S/M

Version History
<Applicable S/N>
<Release Date>
<Part No./Name> May 2018
BF860669: CDR_ASSY NO.315(DVD1XNVX(00-08))
1 Ferret, *Sheep, *Goat, and Hamster have been added in Analyzable animal species.
With this change, Chapter 1 (section 1.10.2), which was the list for animal species that are not
installed, has been excluded.
*For Sheep and Goat, PLT-I, MPV, PCT, P-LCR and PDW are not analyzed.
In addition, the following Error, IP, or Action Messages are not determined.
[Error Message]
RET channel error
[IP Message]
PLT Abnormal Distribution
RET Abnormal Scattergarm
[Action Messages]
PLT channels difference exists
2 MONO_CAL setting for each animal species (service setting) has been added.
3 XN-V series Instructions for Use (IFU) manuals have been updated.
Resolved issues
None
Remarks
Module Version
IPU 00-08
Analyzer 02-60
Sampler 00-16
ECR:317L029
XN-V Series (E) S/M

Version History
<Applicable S/N>
<Release Date>
<Part No./Name> December 2017
1 The number of mixing at the time of sampler analysis using the RBT sample tube for IDEXX has been
changed to 10 times.
In order to make the throughput of the sampler analysis using the IDEXX RBT sample tube the same
as that in the case of the normal rack, service setting for the number of mixing at the time of sampler
analysis of IDEXX RBT sample tube has been added. (Set the initial value as 10 times.) * For details,
refer to Service Manual Chapter 5 Service Program.
2 Analysis settings for IDEXX have been optimized for the data obtained by IDEXX.
As a result of the evaluation using the CELLPACK for IDEXX, it was found that it was necessary to
change the analysis settings below, so the analysis settings for IDEXX were optimized for the data
obtained by IDEXX.
[Target algorithm]
- WDF analysis algorithm: (007) Horse
- RET analysis algorithm: (006) Cat
(1) WDF analysis algorithm: (007) Horse

On WDF analysis algorithm for base animal species (007) Horse in settings for IDEXX, the Neut/
Lymph differentiation has been changed to prevent Neut/Lymph error differentiation.
(Refer to the figure below.)
(Example of error differentiation) (Example after improvement)
(2) RET analysis algorithm: (006) Cat

Service setting of RET analysis for cats for IDEXX has been added.
* When using with IDEXX, make sure this setting is enabled. For details, refer to Service Manual
Chapter 5 Service Program.
Setting Default
Setting name Description
range setting
Enable RET Set whether RET analysis of Cat for 0 to1 0 (Disable)
analysis of Cat IDEXX enable. Restart the IPU program
for IDEXX after changing this setting. [0: Disable,
1: Enable]
XN-V Series (E) S/M

Version History
3 Dolphin can now be analyzed.
"(020) Dolphin" has been added to the analyzable animal species and Base animal species.
4 Marmosets can now be analyzed.

"(014) Marmoset" has been added to the analyzable animal species and Base animal species.
5 Camel analysis algorithm has been optimized.

The analysis algorithm for "(017) Camel" has been optimized for the evaluation result in Dubai.
6 "Base animal species" has been added to Explorer displayable item (initial setting: Hide).
* It can be set on the layout change in the explorer menu.
7 The time series tab is now displayed on the browser screen.
8 Normal range display option has been deleted in scattergram.
9 WBC, PLT priority settings can now be changed for all animal species.
Initial value should be PLT-F > PLT-O > PLT-I.
10 In manual analysis and manual analysis (extension), the particle color in the RBC area of PLT-Fch
has been changed to "blue".
11 Usability of manual analysis has been improved.

Buttons that move the next sample have been added in manual analysis dialog screen so that gates
can be created while confirming multiple samples in manual analysis and manual analysis
(extension).
12 "Reanalysis date" and "Reanalysis time" have been added to the sort condition on the explorer
screen.
XN-V Series (E) S/M

Version History
[Horizontal deployment of XN-series Ver.22.00-00]
13 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”.
14 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.

15 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
16 The performance of blood aspiration sensor has been improved.

To support market requests to increase the aspiration sensor stability, the calibration of blood
aspiration 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)
17 Contents of files sent via SNCS have been changed.
18 When lymphocyte is incorrectly discriminated as monocyte, lymphocyte shows falsely low value. To
resolve this issue, discrimination algorithm has been improved.
(Applied only to analysis algorithm of animal species (000) Other)
19 WDFch LYMP/MONO replacement prevention algorithm has been added to the XN-V series.
XN-V Series (E) S/M

Version History
20 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")
21 When neutrophilic cells are incorrectly discriminated as eosinocyte, eosinocyte shows falsely high
value. To resolve this issue, discrimination algorithm has been improved.
22 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.

22 The monitoring method for “Abnormal pressure loss” has been changed.
(During startup of pneumatic unit, “Abnormal pressure loss” error is monitored.)
23 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.
24 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.
25 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)
26 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.
XN-V Series (E) S/M

Version History
Resolved issues
1 Occurrence of WBC Abnormal Scattergram due to falsely high values of the Neut/Eo particle
discrimination has been resolved for the animal species performing Neut/Eo differentiation in the
WDF (SSC-FSC) channel.
2 CSV setting may fail to be backed up properly in the IPU setting backup file. This has been resolved.
In the CSV item setting, reagents not used in the system configuration are displayed as "blank
(nothing displayed)". (Example: "CELLPACK DFL", "Fluorocell RET" in the configuration without RET
license)
When backing up the setting with one of these items being "Output" and the other being "Do not
output", the problem that the reagents not used in the system configuration are backed up as "Output"
was found.

3 On XN-1000 SA-01 model, lockup when skipping sample aspiration has been resolved.
4 Lockup when suspending measurement while waiting for analysis order has been resolved.
5 Lockup when recovering from sleep mode has been resolved.
6 Lockup when detecting a Micro tube while reagent is depleted during manual measurement has been
resolved.
7 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.
8 “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.

9 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.
10 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.
XN-V Series (E) S/M

Version History
11 Countermeasures for false high WBC (-N) count have been made. (Applied only to analysis algorithm
of animal species (000) Other)
Symptom: WBC related parameters result became high.
Cause: Not specified
Countermeasures:
“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].
A service setting to set the threshold of “Detection of the falsely high WBC-N” algorithm is added.
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
Remarks
Module Version
IPU 00-07
Analyzer 02-60
Sampler 00-16
ECR:317L020
XN-V Series (E) S/M

Version History
<Applicable S/N>
<Release Date>
<Part No./Name> July 2017
None
Resolved issues
1 Countermeasure has been made for incorrect scattergram coloring when doing GP Print.
This phenomenon is only seen in GP printing. Measured values and scattergrams displayed on IPU
monitor are not affected.
[Sample of the defect]
(IPU monitor)
(GP Printing)
Remarks
Module Version
IPU 00-06
Analyzer 02-59
Sampler 00-16
ECR:317G027
XN-V Series (E) S/M

Version History
<Applicable S/N>
<Release Date>
<Part No./Name> June 2016
AB833655: CDR_ASSY NO.271(DVD1XNVX(00-04))
<XN-V related>
1 XN-V now supports system configuration of XN-1500, XN-3100 and XN-9100. (Only for SP-50)
2 XN-V now supports species camel.
3 XN-V now supports SNCS. (Output files, data and timing for SNCS are same as ones for XN Ver.
22.01-00.)
4 License option for RET, PLT-F and BF have been added. (License option screen has been added with
this program version. It appears when the program version 3.00-00 is installed or upgraded from
previous version. Therefore, when these parameters are used, the license information must be
entered. Refer to “XN-V_ver.3.00-00_upgrade_proce.pdf” for detail.)
5 Following exclusive feature for IDEXX have been added.
(1)Scattergram color can now be changed by service setting "Enable IDEXX
function1"
(2)Analysis algorithm for CELLPACK (EPK) for IDEXX can now be selected by
service setting "Enable IDEXX function2"
(3)Using IDEXX test tube analysis function can now be changed by service set-
ting "Enable IDEXX function3"
6 Analysis algorithm for pre-diluted mode has been changed to improve relativity with whole blood
mode.
7 Classification performance of analysis algorithm for whole blood mode has been improved.
8 Channel analysis including manual analysis has been improved as follows.
Result (except unable to be calculated) data will not be masked. ("----") When channel analysis
including manual analysis is performed, MONO_B_CAL calibrate will not performed.
9 Manual analysis gate for manual analysis screen and manual analysis screen (extended) except BF
mode can now be generated on RET, RET (EXT) and PLT-O scattergram.
10 LP print setting is now available on IPU setting by adding List Printer (LP) print format.
11 PLT-O setting for QC parameter has been added to service setting by displaying PLT-O or not
displaying.
12 Q-Flag settings for PLT Clumps? (WNR), PLT Clumps?(WDF), PLT Clumps?(PLT-F) by the species
has been added to service setting.
<Extended from XN-series>

1 XN-V now supports XN-9100 (CV-55).
2 "Error code", "parameter 1" and "parameter 2" can now be displayed on IPU RU error history and can
also be output to SNCS.
3 Following data has been added for SNCS.
- Outputting service data and target limits on QC
- Outputting analyzed data for calibration
- Outputting NVRAM data
XN-V Series (E) S/M

Version History
4 Some parameters are added or changed from research parameters to reportable parameters for EU
markets.
5 Result with barcode read error can now be performed by Auto Validate. The setting can now be
changed for "Output" or "Do not output" in Service Setting. (Initial value) "Do not output" (Service
manual Page 5-60)
6 Mark for outside of linearity on 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
7 Exponential and logarithm formulas have been added to rule function.
8 Generating and outputting of scattergram for HPC in HPC mode is now available. Showing or not
showing of scattergram for other than HPC is now available. (HPC mode is not applied on XN-V)
(This is applied for only species (000) others algorithm.
9 Calculation of grade value for "Atypical Lympho?" has been added. For EU market only) (This is
applied for only species (000) others algorithm.
10 Infection parameters have been masked, when IP message "Blast/Abn.Lympho?" and "Blast?"
appear. (For EU market only)(This is applied for only species (000) others algorithm.
11 Action message "Suspect Sample?" can now be turned off on manual mode by service setting.
Service Setting can be changed with "Used" or "Not Used". (This is applied for only species (000)
others algorithm.
12 Sampling error can now be monitored for multiple sampling analysis (WPC for HPC and WDF for hsA.
(hsA mode is not applied on XN-V) (This is applied for only species (000) others algorithm.
13 Information for connected reagent can now be output.
14 "Giant Platelet?" flag can be added by changing "PLT Clumps?" algorithm. The following settings
have been added in service settings. (This is applied for only species (000) others algorithm.
Type A: (Same as version 00-17, High specific, Not judge "Giant Platelet?") (Default)
Type B: (Same as version 00-18, High gain, Not judge "Giant Platelet?")
Type C: (Added by 21-00, Balanced with type A and B, judge "Giant Platelet?")
15 RE-LYMP classification algorithm has been added. Automatic classification or fixed classification can
now be selected. Default value is automatic classification. (For EU market only)(This is applied for
only species (000) others algorithm.
16 Flag judgment for "Dimorphic Population" has been improved. This is for correct judgment when there
is a peak in smaller area than 4 ch (=25 fl) on RBC distribution; (This is applied for only species (000)
others algorithm.
17 "CELLPACK DFL" has been added to filter function of reagent replacement screen.
18 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.
19 Replacing piercer had been moved from user maintenance to service maintenance.
[Replace Piercer] has been removed from maintenance menu and has been added to Service menu.
XN-V Series (E) S/M

Version History
20 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.
<When 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) When 12L/h is selected in SystemConfig, 0.09MPa will be displayed in the status display.
(4) When “0.09MPa pressure error” occurs, it is possible to jump to the on-line IFU’s troubleshooting
page.
XN-V Series (E) S/M

Version History
<When 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) When 9L/h is selected in SystemConfig, 0.07MPa will be displayed in the status display.
(4) When “0.07MPa pressure error” occurs, it is possible to jump to the on-line IFU’s troubleshooting
page.
- When the RU is connected with two IPUs, SNCS files will not be sent.
- When 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.
- To distinguish two RUs, RU name setting has been added.
-"RU has stopped supplying reagent." has been changed to "RU-20 has stopped supplying reagent."
and "RU-21 has stopped supplying reagent." to distinguish RU-20 or RU-21.
XN-V Series (E) S/M

Version History
21 To support the SP-50, the following changes have been made.
SP-50 can now be selected in SystemConfig.
(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 pull down menu.
In the pull down menu, 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 pull down
menu. XN-20 or XN-10 can be selected in the pull down menu. The default set-
ting is XN-20.
Initial setup wizard screen (new)
(3) When 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.
<When XN-3100 is selected>
XN-V Series (E) S/M

Version History
<When XN-1500 is selected>
(4) System configuration screen is as follows.
XN-V Series (E) S/M

Version History
(5) It is now possible to select connection with DIA (Digital Image Analyzer) when
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 (Standalone) system configuration is selected, “Con-
necting the DIA” button will be displayed in the System Configurator screen.
(6) 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 dis-
played in the System Configurator screen. (Refer to the picture in (5) listed
above.
(7) In the case of connecting XN-1500 or XN-3100, number of slide, smear con-
dition, replications, additional rinse in resist order, modify order screen have
been added.
Smear module in the work list has been changed to SP-50.
Number of slide, smear condition, replications, additional rinse and alarm can now be communicate
with the host computer in ASTM.
When CELLCLEAN AUTO is recognized, it will be delivered to XN and SP-50.
22 The speed of copying files during program upgrade has been increased.
23 Supporting XN-9100
(1)Barcode test can now be available.
(2)Previously, there was a possibility that the status of analyzers on CT-90 (icon)
was not correctly displayed. In order to resolve this situation, the status of the
icon can now always be updated.
(3)XN-9100 can now connect both CV-50 and CV-55. (Both CV-50 and CV55
can now be connected with the one IPU.)
24 For North American markets, analysis algorithm has been developed by modifying ver. 00-20 and ver.
21.00-00.
Resolved issues
1 Previously, piercer adjustment screen could not close even when "CLOSE" button was pressed. This
has been resolved.
2 Previously, lot registration information was not inherited when program was updated. This has been
resolved.
XN-V Series (E) S/M

Version History
3 Following issues have been resolved. (This is applied for only species (000) others algorithm.
- IG became falsely high when NEUT clusters divided into more than two. This has been resolved.
- IG became falsely low when IG cluster is divided from NEUT clusters. This has been resolved.
4 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.
5 Previously "Aspiration unit up-down motor error" occurred when running auto rinse after performing
QC measurement by customers or using control mode / calibrator mode in service program. This
issue has been corrected.
6 Previously, [Asc.] radio button was not displayed properly in the [Sort] dialog box. This issue has now
been resolved.
7 Under a certain condition, there were two identical setting screens for "Auto Validate when result had
barcode read error". This has been resolved.
8 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. (This is applied for only species (000) others algorithm.
9 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 output and related parameters will
be masked with hyphen when NRBC is interfered in WBC area. (This is applied for only species (000)
others algorithm.
10 Previously, there was a possibility that Lymphocyte became falsely low when detected Lymphocyte
was falsely discriminated as monocyte. This has been resolved. (This is applied for only species (000)
others algorithm.
Remarks
Module Version
IPU 00-05
Analyzer 02-59
Sampler 00-16
ECR:317A081
XN-V Series (E) S/M

Version History

<Applicable S/N>
XN-V series (XN-1000)S/N: A1031 and thereafter
<Release Date>
Resolved issues
1 Previously, updown motion error on aspiration unit occurred when auto rinse was performed after the
analysis in control or calibrator mode. This issue has been resolved.
Remarks
Module Version
IPU 00-04
Analyzer 02-57
Sampler 00-15
ECR:316D049
XN-V Series (E) S/M

Version History

<Applicable S/N>
<Release Date>
1 Usability for creating manual analysis gate has been improved as follows.
1. When creating manual analysis gate, the gate can be closed by double-click.
2. At closing a gate, the program has been changed not to transition to the next manual analysis gate.
3. “Modify”, “Add”, and “Delete” menus are now displayed as context menu by right-clicking on
selected vertex coordinate display of manual analysis gate information.
4. Selected vertex on the manual analysis gate can now be moved by pressing arrow keys. However,
the vertex does not move over the scattergram area.
5. All selected manual analysis gates can now be moved by pressing “Shift” and arrow keys.
6. The coordinate which is the display position of gate name can now be saved.
2 Settings for extension parameter names and gate colors on the manual analysis (extended) have
been added as follows.
1. An item “Extension parameter setting” has been added to species setting window so that names
and colors of extension parameter for each channel have been configured.
2. Color and item name for the selected extension parameter can now be configured by right-click the
selected extension parameter gate information on the manual analysis (extended) window.
3 The displaying order of species on the work list screen has been changed to follow the settings of
displaying order on the species configuration.
4 Changing P/N (Positive/ Negative) function on the modification dialogue of analysis result can be
disabled by the service settings.
5 Printing layout for analysis result LP printing has been changed to the layout with large left page
margin.
6 Initial values for species CAL for PLT-I have been changed as follows. (Species: Mouse, Rabbit)
(001)Mouse: 1656
(005)Rabbit: 1177
7 WBC discrimination for WDFch has been improved. (Species : Mouse)
8 The numbers of digits for extension parameters RET-R0# through RET-R8# and RET-R1% through
RET-R8% have been changed so as to enable them to use with the same number of significant figure
for RET# and RET%.
9 Fixed password (c9.0) for “sysmex” account on Windows has now been changeable.
10 Error detection method for “Cannot recognize Fluorocell XXX information” has been changed. (XXX
stands for Dye parameters.)
11 Previously, users who can implement QC had the authority to delete the QC data. So as not to delete
the QC data by mistake, new type of authorized user that only can implement QC has been added.
12 Action messages for reagent replenish errors have been changed from “Open the Fluorocell XXX
cover and install new Fluorocell XX.” to “Fluorocell XXX is installed inside the instrument. Open front
cover of the instrument and install new Fluorocell XXX.”. (XXX stands for Dye parameters.)
13 Analysis results whose sample numbers containing the characters that cannot be used for naming on
Windows such as \, /, *, ?, “, <, >, and | can now be output in FCS files.
14 As a countermeasure against liposome interference, when instrument judges a liposome 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
XN-V Series (E) S/M

Version History
15 "PLT Clumps?" judging algorithm can now be selected for ver. 00-17 or ver. 00-18.
16 The sequence for the WC1 drainage time measurement timing at startup has been changed from 0.1
second after to 0.5 second after.
Resolved issues
1 Previously, the setting of ghost area on the PLT-F scattergram for human and Guinea pig were same.
This could result in falsely low value because PLT-F cluster tends to be depicted on lower value area
in SLF. To resolve this issue, ghost area on the PLT-F scattergram for Guinea pig has been modified.
(Species: Guinea Pig)
2 The initial value for "S_ANA_WNR_SLOPE_WNR" parameter has been changed as follows because
NBRC falsely high values Mouse WNRch could occur.
(001)Mouse: 203。
3 Discrimination error occurred on Non-Human Primates because distance between Neut cluster and
Eo cluster has been close on scattergram. To resolve this issue, the algorithm has been changed and
Neut/Eo re-discrimination process on the WDF (SSC-FSC) scatter gram has been added.
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 Piercer adjustment window could not be closed even after CLOSE button was pressed. This issue
has been resolved.
6 Previously, tube holder moved before checking upward and downward motion of piercer was
implemented and this could result in damaged piercer. To resolve this issue, startup sequence has
been changed to ascend piercer before the sample set unit moves at startup.
7 Previously, the piercer did not descend at cleaning RET/PLT-F chamber.
This has been changed to the piercer descending when cleaning the chamber.
8 The counted values for PLT-O and RBC-O decreased by 20% because FCM charging DP got tainted
by blood and could not discharge proper amount. To resolve this issue, cleaning sequence which
feeding CELLCLEAN into the FCM charging DP and cleaning has been added at shutdown or
cleaning.
9 Depending on the position of the piercer, air gap could not be created properly when switched to the
PD mode. To resolve this issue, the position where the air gap is created soon after switched to PD
mode, has been lowered 1.4mm from the previous position.
Remarks
Module Version
IPU 00-03
Analyzer 01-57
Sampler 00-15
ECR:316D049
XN-V Series (E) S/M

Version History
DVD1XNVX: Ver.1.01-00
<Applicable to S/N> <Release Date>
-
<Part No./Name>
AU089393: CDR_ASSY NO.248
None
Resolved issues
None
Remarks
This is the initial version to the field.
XN-V Series (E) S/M

DVD1XNVX Version History E

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Version History

XN-V Series Program DVD1XNVX

<FDS File Name>

4 Specification changes from XN-Series Ver.22.16-00 have been applied.

XN-V Series (E) S/M

XN-V Series (E) S/M

Before change After change

2 Specification changes from XN-Series Ver.22.12-00 have been applied.

XN-V Series (E) S/M

2 Resolutions on program issues from XN-Series Ver.22.12-00 have been applied.

3 Resolutions on program issues from XN-Series Ver.22.15-00 have been applied.

Measurement Mode Item and unit name

XN-V Series (E) S/M

4 Resolutions on program issues from XN-Series Ver.22.16-00 have been applied.

1) Select Low WBC mode, and click OK to close the dialog.

XN-V Series (E) S/M

Measurement channels Calculated measurement parameters

* RBC = RBC-F, WBC = WBC-F, PLT = PLT-F

2 Specification changes from XN-Series Ver.22.10-00 have been applied.

XN-V Series (E) S/M

(2) The configuration including CV-55 can now be selected in “ConfigTool”.

Setting name Setting value Default value

Affected PLT parameters

XN-V Series (E) S/M

2 Resolutions on program issues from XN-Series Ver.22.09-00 have been applied.

3 Resolutions on program issues from XN-Series Ver.22.10-00 have been applied.

XN-V Series (E) S/M

XN-V Series (E) S/M

DVD1XNVX: Ver.3.04-00 Upgrade Procedure

A decrease in Mono will result in higher Lymph.

* “Enable Species MONO_CAL” had been added by Ver.3.03-00.

3 Applied specification changes from XN-series Ver.22.04-00

4 Applied specification changes from XN-series Ver.22.05-00

XN-V Series (E) S/M

5 Applied specification changes from XN-series Ver.22.06-00

2 Corrected issue where “DeviceContorolManager.exe has stopped working” error message is

XN-V Series (E) S/M

XN-V Series (E) S/M

8 Applied resolved program issues from XN-series Ver.22.04-00

9 Applied resolved program issues from XN-series Ver.22.06-00

10 Applied resolved program issues from XN-series Ver.22.07-00

11 Applied resolved program issues from XN-series Ver.22.08-00

XN-V Series (E) S/M

XN-V Series (E) S/M

XN-V Series (E) S/M

(1) WDF analysis algorithm: (007) Horse

(Example of error differentiation) (Example after improvement)

(2) RET analysis algorithm: (006) Cat

XN-V Series (E) S/M

4 Marmosets can now be analyzed.

5 Camel analysis algorithm has been optimized.

7 The time series tab is now displayed on the browser screen.

8 Normal range display option has been deleted in scattergram.

11 Usability of manual analysis has been improved.

XN-V Series (E) S/M

[Horizontal deployment of XN-series Ver.22.02-00]

16 The performance of blood aspiration sensor has been improved.

17 Contents of files sent via SNCS have been changed.

XN-V Series (E) S/M

[Horizontal deployment of XN-series Ver.22.03-00]

23 Previously, in ASTM communication, when an unavailable parameter (IPF: Research parameter)

Log file Information

XN-V Series (E) S/M

[Horizontal deployment of XN-series Ver.22.02-00]