SYSMEX XE-5000 User manual

Document Number: MKT-70-1096 Revision 1 Page 1
SYSMEX XE-5000TM Quick Guide
Start-Up
QC Analysis
Sample
Processing
Sample Explorer/
Data Browser
Body Fluid Mode
HPC Mode
Reagent
Replacement
QC Setup
Maintenance
If you need further assistance, please contact
the Sysmex Technical Assistance Center:
Phone: 1-888-8SYSMEX
(1-888-879-7639)
Fax: [phone]
SYSMEX AMERICA, INC.
One Nelson C. White Pkwy.
Mundelein, IL 60060

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Document Number: MKT-70-1096 Revision 1 Page 3
SYSMEX XE-5000TM Start-Up
Power On Sequence
1. XE Information Processing Unit.
2. XE-5000 Main Unit.
3. GP Printer
Power On Information Processing Unit (IPU)
1. Turn on IPU power (power switch on monitor).
Windows® system is automatically loaded.
2. When XE log-on displays, input your Lab’s user name _________
and password (if any). ____________
Press [ENTER] or [OK].
Power On Main Unit and Log On
IPU must display XE-5000 program before powering Main Unit on.
1. Turn on Main Unit power (switch on right side).
2. Pneumatic Unit power is controlled by the Main Unit.
Pneumatic Unit power switch should always remain on.
3. XE-5000 performs self-checks. If any checks fail, an error message
displays. Refer to XE-5000 Information for Use, Troubleshooting Chapter.
4. Main Unit log-on displays after the Background is completed.
• If needed, press [NUM/ALPH] to change from “NUM” to “ALP” or
“alp” on XE Main Unit LCD panel.
• Enter your Lab’s user name ___________________ and password
(if any). _____________________ by pressing specific keys until
desired character is displayed.
• Press [ENTER].
CAUTION: If you have to power the Main unit off and on, power off and wait
30 seconds before turning power back on.
Background Checks
1. If no “Background Error” message is displayed, Background check is
within acceptable limits.
2. If background counts are greater than the acceptable limits, a
‘Background Error’ message is displayed.
3. Parameter(s) that exceed the Background limit are displayed and marked
with a ‘+’on Main Unit.
4. Select ‘RETRY’ on Background error screen on Main Unit to perform
another Background check.
5. To resolve a Background Error, refer to XE-5000 Information for Use,
Troubleshooting Chapter.
Reagent Volume Check
1. Click [CONTROLLER] in the IPU Menu Tab.
2. Double click on [Remaining Reagent] (bottle) icon to check for low
volume reagents.
3. Do not replace the reagent until the Replace Reagent error occurs.
(Purple = full, white = empty)
Power button on IPU
IPU Log-on Dialog Box
Main Unit ON/Off Toggle
Main Unit Log-on Screen
Remaining Reagent Screen

Document Number: MKT-70-1096 Revision 1 Page 4
SYSMEX XE-5000TM
SAMPLER (AUTO) MODE
‘Control Entry Error’ occurs if lot is not entered in QC files.
1. Warm controls to room temperature.
2. Pre-mix controls by gentle end-to-end inversion until suspended.
3. Place barcoded QC samples in rack, barcodes facing the front of the
rack.
4. Verify XE Main Unit ‘Ready’ LED is on and ‘Manual’ is displayed on LCD
5. Place rack on the right rack pool of Sampler unit.
6. Press [SAMPLER] on Main Unit keypad.
7. Press [Start] on the function menu or press [SAMPLER] again.
MANUAL OPEN MODE
1. Warm controls to room temperature.
2. Pre-mix controls by end-to-end inversion until suspended.
3. Verify XE Main Unit is ‘Ready’ and ‘Manual’ is displayed.
4. On XE Main Unit Menu, press [QC] and [EXEC. QC]. If ‘QC’ is not
displayed, press [MORE].
5. Press [↓] to control to be analyzed (CRN/New, lot #, ‘Manual’, exp.
date, level) and press [SELECT]. If lot is not listed, press [↓] to next
screen.
6. Uncap and hold open control under aspiration pipette. Press
START SWITCH on XE Main Unit.
7. Remove tube when ‘Ready’ LED stops blinking and ‘beep-beep’ sound is
heard. Wipe top of control cap and reseal.
Note: No need to wipe tip of sample aspiration pipette
8. When results display on XE Main Unit, press [OK] to plot, or press
[CANCEL] to abort.
9. Press [RETURN] to exit from QC Mode on Main Unit.
MANUAL CLOSED MODE
Alternate method for analyzing QC samples in closed mode without using
barcodes: Tube MUST be placed in Tube Position 1.
1. Warm controls to room temperature. Pre-mix controls by gentle end-to-
end inversion until suspended.
2. Verify ‘Ready’ LED is on and ‘Manual’ mode displays on Main Unit.
3. On XE Main Unit Menu, press [QC] and [EXEC. QC]. If ‘QC’ is not
displayed, press [MORE].
4. Press [↓] to control to be analyzed (CRN/New, lot #, ‘Closed’, exp. date,
level) and press [SELECT]. If lot no. is not displayed, [↓] to next QC
screen.
5. Place pre-mixed QC sample in Tube Position1 of rack. Place rack on
right rack pool of sampler unit.
6. Press START SWITCH on XE Main Unit. Rack moves so first tube stops
at the aspiration position. Cap Piercer picks up tube of blood and aspi-
rates it.
7. When QC results display on XE Main Unit, press [OK] to accept QC, or
[CANCEL] to abort. Accepted data transmits to IPU and is plotted on
QC Chart.
8. Repeat steps 4-6 to analyze the other levels of control.
9. To exit from QC Mode on XE Main Unit, press [RETURN] on panel.
10. Remove rack from Sampler Unit manually.
QC Analysis
Sampler Screen
Main Unit Menu Screen
LCD Screen: Manual QC
LCD screen: Manual Closed Mode

Document Number: MKT-70-1096 Revision 1 Page 5
SYSMEX XE-5000TM
To View Radar Charts
Note: Radar Charts for Current Lot only.
1. On IPU, click on QC icon.
2. Click on Radar Tab.
3. Choose level and mode.
4. Control Data are displayed in green on Radar Chart.
5. If any parameter is outside of lower limit (inner red ring) or outside of
upper limit (outer red ring), then go to Control tab to view actual data
on L-J Charts.
To View e-CHECK L-J Charts
1. On IPU, click on QC icon and Control tab.
2. Choose Lot (Current, New, or Current + New), Level, and Mode.
3. QC chart for control is displayed.
4. To scroll down to view all QC parameters, click just above to page down
arrow on vertical cursor bar on right side of QC Chart.
5. When viewing QC, look for data outside of limits (X). Ensure data is plot-
ted and no data are missing (- - - -).
Auto Mode Error Messages L-J Limit Error
• QC Parameter > 1 x Limit %
• QC data plotted with red X, + or - next to data
• Press [HELP], [OK] to clear error message
Manual Mode Error Messages
Check Control Chart Error
• QC Parameter > 1 x Limit %
• + or - in the Judge column
• Press [OK] to accept and plot data
• QC data plotted with red X on QC Chart if plotted.
Re-analyze Control Error
• QC Parameter > 3 x Limit %
• + or - in Judge column
• Press [OK] to accept and plot data or press [Cancel] to exit and QC
data is not plotted.
• QC data plotted with red X on QC chart if plotted.
XM Limit Error
• XM plotted outside Limit %
• Investigate for systematic error or population shift
• Press [HELP], [OK] to clear error message
Erasing QC Data
Note: Delete function may require a special password.
1. On IPU, click on QC icon. Choose Control (Current, New, or
Current + New), Level, and Mode. QC chart is displayed.
2. Click on chart area. Set range of QC data to delete. Click on dark green
line and drag line to last set of data to delete. Click [Delete Data].
3. If undelete function is desired, click [Undelete]. This cancels the
previous Delete command.
4. When exiting QC, a reminder displays that deleted data will be
permanently lost. Click ‘YES’ to delete or ‘No’ to stop delete.
QC Analysis
Printing QC Report
and Resending to LIS
1. On IPU, click on QC icon. Choose Control (Current,
New, or Current + New), Level, and Mode. QC chart
is displayed.
2. Click on chart area. Set range of QC data to print by
clicking on dark green line and drag line to include all
QC data or press [Ctrl] and [A] to select all.
3. LP: After selecting range, click [Report] and select
[Ledger(LP)] to print QC data in line format.
4. GP: After selecting range, click [Report] and select
[Report(GP)] to print QC Charts.
5. HOST: After selecting range, click [Report] and
select [Host(HC)] to transmit QC data to Host (LIS)
computer.
Radar Chart
Report Menu
L-J (Levey-Jennings) Chart

Document Number: MKT-70-1096 Revision 1 Page 6
SYSMEX XE-5000TM
SAMPLER (AUTO) MODE with BARCODES
1. Verify XE Main Unit ‘Ready’ LED is on and ‘Manual’ is displayed on
Main Unit.
2. Place barcoded sample(s) in sample rack(s) with barcodes facing front of
rack.
3. Place rack on right side of Sampler Unit.
4. Press [SAMPLER] on the Main Unit keypad.
5. Select test to be performed for instruments that are not interfaced.
6. Press [Start] on the Main Unit menu or press [SAMPLER] again.
Sample Number and Discrete test will be transmitted from LIS.
Note: If XE is in sleep status, XE will automatically return to Ready when the
Sampler Mode is started. Wait for Ready to appear on the screen.
Sampler Screen
SAMPLER (AUTO) MODE without BARCODES
(Sequential numbering)
1. Set the ID Barcode reader to off on the IPU.
• From the IPU Menu Window area, select ‘Controller’, ‘Settings’ and
‘ID Reader’. Deselect the ID Reader to turn it off. Click [APPLY].
• From the Menu bar, click [Settings] and [Analysis Ordering].
Select ‘Rack No./Tube Pos.’
2. Press [SAMPLER] on Main Unit and sampler setting screen appears.
3. Enter the first sample number (up to 15 alphanumeric characters) in the
rack and the tube position. (ex. 101) Numbers are assigned sequentially
thereafter.
4. Press [↓] to select Discrete test (1 to 7).
5. Place rack on Right Rack Pool and press [START] on the Function Menu,
or press [SAMPLER] again.
INTERRUPT AUTO MODE FOR STAT
1. Press [SAMPLER] on Main Unit LED to interrupt Sampler Operation.
2. ‘S-READY’ appears at the upper left of Main Unit. Ready LED is on.
3. Analyze STAT using the Manual or Capillary Mode.
4. After STAT is completed, ‘S-READY’ appears at the upper left of the Main
Unit screen. Press [SAMPLER] and XE resumes Sampler Mode Analysis.
Sample Processing
XE-5000 MANUAL OPEN MODE
1. Verify XE green ‘Ready’ LED is on.
2. Press [MANUAL] on XE Main Unit LCD panel.
• Enter Sample No. or Name. (13 characters). For
Name, press ‘Num’ key 1, 2 or 3 times to display
desired character (NUM, ALP, alp).
• Press [↓] and [1] to select ‘Manual Mode’.
• Press [↓] to select Discrete test. Press number
(1 to 7) to select desired test.
• Press [ENTER].
3. Mix sample prior to analysis. Uncap tube.
4. Hold uncapped tube under aspiration pipette. Press
the START SWITCH.
5. Remove tube when ‘Ready’ LED stops blinking and
‘beep-beep’ sound is heard. No need to wipe pipette.
6. Results display after completion of analysis.
Manual Aspiration/START SWITCH
Manual Screen

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SYSMEX XE-5000TM Quick Guide
XE-5000 Capillary Mode
Prepare 1:5 dilution. Minimum Volume 40µL blood and 160µL of CELLPACK
(aspiration volume 130µL). Analyze within 30 minutes.
1. Verify XE green “Ready” LED is on.
2. Press [MANUAL] on XE Main Unit LCD panel.
• Enter Sample No. or Name. (13 characters).
• For Name, press ‘Num’ 1, 2 or 3 times to display desired character
(NUM, ALP, alp).
• Press [↓] and [2] to select “Capillary”.
• Press [↓] and select Discrete test 1 to 7.
• Press [ENTER] on the panel.
3. Place well mixed 1:5 diluted sample under Manual Aspiration Pipette.
4. Press [Start] on XE Main Unit.
5. Remove tube when “Ready” LED stops blinking and “beep-beep” sound
is heard. No need to wipe tip of sample aspiration pipette.
6. Results will display after completion of analysis. (Capillary results labeled
with “C”)
7. When all Capillary Mode samples are completed, return to Manual
Mode. Press [MANUAL] on XE Main Unit LCD. Press [↓] and select “1
Manual Mode”. Press [ENTER].
XE-5000 Manual Closed Mode
Blood analyzed using Cap Piercer (without mixing or reading barcode).
1. Verify ‘Ready’ LED is on.
2. To change XE Main Unit to Closed Mode, press [MANUAL] on Main
Unit LCD panel.
• Enter Sample No. or Name. (13 characters).
• For Name, press ‘Num’ 1, 2 or 3 times to display desired character
(NUM, ALP, alp).
• Press [↓] and select “Closed”.
• Press [↓] and select Discrete test 1 to 7.
• Press [ENTER].
3. Mix sample (10 times inversion) and place tube in first tube position of
rack.
4. Set rack on right end of analysis line on XE Sampler Unit.
5. Press START SWITCH. Sampler moves rack until tube is in front of CP
aspiration hand.
6. Press [Start] on Main Unit. Cap Piercer picks up tube of blood and
aspirates it. Results display after completion of analysis (Closed results
labeled with P).
7. After measurement is completed, remove rack from the Analysis Line.
8. To change XE Main Unit back to Manual Mode, press [MANUAL] on XE
LCD panel, [↓] to Discrete and select “1 Manual”. Press [RETURN] to
exit Manual Mode.
Capillary Screen
Manual Closed Screen

Document Number: MKT-70-1096 Revision 1 Page 8
SYSMEX XE-5000TM
Finding A Sample
1. Click [Sample Explorer]. Verify “Last 20” icon is de-selected (top blue
line displays “Filter All”).
2. Click sample number at top of list.
3. From Tool Bar, click [Edit] and [Find].
4. Find dialog box is displayed. Enter Sample number or Patient ID.
(If you are using leading zeros, zeros have to be entered.)
“*” or “?” can be used as a wildcard for following situations:
? Use in place of a single digit for an unknown number or letter.
* Use for multiple unknown letters or numbers and placed at the end
of a string.
6. Click [NEXT] to search below sample number in list or [PREV] to search
above the sample number in list. The selected sample will display with
cursor on it.
Edit Sample ID# or Patient ID#
1. Click [Sample Explorer] icon. Verify “Last 20” icon is de-selected (top
blue line displays “Filter All”). Click sample number to be changed.
2. Click [validate] icon to un-validate sample. (“V” disappears in first
column of Sample Information Tab).
4. Click [property] icon from Tool Bar. Sample Property box displays with
selected Sample ID.
5. Click Sample ID or Patient ID to select number to edit. Delete old num-
ber and input new ID number.
6. Click [OK] and new sample information will be stored. Screen displays
Stored Data with cursor on edited sample.
7. Click [validate] box and corrected ID number is reprinted to GP and
retransmitted to HOST.
Reprint to Graphic Printer
or Retransmit Data To Host
Note: Un-validated data may not be reprinted or retransmitted.
1. Click [Sample Explorer].
2. Verify “Last 20” icon is de-selected (top blue line displays “Filter All”).
Click on sample(s) by ID number to reprint or retransmit.
• To select any single sample, click on sample ID.
• To select multiple samples (not necessarily in order), press and hold
[Ctrl] on keyboard and click each sample.
• To highlight a block of samples, click on first sample to output. Then
press and hold [Shift] and click on last sample to output.
3. To reprint to GP, click [Report] and [Report(GP)].
4. To retransmit to LIS or HOST, click [Report] and [Host (HC)].
Sample Explorer
/Data Browser
Edit Menu
FIND Dialog Box
property validate
Property Screen
Report Menu

Document Number: MKT-70-1096 Revision 1 Page 9
SYSMEX XE-5000TM
To Disconnect Host When LIS is Down
1. When the HOST is down, a pop-up error message displays on the IPU.
HOST icon will be red on Status display line at bottom of IPU.
2. Click the IPU error box to close the message.
3. Go to the IPU Settings, [HOST(HC)] Setting.
4. Click the “Host(HC) Connect” to remove the check. This disconnects
the IPU from the LIS .
5. Click [OK] to save the changes.
6. The red HOST(HC) icon disappears. The XE-5000 is ready to analyze
without using Host/LIS orders.
Select “Chartable GP Report” From Desktop
1. GP Customize is only available on XE pro software. Click “XE Pro” tab
from IPU Main Menu.
2. Click “GP Customize” icon.
3. Select “Report” for Format type.
4. From the top grey menu line, click [RECORD] and [RESTORE].
5. An “Open” dialog box displays with the message “A is not accessible”.
Click [CANCEL] to go to the Desktop.
6. Click the GP Customize folder. The desktop files are displayed. Select GP
report format from list.
7. Click “Open” tab.
8. Click [OK] to restore.
Note: When the HOST connection is resumed, restore your lab’s original GP
format.
To Re-connect the Host When LIS is Up
1. Go to the IPU Settings, HOST (HC) Setting.
2. Click the empty box next to “Host(HC) Connect” to reconnect IPU and
Host.
3. Click [OK] to save the changes.
4. The green HOST icon displays. The XE-5000 is now reconnected to the
HOST.
Sample Explorer
/Data Browser
Host HC ready Icon
Host(HC) connect
Host Tab On Browser
GP customize icon
Record menu

Document Number: MKT-70-1096 Revision 1 Page 10
SYSMEX XE-5000TM
Summary of Body Fluid Analysis
The body fluid analysis mode of the XE-5000 uses the 4 DIFF scattergram
and the RBC distribution obtained from a specialized analysis sequence to
calculate and display the WBC counts, mononuclear cell (MN) /
polymorphonuclear cell (PMN) count and percentages, and the RBC (RBC-BF)
counts found in the body fluid.
Analysis Parameters
WBC-BF, RBC-BF, TC-BF #, MN#, MN%, PMN#, PMN%
Sample Analysis In Body Fluid Analysis Mode
Body Fluid Mode must be selected to perform body fluid analysis.
1. Make sure that the instrument is in READY status. The READY LED
should be lit.
2. Press the MANUAL key on the Main Unit panel keypad. The Manual
Sample No. Setting screen will appear on the LCD.
3. Using the numeric keys, input the sample ID number or, read the bar-
code using a hand held barcode reader (optional).
4. When analysis mode is not set in manual mode, press the ↑ key and
change the set item to “Mode.” Then using the → and ← keys, set the
manual mode.
5. Use the ↑ key to change the setting parameter to Discrete, then use the
→ and ← keys to set CBC + DIFF unless any of the following is already
selected:
a. CBC+DIFF
b. CBC+DIFF+RET
c. CBC+DIFF+NRBC
d. CBC+DIFF+NRBC+RET
Note: Whichever of the above discrete settings is chosen, Discrete will change to
CBC+DIFF when the ENTER key is pressed to confirm the input.
6. Using the ↑ key to change the setting parameter to Sample, and then
use the → and ← keys to set to Body Fluid.
7. After all the setting are completed, press the ENTER key to set sample
NO.
8. When the ENTER key is pressed, a background check is run at the same
time. Background check analysis is repeated three times for the back-
ground check. If the background value is judged to be within range the
background check is completed.
If the background value is not within the specified range, the message
“Background Error” will be displayed on completion of the background
check.
In the case of a “Background Error,” select “B-Check” on the LCD menu
to perform automatic cleaning and repeat background. If the value af-
ter the automatic cleaning is not lower than the acceptable background
value, a “+” is displayed to the right of the value. To resolve background
error, see the Instructions for Use.
Note: The basic analysis procedure is the same as for Normal Mode, but for
body fluid analysis it is necessary to reliably eliminate background influ-
ences.
Body Fluid Mode
Body Fluid Order

Document Number: MKT-70-1096 Revision 1 Page 11
SYSMEX XE-5000TM
9. If the results of the background check is such that the blank value is at
or below the acceptable limit, the READY LED lights and the Main Unit
enters body fluid analysis ready status.
10. Mix the contents of the test tube gently but thoroughly.
Note: Excess mixing can break blood cells in the body fluid,
making it impossible to obtain accurate results.
11. Remove the cap carefully so as not to splatter the sample.
12. Set the test tube into the manual aspiration pipette, and then press the
START SWITCH. Do not remove the test tube while the READY LED is
blinking, sample is being aspirated.
13. After the READY LED turns off (and a short beep sounds two times),
remove the test tube. Once analysis is completed, set Sample to Normal
on the Sample No. setting screen to return to normal mode.
CAUTION: If either the analysis values from body fluid analysis (WBC-BF
and/or RBC-BF) are high, there is the possibility of an influence
on the analysis results for the next sample. If analysis results
for WBC-BF and RBC-BF exceeds specifications, the “Execute
Background Check” Error is displayed, asking the user to per-
form a background check before analyzing the next sample.
14. The results of Body Fluid Mode are displayed on the menu screen of
the Main Unit LCD screen. The results are also displayed on the sample
explorer and the data browser screen Body Fluid Tab on the information
processing unit (IPU)
Analysis samples analyzed in body fluid analysis mode are marked with
an “F” mark to the left of the sample No. on the Main Unit LCD screen.
“F” is displayed in the analysis mode display column of the sample
explorer and data browser screens.
Body Fluid Mode
Explorer Screen “F” and Red “F”
Body Fluid Tab on Browser

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SYSMEX XE-5000TM
Summary of HPC Analysis
The HPC (hematopoietic progenitor cell) analysis mode provides a rapid
count of HPCs using peripheral blood and cord blood for screening purposes.
The HPC count can help determine the optimal time for harvesting stem cells
more quickly and at a lower cost.
The instrument must be set to HPC analysis mode in order to correctly ana-
lyze a sample for HPC#. HPC analysis can be performed on peripheral blood
or umbilical cord blood.
CAUTION: The clinician must take into consideration the full clinical picture to
determine when to use the HPC results.
Sample Analysis in HPC Analysis Mode
Samples for HPC testing should be analyzed immediately after drawing.
1. Make sure that the instrument is in READY status on the LCD screen on
the Main Unit. The READY light should be lit.
2. Press the MANUAL key on the Main Unit panel keypad. The Manual
Sample No. Setting screen will appear on the LCD.
3. Using the numeric keys, input the sample ID number or read the bar-
code using a hand held barcode reader (optional).
4. Set analysis mode to manual mode, by pressing the ↑ key to “Mode.”
Then using the → and ← keys, set to Manual Mode.
5. Use the ↑ key to move the cursor to Discrete. Then use the → and ←
keys to select CBC + DIFF as Discrete test.
6. Use the ↑ key to change the setting parameter to Sample. Then use the
→ and ← keys to set to HPC.
7. After all the settings are completed, press the ENTER key to initiate
analysis. When the ENTER key is pressed, a preparation sequence is
executed.
8. Mix the contents of the test tube gently but thoroughly.
9. Remove the cap carefully so as not to splatter the sample. Set the test
tube into the manual aspiration pipette, and then press the START
SWITCH. Do not remove the test tube while the READY LED is blinking
as the sample is being aspirated.
10. After the READY LED turns off (and a short beep sounds two times),
remove the test tube. Once analysis is completed, set Sample to Normal
on the Sample No. setting screen to return to normal mode.
HPC Order
HPC Mode

Document Number: MKT-70-1096 Revision 1 Page 13
SYSMEX XE-5000TM
11. The results of HPC Mode are displayed on the Main Unit LCD screen.
Samples analyzed in HPC Mode are marked with an “H” to the left of
the Sample No. on the LCD screen.
The results are also displayed on IPU screens. On the Sample Explorer
screen samples analyzed in HPC analysis mode are marked with an “H”
to the left of the Sample No. Results are listed in the column to the right
when the operator clicks on that sample.
On the Data Browser screen both the Graph and HPC tabs display HPC
results. The sample mode is noted with an “H” to the left of the sample
number.
Note: In the HPC Analysis mode READY status is maintained for approximately 3
minutes after the last operation on the Main Unit. If no new operation is
performed within approximately 3 minutes the preparation sequence will
be executed again when the next operation is started.
HPC Results on Browser
HPC Results on Explorer
HPC Mode

Document Number: MKT-70-1096 Revision 1 Page 14
SYSMEX XE-5000TM
1. When a reagent container is empty, an alarm sounds and error message
displays. Press [HELP] on XE-Main Unit. Select [OK].
2. Reagent Setting Screen is displayed with “Replace” next to reagent that
needs replacing. Verify which reagent to change by matching reagent
abbreviation to proper name of reagent. (See reagent label)
3. Using hand held barcode reader, scan long reagent barcode
(EAN-128) on reagent box. Updated information is displayed (lot,
exp. date, volume).
Note: Use barcode on box for RED, SNR, and FFS. Do not use barcode label on
bottle or foil dye pack.
Caution: NR(S) MUST be replaced each time the NR(L) cube is replaced.
Empty NR(S) does not trigger message.
If needed, manually input Reagent information:
a. Press [↑] or [↓] to select reagent for manual entry.
b. Press [MANUAL] on function menu. Manual Input is displayed.
c. Press [↑] or [↓] and input information for new lot:
• For Lot No.
• Press [NUM/ALP] 1 time (ALP). Input 1st letter of Lot No.
• Press [NUM/ALP] 2 times (Num). Input 4 digit Lot No.
• [↓] to Exp. Date. Use “Num” key, input Month (nn).
Press [→] to Day. Use ‘Num” key (nn).
Press [→] to Year. Use ‘Num” key (nnnn).
• [↓] to Exp. after Opened. Use “Num” and input open dating.
Open dating is 60 days except SULFOYSER which is 90 days.
• [↓] to package size. Input size from box.
d. Press [OK] to exit Manual input display and return to Reagent Setting
screen. Lot No., open Exp. Date, and package size is displayed.
4. Remove cap from new reagent container. Using clean technique, remove
reagent tubing from empty container and insert into new container.
Initial and date new reagent container.
5. Select [EXECUTE] from reagent replacement screen. The new reagent is
primed.
6. Reagent replacement is documented on Reagent Log in XE Main Menu,
Controller icon, Reagent Log icon. This Log may be printed by Report,
Ledger (LP) Print. A Remaining Reagent Volume icon is also available.
Notes:
• When changing NR(L) and RED, the diluent and dye must be changed at
the same time. NR(S) does not trigger message.
• If STROMATOLYSER-NR or RET-SEARCH (II) reagents are empty and no
replacement reagents are available, XE may still be analyzed using Open
Manual Mode for CBC and DIFF orders only. Do not perform Auto Rinse or
Shutdown.
• STROMATOLYSER-4DS (FFS) is replaced when the FFS reagent cycle coun-
ter reaches 2000. Do not replace this reagent unless “Replace FFS” Error
message displays or counter will be incorrect.
If replacing reagent foil packs, verify packs are properly seated in holders.
For FFS reagent, both labels must face same direction.
REAGENT MESSAGE VOLUME
CELLPACKTM EPK 20L
CELLSHEATHTM ESE 20L
STROMATOLYSER -4DLTM FFD 5.0L
STROMATOLYSER -4DSTM FFS 42mL
STROMATOLYSER -FBTM FBA 5L
STROMATOLYSER –NR(L)TM SNR
NA
3.6L
42mL
STROMATOLYSER –NR(S)TM
STROMATOLYSER -IMTM SIM 10L
SULFOLYSERTM SLS 5.0L
RET-SEARCH (II) DILUENTTM
RED 1.0L
RET-SEARCH (II) DYETM
Open reagent stability is 60 days with the exception of
SULFOLYSER which is 90 days.
Replace Container Message
Reagent Scanned with Wand
Reagent Entered Manually
Reagent Replacement

Document Number: MKT-70-1096 Revision 1 Page 15
SYSMEX XE-5000TM
Input New Lot Number
1. Click Control tab. Select Level, Mode, and New lot.
2. Click Lot No. A box displays a window for lot information.
3. Input 8 digit lot number of new control. Click or tab to move cursor to
expiration date. Input date in Year/Month/Day order.
4. Click [OK] to save new lot. Verify new lot information is correct.
5. Lot number and date may only be edited while in NEW file.
To Set Variable Target
(Used to establish lab’s running mean for control)
1. Click QC icon. Choose Control tab. Select Level, Mode, and New lot.
QC chart is displayed.
2. Click [TARGET/LIMIT].
3. First parameter is highlighted. Click first parameter and drag cursor to
include all QC parameters.
4. Click [VARIABLE TARGET] and [OK].
To Autoset Target Values (setting mean value)
• Analyze New Lot at least10 times before auto setting target values
(preferably covering all shifts over 5 days).
• If desired, compare Current and New data before proceeding.
1. Click QC icon. Choose Control tab. Select Level, Mode, and Lot.
QC chart is displayed.
2. If using XE pro software, set range of QC data for calculating targets.
Click dark green line and drag line to left to include QC data or press
[CTRL] and [A] to select all data.
3. Observe right data column for Mean, SD, CV%.
4. Click [TARGET/LIMIT].
5. First parameter is highlighted. Click top of list of parameters and
drag cursor to include all QC parameters.
6. Click [AUTO SETTING]. Auto setting window is displayed.
7. Click [TARGET] and [OK]. Do not check limit. Observe target
column. Target values should now be displayed.
Erasing QC Data (DELETE)
1. On IPU, click QC icon. Choose Control tab. Select Lot, Level, and
Mode. QC chart is displayed.
2. Set range of QC data to delete. Click dark green line and drag line to last
set of data to delete. Click [DELETE DATA].
3. If undelete function is desired, click [UNDELETE]. This cancels the
previous Delete command.
Note: When exiting QC, a reminder displays that deleted data will be perma-
nently lost. Press YES to delete.
Printing QC Report and
Resending to LIS
1. On IPU, click QC icon. Click Control tab and select
Lot, Level, Mode. QC chart is displayed.
2. Click dark green line and drag line to include all QC
data or press [CTRL] and [A] to select all.
3. After selecting range, click [REPORT], [LEDGER
(LP)] to print QC data in line format.
4. After selecting range, click [REPORT], [GP] to print
QC Charts.
5. After selecting range, click [REPORT], [HC] to
transmit QC data to Host/LIS computer.
Report Menu
Level, Mode, Lot Boxes
Lot No screen
Variable Target button
Auto Set button
QC Setup

Document Number: MKT-70-1096 Revision 1 Page 16
SYSMEX XE-5000TM
Save QAP Data Using Sysmex InsightTM
• Sysmex Insight icon MUST be used for saving QC data for QAP.
• Review data and if desired, edit (delete) control data prior to submission.
Ensure all QC data is plotted and no analysis error data is included (- - -)
or (+ + +).
1. Click [SysmexInsight] icon on Main Menu. Sysmex Insight screen
is displayed.
2. Click combo boxes to select QC chart:
• [MATERIAL] to select Control.
• [LEVEL] to select Level 1, Level 2, or Level 3.
• [ANALYSIS MODE] to select Manual or Closed Mode.
• [LOT] to select Lot (Current or New)
• [INSTRUMENT ID] to select Main Unit.
• Verify QC Data Info in right column.
3. Insert Flash Drive into USB port on right side of IPU and click
[SAVE]. The Save As dialog box opens.
4. Check that the name for the Flash drive appears in the Save As
box. If not, click the drop down arrow and select the Flash drive
(Removable, Securegard, Data Traveler, or similar name) from
the list
5. Click the Save button.
6. Repeat steps 2 – 5 for other levels or modes if applicable.
7. With the Flash drive still inserted To verify QC data was downloaded
to the Flash drive press and hold the Windows™ key (between Ctrl
and Alt on keyboard) and press the “E” key once.
8. Verify lot numbers and extension ending with “Lot No. ins”.
9. Remove Flash drive electronically by clicking on the .
10. Click [CLOSE] to exit Sysmex Insight function.
Note: Save each file separately. If saving both Closed and Manual Mode QC
on the same device the operator should enter the letters “C” or “M”
respectively as the first digit of file name. This prevents the second set
of data from overwriting the first.
Submit QAP Data To Sysmex
1. Go to www.sysmex.com. Click on Sysmex America Inc. “Go to Insight.”
2. Log on: User name: Input first 4 digits Insight Customer No. Password:
Input first 4 digits of Insight Customer No. and first 5 digits of institution
Zip code. Press [ENTER].
3. Your name and institution displays. Click Submit QC.
4. Click on type of data to be submitted: “Data Disk Uploaded”
5. Choose Analyzer and Shift by clicking [↓]. Insert floppy disk into drive
(A-drive). Click “Browse”. Using “Look in” box, select drive by clicking
[↓]. Select 31/2 Floppy (A).
6. Click on One of three QC files. Click “Open”. File displayed by Browse
box. Click [SUBMIT]. Then click [SUBMIT MORE FILES] and repeat for
other files.
7. Click [REVIEW REPORT] to view submitted data. Lot-to-Date report is
displayed.
8. Click [CLOSE]. Click [LOG OUT].
Change Lot:
• Current Lot is deleted and New Lot moves to Current
• Print Current L-J Charts to GP and QC Data to LP and
Submit QAP data to Insight before proceeding with
Change Lot.
1. On IPU, click QC icon. Select e-CHECKTM. Select lot
“Current”, Level, Mode. QC chart is displayed.
2. Click [CHANGE LOT].
3. A warning message is displayed “Save QC Data
before changing lot?” about losing the Current Lot
(which is replaced by New Lot). Insert a floppy
disk into the floppy drive if saving QC data to a
floppy disk. Click on “Yes”. Save file box displays.
Enter File Name using Lot # (Example: e-CHECKTM
NNNN 0). Click “No” if you do not want to save
QC to disk.
5. Current QC Data is deleted and is replaced by the
New Lot.
Insight Screen
Save As dialog box
“Safe Removal” Icon
QC Setup

Document Number: MKT-70-1096 Revision 1 Page 17
SYSMEX XE-5000TM
XE Pneumatic Unit:
Inspect Trap Chamber for Fluid
• Visually inspect Trap Chamber for fluid.
• If fluid is present, turn Pneumatic Unit off. Remove Trap Chamber by
turning clockwise. Discard fluid. Dry chamber and re-assemble trap on
Pneumatic Unit. Do not over-tighten.
• Turn Pneumatic Unit On. Verify vacuum gauge is accurate.
XE Pressure and Vacuum Checks
• XE Main unit sensors monitor ranges for pressure and vacuum. If moni-
tored ranges are exceeded (see Table), error messages are displayed.
Press [HELP] and [OK] to display Sensor 1 screen. Then adjust to cor-
rect the error.
• Check pressure and vacuum on Pneumatic Unit before checking the
Main Unit.
• Adjustment procedures listed below. Set using the adjust range (see
Table).
To Adjust XE Pneumatic Unit Pressure
• View XE Sensor 1 screen
• Loosen fixing screw using screwdriver
• Adjust 0.25 pressure using knob
To Adjust XE Main Unit Pressure
• View Sensor 1 screen
• Pull knob to unlock
• Adjust regulator to range
• Push knob in to lock in place
To Adjust XE Main Unit Vacuum
• View Sensor 1 screen
• Loosen lock nut on bellows unit
• Adjust using adjustment knob
• Retighten lock nut
Vacuum Trap Chamber
Sensor 1 Screen
Maintenance
Pressure and Vacuum (In Order of Sensor 1 Screen)
XE-5000 Adjust Range
MPa
Monitored
Static Range
Adjust
Location
PU
Pressure 0.24 to 0.26 2100 to 2900 PU Regulator
0.16
Pressure 0.159 to 0.161 1500 to 1700 XE Main Unit
0.07
Pressure 0.069 to 0.071 620 to 780 XE Main Unit
0.03
Pressure 0.029 to 0.031 270 to 330 XE Main Unit
PU
Vacuum must be ≥- 0.05 400 to 700 No PU Adjustment
- 0.04
Vacuum
- 0.039 to
- 0.041 285 to 315 XE Main Unit

Document Number: MKT-70-1096 Revision 1 Page 18
SYSMEX XE-5000TM
XE Daily Shutdown
Perform daily or when “Execute Shutdown” displays (every 500 samples) or
perform instead of Rinse Flow Cell when “Execute Rinse Flow Cell”
message displays (every 400 retics).
1. Press [SHUTDOWN] on Main Unit.
2. Hold 5mL of 5% NaClO filtered bleach (Clorox brand) up to manual
pipette. Press START SWITCH. Bleach is aspirated.
3. When beeping stops and ‘READY’ LED turns off, remove tube of bleach.
4. After about 15 minutes, Main Unit displays “Please POWER Off.”
5. To continue analysis, select “RESTART” on LCD screen. After auto-rinse
and background check is completed, XE-5000 is “Ready”.
Weekly: Power IPU off after performing
Daily Shutdown
XE Power Off Order: 1) XE Main Unit 2) IPU
1. To power off XE, turn off Main Unit power switch.
2. To Power off IPU, click [FILE], [EXIT] on screen. Click [YES] to exit
XE-5000 program.
3. Click [START] at bottom of Windows desktop. Then click
[SHUTDOWN].
4. Click “Shutdown the Computer” and press [ENTER].
5. The system displays: “Please wait while the system writes unsaved data
to the disk”.
6. When dialog box displays: “It is now safe to turn off your computer”,
turn IPU power off.
Every 30,000 Samples
• Clean Sample Rotor Valve with 1:10 Bleach and DI water.
Reset SRV Cycle Counter.
Convenient to clean Manual Rinse Cup and SRV Tray when SRV is
cleaned.
• Replace Piercer Needle and Reset PIAS Cycle Counter.
Convenient to clean Piercer Tray when Piercer is replaced.
• Resetting Cycle Counters
1. On XE Main Unit press [MORE], [TEST] and [STATUS] on the
function menu. Select [COUNTER] from Status function menu
screen.
2. Use [↓] or [↓] arrows to select item to be reset. [toggles between
SRV and PIAS (Piercer assembly)]
3. Press [OK] on function menu to reset to zero. Press [CANCEL] to
exit.
As-needed Maintenance:
Remove IMI or RBC clog
• Use HELP key if error occurs.
• Press Maintenance, [3] Clog removal on XE Main
Unit.
• Clean IMI detector aperture if IMI Clog removal does
not remove clog.
• Clean RBC detector aperture if RBC Clog removal
does not remove clog.
Perform Rinse Flow cell
• Perform if “Execute Rinse Flow Cell” message displays
(> 400 Retics per day).
• Perform if abnormal Scattergram pattern occurs.
• Perform if QC errors occur on flow cell parameters.
• Clean Flow Cell with 1mL of 5% Clorox bleach using
Maintenance, [4] Rinse Flow Cell Procedure.
• When cleaning is completed, perform Maintenance,
[2] Air Bubble Removal.
Remove Air Bubbles from flow cell if abnormal
scattergram patterns occur. Also perform after execut-
ing Rinse flow cell (Maintenance, [2] Air Bubble Removal
program).
Refer to Instructions for Use
to Clean
• Manual Rinse Cup
• SRV Tray
• Cap Piercer Tray
Shutdown Instructions
Maintenance