PEP to Go

SIEMENS SIEMENS (REF] 11170846 SIEMENS SMN 11170846 CE ADVIA 560 ADVIA® 560/560AL Hematology System LOT 113 Lyse 2016-10 S301511310145 ADVIA 560 5 L IVD For USA Haagent for offerentiation of leucocyte 70847 SIEMENS SIEMENS CE sopopulations, Contains: Surfactants Hematology System BAurs. Preservatives, Stabilzers in ADVIA 560 ion fes water. Open bolle stabdty: 60 days 5P Diff 1 L IVD For USA PEP to Go Reagent to for Wilam Siemer Sta Oper bon Answers for life. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. HILS# 00001408 Effective date: 05/15/2015 Global Product Education Page 1 2014-07-22 Table of Contents 1. Hardware Overview 2. Software Overview 3. Daily Setup 4. Sample Processing 5. Technologies 6. Calibration SIEMENS 7. Quality Control 8. Maintenance ADVIA 560 Hematology Sites © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 2 2014-07-22 Global Product Education Hardware Overview Front Panel Components: 1. Touchscreen 2. Status Light – Green (Ready), Red (Busy), Orange (Standby) 2 3. Sample Rotor Station and tube adaptor 4. Barcode Scanner (Scans sample and control SIEMENS barcodes, and product IFU and reagent 1 barcodes) ADVIA'560 Hematology System 3 4 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Hardware Overview © Siemens AG 2013. All rights reserved. Page 3 2014-07-22 Global Product Education Hardware Overview Front Assembly: 1. Dilutors A 2. Shear Valve 3 3. Optical Head Unit 4. Sample Rotor 2 ........... 4 1 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 4 2014-07-22 Global Product Education Hardware Overview Back Panel Components: 1. Power Connector 4 2. Power On/Off Switch 3. I/O Ports Panel [contains 2 USB (A) ports] 4. System Computer On/Off Switch 5. Label displaying the power rating, serial number, and other manufacturing information 6. Tubing Connection Points 3 ADVLE 349 ( @ C 52 Note: The 2D barcode reader/scanner that 5 2 MEN ships with the system can be connected via one of the USB (A) ports. 1 6 Note: You may connect an external USB keyboard and/or a USB mouse to the system, but these do not ship with the system. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 5 2014-07-22 Global Product Education Hardware Overview Back Panel Liquid Connectors: 1. Diluent: ADVIA 360/560 Dil 2. ADVIA 560 5P Diff ADVIA 560 (€ @ C 3. ADVIA 560 Lyse Hematology System SN S020006 ( 10/2014 4. Waste Out 1 REF 11170842 Made in Hungary Siemens Healthcare Diagnostics Inc. 511 Benedict Aveny 5. Waste Out 2 Tarrytown, NY 10691-5091 USA Class 1 Later Product EC REP Siemens Healthcare Diagnostics Lid. Sir William Siemens Sa finley Camberey. UR GU16 800 100-240VAC, 400VA. 47-63Hz [D] SIEMENS 1 Diluent 2 Diff 5P Waste 4 3 Lyse Waste 5 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 6 2014-07-22 Global Product Education Hardware Overview Left Side Assembly: 1. Pressure Sensors 2 4 2. Drain Buffer 1 3. Mix Chamber 3 5 4. RBC Chamber 5. WBC Chamber OOOO 6 6. Valves 1 – 22 7. Valves 23 – 44 7 8. Diluent Buffers 9. Diff and Lyse Buffers 10.Sheath Buffer 11 11.Small Measure Buffer 10 9 8 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 7 2014-07-22 Global Product Education Hardware Overview Right Side Assembly: 1. Wash Head 2. Horizontal, Vertical motion (XY) Unit 4 3. Aspiration Needle 4. Optical Head 5. Power Supply 6. Auto-loader Connector 2 3 1 5 6 Note: The Autoloader/Autosampler is a separate unit that connects to the right side of the ADVIA 560 system. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 8 2014-07-22 Global Product Education Software Overview The Graphical User Interface (GUI): Measure AS Database Print Menu  Use the touchscreen and on-screen keyboard to navigate the GUI or an external mouse and keyboard  If using an external keyboard and mouse, turn off the on-screen keyboard via: Patient 1. Menu 2. Settings 3. Customize Diagnostics Exit 4. Select the checkbox for “On screen keyboard active” to deselect it  The Top Navigation Section (header) contains 5 menu icons that are visible during all operations: QC Settings 1. Measure 2. AS – Auto-loader 3. Database 4. Print 5. Menu – Home screen Calibration Maintenance Note: Even if the on-screen keyboard is displayed, it can be dismissed by selecting ESC on the i AS state U 51 en-US None % 29 31 external keyboard. 10 : 17 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Software Overview © Siemens AG 2013. All rights reserved. Page 9 2014-07-22 Global Product Education Software Overview The Graphical User Interface (GUI): Measure AS Database Print Menu  Depending on which menu icon is selected determines what displays in the Main Display Area or Interactive Display Area (center of the screen) Patient  The active icon is highlighted  The Main Display Area contains the following Menu icons: Diagnostics Exit • Patient • Exit • Settings • Maintenance • Calibration • QC QC Settings • Diagnostics Calibration Maintenance i AS state 51 en-US None % 29 31 10 : 17 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Software Overview © Siemens AG 2013. All rights reserved. Page 10 2014-07-22 Global Product Education Software Overview The Graphical User Interface (GUI): Measure AS Database Print Menu  The Status Display Area is at the bottom of the screen and contains 8 elements: 1. AS state – Status of the Auto-loader unit: • When backlit– Auto-loader is turned on Patient • When not backlit – Auto-loader is turned off or not connected 2. Reagent and Waste container Diagnostics Exit status: • Green – Diluent • Yellow – Lyse • Orange – Diff • Red – Waste 3. Error and Warning icons QC Settings • Select the icon for detailed information Calibration Maintenance i AS state 51 29 31 en-US None % 10 : 17 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 11 2014-07-22 Global Product Education Software Overview The Graphical User Interface (GUI): Measure AS Database Print Menu  The Status Display Area is at the bottom of the screen and contains 8 elements: 5. Printer status – In-progress or in Standby 6. Pneumatic system status – Standby, manual measure, rinse, clean, etc. Patient 7. Language and Keyboard – Selected language and keyboard layout language Diagnostics Exit 8. Current time – Select to show date and time setting window QC Settings Calibration Maintenance i AS state 51 31 en-US None % 29 10 : 17 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 12 2014-07-22 Global Product Education Daily Setup Power On/Start Up the System: Measure AS Database Print Menu  Before powering on/starting up the system: 1. Inspect the reagent tubes to ensure Reagent status they are not loose 2. Check for leaks around the shear valve and syringe pumps 3. Check for salt stains around the reagent tubing and containers 4. Confirm the power cord is plugged in 5. Turn on the Main Power switch 6. Turn on the System Computer switch 7. Turn on the Auto-loader if installed 8. Empty waste and reset the waste level via: Menu > Diagnostics > Reagent status > Reset Waste 0% 51% 29% 31% 9. Check Reagent status 0 ml 2559 ml 298 ml 6369 ml Reset Reset Lyse- Reset Diff- Diluent 5P 5P Reset Waste  The following sequence occurs after powering up the system: 1. The internal system computer starts up 2. Windows XP operating system boots up View reagent data Back 3. The Home screen displays i AS state 51 % 29 31 en-US Note: Your daily setup routine may differ from the one None 10 : 20 described here. Refer to your laboratory policy. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 13 2014-07-22 Global Product Education Daily Setup Check/Replace Reagents: Measure AS Database Print Menu  The system displays a warning icon in the Reagent status Status Display Area to warn the operator when a reagent is going to run out  To open an explanation screen for this, double-select the warning icon, then select Go to, to navigate to the Reagent Status screen  You can also view the status of the reagents by navigating to Menu > Diagnostics > Reagent status 0% 51% 29% 31% 0 m 2559 ml 298 ml 6369 ml  After the warning displays, the system’s Reset Reset Lyse- Reset Diff- Diluent 5P 5P Reset Waste internal buffers keep sufficient reagents for one measurement cycle  Once you replace the reagent(s), select Reset for the corresponding reagent View reagent data Back i AS state 51 29 31 en-US  If you are replacing the Lyse reagent, insert None % 10: 20 the reagent hardware key into the key slot on the right panel. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Daily Setup Page 14 2014-07-22 Global Product Education Daily Setup Reagents: 1. ADVIA 360/560 Dil (Diluent):  Dilutes whole blood samples  Rinses the fluidic system between measuring cycles  Used as the sheath for optical ------------ measurement --- 2. ADVIA 560 Lyse 5P: H) 11170545 MEMENS ADVIA' 360/560 CE 1020 251 @ 2017.10 20 L  Color code – Yellow (FEF) 11170846 SIEMENS CE 11170546 ADVIA' 560 Lyse  Lyses RBCs and PLTs to determine WBC 2016-10 SL count, 5-DIFF and HGB concentration ------- © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 15 2014-07-22 Global Product Education Daily Setup More Reagents: 3. ADVIA 560 Diff-5P:  Color code – Orange  Stops the lysing process in order to prevent the WBC’s from lysing 4. ADVIA 360/560 Hypoclean CC: 70847 SIEMENS CE ADVIA® 560  Used to clean capillaries, tubing and 18-10 5P Diff chambers and remove blood 1 L 7170851 VD Ferial SIEMENS component precipitates ADVIA* 360/580 Hypoclean CC Not an on-board reagent 100 ml  --- © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 16 2014-07-22 Global Product Education Daily Setup Reagent Lock System/Hardware (HW) Key:  Each ADVIA 560 Lyse reagent container comes with a reagent hardware (HW) key that contains 900 measurement credits  The HW key is contained in an electrostatic plastic envelope located underneath the tear- out flap on the top of the reagent container cardboard box  The system counts the number of measurements performed and warns the operator when the number of measurement credits remaining is 50 HW Key for reagent lock  The system ceases performing sample measurements when measurement credits reach zero  Blank, Calibration, and QC measurements are included in the overall measurement count © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 17 2014-07-22 Global Product Education Daily Setup Reagent Lock System/Hardware (HW) Key: Measure AS Database Print Menu  Replace the reagent key before replacing the Reagent status Lyse reagent container by first removing the depleted key and then inserting the new key. Then, navigate to: 1. Menu 2. Diagnostics 3. Reagent status 4. Reset Lyse-5P  The Reagent key uploads the new license for 900 measurement credits and resets the 0% 51% 29% 31% counter for the Lyse reagent to 100% or 900 0 ml 2559 ml 298 ml 6369 ml credits Reset Reset Lyse- Reset Diff- Diluent 5P 5P Reset Waste View reagent data Back i AS state 51 en-US None % 29 31 10 : 20 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 18 2014-07-22 Global Product Education Daily Setup Perform the Pneumatics Initialization: Measure AS Database Print Menu  Initialize the pneumatic system prior to running samples or controls. Navigate to: Sample ID 0 1. Measure Autoincrement mode 2. Start Mode Blank 3. Perform cleaning cycle if requested 4. The following sequence occurs: 1. Status light turns red 2. Reagents are primed 3. Measuring system is flushed 4. Sample door, syringe, needle X/Y movement, and shear valve motors are activated and tested 5. Vacuum system is activated, pumps, pressure sensors, and vacuum leakage is tested 6. An empty result screen displays 7. A Blank measurement is performed automatically and Start displays i AS state 51 29 en-US % 31 5. Select Accept to accept results None % 10 : 24 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 19 2014-07-22 Global Product Education Daily Setup Perform a Blank Measurement: Measure AS Database Print Menu  Prior to running patients, controls or calibrations on the system, perform a Blank Sample ID 0 Autoincrement mode  When a reagent container is replaced, perform 4 to 5 Blank measurements before accepting Mode Blank the blank results  If more than 2 hours have elapsed since the last sample of a batch, and the first sample of the next batch, repeat the Blank measurement  Navigate to: 1. Measure > Start (Blank is the default mode) 2. The status light turns red and rotor rotates into and back out of system 3. Once the Blank is complete, the results display and the status light turns green 4. Select Accept if results are within acceptable range 5. Select Start next if results are not Start within acceptable range i AS state 51 None % 29 31 en-US 10 : 24 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 20 2014-07-22 Global Product Education Daily Setup Perform a Blank Measurement: Measure AS Database Print Menu  To troubleshoot Blank measurement flags: 1. Perform a Cleaning on the system by Maintenance preparing 1mL of ADVIA Hypoclean Cleaning Bleaching Flow cell Shearvalve CC with 2mL of deionized water in a cleaning cleaning 5mL sample tube Rinse Cleaning Hard 2. Place the tube in the sample rotor and cleaning select Menu > Maintenance > Draining Cleaning Drain Diff-5P Drain sheath 3. Select Accept if the Blank measurement is within range Drain all Drain Lyse- 5P Drain diluent  If Blank measurement continues to be out of range: Empty chamber Empty mix Empty RBC Empty WBC 1. Perform a Hard Cleaning on the chamber chamber chamber system by preparing 1mL of ADVIA Prime Prime Diff- Prime Hypoclean CC with 2mL of deionized 5P sheath water in a 5mL sample tube Prime all Prime Lyse- Prime 2. Place the tube in the sample rotor and 5P diluent select Menu > Maintenance > Hard Fill Show MS On- Cleaning Fill Screen Keyboard Show 3. Select Accept if the Blank measurement is within range Touchscreen Touchscreen Reset calibration AutoSampler Reset  If Blank measurement still continues to be out of range:  Replace the ADVIA 360/560 Diluent i AS state 51 29 31 en-US None and perform a series of 4-5 Blank 10 : 28 measurements © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved.  © Siemens AG 2013. All rights reserved. Page 21 2014-07-22 Global Product Education Daily Setup Shutting Down the System / Cleaning: Measure AS Database Print Menu  A normal shutdown requires a 2-step process involving both software and hardware: 1. Software:  Shut down the system’s internal computer by navigating to: Patient 1. Menu 2. Exit 3. Shutdown Diagnostics Exit 4. The software will Are you sure you want to exit? request a cleaning 2. Hardware: Cancel Prepare for shipment Log of Shutdown  Once the screen indicates that it is safe to turn off the system: 1. Press the Main Power switch located on the QC Settings lower back panel, above the power receptacle 2. Press the spring-loaded System Computer switch on the upper Calibration Maintenance back panel to turn off power to the internal computer i AS state U 51 % 29 31 en-US None 10 : 26 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 22 2014-07-22 Global Product Education Daily Setup Perform a Cleaning during Shutdown: Measure AS Database Print Menu  A Cleaning cleanses the system with external reagent cleaner introduced through the Maintenance sample rotor Cleaning Bleaching Flow cell Shearvalve cleaning cleaning  Perform a cleaning upon shutdown by: Placing a clean 5mL sample tube Rinse Cleaning Hard 1. cleaning containing a dilution of 1mL of Draining Hypoclean CC with 2mL of Drain Diff-5P Drain sheath deionized water into the sample Drain all Drain Lyse- rotor 5P Drain diluent 2. Navigating to Menu > Maintenance > Cleaning Empty chamber Empty mix Empty RBC Empty WBC 3. Follow the on-screen instructions chamber chamber chamber to complete the Cleaning Prime Prime Diff- Prime 5P sheath Prime all Prime Lyse- Prime 5P diluent Fill Fill Show MS On- Screen Keyboard Show Touchscreen Touchscreen Reset calibration AutoSampler Reset i AS state 51 29 31 en-US None 10 : 28 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 23 2014-07-22 Global Product Education Sample Processing Sample Modes: Measure AS Database Print Menu  Blank mode – No sample required 0 • Checks that the measuring system is Sample ID operating correctly and that Blank Autoincrement mode measurement results are acceptable Mode Blank  Human blood mode – 10 human blood modes where each can be configured with mode specific normal and panic ranges • Human • Male • Female • Profiles 1–7 – User defined normal ranges  Control mode – For QC material (controls) • Checks long term stability of the system Start i AS state 51 29 31 en-US None % ! 10 : 24 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Sample Processing Page 24 2014-07-22 Global Product Education Sample Processing Run Patient Samples: Measure AS Database Print Menu  Manual Mode (Non-Barcoded and Barcoded): Sample ID 0 1. Select Measure Autoincrement mode 2. Select the Mode 3. Select Sample ID field and enter the Mode + Blank Sample ID, or scan sample barcode 4. Invert sample 8 times to mix and place in sample rotor 5. Select Start to start measurement 6. The Status light turns red, the sample rotor rotates into the instrument, the sample is aspirated, then the sample rotor rotates the sample back out 7. Once measurement is complete, the Results screen displays results, and the status light turns green indicating the system is ready for the next sample 8. Select Print at the top of the screen to print results and Back to return to the measurement screen 9. To run the next sample: Start • Enter or scan the barcode for the Next sample ID field just i AS state 51 en-US None % 29 31 below the displayed results 10 : 24 • Select Start next © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 25 2014-07-22 Global Product Education Sample Processing Run Patient Samples: Measure AS Database Print Menu  Automatic Mode Using the Auto-loader (Auto-sampler) 1. Select AS (Auto-loader) 2. Select desired mode • Full Scan Mode – Auto-loader scans the whole sample tray Patient • Free List Mode – Samples to run are defined in a list • Select Samples Mode – Diagnostics Exit Samples can be defined for each physical position on the sample tray 3. Samples are scanned and processed in the following order: • Rack order starting from rack A to rack J QC Settings • Sample order for each rack starting from sample 1 to sample 10 Calibration Maintenance i AS state U 51 % 29 31 en-US None 10 : 17 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 26 2014-07-22 Global Product Education Sample Processing Run Patient Samples: • If the system cannot read a sample  Full Scan Mode barcode and the Sample ID is auto-  Defaults to Table view Samples must all use the same mode generated, you can edit the ID in tray • Uses barcode labels view by: • • Uses an LIS system to associate 1. Selecting the sample position patients with sample results of the sample(s) 2. Entering the correct Sample ID • Neither the Patient ID nor Sample ID can be edited 3. Selecting OK • Progress of the sample tray can be 4. Save IDs followed in View tray or the View list • To review all completed results: • To add sample tubes to a full scan 1. Select View list already in progress: 2. Select the sample you wish to 1. Select Stop > OK to the review message “Please wait until 3. Select Details current measure ends!” • You can also select a single tray 2. Insert the new sample into a position icon and then select Details rack and open the AS cover to view results for that sample 3. Place the new samples behind the last measured sample 4. Close the AS cover 5. Select Start Note: As the system scans each sample, a small barcode displays at the bottom of the sample position provided the barcode was scanned successfully, and a yellow indicator line at the top while In Progress, then changes to green once complete © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 27 2014-07-22 Global Product Education Sample Processing Run Patient Samples: • After automated measurements have  Free List Mode started additional samples cannot be  Defaults to List view added to the batch • Barcode labels may or may not be • To review all completed results: used • The system does not auto-generate a 1. Select View list if you had Sample ID for barcodes that cannot be switched to tray view read, but the operator can enter the 2. Select the sample you wish to review Sample ID after measurement 3. Select Details • Samples within a batch can use • If you had not switched to tray view and different modes with different normal you are still in list view: ranges • It is not required that samples are 1. Select the sample you wish to matched to exact rack and sample review from the list at the top 2. Select Details positions • To start sample measurement:  Select AS  Select Free list mode  Enter each Sample ID or use the barcode scanner for each sample to be run  Select Add for each sample  Select Start  Select View tray to view the sample tray positions © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 28 2014-07-22 Global Product Education Sample Processing Run Patient Samples: 5. Once each sample ID is added,  Select Samples Mode then the indicator within each tray  Defaults to Table view position is yellow • Barcode labels are not used 6. Upon completion, the yellow • Samples within a batch can use indicator turns green different modes with different normal • To review all completed results: ranges 1. Select View list • Samples cannot be added to the 2. Select the sample you wish to sample tray once automatic review processing is started in this mode 3. Select Details • The system looks for samples only in • You can also select a single tray position those sample positions that are icon and then select Details to view selected for analysis results for that sample • Select Sample mode screen allows the operator to define samples to be measured by: 1. Selecting the sample tray position icon where the selected sample is located 2. Select the appropriate measure mode 3. Define the sample ID 4. Select Add © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 29 2014-07-22 Global Product Education Sample Processing Interrupt Automatic Processing for STAT Measure AS Database Print Menu Specimens: 1. Select Stop 2. Select OK 3. Place the STAT sample into the sample rotor 4. As soon as the current measurement completes, select Measure from the Top Patient Navigation Menu 5. Process the STAT sample in manual mode 6. Select the AS icon to return to the automated Diagnostics Exit measurement screen 7. Select Start to restart the measurement QC Settings Calibration Maintenance i AS state U 51 % 29 31 en-US None 10 : 17 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 30 2014-07-22 Global Product Education Sample Processing View and Interpret Results: Measure AS Database Print Menu 1. The result screen displays all measured parameters, flags (Warning and Interpretive) Sample ID: 01 Name Date 8/14/2013 3:54 PM Mode: Human histograms, and scatter plots (4 major areas) WBC: 8.92 103/UL [5.00 10.00 ] NEU: 5.57 103/UL [2.00 7.50] DIFF 2. Parameter values falling above the normal LYM: 2.50 10%/UL [ 1.30 4.00 ] range are marked with an H for high, and the MON: 10%/UL [0.15 0.70] EO: 0.21 103/UL [0.00 0.50] normal range values are red BAS 0.08 10%/UL 10.00 0.15 ] NEU%: 62.4 % [ 40.0 75.0] 3. Parameter values falling below the normal LYM%: 28.0 % [21.0 40.0] MON%: 6.4 % [3.0 7.0] range are marked with an L for low, and the E0%: 2.3 % [0.0 5.0] BAS BAS%: 0.9 % 10.0 1.5] normal range values are blue RBC 4.21 10%/uL [4.00 5.50 ] 4. Histogram and scatter plots can be zoomed HGB 13.9 g/dl [ 12.0 HCT 17.4 ] 40.4 % [ 36.0 52.0 for closer inspection (visual elements showing MCV: 95.8 fL [76.0 96.0 ] MCH: measured population dispersion) 33. H pg [27.0 32.0 MCHC: 34.5 g/dl 1 30.0 35.0 RBC 5. Select a histogram or scatter plot to modify it RDWsd: 40.4 L fL [ 46.0 59.0 ] RDWcv: 13.1 % [0.0 16.0 ] 6. Select Close at the upper-right corner of the PLT: 312 10%/uL 400 1 image to return to the result display fL [ 150 MPV [8.0 15.0 ] 7. Comparison of parameters to the normal PLT range can be displayed numerically or graphically based on settings 8. The flag area displays warning and Warning flags Interpretive flags interpretive flags associated with the sample Note: Refer to Appendix B: Warning, Interpretive and Down Up Ok Morphology Flags in the ADVIA 560 Operator’s Guide AS state en-US for more information regarding Warning and i 51 29 31 None % 10 : 29 Interpretive Flags. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 31 2014-07-22 Global Product Education Technologies Measurement Methods: Measure AS Database Print Menu  Volumetric Impedance – Determines the Sample ID: 01 Name cellular concentrations and volume Date: 8/14/2013 3:54 PM Mode: Human distributions of WBCs, RBCs, and platelets WBC: 8.92 103/uL [5.00 10.00 ] NEU: 5.57 103/UL [2.00 7.50] DIFF LYM: 2.50 103/uL [ 1.30 4.00 ] MON: 103/UL [0.15 0.70] EO: 0.21 10%/UL [0.00 0.50 ] The system measures changes in electrical BAS: 0.08 10%/UL 10.00 0.15 ]  NEU%: % [ 40.0 75.0] impedance when particles that are LYM%: 62.4 MON%: 28.0 % [21.0 40.0] 6.4 % [3.0 7.0] suspended in a conductive liquid pass E0%: 2.3 % [0.0 5.0] BAS BAS%: 0.9 % 10.0 1.5] through a small aperture at a fixed flow rate RBC 4.21 10%/UL [ 4.00 5.50 ] HGB 13.9 g/dl [ 12.0 17.4 ] HCT 40.4 % [ 36.0 52.0 MCV: 95.8 fL [76.0 96.0 ] There is a constant electrical current that MCH: 33. pg [27.0 32.0  MCHC: H 34.5 g/dl 1 30.0 35.0 RBC flows between the electrodes on both sides RDWsd: 40.4 L fL [ 46.0 59.0 ] RDWcv: 13.1 % [0.0 16.0 ] of the aperture and each cell that passes PLT: 10%/UL 400 1 through the aperture causes a change in MPV fL [ 150 [8.0 15.0 ] 00 CN electrical impedance of the conductive blood cell suspension PLT Warning flags Interpretive flags  The impedance change is converted to an electrical pulse Down Up Ok  The quantity of pulses is proportional to the number of particles, while the intensity of i AS state 51 29 31 en-US None % 10 : 29 each pulse is proportional to the volume of particles © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Technologies Page 32 2014-07-22 Global Product Education Technologies Measurement Methods: Measure AS Database Print Menu  The volume distribution diagrams of the Sample ID: 01 Name particles result in the WBC, RBC, and PLT Date 8/14/2013 3:54 PM Mode: Human histograms that are measured in WBC: 8.92 103/UL [5.00 10.00 ] NEU: 5.57 [2.00 7.50] LYM 2.50 103/UL DIFF femtoliters (fL) units 10%/UL [ 1.30 4.00 ] MON: 10%/UL [0.15 0.70] EO: 0.21 103/UL [0.00 0.50 ] BAS 0.08 10%/UL 10.00 0.15 ] NEU%: % [ 40.0 75.0] Electronic discrimination allows separation LYM%: 62.4 28.0 % [21.0 40.0]  MON%: 6.4 % [3.0 7.0] of RBCs and PLTs based on their different E0%: 2.3 % 5.0] BAS BAS%: 0.9 [0.0 % 10.0 1.5] sizes RBC 4.21 10%/UL [ 4.00 5.50 ] HGB g/dl [ 12.0  A lytic reaction lyses RBCs to clearly measure 13.9 17.4 ] HCT 40.4 % [36.0 52.0 MCV: [76.0 96.0 ] WBCs. 95.8 fL MCH: 33. H pg [ 27.0 32.0 MCHC: 34.5 RBC RDWsd: 40.4 g/dl [30.0 35.0 L fL [ 46.0 59.0 ] RDWcv: 13.1 % 10.0 16.0 ] PLT: 312 10%/UL [ 150 400 ] MPV fL [8.0 15.0 ] PLT Warning flags Interpretive flags Down Up Ok i AS state 51 % 29 31 en-US None 10 : 29 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 33 2014-07-22 Global Product Education Technologies Measurement Methods: Measure AS Database Print Menu  Photometric Measurement – Measures Sample ID: 01 Name light absorbance to determine hemoglobin Date: 8/14/2013 3:54 PM Mode: Human (HGB) concentration based on its stable WBC: 8.92 103/uL [5.00 10.00 ] NEU: 5.57 10%/UL [2.00 7.50] DIFF chromogen content LYM 2.50 10%/UL [ 1.30 4.00] MON: 10%/UL [0.15 0.70] EO: 0.21 10%/UL [0.00 0.50 ] BAS: 0.08 10%/UL 10.00 0.15 ] NEU%: % [ 40.0 75.0] Lyse reagent destroys the membrane of the LYM%: 62.4 28.0 % [21.0 40.0]  MON%: 6.4 % [3.0 7.0] red blood cells causing them to release E0%: 2.3 % [0.0 5.0] BAS BAS%: 0.9 % 10.0 1.5] hemoglobin RBC 4.21 1.05/ul 14.00 5.501 HGB 13.9 g/dl [ 12.0 17.4] ACT. 40.4 136.0 52.0] MCV: 95.8 fL [76.0 96.0 ] 33. H [27.0 32.0]  A photometric reading is taken across the MCH: MCHC: 34.5 pg g/dl [30.0 35.0] RBC WBC chamber RDWsd: 40.4 L fL [ 46.0 59.0 ] RDWcv: 13.1 % [0.0 16.0 ] PLT: 312 10%/UL fL [ 150 400 1 MPV [8.0 15.0 ]  The HGB result is calculated as the difference between a blank and a sample PLT reading Warning flags Interpretive flags Down Up Ok i AS state 51 29 31 en-US None % 10 : 29 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 34 2014-07-22 Global Product Education Technologies Measurement Methods: Measure AS Database Print Menu  Optical Measurement – Measures light Sample ID: 01 Name scattering and diffraction Date 8/14/2013 3:54 PM Mode: Human WBC: 8.92 103/uL [5.00 10.00 ] NEU: 5.57 108/UL DIFF [2.00 7.50 ] LYM 2.50 10%/uL [ 1.30 4.00 ] Determines these 5-part WBC differential MON: 103/uL [0.15 0.70]  EO: 0.21 10%/UL [0.00 0.50 ] parameters: BAS 0.08 10%/UL 10.00 0.15 ] NEU%: 62.4 % [ 40.0 75.0] LYM%: 28.0 % [21.0 40.0 ] • LYM% MON%: 6.4 % [3.0 7.0] E0%: 2.3 % [0.0 5.0] BAS MON% BAS%: 0.9 % 10.0 1.5] • RBC 4.21 10%/UL [ 4.00 5.50 ] NEU% HGB 13.9 g/dl [ 12.0 17.4 • HCT 40.4 % [36.0 52.0 MCV: 95.8 fL [76.0 96.0 ] MCH: 33. H • EOS% 1 27.0 MCHC: pg 32.0 34.5 RDWsd: 40.4 g/dl [30.0 35.0 RBC BAS% L fL [ 46.0 59.01 • RDWcv: 13.1 % [0.0 16.0 ] PLT: 312 10%/uL fL [ 150 400 1 MPV [8.0 15.0 ]  The optical head contains a focused laser source that illuminates a stream of WBCs PLT that are suspended in an optically clear diluent moving through a glass flowcell Warning flags Interpretive flags  The cells scatter light as they flow through Down Up Ok the path of the laser beam i AS state 51 29 31 en-US None % 10 : 29  Optical detectors sense changes in the intensity of scattered laser light © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 35 2014-07-22 Global Product Education Technologies Measurement Methods: Measure AS Database Print Menu  The changes are proportional to the cell Sample ID: 01 Name volume and granularity of the cell’s internal Date 8/14/2013 3:54 PM Mode: Human structure WBC: 8.92 5.57 103/uL [5.00 10.00 ] NEU: 108/UL DIFF [2.00 7.50 ] LYM 2.50 10%/uL [ 1.30 4.00 ] MON: 103/uL [0.15 0.70] EO: 0.21 10%/UL [0.00 0.50 ] BAS 0.08 10%/UL 10.00 0.15 ]  The changes are converted to electrical NEU%: % [ 40.0 75.0] pulses via built-in amplifiers, and are LYM%: 62.4 28.0 % [21.0 40.0 ] MON%: 6.4 % [3.0 7.0] recorded and stored for analysis E0%: 2.3 % 5.0] BAS%: 0.9 [0.0 BAS % 10.0 1.5] RBC 4.21 10%/UL [ 4.00 5.50 ] HGB 13.9 g/dl [ 12.0 17.4  The 5 part discrimination is based on an HCT 40.4 % [36.0 52.0 MCV: 95.8 fL [76.0 96.0 ] analysis of the two-dimensional volume and MCH: 33. H pg 1 27.0 32.0 MCHC: 34.5 [30.0 35.0 RBC granularity distribution diagram RDWsd: 40.4 g/dl L fL [ 46.0 59.01 RDWcv: 13.1 % [0.0 16.0 ] PLT: 312 10%/uL [ 150 400 1 MPV fL [8.0 15.0 ]  Cells with greater volume or size or more granularity tend to scatter greater amounts PLT of light Warning flags Interpretive flags  External structure and the size of the cell causes lower angles of light scatter, whereas internal granularity or complexity causes Down Up Ok higher angles of diffraction i AS state 51 29 31 en-US None % 10 : 29 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 36 2014-07-22 Global Product Education Technologies Measurement Methods: Measure AS Database Print Menu  Two independent measurements for each Sample ID: 01 Name cell that crosses the path of the laser beam Date 8/14/2013 3:54 PM Mode: Human are provided by optical sensors WBC: 8.92 103/uL [5.00 10.00 ] NEU: 5.57 2.50 108/UL DIFF [2.00 7.50 ] LYM 10%/uL [ 1.30 4.00 ] MON: 103/uL [0.15 0.70] EO: 0.21 10%/UL [0.00 0.50 ]  The light scatter data is plotted as a two- BAS 0.08 10%/UL 10.00 0.15 ] NEU%: % [ 40.0 75.0] dimensional scatter diagram LYM%: 62.4 28.0 % [21.0 40.0 ] MON%: 6.4 % [3.0 7.0] E0%: 2.3 % [0.0 5.0] BAS BAS%: 0.9 % 10.0 1.5] RBC 4.21 10%/UL [ 4.00 5.50 ]  Similar cells have similar scatter HGB 13.9 g/dl [ 12.0 17.4 characteristics and tend to group together HCT 40.4 % [36.0 52.0 MCV: 95.8 fL [76.0 96.0 ] MCH: 33. H 1 27.0 32.0 MCHC: pg 34.5 g/dl [30.0 35.0 RBC RDWsd: 40.4 L fL [ 46.0 59.01 This allows the analytical software to RDWcv: 13.1 % [0.0 16.0 ]  differentiate and identify the leukocyte PLT: 312 10%/uL fL [ 150 400 1 MPV [8.0 15.0 ] populations and generate the 4-DIFF and BASO scatter diagrams PLT Warning flags Interpretive flags Down Up Ok i AS state 51 % 29 31 en-US None 10 : 29 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 37 2014-07-22 Global Product Education Technologies Measurement Sequence: 1. When the operator presents a sample tube 6. RBCs/PLTs and WBCs are measured with and selects Start, the system rotates the impedance technology through 70 and 80 sample rotor inside the system µM apertures respectively 2. The piercing needle moves into the sample 7. Two portions of the sample are used for and aspirates ~110µL of the primary blood determining a 5-part differential in two sample independent optical measurements:  4-DIFF 3. The aspirated blood travels to the blood  BASO sensor which ensures the primary sample is continuous and free of bubbles as it moves to the shear valve 4. The shear valve separates the primary sample into 3 further samples of exact volumes which are distributed to provide dilutions for the RBC, PLT, WBC, HGB, BASO, and 4-DIFF measurements 5. Lysing reagents are used to eliminate RBCs for dilutions to measure WBCs © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 38 2014-07-22 Global Product Education Calibration Perform a Calibration:  Perform a calibration: • Upon installation • After replacing any component that is critical to the dilution or measurement process SIEMENS ADVIA® 360/560 Calibrator • Any time QC results show a systematic [REE] 11170852 HEMATOLOGY SMN 11170852 2x 30ml error or is outside predefined limits [OT] PLUS025 8 2015-03-05 ==---- • At periodic time intervals determined by laboratory regulations SIEMENS ADVIA" 360:560 00 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Calibration Page 39 2014-07-22 Global Product Education Calibration Perform a Calibration: 7. To discard run, select Resample  Before performing a calibration, ensure the pneumatic system is started up and that 8. Proceed with the next run by there is a valid blank measurement: selecting Start next 1. Prepare a sample tube with 9. The calibration ends when three or calibration or human whole blood, seven accepted calibrations are enough for three or seven completed consecutive runs 10.Evaluate calibration 2. Select Three or Seven runs according to your laboratory’s policy from the 11.Select Accept to accept results Calibrate screen (Menu > Calibration 12.The calibration factors are calculated > Calibrate) and presented along with the 3. Select Calibrator previous calibration factors and the CV of the sample run for each 4. Manually enter or scan the barcode parameter on the Calibrator package insert provided with the calibrator material 13.Select Accept to replace the current calibration factors with the accepted 5. Mix calibrator well factors 6. Place the calibrator material in the sample rotor 7. Select Start next 8. Wait for the results to display and Note: Selecting Abort erases the current calibration data select Accept to accept the run being run on the system. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 40 2014-07-22 Global Product Education Calibration View Calibration History, Results, and Measure AS Database Print Menu Targets:  To view the calibration history, navigate to: Calibration 1. Menu 2. Calibration 3. Calibration history Calibrate • Displayed in table view • Sort by selecting the header of Calibration history each column View calibration results  To view calibration results, navigate to: 1. Menu View calibration targets 2. Calibration 3. View Calibration results • The software displays the Results screen for each run of the calibration. • Select a specific run and Details to view the run Results i AS state 51 29 31 en-US screen None % ! 10 : 36 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 41 2014-07-22 Global Product Education Calibration View Calibration History, Results, and Measure AS Database Print Menu Targets: Calibration  To view calibration targets, navigate to: 1. Menu 2. Calibration 3. View Calibration targets Calibrate Calibration history View calibration results View calibration targets i AS state 51 29 31 en-US None % ! 10 : 36 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 42 2014-07-22 Global Product Education Quality Control Set QC Reference Values: Measure AS Database Print Menu  Before running QC, the target values, and QC Reference acceptable ranges must be entered for a new lot of control material QC name LOT No. 1. Navigate to Menu Expiration date 2. Select QC Control type Low 3. Select Set QC references WBC 103/UL MCV TL 4. Manually enter the QC identifying NEU% % MCH pg information, target values and LYM% % MCHC g/dl I+ tolerance ranges for any parameters in MON% % RDWsd fL use or scan the QR code on the Assay E0% % RDWCV % Values and Expected Ranges sheet BAS% % PLT 103/UL provided with the control material NEU 108/UL MPV fL 1+ 1+ 1 + LYM 103/UL 5. After several seconds the QC identifying MON 103/UL information, target values, and EO 103/ UL tolerance ranges populate the fields in BAS 10 3/ UL the screen RBC 10%/UL 6. Then system then returns to the QC HGB g/dl screen and the low, normal and high HCT + lots/levels show in the QC lot/level field Load QC Save Back beneath QC measure reference reference i AS state None 0% 51 29 31 en-US % 10:41 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Quality Control Page 43 2014-07-22 Global Product Education Quality Control View QC Reference Values: Measure AS Database Print Menu  To view QC References navigate to: QC references 1. Menu QC name LOT Expiration WBC WBC No. date range 2. QC U031_SW706_N U0312+ 5/2/2011 12:00 AM 8.3 0.8 T 3. View QC references 4. Select the specific control product 5. Details 1/1 + Delete Details Back i AS state O 51 29 en-US None 0% 31 % 10 : 42 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 44 2014-07-22 Global Product Education Measure AS Database Print Menu Quality Control Sample ID: QC_U031_SW706_N_12 Name Date 3/27/2015 10:40 AM Mode: QC WBC: 103/UL [7.50 9.10] NEU: 103/uL DIFF Measure QC: LYM: 103/UL MON: 103/UL EO 103/UL  Ensure a valid Blank measurement has been BAS: 103/UL run and accepted, then navigate to: NEU%: % [56.1 72.1] LYM%: % [ 20.6 34.6] 1. Menu MON%: 9.8 ] E0%: % [0.0 10.0 4.8 ] BAS BAS%: % 1 0.0 2.0] 2. QC RBC: 10%/uL [ 4.32 4.72 ] HGB g/dl [ 12.3 13.3 ] 3. Verify the QC level and lot number HCT: % [41.0 45.8 ] MCV: fL 92.0 100.0 ] below “QC measure” (The system MCH: pg [ 26.3 30.3 ] defaults to the last QC lot/level that was MCHC: g/dl [26.7 32.3 ] RBC RDWsd: fL run). Use the left/right arrows to RDWcv: % [ 12.2 18.2] change level/lot or scan the control PLT 103/uL 270] MPV: fL [ 190 [6.6 12.6 ] sample barcode PLT 4. Select QC Measure 5. Place the mixed QC sample tube in the Warning flags Interpretive flags sample rotor and select Start next 6. The system rotates the sample into the Ord/Sel.: system for aspiration and changes the Start next Menu status light to red 7. The system rotates the control sample i AS state O en-US None % 51 % 29 % 31 % back out and the measurement starts 10 : 40 8. When complete, results display and the Note: Running a QC sample in Control mode under the status light turns green. Measure Menu icon will not yield statistical data; 9. Review results therefore, it will not be stored in the QC database. 10.To exit, select Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 45 2014-07-22 Global Product Education Quality Control View QC Data and Diagrams Measure AS Database Print Menu  To display QC runs stored in the QC database, QC Database navigate to: 1. Menu U031_SW706_N 2. QC Sample ID Patient Analysis time Mode 3. View QC data ID QC_U031_SW706_N_1 4/15/2011 4:26 PM QC T a) To view data for a run, select QC_U031_SW706_N_2 4/15/2011 4:27 PM QC that run, then select Details QC_U031_SW706_N_3 4/15/2011 4:28 PM QC b) To view the Levey-Jennings QC_U031_SW706_N_5 4/15/2011 4:31 PM QC graphs select that run, and then QC_U031_SW706_N_7 4/15/2011 4:33 PM QC View QC diagrams QC_U031_SW706_N_8 4/15/2011 4:34 PM QC QC_U031_SW706_N_9 4/15/2011 4:35 PM QC QC_U031_SW706_N_10 4/15/2011 4:37 PM QC QC_U031_SW706_N_11 4/15/2011 4:38 PM QC 1/9 Multiselect Delete Send to Print View QC LIS Report diagrams Details Back i AS state O en-US None 0% 51 % 29 31 10 : 43 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 46 2014-07-22 Global Product Education Quality Control View QC Data and Diagrams Measure AS Database Print Menu  QC Diagrams: QC Diagrams • Select Menu > QC > View QC U031_SW706_N diagrams to view graphs for all runs WBC • Means, standard deviations (StDev), Target 8.3 + 0.8 and coefficients of variation (Cvar) are Mean 8. 19 + 0.21 StDev 0.09 calculated based on the QC analyses CVar 1.1 % n 9 • Dotted lines delineate acceptable WBC Target 8.3 + 0.8 Mean 8.19 + 0.21 ranges n 9 StDev 0.09 CVar 1.1 % NEU Target 0 + 0 • Use the selector control at the top of NEU% Target 64.1 # 8 Mean 65.5 + 1.9 Mean 5.36 + 0.16 the screen to view graphical control n 9 StDev 1.42 n g StDev 0.11 CVar 2.17 % CVar 1.96 % information for other lots of control LYM% Target 27.6 + 7 LYM Target 0 + 0 Mean 24.9 + 1.8 Mean 2.04 + 0.2 materials n 9 StDev 0.9 n 9 StDev 0.09 CVar 3.6 % CVar 4.3 % MON% Target 4.9 + 4.9 MON Target 0 + 0 Mean 6.7 + 1.1 Mean 0.54 + 0.09 n 9 StDev 0.71 n 9 StDev 0.06 CVar 10.6 % CVar 10.95 % E0% Target 2.4 + 2.4 Mean 2.7 + 0.6 EO Target 0 + 0 Mean 0.22 + 0.05 n 9 StDev 0.42 n g StDev 0.03 CVar 15.25 % CVar 15.29 % BAS9 Target 1 + 1 BAS Target 0 + 0 Mean 0.2 + 0 Mean 0.02 + 0 n 9 StDev 0 n 9 StDey 0 CVar % CVar 0 % View QC Previous Next data di agrams diagrams Back i AS state O 51 29 31 en-US None 10 : 44 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 47 2014-07-22 Global Product Education Quality Control Print Monthly QC Report Measure AS Database Print Menu  To print the monthly QC report, navigate to: QC 1. Menu 2. QC QC measure 3. Monthly QC Report U031_SW706_N 4. Select a month and then select OK Set QC reference Please select a month for the QC report! February, 2011 Ok Cancel Moving average data Moving average diagrams Send to LIS Monthly QC report i AS state 51 29 31 en-US None % 10 : 47 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 48 2014-07-22 Global Product Education Maintenance Daily Maintenance: Measure AS Database Print Menu  Perform a Daily Shutdown / Cleaning: 1. Select Exit > Shutdown 2. The software will request a Cleaning to be performed 3. Dilute 1mL of ADVIA Hypoclean CC Patient with 2mL of deionized water in a clean 5mL tube Diagnostics Exit 4. Place the tube in the sample rotor Are you sure you want to exit? and select Start Cancel Prepare for Log off 5. When complete, power off the main shipment Shutdown power switch 6. Then, power off the Auto-loader and printer, if applicable QC Settings  Perform a Daily Startup: 1. Power on the Main Power switch followed by the System Computer Calibration Maintenance switch 2. Power on the Auto-loader and i AS state O 51 29 31 en-US printer, if installed None % % 10 : 26 3. Follow Startup as per you lab policy © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance © Siemens AG 2013. All rights reserved. Page 49 2014-07-22 Global Product Education Maintenance Weekly Maintenance:  Clean the Wash head  Salt build-up on the lower surface of the wash head may cause a malfunction during operation  In order to clean the Wash head: 1. Perform the shutdown procedure 2. Open the front cover and secure it in position 3. Locate the sample rotor 4. Unlock the sample rotor by pressing the latch in the hole on the left side of the rotor 5. Turn the rotor door clockwise 6. Using a cotton-tipped applicator swab moistened with distilled water, clean the bottom of the Wash head Caution: Do not remove the Wash head because of the risk of injury 7. Turn the sample rotor door back to from the aspiration needle. the default position and close cover 8. Power on the system © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 50 2014-07-22 Global Product Education Maintenance Every 1200 Samples: Measure AS Database Print Menu  Clean the Shear Valve Maintenance Cleaning Bleaching Flow cell Shearvalve Clean the inner surfaces of the valve cleaning cleaning  regularly to prevent salt deposits resulting in Rinse Cleaning Hard analyzer malfunction cleaning Draining Drain Diff-5P Drain sheath  Navigate to: Drain all Drain Lyse- 5P Drain diluent 1. Menu > Maintenance > Shear valve cleaning (under Cleaning) Empty chamber Empty mix Empty RBC Empty WBC 2. Unscrew and remove the Axis screw chamber chamber chamber 3. Rinse the Axis screw with water and Prime Prime Diff- Prime wipe dry 5P sheath 4. Separate the surfaces of the Shear Prime all Prime Lyse- Prime 5P diluent valve by sliding the upper disc off Fill Show MS On- 5. Gently clean the surfaces of the Fill Screen Keyboard Show Shear valve, housing, tubing connections, as well as outside of the Touchscreen Touchscreen Reset calibration AutoSampler Reset valve 6. Reassemble the Shear valve and place i AS state 51 29 31 en-US the Axis screw in the center of the None 10 : 28 valve © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 51 2014-07-22 Global Product Education Maintenance Clean the Shear Valve: 7. Gently tap down and rotate the Axis screw clockwise until it clicks into the lower disc of the Shear valve 8. Continue to turn the Axis screw until it stops 9. Lower the front panel 10.Select OK to complete the process © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 52 2014-07-22 Global Product Education Note: This document is for supplemental use only, and not meant to be used in place of primary technical materials. © 2015 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. ADVIA is a trademark of Siemens Healthcare Diagnostics Inc. or its affiliates. Other trademarks used herein are the property of the respective owners. 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 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 53 2014-07-22 Global Product Education