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Sysmex® CA-600 Series Analyzer PEP to Go

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SIEMENS sysmex - CA-600 series Sysmex® CA-600 Series Analyzer PEP to Go Answers for life. GPE05010.014 Effective Date: 10/21/2014 Table of Contents 1. Hardware Overview 2. Software Overview 3. Maintenance 4. Loading Reagents 5. Sample Processing Ready ce Rack? YES! Group 1 6. Operation Symbols Prev 7. Quality Control 6479 Repeat 8. Stored Data 9. Calibration 10. System Alarms 11. Coagulation Curve Errors 1 Hardware Overview External (Front) Hardware Overview 1. On/Off switch Turns the power on and off 2. Sampler Has a load capacity of one sample rack 3 with 10 sample tubes 3. Light shield Prevents photoelectric detection from being affected by scattered light from external sources 6 4. Mechanical stop switch Stops the operation of the instrument 5 5. Printer 4 Settings, error messages, and results are printed on thermal paper 1 6. Touch screen Displays analysis results, reaction curves, sample 2 numbers, and conditions, etc. 2 Hardware Overview External (Rear) Hardware Overview 1. Tube trash box (not shown) Collects used reaction tubes 2. Trap chamber 5 Prevents the waste fluid from flowing back to the vacuum pump 3. Fuse holder Location of the two time-lag type fuses 4. Power connector For connecting the main power supply (via the supplied power cable) 5. Host computer connection (not shown) The location of the connection to the LIS system 1 W 2 4 3 Internal Hardware Overview 1. CA Clean and Buffer holder Holds CA Clean I, CA Clean II, and Buffer 2. Barcode scanner (not shown) Moves in front of the sample rack and reads the 4 barcode label automatically 3. Detection wells Sample results are detected for coagulation, chromogenic, and immunologic assays 4. Probe 3 Aspirates samples and reagents 5 1 5. Reaction tube racks Each rack holds up to 30 reaction tubes; 6 two reaction tube racks can be set 2 6. Reagent holder Holds the reagents onboard 4 Software Overview 1. Sysmex key Displays error list, temperatures, and paper feed 1 2 3 4 5 6 2. Analysis status Sysmex Ready Replace Rack ? YES ! HC HB Start 7 Displays system status Main Menu Group 1 1 PT 2APTT 3 Fbg 4 DDI 5 AT3 3. Rack replacement - - - - - Indicates if sample rack can be replaced 4. Host computer connection Rack ID No. 123 45 Prev 1-01 Indicates if the HC is connected ----- 8 1-02 ----- 5. Hand held barcode reader connection 1-03 Next 1-04 Indicates if the HB is connected 1-05 6. Start key Start/Stop analysis Repeat ID No. Entry HC 9 7. System status area Stored Special Displays error messages, analysis status, and Data QC Standard Test Curve Group Menu status of externally connected instruments 8. Data processing area Displays analysis progress status, work list, and test keys 9. Menu processing area Displays the menu for function selection. In selecting a menu, touch a key that shows the menu you want displayed 5 Software Overview Software Overview 1. Stored Data Displays analysis results for samples, QC, standards Ready HC HB 2. QC Sysmex Replace Rack ? YES ! Start Displays quality control results on a Levey-Jennings chart Main Menu 8 Group 1 1 PT 2APTT 3 Fbg 4 DDI 5 AT3 3. Standard Curve Review, input standard curve data, and order calibrations Rack ID No. 123 45 Prev 4. Test Group Used to change the group displayed and available to order 1-01 1-02 ---- 5. Special Menu 1-03 Next 1-04 9 Navigates to other areas of the software such as set reagents 1-05 and rinse probe ID No. 6 Entry HC 6. Repeat Repeat 7 Used to order same tests on an entire rack of samples Stored QC Standard Test Special 7. ID No. Entry Data 1 2 Curve Group Menu Manually enter sample ID number and quality control 4 5 W 8. Group Displays which group of tests is currently displayed; there are three groups 9. Rack/ID No./Test Displays the rack number, rack position, and ID number of the sample and tests ordered 6 Daily Maintenance 1. Turn power off, wait 15 seconds, and turn on 2. Check/Replace distilled water Note: Trans light calibration is automatically performed at start up and every 3. Load fresh buffer as needed 24 hours, if chromogenic or immunologic assay is included in the active 4. Check/Empty waste container test group. 5. Check/Discard pneumatic trap chamber fluid Attention: OVB is required on-board at start up of the instrument. 6. Check/Replenish reaction tubes 7. Empty/Clean reaction tube trash box 8. Load CA Clean I and II 9. Run ‘Rinse Probe’ Special Menu > Rinse Probe 11. Check/Prepare reagents 12. Clean sample probe 13. Check temperatures Sysmex > Temperature 13. Remove condensation from reagent rack 7 Maintenance Weekly Maintenance sysmex Clean Instrument Exterior 1. Wipe off stains using a cloth soaked with water and neutral detergent. 2. Wipe the exterior using a dry cloth. Clean Instrument Interior 1. Open the light shield cover and check that it will not fall down with its own weight. 2. Take out the reaction tube racks and reagent rack . 3. Using a cloth soaked with water and neutral detergent, wipe off stains. Clean likewise the reaction tube racks and reagent rack that were taken out before. 4. Wipe off stains using a dry soft cloth. 5. Close the light shield cover. 8 Quarterly Maintenance LED Calibration Filter Inspection and Cleaning Refer to page 10 to perform an LED 1. Remove filter NO.598 located underneath of the calibration. sampler in the front of the instrument. Cleaning the Rinse Container 2. Use a vacuum cleaner or similar tool to remove dust from the filter. 1. Turn OFF the instrument power. 3. After cleaning, push filter NO.598 fully back into 2. Turn the cap of the rinse bottle counterclockwise place, in the reverse order of removal. to release the pressure from the bottle. Place cap on a clean paper towel. 3. Discard any remaining liquid in the rinse bottle. Note: 4. Add 250 – 300 mL of 70% isopropyl alcohol LED Autocalibration (coagulometric channels only): to the rinse bottle. every 90 days using CA CAL S or monthly if Derived 5. Replace the cap on the rinse bottle and Fibrinogen is reported tighten securely. 6. Mix the alcohol inside the rinse bottle to make sure it comes in contact with all surfaces, including the float switch. 7. Discard the alcohol and rinse the rinse bottle well with distilled water. 9 LED Calibration Sysmex Ready Replace Rack ? YES ! HC HB LED Calibration Running LED Calibration Target Value 883 1. From Main Menu, press Special Menu. Vial Type Cup 8 9 2. Press Special Operate. Required Volume 1450 ul 5 6 3. Press LED Calibration. Please set Calibration on Reagent Holder 1 and set Clean1 on Reagent Holder 11. 2 3 4. Press Calibration. Press { Set } key. 5. Enter the target value (100 -999) found in the 0 Enter calibrators insert sheet on the table of assigned Set C QC | Quit values. Use the numeric keys to enter the value then press Enter. 6. Move the cursor to “Vial Type” using q and p keys, Evaluating LED Calibration and press Next to select the container 1. When the operation is completed, the LED Calibration 7. Set the calibrator solution in reagent holder 1. Update screen will appear. 8. Set CA CLEAN I in reagent holder 11. 2. Check each well that is displayed. 9. Press Set, confirmation screen will appear press OK. OK: Available *OK: Available. However, replacement is required within a few months Note: ERRxx: Not available LED Autocalibration (coagulometric channels only): every 90 days using CA CAL S or monthly if Derived 3. Press FIX to update the new adjustments when all Fibrinogen is reported wells are OK. Press Cancel to rerun the LED calibration. 10 As-Needed Maintenance Replace Fuse Replace Printer Paper 1. Turn off the power supply and disconnect the 1. Remove the printer cover by raising its lower edge. power cord. 2. Raise the printer lock lever to unlock. 2. Remove the fuse cap holder at the rear panel while pushing the tabs using a flat-tip screwdriver. 3. Remove the paper roll core and attach a new printer paper roll. 3. Replace the fuses and attach the fuse cap holders. 4. Place the printer paper as shown (right) and push down the lock lever to lock. 5. Press the Sysmex key, 250V then press P.FEED key T 4A to advance the paper. 6. Attach the printer cover. 11 Loading Reagents Set reagents according to the test protocol and label on the reagent holder. 1. Press Special Menu to select Set Reagents. 2. Set reagents in their appropriate positions on the instrument. 3. Enter the reagent volume if the reagent volume alarm is ON. Cacla S APTT FOR 10 Note: It is not necessary to enter the reagent volume if the reagent alarm is OFF, because the Sysmex CA-600 series analyzer has level sensing to recognize insufficient reagent. 12 Loading Reagents Reagent Positions Position I (11) • CA Clean I position • Room temperature 1 3 5 7 9 - • GW5, PV10, SLD vials directly PT 3 Fbg 5 APTT 7 CaCl2 I 9 B IT II • 4 mL cup requires an adaptor B 2 4 6 8 10 Position B (12) R 10 • Buffer position • Room temperature • GW5, PV10, SLD vials directly • 4 mL cup requires an adaptor Positions 1 – 4 Positions 5 - 10 • Cooled to 15° C Position II (13) • Room temperature • GW5, PV10, SLD vials directly • GW5, PV10, SLD vials directly • CA Clean II position • 4 mL cup requires an adaptor • 4 mL cup requires an adaptor • Room temperature (1) PT, (2) APTT, (3) Fbg, (4) DDi Buff 4 mL vial directly • • (6) DDi Reag, (7) CaClCl2, (8) DDi Sup, • (10) DDi Dil 13 Vial Types 1. Sysmex 4 mL cup 4. PV10 (Push Vial) Holds up to 4 mL • Holds up to 10 mL • • Dead volume – 0.3 mL • Used for CA Clean I and Buffer • Used for CA Clean II, reagents, • Dead volume – 0.9 mL calibrators, and controls • Use an adaptor in reagent holder 2. SLD Holds up to 5 mL 1 2 4 W • • Dead volume – 0.4 mL 3. GW5 (Gewinde – “Twist Top”) • Holds up to 5 mL • Used for reagents • Dead volume – 0.8 mL 14 Select Test Group A maximum of five analysis parameters can be displayed on a menu test group. If other parameters Sysmex Ready Replace Rack ? YES ! HC HB are required, such as +Fbg and –Fbg, the test group must be changed. Test groups may only be changed Test Group when the cursor is on a rack that has not yet been analyzed and “Start” is displayed in the upper right hand box. Group 1 1 PT 2 APTT 3 Fbg 4 +DDi 5 -DDi 1. In the Main Menu, press Test Group. Group 2 1 PT 2 APTT 3 +Fbg 4 -Fbg 5 2. Press Group 1, Group 2, or Group 3 to select the Test Group. Group 3 1 PTX 2 PTTX 3 PTN 4 PTTN 5 3. Press Main Menu. 4. Press FIX to return to the Main Menu. Main Menu 15 Sample Processing Manually Entering Work List Sysmex Ready Replace Rack ? YES! HC HB Start Main Menu Group 1 11 PT 2APTT Fbg 4 DDI 5 AT3 1. In the Main Menu, press ID No. Entry. 2. Enter the sample ID number. Rack ID No. 123 45 ID No. 1-01 7 8 9 2. Select the parameter to be tested. 1-02 1-03 5 6 O = ordered 1-04 1-05 not ordered 1 2 3 - = 3. Confirm the settings and press Enter. 0 Enter 4. Press the Start key. Repeat C QC | Quit 5. Select Tube Position. First Tube = start at the first sample reaction tube position Sysmex Analyzing Replace Rack ? NO ! HC HB Continue = start at the next sample reaction Select Tube Position Group 1 tube position after the last run Continue First Tube 16 Automatic Work List 1. Set the samples with the barcode labels facing away from the analyzer. 2. From the Main Menu, press the Start key. 3. Select Tube Position. First Tube = start at the first sample reaction tube position Continue = start at the next sample reaction tube position after the last run Sysmex Analyzing Replace Rack ? NO ! HC HB Select Tube Position Group 1 Continue First Tube 17 Set Sample Rack Sysmex Ready Replace Rack ? YES ! HC HB Start Main Menu Group 1 1 PT 2APTT 3 Fbg 4 DDI 5 AT3 The Main Menu should read “Replace Rack? YES!” before setting the sample rack. Rack ID No 123 45 ID No 1. Pull out the sampler. 1-01 7 8 9 1-02 2. Put the primary tubes into the sample rack and set 1-03 4 5 6 the rack in the sampler (max. 10 tubes + 1 STAT 1-04 position). Set the sample with the barcodes facing 1-05 2 3 away from the analyzer. 0 Enter Repeat C QC | Quit O series 18 Operation Symbols Symbols Sysmex Ready Replace Rack ? YES ! HC HB Start Analysis is not ordered for the parameter Main Menu Group 1 — O Analysis is ordered 1 PT 2APTT 3 Fbg 4 DDI 5 AT3 Analysis in progress Rack | ID No. 123 45 Prev O Analysis is completed 1-01 123-456-789 OO x - x Analysis is not completed due 1-02 123-456-710 to interruption or error 1-03 123-456-711 Next 1-04 - -- -- 1-05 - -- Repeat ID No. Entry HO Stored QC Standard Test Special Data Curve Group Menu 19 Operation Symbols Ordering QC 1. Pour QC material into a cup. Sysmex Ready Replace Rack ? YES ! HC HB Start 2. From Main Menu, Press No. ID Entry. Main Menu Group 1 3. Press QC and the file number (i.e. QC01). 1 PT 2APTT 3 Fbg 4 DDI 5 AT3 4. Select tests to run. 5. Place the rack into the sampler and press Start. Rack | ID No. 12345 ID No. 1-01 QC 8 9 ----- 1-02 ----- 1-03 -- - - 4 5 6 1-04 -- -- 1-05 - - 1 2 3 0 Enter Repeat C QC | Quit 20 Quality Control Quality Control Menu Viewing QC Results Sysmex Ready Replace Rack ? YES ! HC HB 1. From the Main Menu, Press QC. Quality Control Lot. No. 548165 2. Press Select Test in the QC menu. File No. PT QC01 Exp. 12/31/2013 Mean 11.8 sec Cursor 3. Select the Test parameter then the QC file to display SD 3.3 12.7 sec in the QC menu. CV 1.2% 08/10/2011 N 60 15:09 Stop - UL 18.0 Flag - UL 14.5 Flag - LL 12.5 10.0 Note: Flag - LL 9.0 The Sysmex CA-600 series analyzer stores six different QC files for each test parameter. Each file stores up to 180 data Settings Change Scale points. First points entered will be consecutively deleted when additional points are added (first in – first out). Delete Print Standard Select Special Curve Test Menu 21 Printing QC Sysmex Ready Replace Rack ? YES ! HC HB Quality Control Lot. No. 548165 File No. PT QC01 Exp. 12/31/2013 1. Press QC from the Main Menu. Mean 11.9 sec Cursor SD 3.5 12.7 sec 2. Display the QC chart you want to print, CV 1.3% 08/10/2011 if not displayed press Select Test. N 180 15:09 Stop - UL 18.0 3. Select the Test parameter, then the Flag - UL 14.5 QC file to display chart to print. Flag - LL 12.5 4. Press Print. Flag - LL 10.0 9.0 5. Press Graph or List. 31/07/2011 16:03 QC CHART Graph: Prints out QC data and QC chart P Lot. No QCO5 Exp. Date 31/10/2011 6Sample List: Prints out QC data and data list 17/07/2011 15:16 Graph List Return Stor-Li Stop-UL CHART 31/07/2011 16:02 QC PT ot. No QC05 Exp. Date 31/10/2011 6Sample Stoe- Stop-UL * 7/07/2011 15:59 ..... PONAA 00000 ...... Maar 9% Mea Stop-UL Stop- lag- las ARGET TARGET cto OOOOOWNUI ONDUO WP.NO Graph List 22 Stored Data Overview Sysmex Ready Replace Rack ? YES ! HC HB Stored Data All Seq 01/142 (142) 1. From the Main Menu, select Stored Data. ID No. PT PT APTT sec INR sec 2. Sample ID No., calculation parameter and analysis results in 123-456-78901 **** * 32.0 terms of coagulation time or OD/min are displayed. Failures 123-456-79902 11.6 1.14 32.1 123-456-79902 11.4 1.02 32.1 occurring during analysis exhibit the following error keys: 123-456-79902 m 11.5 1.00 32.1 QC01 13.1 1.12 33.1 *** * Analysis data not obtained due to error or other causes QC03 31.4 2.34 67.2 . 123 16.3 The calculation parameter could not be calculated 1.35 59.0 123-456-79910 V 9.8 0.39 31.0 --- - . +++.+ The calculated value exceeded the available number Mark of digits for display 3. Abnormal flags on the right of the sample ID No. indicate Main the following: Graph Prev Next More Menu m Mean value calculated from replicates [Mark] Adds or removes a mark to the sample d Dilution ratio other than 100% was used DATE Date of analysis * Error flag, or variation in repeat testing too high TIME Time of analysis SEQ Sequence number of analysis (counting from power turn-on) > Result above the Upper Report Limit ID No. Sample ID No. entered by operator, host computer, or < Result below the Lower Report Limit barcode reader RACK Rack number and tube position + Result is above the Upper Mark Limit OUT Result is below the Lower Mark Limit Data ouput flag: - H disappears after transmission to the host P disappears after printout Note: < or > flag with Fibrinogen: redilution may be considered. * flag supersedes > or < flag, but limits are still displayed: evaluate result. 23 Stored Data Stored Data Output Printing a Single Data Point Printing a Batch 1. Select Stored Data from the Main Menu. 1. Select Stored Data from the Main Menu. 2. Press [p] [q] [t] [u] keys to select data. Place 2. Press [p] [q] [t] [u] keys to select data. the black cursor on the result to be reprinted. Place the black cursor on the result to be reprinted. 3. Press the More key to access the output option. 3. Press Mark key on the Stored Data list display. When the Mark key is press the analysis data in 4. Press Output key. the current cursor position will be marked Arrow Select Current to print the highlighted sample. [p] [q] and select Mark for all desired results. Select IP Graph to print with graph. 4. Press More key to access the ouput option. Select IP List to print results only. 5. Press Output key. Select Marked to print the highlighted sample. Select IP Graph to print with graph. Select IP List to print results only. 6. After printing, press Marked All Clear to remove all the marked samples. 24 Stored Data Output Retransmitting a Single Data Point Transmitting a batch to Host 1. Select Stored Data from the Main Menu. 1. Select Stored Data from the Main Menu. 2. Press [p] [q] [t] [u] keys to select data. Place the 2. Press [p] [q] [t] [u] keys to select data. Place the black cursor on the result to be retransmitted. black cursor on the result to be retransmitted. 3. Press Mark key on the Stored Data list display. 3. Press the More key to access the output option. When the Mark key is press the analysis data in the current cursor position will be marked. Arrow [p] 4. Press Output key. [q] and select Mark for all desired results. 5. Select Current to print the highlighted sample. 4. Press the More key to access the output option. 6. Select Host Computer to transmit results to the 5. Press Output key. host computer. Select Marked to print the highlighted sample. Select IP Graph, to print with graph. Select IP List to print results only. 6. After printing, press Marked All Clear to remove all the marked samples. 25 Coagulation Curve Components 1. < PT : 100% > Ready Analysis parameter and dilution ratio of the displayed Sysmex Replace Rack ? YES ! HC HB reaction curve Stored Data All Seq 01/142 (142) 2. ERR [ 0 ] ID No. 123 - 456 - 79902 36.8ºC Error code. When an error occurs in analysis result. 03 - 02 7/22/2011 12:20 1 11.4 sec (50) 8 When there is no error, 0 appears 1.02 INR 3. dH [ 56 ] Delta Height, increase of scattered light intensity 7 2 ERR [ 01 in reaction process 3 dH [ 56 ] 4 H [ 123 ] 6 4. bH [ 123 ] 0 60 CH No. [ 1] Base Height, scattered light intensity at the start Info. of analysis 5. CH No. [ 1 ] Change Edit Scale ID No. Output Delete Return Detection channel in which analysis was conducted 6. Graph x - axis Plotted as time in seconds 7. Graph y - axis Plotted as light scattered intensity or light absorbance 8. (50) Sample result coagulation detection point 26 Calibration Before starting a new calibration, print the old curve 3. Start the Calibration . Place calibrator in position 1 on the sample rack. 1. Load Reagents . Press Start when ready. . From Main Menu, press Special Menu, press Set Reagents. Set reagents in their appropriate positions (enter 4. Evaluate the Calibration reagent volume if reagent volume alarm is ON). . Once the analysis is complete, the screen of the new Standard Curve is displayed. 2. Prepare the Calibration . Press Graph to display the new Standard Curve graph (solid line with square plots). When . From Main Menu, press Standard Curve. Current Graph key is pressed, the current . Press Select Test, then select the parameter Standard Curve graph (dotted-line graph with to be calibrated. triangular plots) will overlay the new Standard Curve. Press Current Graph again to remove the • Press Lot No. Entry to verify the correct lot numbers overlay. Press Return to return to the Standard are entered for all reagents and calibrators Curve Data Confirmation Screen. . Press Standard Analysis. • Press Set to save the new Standard Curve or Press Select Dil. Set. Press Quit to reject the new Standard Curve #9 = Fibrinogen #1 = INNOVANCE DDimer · Enter the calibrator reference value in cursor position of activity column. 27 Calibration Manually Entering Standard Sysmex Ready Replace Rack ? YES ! HC HB Curve Data Standard Curve PT ID No 1. Press Standard Curve from the Main Menu. 7 8 9 2. Display the standard curve data of the desired 4 5 6 parameter. Normal 11.5 sec 1.02 3 3. Press Manual Entry ISI 2 . 4. Enter the correct standard curve data on the numeric 0 Enter key pad, using the [ p] [ q] to move to the desired position. Confirm data by pressing Enter C QC Quit . 5. Once all of the correct standard curve data is entered, press Quit Sysmex Ready . Replace Rack ? YES ! HC HB Start Continue: Returns to the Manual Entry screen Standard Curve Fbg Set: Sets the entered data as Standard Curve data 100.0 mg/dL and returns to the Standard Curve screen 9 Fbg.C Replic. 200.0 mg/dl Replic. Quit: Discards the entered data and returns to the 150.0 mg/dl 7 8 9 100.0 Standard Curve screen mg/dl --- 50.0 mg/dl 33.3 mg/dl 4 5 6 O 0.0 mg/dl O 1 2 3 Note: Entering standard curve data can be used to input PT, Fbg, Next Select Enter O and other assays that contain standard curves. Dil . Set C Quit 28 Using Hand-Held Barcode Reader Sysmex Ready Replace Rack ? YES ! HC HB to Enter Standard Curve Data Standard Curve PT ID No 1. Press Standard Curve from the Main Menu. 7 8 9 2. Display the standard curve data of the desired 4 5 6 parameter. Normal 11.5 sec 3 3. Press Manual Entry ISI 1.02 2 . 4. The hand-held barcode reader is ready to read when 0 Enter the icon (displayed to the right) appears in the upper-right of the screen. C QC Quit 5. If the barcode reads correctly, a confirmation screen will appear to verify the values. Sysmex Ready Replace Rack ? YES ! HC HB Start Register: confirms that the values are correct and Standard Curve Fbg returns to the Manual Entry screen 100.0 mg/dL Cancel: discards the values and returns to the 9 Fbg.C Replic. Manual Entry screen 200.0 mg/dl Replic. 150.0 mg/dl 7 8 9 100.0 6. Once all of the values have been confirmed, press mg/dl --- 50.0 mg/dl Quit to set the values. 33.3 0.0 mg/dl 4 5 6 O mg/dl O 1 2 3 Note: Note: Entering standard curve data using the hand-held barcode Next Select Enter O reader can be used to input PT, Fbg, and other reagents that Dil . Set contain values. C Quit 29 System Alarms Viewing System Alarms Ready Replace Rack ? YES ! HC HB 1. From the Main Menu, press Sysmex. Sysmex 2. Press Error List to view alarms. 3. Date, time, and error are displayed. Error List 4. Refer to the instruction manual for details. Temperature P. FEED Main Menu 30 System Alarms Coagulation Curve Errors ERROR 002: Slight Coagulation NOTES: ERROR 004: Analysis Time Over Check reagent — ensure reagent is not expired, contaminated, or ERROR 008: Coagulation Curve Error: Caution Review Curve improperly made. Also ensure that volume is adequate and reagent is dispensed properly. ERROR 016: (Overflow) Turbidity Level Over Check sample — examine sample for clots, adequate volume, and ERROR 032: No Coagulation contamination. Follow your own lab protocol for sample acceptability and redraw request. ERROR 064: Aged Sample For more information about Coagulation Curve Errors, ERROR 100: Range Over please refer to the CA-series Measurement Evaluation & ERROR 128: Early Reaction Error Check Methods Scientific Bulletin 31 Coagulation Curve Errors ERROR 002: Slight Coagulation ERROR 004: Analysis Time Over Possible Cause Possible Cause Coagulation reaction was weak due to abnormal sample, Analysis was not completed in set detection time due e.g. low fibrinogen, or a reagent problem exists. to sample, reagent, or cold buffer. Result Message Result Message Numerical result flagged by an asterisk (*). Numerical result flagged by an asterisk (*). Result message: “Slight Coagulation.” Result message: “Analysis Time Over.” Solution/Comments Solution/Comments Check sample, check reagent volume and integrity. • Check sample for possible anticoagulant contamination, • Verify delivery of sample and reagent. hemolysis, lipemia, etc. • Re-analyze the sample. If re-analysis gives results • Verify delivery of sample and reagent. • without an asterisk (*), that result may be reported. • Re-analyze the sample. If re-analysis gives results without If Slight Coagulation error occurs again, and if the an asterisk (*), that result may be reported. • curves are acceptable and if the results are equivalent • If re-analysis gives Analysis Time Over error again, the at the 50% coagulation detection point, the mean sample may not be capable of forming a firm clot. Follow of the two results may be reported as determined your laboratory's alternate protocol. by your laboratory policy. 32 ERROR 008: Coagulation Curve Error: ERROR 016: Overflow (Turbidity Level Over) Caution Review Curve Possible Cause Possible Cause There was an unexpected curve fluctuation due to abnormal Turbidity is too high for the analyzer to make analysis. sample, reagent, or air bubble present in reaction tube. Result Message Result Message No numerical result listed; instead *** * . No numerical result listed; instead *** * Result message: “Turbidity Level Over.” . . Result message: “Coag Curve Error Caution: Review Curve with analysis data.” NOTE: Numerical value may be obtained Solution/Comments in Stored Data, where it is displayed with an asterisk (*). • Check sample for hemolysis, lipemia, etc. Solution/Comments • Verify delivery of sample and reagent. Check sample, check reagent volume and integrity. • Re-analyze the sample, or re-analyze the sample • diluted with the buffer if protocol uses a diluted • Verify delivery of sample and reagent. sample (i.e., fibrinogen, Clauss method) • Review the analysis data format for clot formation. • If re-analysis gives a result without an asterisk (*), • Re-analyze the sample. If re-analysis gives results without that result may be reported. an asterisk (*), that result may be reported. • Do not report result without numerical values. • If Coagulation Curve Error occurs again, and if the curves are acceptable and if the results are equivalent at the 50% coagulation detection point, the mean of the two results may be reported as determined by your laboratory policy. 33 ERROR 032: No Coagulation ERROR 100: Range Over Possible Cause Possible Cause No coagulation reaction was detected due to abnormal A short time has been observed; e.g. for the PT (<7 sec) sample or reagent problem. or aPTT(<15 sec). Result Message Result Message No numerical result listed; instead *** * No numerical result listed; instead *** * . . . Result message: “No Coagulation” Result message: “Range Over” Solution/Comments Solutions/Comments Check sample for possible anticoagulant contamination, • Reagent contamination or lack of analyzer maintenance • hemolysis, lipemia, etc. could cause this message. The tech should check the Verify delivery of sample and reagent. sample, reagents, and instrument condition. • • Review the analysis data format for clot formation. • Re-analyze the sample. If re-analysis gives results without an asterisk (*), that result may be reported. • If sample, reagent, and instrument conditions are acceptable, re-analyze sample and look for clot formation • If re-analysis indicates “No Coagulation” again, follow your laboratory's alternate protocol. in the reaction cuvette or follow your laboratory protocol. DO NOT REPORT OUT A RESULT WITHOUT A NUMERICAL VALUE. 34 ERROR 128: Early Reaction Error Possible Cause An abnormally short aPTT result has been observed. Results may be caused by an early reaction. Result Message No numerical result listed; instead *** * . Result message: “Early Reaction Error” Solutions/Comments • Verify sample and reagent integrity along with maintenance procedures. • Print out the analysis data. Obtain the ERE sub-code associated with the error. • If an ERE 4 sub-code was obtained and re-analysis produces equivalent results at the 50% detection point, the mean of the two samples may be reported as determined by your laboratory policy. • If any other ERE sub-code was obtained and repeats upon re-analysis, the result may not be reported. Refer to your laboratory's alternate protocol. 35 Note: This document is for supplemental use only, and not meant to be used in place of primary technical materials. © 2014 Siemens Healthcare Diagnostics Inc. All rights reserved. This guide and the software described within, are copyrighted. No part of this may be copied, reproduced, translated, or reduced to any electronic medium or machine-readable form without the prior written consent of Siemens Healthcare Diagnostics. All trademarks are the property of their respective owners. PN: 10712681 GPE05010.014 Effective Date: 10/21/2014 Order No. A91DX-HHS-120682-GC1-4A00 Note: This document is for supplemental 05-2012 | All rights reserved use only and is not intended to be used in © 2012 Siemens Healthcare Diagnostics Inc. place of primary technical materials. Global Siemens Headquarters Global Siemens Healthcare Headquarters Global Division Siemens AG Siemens AG Siemens Healthcare Diagnostics Inc. Wittelsbacherplatz 2 Healthcare Sector 511 Benedict Avenue 80333 Muenchen Henkestrasse 127 Tarrytown, NY 10591-5005 Germany 91052 Erlangen USA Germany www.siemens.com/diagnostics