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Sysmex CS-2500 SystemQuick Reference GuideMicrosoft® Windows 10 Version 01-70
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Table of ContentsLogging onto the system ................................................3
Hardware overview ........................................................4
Software overview .........................................................9
Daily maintenance .......................................................13
Loading reagents .........................................................15
Quality control .............................................................21
Sample processing .......................................................26
Factor assay MDA .........................................................29
Joblist result information ..............................................31
Joblist printing/export ..................................................35
Preanalytical sample integrity .......................................37
Enter reagent information ............................................39
Weekly maintenance ....................................................41
Monthly maintenance ..................................................42
As-needed maintenance ...............................................43
Calibration ...................................................................48
Enter ISI and Normal ....................................................51
Backup .........................................................................52
System shutdown and startup ......................................54
Error help .....................................................................55
Troubleshooting results ................................................56 SMN: 11554034 | T05013.001 | Effective date: 05/14/21 © Siemens Healthcare Diagnostics Inc., 2021
3
Logging onto the system
Logging onto the system1. Press Menu on toolbar.
2. Press Logoff icon.
3. Press OK to logoff system.
4. Select icon name.
5. Enter password.
6. Press OK.
4
Hardware overview
Hardware overview
External hardware
1. Sampler Holds 5 racks of 10 tubes Barcode reader for samples Automatically delivers sample racks
2. Light shield Protects the sample arm and probes
3. Reagent section lid
4. Alarm indicator light Green: ready to start analysis Flashing green: Warming up/analyzing Orange: Consumables are used up Flashing orange: Analysis being performed Red: Analysis stopped due to an error
5. Start button Start analysis
6. Mechanical stop
7. Cuvette hopper Holds approximately 500 cuvettes
8. Cuvette trash box
5
Hardware overviewLeft side hardware overview
1. Fuse box and power cord
2. Power switch
3. Trap chamber Prevents fluid from entering the compressor
4. Adjustment knobs -0.067 MPa vacuum 0.10 MPa pressure
5. Filter No. 16 Prevents dust from entering the system
6
Hardware overview
Right side hardware overview
1. Halogen lamp Light source for all assays
2. IPU connector Connects main unit to computer
3. Air filters Prevent dust from entering the system
7
Hardware overviewInternal hardware overview
1. Sample arm – Cap piercing – Primary aspirating and dispensing of sample – Sample volume check
2. Dispensing table Holds sample cuvettes
3. Reagent table – Holds reagents, calibrators, controls, and cleaners – Temperature: 10 °C
4. STAT / buffer table – Five buffer/diluent positions – Five STAT sample positions – Room temperature
8
Hardware overviewIPU computer and touch screen with 2D barcode reader Pneumatic unit with pressure adjustment knob
9
Software overview
Software overview1. Toolbar
Contains shortcut icons for main functions
2. View Displays the operational functions of the instrument
3. Status bar Displays the status of the IPU and instrument
10
Software overview1. Reagent
Reagents and buffer/diluents status
2. Calib. Curve Displays calibration curves for each assay and Normal/ISI values
3. QC Chart QC Levey-Jennings charts
4. Order Register samples, QC, and calibrations
5. Joblist Displays results, orders, and status of samples
6. Status Displays instrument consumables and temperatures
7. Maint. Documents maintenance tasks
8. Shutdown Cleans and powers down computer and main unit.
9. Start
10. Reagent Lot Master Enter lot numbers and expiration dates
11. Operation Log Records instrument activities with user name
11
Status bar
Status of instrument
Green: Ready
Orange: Analyzing, consumable is used up
Red: Error
Grey: Instrument not connected
Error help
Displays error messages and corrective action
Status of host computer
Green: Connected
Red: Communication error
Icon not displayed: Disconnected in the System Settings
12
Status bar indicators
Temperature
Black: All temperatures are in normal range.
Red: Some temperatures are outside normal range.
Grey: The main unit is not connected.
Reagent Cuvettes Rinse
Black: There is a sufficient amount.
Yellow: Low level
Red: Out. Needs replacement.
Grey: The main unit is not connected. Cannot detect level.
13
Daily maintenance
Daily maintenance
Shutdown
1. Verify CA Clean I vial is loaded on the Reagent Table.
2. Press Shutdown icon. Select option: Turn the Main Unit OFF.
3. Press OK.
4. Cleaning will take 5 minutes.
5. Wait for IPU computer to automatically shut down.
6. Press analyzer power switch off.
7. Check Trap Chamber for fluid. Remove fluid if present.
Startup
1. Press Power button on IPU computer.
2. Computer starts up.
3. Press enter on keyboard to select User. (lower left side)
4. Enter User password.
5. Instrument software starts up.
6. Select logon icon, enter password.
7. Press analyzer power switch on.
Tasks
1. Select Status icon to check rinse, waste, cuvettes.
2. Press Maint. icon.
3. Empty cuvette trash box. Reset trash counter.
4. Empty Waste Tank: Press Change Waste Tank key Empty waste. Press OK.
5. Check/replace DI water.
6. Add cuvettes to hopper. Do not fill above the red line.
7. Select Manual Maintenance key: check off completed tasks
8. Press the Menu icon to view the Main Menu.
9. Select Operations Log to initial for maintenance tasks. Directions on page 14.
10. Replace reagents and QC as needed.
11. Run QC for assays.
14
Operation logEnter initials or comment
1. Press Menu.
2. Select Operation Log.
3. Select the Pencil icon.
4. Enter initials on the comment line.
5. Select OK.
6. Repeat for each maintenance item performed.
7. Press Close.
Save file
1. Select Operation Log.
2. Select Filter operation key.
3. Enter start/end dates using calendar.
4. Select OK.
5. Select Export operation key.
6. Name file and select location.
7. Select Save.
8. Select Filter, Select Clear, Select OK.
9. Press Close.
Note:To view a saved file, use Import button and select file. Press Display Current Log to return to current.
15
Loading Reagents
Reagent Table Features
elapsed time-hours on-board
lot needs calibration
on-board stability expired
remaining stable time
number of tests
usable volume
16
Reagent messagesMessage Cause Corrective action
This symbol occurs if diluent is placed on the reagent table or if a mixed and cooled reagent is mistakenly placed in a wrong position in rack.
This status also occurs if the reagent barcode ID is not listed in the Reagent Master. Contact Siemens Healthineers Technical support.
Remove reagent and load into the correct location or enter the barcode ID into the Reagent Master screen.
This symbol occurs if the reagent lot has expired. Replace with new lot of reagent.
This symbol occurs if a barcode read error occurs or when loading a cup.
Readjust reagent vial in the reagent table or manually edit reagent information.
This symbol occurs when a new reagent lot is added.Remove and replace with current lot of reagent.
This state occurs if the reagent stability has expired. Replace with a new vial of reagent.
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Buffer table loadingLoading barcoded vial
1. Verify buffer table cover LED is green.
2. Open buffer table cover.
3. Place reagent in an adaptor with barcode facing out.
4. Place into the STAT/buffer table and close cover.
5. Press OK on barcode reading screen.
6. On Reagent screen, touch reagent position just loaded, and press Change to update the set date and time.
Loading 4 mL cup
1. Verify buffer table LED is green.
2. Place cup into adaptor and load.
3. Close STAT/buffer table cover.
4. Press OK on barcode reading screen.
5. On Reagent screen, see position display as red question mark.
6. Highlight red question mark position.
7. Press Edit Reagent Info operation key.
8. Select reagent name, vial type is 4 mL cup, verify lot number.
9. Press OK.
10. With cup position highlighted, press Change to update date and time.
18
Reagent table loading
1. Press Reagent icon on toolbar.
2. Highlight a reagent position for removal.
3. Press Change/Add.
4. Lift the reagent section lid.
5. Verify reagent table cover LED is solid green.
6. Slide the lock lever and remove cover.
7. Lift out rack. Remove empty or expired reagents.
8. Add new vial to rack with 1D barcode showing.
9. Load rack into the reagent table.
10. Replace cover and slide the lock lever.
11. Close the reagent section lid.
12. Press OK on screen to read barcode.
13. Wait for barcode reading to finish.
14. On Reagent screen, touch reagent position just loaded, and press Change to update date and time.
Note:Now you can add reagents to reagent table B (small cover) without interrupting analysis.
19
Loading QC or calibrator into C-rackUse C-rack and SLD mini cup
1. Reconstitute vial observing package insert instructions.
2. Aspirate entire content of GW5 vial using appropriate pipette.
3. Slowly dispense the entire volume into a new SLD mini cup, avoiding any air bubble formation.
4. After reagent transfer, carefully check for bubbles and, if required, remove using smaller pipette tip.
5. Set SLD mini cup into corresponding GW5 vial.
6. Remove C-rack using reagent table loading directions (page 18).
7. Insert vial with SLD mini cup into C-rack and place back into Reagent Table.
8. Lock lever and press OK to read barcode.
9. On Reagent screen, highlight vial just loaded and press Change to update date and time.
Note:SLD mini cup is for C-rack only.
20
Vial types
Letter NameDead volume
(reagent table)Dead volume
(STAT/Buffer table)
A GW50/CA Clean 7.0 mL 7.0 mL
B GW15 0.4 mL 3.9 mL
C GW5 0.3 mL 2.3 mL
D SLD mini cup in GW5 0.15 mL N/A
E 4 mL cup 0.2 mL 0.5 mL
A B C D
E
21
Quality control
Quality controlProcessing from the reagent table: QC files
1. Load QC onto a C-rack. Refer to the Loading Reagents tab to load QC material in a C-rack using a SLD mini cup.
2. Select Order.
3. Select Switch Order.
4. Select Holder QC Order.
5. Press Order Entry.
6. Select QC01-QC20 radio button.
7. Select QC file from the list on the right.
8. Select the appropriate assay(s).
9. Press the down arrow to order the next control.
10. Select QC01-QC20 radio button to continue ordering controls.
11. Press OK once controls have been ordered.
12. Press Start.
22
Quality controlProcessing from the reagent table: Control lot
1. Load QC onto a C-rack. Refer to the Loading Reagents tab to load QC material in a C-rack using a SLD mini cup.
2. Select Order.
3. Select Switch Order.
4. Select Holder QC Order.
5. Press Order Entry.
6. Select control material from the list.
7. Place cursor in the Lot No. field and select lot from list.
8. Select the appropriate assay(s).
9. Press the down arrow to order the next control.
10. Press OK once controls have been ordered.
11. Press Start.
23
Quality controlProcessing from the sample rack
1. Place QC in cup and place in sample rack.
2. Press Order.
3. Select Switch Order.
4. Select Rack.
5. Select tube position.
6. Select Order Entry.
7. Select QC Sample radio button.
8. Select control from the list.
9. Place curser in the Lot No. box and select the lot number from the list.
10. Select the appropriate assay keys.
11. Press the arrow down to order next control.
12. Press OK once all controls have been ordered.
13. For Micro Mode, check the MC column for each control.
14. Press Start.
24
QC ChartAdd a comment to a point
1. Press QC Chart.
2. Highlight specific QC Chart.
3. Place cursor on point.
4. Press Confirm Data key.
5. Enter comment in field.
6. To exclude point: check box.
7. Press Update.
Print a QC report
1. Select tab for printing.
2. Press More. Press Print Report.
3. Select Active Tab.
4. Select Date Range and enter start/end dates.
5. Select format: List 1.
6. Press Print.
25
QC ChartExport QC data to a file
1. Press QC Chart.
2. Highlight specific QC Chart.
3. Press More two times.
4. Press Export.
5. Select a location to place file.
6. Name file: date.Assay.control
7. Press Save.
26
Sample processing
Sample processingLIS order processing
1. Place rack with barcoded sample tubes on the sampler.
2. Check host connection (HC) status. HC status icon must be green or orange.
3. Press Start.
4. After barcode reading, confirm sample order status and progress on the Joblist screen.
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Sample processingManual order processing
1. Press Order.
2. Enter Rack number.
3. Select tube position.
4. Press Order Entry.
5. Place cursor in Sample No. and input sample ID if sample does not have a barcode.
6. Select assays to be analyzed.
7. Press the down arrow to order the next sample.
8. Press OK.
9. Press Start.
10. Place sample rack with tubes/cups on the sampler.
11. Confirm sample order status on the Joblist.
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Sample processing — detailed settingsMicro mode
1. Follow Manual order Processing steps on previous page to ID sample and order test.
2. Press Mc column on Order screen.
3. Press Start.
4. Place sample rack with cups/uncapped tubes onto system.
Change to longer measurement time
1. Follow Manual Order Processing steps on page 27 to ID sample and order test.
2. Press Detailed Settings button.
3. Click box below Measurement Time.
4. Select measurement time.
5. Select OK.
6. Select Start.
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Factor assay MDA
Factor assay: Multiple dilution analysisOrder MDA
1. Press Order.
2. Order a factor assay on a specimen. Follow Manual Order Processing directions.
3. Press Detailed Settings operation key.
4. Select 1/1 key under Dilution Ratio.
5. Select MDA dilution.
6. Press OK.
7. Press Start.
MDA name Dilution ratio
MDA stand 1/1 1/2 1/4
MDA high 1/2 1/4 1/8
MDA low 1/1 3/2 2/1
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Factor assay: Multiple dilution analysisView results
1. Press Joblist.
2. View Sample ID. View results for three MDA dilutions and mean.
3. Highlight mean result.
4. Press Browser key.
5. Press graph to display large graph. – View graph of results – View dilutions with results – View mean result
31
Joblist information
Joblist information: Status
Status Meaning
Pending Order is registered but analysis has not started.
Processing Assay groups are being analyzed.
On Hold All assay groups have been analyzed but a validated calibration curve is missing.
(Blank) Analysis of all assay groups has been completed normally.
Review Analysis completed but requires confirmation due to an analysis error.
Error A hardware or reagent error has occurred.
32
Joblist information: SymbolsResult flags
* Low reliability flag
d Dilution analysis
< Below report limit
> Above report limit
R Reanalyzed
***.** No result due to error
XXX.XX No calibration curve
Analysis progress
Test ordered
Sample dispensed
Sample incubating
Sample measuring
33
Joblist informationBrowser
1. Highlight sample on the Joblist.
2. Press Browser.
3. Press Detail key.
4. View Detail screen. – Displays sample volume error – Displays analysis result error – Displays wave change – Displays hardware or reagent error
5. Press the graph for Reaction Curve information.
6. Proceed to next page for reaction curve information.
34
Joblist informationReaction curve
• Press graph on Browser to view reaction curve.
• View the reaction curve shape.
• Press the three tabs for more information.
1. Evaluation Info tab displays: – bH: baseline – dH: reaction intensity – Coag %: where clot time is read – Wavelength: alternative wavelength used – Start and end time for chromogenic/DDi
2. Evaluation Data tab displays 1%–100% time for reaction curve
3. Measurement Info tab displays: – Reagent lot used – Dilution ratio – Reagent elapsed time-hours onboard – Hem detection level – Lip detection level – Vol detection level – QC performed date – Reagent table temperature
35
Joblist printing/export
Joblist printingPrinting a single sample result
1. Select Joblist.
2. Select a sample result.
3. Press More operation key.
4. Select Print operation key.
5. Select Cursor Data.
6. Select a format: Graph, List, Simple.
7. Select Print.
Printing multiple sample results
1. Select Joblist.
2. Press More operation key.
3. Press Mark operation key.
4. To mark results for printing: Press Same Date for all samples of specific date. Press Current on individual sample results.
5. Select Back.
6. Select More.
7. Select Print.
8. Select Simple Print.
9. Select Print.
10. Go back to Mark and select Release All.
11. Press Back.
36
Joblist exportExporting daily joblist results
1. Press Joblist.
2. Select Display Condition.
3. Select Specify Date.
4. Select date using calendar.
5. Press Display.
6. Select More twice.
7. Select Export.
8. Select All.
9. Press Export.
10. Choose location for file.
11. Name file with the date.
12. Press Save.
13. Press Display Condition.
14. Select Today or Latest 50.
37
Preanalytical Sample Integrity
Preanalytical sample integrity
Hemolysis, lipemia, tube volume check
1. View Joblist .
2. View Sample Info column:
Hem Flag for hemolysis
Lip Flag for lipemia
H* Interference in hemolysis reading.
Check tube manually
L* Interference in lipemia reading.
Check tube manually
Vol Sample tube fill out of range
38
Preanalytical sample integrityTo view levels for a sample:
1. View Joblist. Highlight sample result.
2. Select Browser.
3. Press Reaction Curve.
4. Select Measurement Info tab.
39
Enter reagent information
Enter reagent informationUsing vial barcode or manual entry
1. Press Menu from IPU toolbar.
2. Press Reagent Lot Master icon.
3. Enter lot number in Lot No. field or scan barcode with 2D barcode reader.
4. Place cursor in Exp. Date field.
5. Enter Exp. Date using calendar.
6. Press Add.
7. Press Save.
Important:You must always manually enter the expiration date for each reagent. Expiration dates are not entered via the scanned barcode.
40
Enter reagent information
Using 2D barcode on Table of Assigned Values
1. Press Menu from IPU toolbar.
2. Press Reagent Lot Master.
3. Select Import.
4. Select Barcode.
5. Scan assay value sheet CS Systems 2D barcode.
6. Press Save.
7. Press Exit.
8. Press Close.
Note:2D barcodes are found on the Table of Assigned Values insert sheet for Siemens PT reagents, calibrators, and all assayed controls.
41
Weekly maintenance
Weekly maintenanceCleaning the instrument
1. Shut down the main unit and unplug the power cord.
2. Wipe the instrument with a moistened paper towel with water and a neutral detergent.
Cleaning the rinse tank
1. Remove the cap of the rinse tank by turning counterclockwise.
2. Use 70% isopropyl to wash the inside of the tank and float switch.
3. Rinse the tank and float switch with distilled water.
4. Attach the float switch and tighten cap clockwise.
Note:Document manual maintenance in the Maint. screen under Manual Maintenance in the operation panel.
42
Monthly maintenance
Monthly maintenanceCleaning the filter (rear)
1. Remove filters #514 and #513.
2. Use a vacuum or similar tool to remove dust from the filters.
3. Install the clean filters.
Cleaning the filter (left side)
1. Remove filter #16A.
2. Use a vacuum or similar tool to remove dust from the filter.
3. Install the clean filter.
4. Document in the Maint. screen under Manual Maintenance.
43
As-needed maintenance
Pressure adjustment
Adjusting the 0.10 MPa pressure (range 0.10 to 0.11)
1. Press Maint.
2. Press Pressure Adjustment (press More if not visible).
3. Press Power ON Pressure (if pneumatic unit does not automatically turn on).
4. Open the cover door on left side of instrument.
5. Pull the 0.10 MPa adjustment knob toward you to unlock.
6. Adjust the pressure slowly.
7. Once adjustment is complete, press the adjustment knob in until it locks.
8. Close the cover door.
9. Press OK.
Adjusting the 0.22 MPa pressure (range 0.22 to 0.25)
1. Press Maint.
2. Press Pressure Adjustment (press More if not visible).
3. Press Power ON Pressure (if pneumatic unit does not automatically turn on).
4. The 0.22 MPa adjustment knob is located on the pneumatic unit.
5. Loosen the fixing screw on the adjustment knob by turning the screwdriver counterclockwise.
6. Adjust the pressure slowly.
7. Once adjustment is complete, tighten the fixing screw while taking care not to rotate the adjustment knob.
8. Press OK.
0.10 pressure adjustment 0.22 pressure adjustment
44
Vacuum adjustmentAdjusting the vacuum (Range -0.071 to -0.067)
1. Press Maint.
2. Press Pressure Adjustment (press More if not visible).
3. Press Power ON Pressure (if pneumatic unit does not automatically turn on).
4. Open the cover door on the left side of the instrument.
5. Loosen the fixing nut of the bellows unit.
6. Turn knob clockwise to increase, counterclockwise to decrease.
7. Adjust the pressure between -0.071 and - 0.067.
8. Tighten the fixing nut.
9. Close door.
10. Press OK.
Vacuum adjustment
45
Lamp replacement1. Turn OFF the power of the main unit and unplug the power
cord. Wait 30 minutes for lamp to cool down.
2. Open the lamp cover located on the right side of instrument.
3. Disconnect the white connector.
4. Loosen the thumb screw.
5. Remove lamp holder.
6. Squeeze and lift the lamp retainer to remove the lamp.
7. Install a new lamp in reverse order.
8. Reconnect the power cord and turn power ON.
9. Allow lamp to burn in for 30 minutes before calibration.
10. Go to next page for lamp calibration directions.
Note:Do not touch the lamp reflector with your fingers, or lamp performance could be affected.
46
Lamp calibration1. Press Maint.
2. Press Lamp Calibration.
3. Press Execute.
4. Select the correct option when the lamp confirmation dialog box appears. • Reset lamp counter when calibrating a new lamp. • Do not reset the lamp counter when calibrating the same lamp.
5. Press OK.
6. Enter initials in Operation Log for calibrating a new lamp.
7. Enter initials/date in Maint. Screen Remarks field next to lamp calibration to record a recalibration of the same lamp.
8. Perform QC on all assays.
Note:Lamp calibration requires a 30-minute warming-up of the lamp to allow light intensity stabilization. Do not start calibration earlier; this will affect patient results.
47
As Needed Maintenance (continued)Clean the Sysmex racks
1. Wipe racks with soft cloth with water or ethanol.
2. Document in Manual Maintenance.
Wipe the piercer clean
1. Verify light shield is closed
2. Press Maint. on the toolbar.
3. Press Wipe off Piercer operation key
4. Wait for piercer to move to position. Press OK.
5. Power off Main unit.
6. Open light shield.
7. Set the jig on the piercer.
8. Wipe piercer with gauze moistened with distilled water.
9. Remove the jig.
10. Close the light shield.
11. Power on the Main unit.
48
Calibration
CalibrationIdentify the reagents
1. Enter reagent and calibrator lot information in Reagent Lot Master. Refer to the Enter Reagent Information tab for more details.
2. Load reagents, calibrator, buffer. Refer to the Loading Reagents tab for more details.
Order the calibration
3. Select Order.
4. Select Switch Order.
5. Select Holder Calib Curve Order.
6. Select the desired assay to be calibrated.
7. Select Change and select the correct lot number.
8. Select OK.
9. Select the correct calibrator lot number from list. Assay value automatically displays.
10. For manual entry of assay value: Place the cursor in the Assay Sheet Value field and enter value using keypad.
11. Select OK.
12. Select Start.
13. To view the calibration status and progress, press Joblist.
Note:Calibrator plasma should be transferred into a SLD mini cup and placed in the vial. Place vial in a C-rack. Refer to Loading Reagents tab for more details.
49
Calibration validationView new calibration curve
1. Select Calib. Curve.
2. Select Change.
3. Select assay.
4. Select lot number.
Compare new/current calibration curve
5. Select Detailed Display.
6. Select Select Compared Calib. Curve.
7. Select a calibration curve to compare and press Load.
8. Compare calibration curves.
9. Select Close.
Validate new calibration curve
1. Select Validate to validate the calibration curve.
2. Select OK.
3. Select Print. Note:Validate calibration by performing QC.
50
Calibration: Restore Restore Old calibration curves
1. Display the calibration curve for the selected assay.
2. Select Restore on the operation panel. *If Restore is not displayed, press More.
3. Select the desired calibration curve to restore.
4. Press OK.
5. Select Validate to validate the calibration curve.
6. Select OK.
51
Enter ISIand Normal
Enter ISI and normalEnter the ISI and Normal value
1. Enter PT lot and ISI value in Reagent Lot Master with 2D barcode from PT ISI value sheet. See Enter Reagent Information tab for more details.
2. Load PT reagent onto reagent table.
3. Press Calib. Curve.
4. Press Change.
5. Press PT.
6. Select specific lot number.
7. Select Edit.
8. Select Lot Master key to enter ISI value.
9. Select Yes.
10. Manual entry of Normal Patient Mean: Place cursor in Normal Value field and enter value using keypad. Press Enter. ISI Value can be entered manually if needed.
11. Select OK.
12. Select Validate.
13. Select OK.
Note:ISI Value with 2D barcode is found on the ISI Value sheet for Dade® Innovin. The Normal Value is established by the laboratory for each new lot of PT reagent.
52
Backup
Backing up the databaseSaving to IPU backup folder
1. Exit the IPU software by selecting X in upper right of screen.
2. Press OK.
3. Power OFF analyzer.
4. Select the Backup icon on the desktop.
5. Select IPU Backup folder for location (C:\IPU_Backup).
6. Check box for Saved date is added to backup destination.
7. Select Option.
8. Select Specify Date. Enter the date range from last backup.
9. Select OK to close dialog box.
10. Select OK to start backup.
11. Wait for “Backup is correctly completed” message.
12. Select OK.
13. Select Cancel on Backup screen to close.
14. Find file in IPU Backup folder.
15. Save file to a thumb drive. Go to the next page for instructions.
Note:The file created is identified with date and time. The Joblist with the last 10,000 results will be saved.
53
Backing up the databaseSaving to a flash drive
1. Place flash drive in computer.
2. Open IPU_backup folder on desktop.
3. Right-click the file, select Send to, and select Compressed (zipped) folder.
4. Right-click on Compressed backup file.
5. Select Send to and select the flash drive.
6. To delete files from IPU backup folder, highlight file, right click, select Delete.
Note: It is not recommended to keep all backup files in the IPU backup folder. This may slow down computer.
54
System shutdown and startup
Shutdown and startupShutdown the system
1. Verify CA Clean I is set on the Reagent Table.
2. Press Shutdown icon. Select option: Turn the Main Unit OFF.
3. Press OK.
4. Cleaning will take 5 minutes. IPU computer will shut down.
5. Press analyzer power switch off.
Startup the system
1. Press Power button on IPU computer.
2. Computer starts up.
3. Press enter to select User. (lower left side)
4. Enter User password.
5. Select Logon icon, enter password.
6. Press analyzer power switch on.
55
Error help
Error help1. Select yellow triangle on bottom right of
status bar to view Error Help dialog.
2. View the error and action message.
3. Correct the error.
4. Press Log Corrective Action key.
5. Select or write a corrective action.
6. Press OK.
7. Press Error Log to view.
Note:Refer to Sysmex® CS-2500 System Instructions for Use, Troubleshooting chapter, for a list of error messages and corrective actions.
56
Troubleshooting results
Analysis Result Error Review the result on the Joblist.
No further action needed.
Report result per laboratory protocol.
Highlight the sample and select Browser.
Locate result with Detail key.
Use Sysmex® CS-2500 Quick
Reference Guide to troubleshoot
Analysis Result Error.
Analysis Result Error occurred.
View Detail screen for Analysis Result
Error and Error Code number.
On Browser, select the Reaction Curve,
review Evaluation Info, Evaluation Data, and Measurement Info.
Mechanical error or reagent
problem occurred.
View Detail screen for message.
Troubleshoot problem.
Is the status Review or Error?NO
YES
RED YELLOW
57
Analysis Result Error list
Code Analysis Result Error
0002.0000.0000 Slight Coagulation Error
0004.0000.0000 Analysis Time Over Error
0008.0XXX.0000 Coagulation Curve Error
0008.0128.00XX Early Reaction Error
0008.0256.0000 Noise Check Error
0016.0000.0000 Turbidity Level Over Error
0032.0000.0000 No Coagulation Error
0032.0002.0000 Flat Curve Error
0000.0000.8000 Coag % Changed Note:For more information, refer to Sysmex CS-2500 System Evaluation and Check Algorithm booklet
58
Slight Coagulation Error
Joblist display Numerical result with asterisk (ie. *11.0)
Cause The detected coagulation reaction was weak:
• Possible low fibrinogen concentration
Corrective action
Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
Reanalyze the sample. The instrument will typically perform an automatic reanalysis of the sample.
Reportable result Reanalysis produces a result without an error, it may be reported.
If reanalysis produces Slight coagulation error again with comparable results to first run, the result may be reported as determined by your laboratory policy.
No Coagulation Threshold Slight Coagulation Threshold
Normal Sample
Time
A/D
val
ue o
f pho
tom
etry
0%
100%dH
59
Analysis Time Over Error
Joblist display Numerical result with asterisk
Cause The coagulation reaction did not finish within the set measurement time. This occurs with samples that have prolonged clotting times.
Corrective action
• Check the sample for possible anticoagulant contamination, hemolysis, and lipemia.
• Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
• Reanalyze sample at longer measurement time. (Sample Processing Tab) An automatic reanalysis at a longer measurement time is typically performed.
Reportable result
• Reanalysis produces a result without an error: report the result.
• If Reanalysis produces Analysis Time Over again, the sample may not be able to form a firm clot. Follow your laboratory policy.
Maximum Reading Time Time
A/D
val
ue o
f pho
tom
etry
0%
True End Point ?
Reaction Start Level
60
Coagulation Curve Error
Joblist display Numerical result with asterisk
Cause • This occurs when there is an unexpected fluctuation in the curve. The most common reason is a bubble in the cuvette.
• In fibrinogen test: cold buffer or sample inhibitor
Corrective action
• Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
• Review result reaction curve.• Reanalyze sample.
Reportable result
• Reanalysis produces a result without an error: report the result.
• If Reanalysis produces Coagulation Curve Error again, review acceptability of both curves, and if results are equivalent, the mean of the results may be reported as determined by your laboratory policy.
Error sub-types
• Initial fluctuation drop• Sharp drop• Stepping curve• Jump up
• Fbg curve error• Terrace• Step curve
Normal Sample
Time
A/D
val
ue o
f pho
tom
etry 0%
Check T[4 sec.]
delta
Mask Time
100%
dH
61
Early Reaction Error
Joblist display No numerical result ***.*
Cause For APTT results only
1. Patient is on anticoagulant drugs (ie. Heparin)
2. Poor sample collection, a line draw with anticoagulant, other contamination.
3. Unusual clinical situation.
Corrective action
1. Verify sample, reagent integrity, patient clinical history and delivery of reagent and sample.
2. Verify Error code type in the Detail screen. Follow guidance for that code.
3. View the reaction curve: Does it have clear baseline, clot phase, and endpoint?
4. View Evaluation data in Reaction curve screen for the numerical results.
5. If upon reanalysis, there is no error, it may be reported.
Error code types:
ERE: Slow Reaction- for a result 100 sec or more: Reanalyze the sample with a longer measurement time. Check the reaction curve for clear baseline, a clotting phase and endpoint. If curve is normal, it may be reported. Follow your laboratory policy.
ERE: Slow Reaction- for a result less than 100 sec: Reanalyze the sample. If the result is free from error, report. If repeated result has Slow Reaction, less than 100 sec, do not report. Follow your laboratory policy. (ie. Recollect sample)
ERE: Start Angle 1- Reanalyze the sample. If the result is free from error, report. If repeated result has Start Angle 1, do not report. Follow your laboratory policy. (ie. Recollect sample)
ERE: Start Angle 2- The result may be reported after inspecting the reaction curve for clear baseline, a clotting phase, and endpoint. If reaction curve is not normal, do not report. Follow your laboratory policy. (ie. Consider remix tube, re-centrifugation for a longer duration/ higher speed. Reanalyze).
ERE: Early %- Reanalyze the sample. If the result is free from error, report.
Check the Evaluation data- if the 8% value is less than 16.8 seconds Do not report.
If the 50% value is less than 20 seconds, do not report
If the 50% value is greater than 20 seconds, Follow your laboratory policy. (ie. Consider re-centrifugation at higher speed/longer duration and reanalyze. If reaction curve indicates, use longer measurement time for repeat analysis. Consider recollection unless patient history indicates otherwise.)
Do not report any result with an “Early Reaction Error” without reviewing the reaction curve.
An aPTT result <20 seconds should not be reported.
62
Coag % Changed
Joblist Numerical result
Cause Occurs on samples that have a biphasic reaction curve. The coagulation time is corrected and the Coagulation detection % is changed.
Corrective action
Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
Verify Error code type in the Detail screen.
View the reaction curve. View the Evaluation data to view Coag % change.
Reportable result
If coagulation curve is acceptable, the result may be reported as determined by your laboratory policy.
Time
A/D
val
ue o
f ph
otom
etry
0%
100%
Reanalysis solidification start level
Reanalysis freezing point (e.g. 60%)
Initial clo�ing point (50%)
63
Noise Check Error
Joblist display No numerical result
Cause The coagulation curve reaction may have been contaminated with some kind of electronic noise.
Corrective action
• Recalibrate lamp or replace it with a new lamp. Follow maintenance procedure to calibrate lamp and perform QC analysis.
• Reanalyze the sample.
Reportable result
• If Reanalysis produces a result without an error, it may be reported.
• If Reanalysis produces Noise error again, call the Siemens Healthineers Technical support for assistance.
Diff
Time of End Point
Normal Sample
Time
A/D
val
ue o
fph
otom
etry
0%
100%
Ave1
Mask Time
Ave2 + nSD2
Ave2
Time of Baseline
Ave1 - nSD1
64
Turbidity Level Over Error
Joblist display No numerical result
Cause The sample turbidity was high and the transmitted light was extraordinarily low level.
Corrective action
• Check the sample for turbidity and lipemia.
• Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
• Reanalyze the sample.
Reportable result
• Reanalysis produces a result without an asterisk (*): report the result.
• Reanalysis produces Turbidity Level over again: recollect the sample or follow your laboratory policy.
AD Low Limit
Time
A/D
val
ue o
f pho
tom
etry
Mask Time
65
No Coagulation ErrorJoblist display No numerical result ***.*
Cause The coagulation reaction is not detectable. May be due to:
1. Poor sample collection, a line draw with anticoagulant, other contamination.
2. Patient is on anticoagulant (ie. Heparin, warfarin)
3. May be due to low fibrinogen concentration.
4. An interference or a reagent problem
Corrective action
• Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
• Reanalyze the sample with a longer measurement time. An automatic reanalysis at a longer measurement time is typically performed.
Reportable result
• Reanalysis produces a result without error, it may be reported.
• Reanalysis produces No Coagulation again, determine if result is plausible. (ie. Sample integrity)
• May be reported as greater than your Report limit. Follow your Laboratory policy.
Time
Slight Coagulation Threshold
No Coagulation Threshold
Normal SampleA/D
val
ue o
f pho
tom
etry
0%100%
dH
66
Flat Curve Error
Joblist display No numerical result (***.*)
Cause PT Test only. Due to Warfarin in high dose.
Corrective action
• Verify reagent integrity, sample integrity, patient clinical history, and instrument delivery of reagent and sample.
• Reanalyze the sample with a longer measurement time. An automatic reanalysis at a longer measurement time is typically performed.
• View reaction curve for normal baseline, clot phase, and endpoint.
• View Evaluation data results of first run and reanalysis.
Reportable result
• Reanalysis produces a result without error, it may be reported.
• If reanalysis at longer measurement time produces a Flat Curve again, follow your laboratory policy.
Normal Sample
Time
0%
100%
50%
Width
A/D
val
ue o
f pho
tom
etry
Slope
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05-2021 | All rights reserved© 2021 Siemens Healthcare Diagnostics Inc.
T05013.001 Effective date 05/14/21
Note: This document is for supplemental use only, and not meant to be used in place of primary technical materials
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