PEP to Go

SIEMENS ADVIA 360 13:57 SIEMENS O A 848 SIEMENS ADVIA' 360 CE 2049 Lyse 3P Diff 1849 SIEMENS CE ADVIA 360 1 L Cleaner IVD +15'c.1 For USA Reagent for 1 L Subpopulations Co IVD RC Butlers, Presenti For USA ion free wale Detergent solutions Open botte st cellular debeia an Si Contains: Dete ADVIA® 360 Hematology System MOTOROLA .. PEP to Go ADVIA® 360 Hematology System Answers for life. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. HILS# 00001401 Effective date 04/09/2015 Global Product Education Page 1 2014-07-22 Table of Contents 1. System Overview 2. Daily Setup 3. Sample Processing 4. Technologies 5. Calibration 6. Quality Control 7. Maintenance SIEMENS A ADVIA 360 Hematology System © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 2 2014-07-22 Global Product Education System Overview Front, Top, and Right Side External Panel 2 Components: 1. LCD Capacitance Touch-screen 2. On-board Printer (Prints to 58mm wide thermal paper) 5 3. Right Side Door Lock 1 4. Sample Rotor Station SIEMENS 5. Status light – Green (Ready), Red (Busy), Orange (Standby) 6 00 4 6. Barcode scanner (Scans sample and control 3 CE 14 barcodes and product and IFU reagent VEMENS AOMA MA Cleaner CE barcodes) IL Note: The 2D barcode reader/scanner that ships with the system can be connected via one of the USB (A) ports. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. System Overview © Siemens AG 2013. All rights reserved. Page 3 2014-07-22 Global Product Education System Overview Back Panel and Reagent Connectors: 1. Reagent Connectors 2. Waste Connectors 3. Power Switch 4. Power Connector 5. USB (A) Port 1 and 2 3 6. LAN/Ethernet Port 4 7. USB-B Port ADVIA' 360 -- E 5 CHOC E SIEMENS 6 1 7 2 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 4 2014-07-22 Global Product Education System Overview Reagent Connectors and Waste Outlets: ADVIA 360 Hematology System SN S010006 10/2014 1. Diluent REF 11170841 10995070 Rev. A Made in Hungary Siemens Healthcare Diagnostics inc. 2. Lyse $11 Benedel Avery Tartyown NY 10591-5091 USA EC REP eners Healthcare Diagnosics Lid Wlan Sevens 54. Canbe UR GU16 BOD CEC 3. Cleaner INPUT: 12V === 7A SIEMENS 4. Waste Outlet Connector 1 Diluent 1 5. Waste Outlet Connector 2 Lyse 2 Clean 3 Waste Waste 4 5 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 5 2014-07-22 Global Product Education System Overview Left Side External Components: 1. USB (A) Port 1 2. USB (A) Port 2 Note: The 2D barcode reader/scanner that ships with the system can be connected via one of these USB (A) ports. Note: You may connect an external USB keyboard and/or a USB mouse to the system, but these do not ship with the system. 1 2 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 6 2014-07-22 Global Product Education System Overview Right Side Internal Components: 1. Needle Chamber / Drain Chamber 2. Mixing Chamber 5 3. RBC Chamber 4. X-Y Sampling Unit with Piercing Needle 4 6 7 5. Sampler Head 6. Reagent Sensors 7. Vacuum Receiver 8. Sample micro-dilutor 8 O 9 9. Lyse Dilutor 10 1 2 3 12 10.Dilutors 11 11.Valves 12.WBC Aperture Assembly Chamber and HGB Head © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 7 2014-07-22 Global Product Education System Overview ADVIA 360 12:52 PM Home Screen Components: 1. Measure – New Sample, Re-run, Print, Discard 2. Database – Details, Print, Filter, Statistics, Manage 3. Maintenance – Cleaning, Calibration, 1 2 Diagnostics, Reagent Status 4. Exit – Shutdown, Preparing for Shipment, Logout Admin, User Management Measure Database 5. Settings – General, Communication, Measurement, Printer, Date and Time 6 3 6. Quality Control – New Lot, Delete, Print, Export, Monthly View Quality control Maintenance 5 4 Settings Exit Note: The Header at the top of the screen displays warning messages, the title of the Menu or function and the current time © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 8 2014-07-22 Global Product Education Daily Setup Power On/Start Up the System:  Turn on all external and peripheral devices prior to powering on the system  Press the Main power switch located on the back of the system above the DC power input connector O  During startup, the ADVIA 360 screen appears, followed by the Home screen POWER  The system automatically runs a priming cycle if the fluidic system requires additional liquid and the fluid sensors are turned on 12V DC! Caution: Wait 5 minutes before initiating any measuring processes after turning on the power to allow the instrument to warm up. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 9 2014-07-22 Global Product Education Daily Setup Reagent status 12:51 PM Check/Empty Waste:  Check the contents of the waste tank Diluent Level: 90% Exp.: 04/25/2015 LOT: S151225110147  If the level is above 80% full, empty the tank Prime  After disposing of the waste contents, navigate to: Lyse Level: 94% 1. Home Exp.: 05/25/2015 LOT: S20111651014N 2. Maintenance 3. Reagent status Prime 4. Empty Waste (located within the Waste box) Cleaner Level: 78% Exp.: 05/12/2015 LOT: S501111109149  Selecting Empty waste resets the waste counter to 0% Prime The waste level % calculation is based on the Waste Level: 28%  setting of the tank capacity ON tracking Empty waste Note: If your system empties directly into a Measurement credits drain, the Waste tracking setting will be set to OFF, and you will not need to track Volume Replace Calibrate the waste level. sensors Prime all View log Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 10 2014-07-22 Global Product Education Reagent status 12:51 PM Daily Setup Diluent Level: 90% Exp.: 04/25/2015 LOT: S151225110147 Check/Replace Reagents: To check reagents navigate to: Prime  1. Home 2. Maintenance Lyse Level: 94% 3. Reagent status Exp.: 05/25/2015 LOT: S20111651014N Check if the there is sufficient reagent for the Prime  expected number of daily measurements. Cleaner Level: 78% Exp.: 05/12/2015 LOT: S501111109149  The reagent level % calculation is based on the setting of the tank capacity Prime  To replace reagents navigate to: Waste Level: 28% 1. Home 2. Maintenance ON tracking 3. Reagent status Empty waste 4. Replace 5. Reagent type Measurement credits 6. Scan the reagent barcode 7. Accept Volume Replace Calibrate sensors If you are replacing the lyse reagent, insert Prime all View log Back  the reagent hardware key into the key slot on the back of the system. Note: Run a Priming cycle and a Blank cycle after the replacement of any reagents. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Daily Setup © Siemens AG 2013. All rights reserved. Page 11 2014-07-22 Global Product Education Daily Setup Reagents: 1. ADVIA 360 Lyse 3P Diff 1L:  Color code – Yellow  Creates hemolysate for 3-part WBC differential, WBC count and HGB determination -  Reagent key is attached to the bottle ---------------- 2. ADVIA 360/560 Dil 20L: --------------  Color code – Green Dilutes whole blood samples HET 1117OMS SIEMENS 11170865 CE  ADVIA' 360/560 251 Dil 2017-10  Rinses the fluidic system between 20 L measuring cycles SIEMENS CE SIEMENS ADVIA 360 ADVIA 340 Ct Lyse 3P DiHl Cleaner IL 1L 3. ADVIA 360 Cleaner 1L:  Color code – Dark Blue - --------  Cleans the tubing, counting chambers, and apertures 1 2 3 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 12 2014-07-22 Global Product Education Daily Setup More Reagents: 4. ADVIA 360/560 Hypoclean CC 100mL:  Color code – Black  Used for the Hard Cleaning procedure to remove protein and lipids from sample tubes, chambers, and apertures  1mL should be dispensed into a 5mL sample tube and run before a Hard cleaning is started 7170851 SIEMENS ADVIA*360/560 Hypoclean CC 100 ml www peterson 4 © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 13 2014-07-22 Global Product Education Daily Setup Reagent Lock System/Hardware (HW) Key  Each ADVIA 360 Lyse 3P Diff reagent comes with a hardware key containing 900 measurement credits.  When the number of measurement credits reaches zero (0), the system can no longer perform a measurement, and Error 6003 displays: HW Hey  Hardware key not found, or is not for reagent lock suitable for this device! Please connect a proper hardware key!  Each measurement cycle decreases the number of measurement credits by one, except for initialization, standby, and wake- up cycles which do not affect the credits  To restore measurement credits, obtain a new reagent hardware key, remove the depleted key, and insert it into the HW Key reagent slot  To display the number of measurement credits:  Navigate to Home > Maintenance > Reagent status > Measurement credits © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 14 2014-07-22 Global Product Education Daily Setup Measure 12:59 PM Perform a Blank Measurement: PID 00/00/0000 12:00 AM SID Type  To ensures the cleanliness of the system Human  Prior to running patients, controls, or calibrations on the system Parameters Normal Ranges Tech Details  At the beginning of each shift and before WBC 0.00 10%ul sample analysis Blank measure If reagents are replaced and/or maintenance is There is no valid blank measurement.  performed Press OK to measure a blank first. If the system has not been used for more than OK Cancel  3 hours HCT 0.00 % PLT 0 10%/ul 2008  Navigate to: 1. Home > Measure > New Sample MPV 0.01 PLT 2. If a Blank measurement was not performed before running a sample, a message appears: “There is no valid blank measurement”. Select OK to continue with the Blank measurement 3. Otherwise, select Blank New sample Re-run Print  After one minute, the system displays the Discard Back blank values. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 15 2014-07-22 Global Product Education Daily Setup Measure 01:06 PM Perform a Blank Measurement Continued: PID 03/09/2015 01:00 PM If the Blank values are within the acceptable SID Type  Blank O ranges, select Accept  If one or more parameters are out of range, re-run the blank by selecting Re-blank Parameters Normal Ranges Tech Details WBC 0.03 103/ul WBC LYM 103/ul  If Blank values are consistently high for any of MID 103/ul % the parameters, run a Cleaning by selecting GRA 103/ul Maintenance > Cleaning > Cleaning HGB 0.0 g/dl MCH 400fl ...................... pg MCHC g/dl RBC  Repeat Blank once Cleaning is complete RBC 0.01 106/ul MCV  If Blank measurement continues to be out of RDW range after performing a Cleaning, perform a HCT % 29 200fl Hard Cleaning on the system: PLT 9 103/ul 1. Put 1mL of ADVIA Hypoclean CC MPV 13.4 fl PLT reagent in a 5mL sample tube 2. Place sample tube in the sample rotor 3. Select Maintenance > Cleaning > 29 50fl Hard Cleaning > OK 4. When complete, repeat Blank measurement and select Accept if Blank is in range Accept Re-blank Print 5. If the Blank measurement is still out of Discard Back range call the Customer Care Center – Technical Solutions for assistance © 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 status 12:51 PM Check for Air Bubbles: Inspect the rear reagent liquid connectors and Diluent Level: 90%  syringes (except waste line) Exp.: 04/25/2015 LOT: S151225110147 If you see bubbles, prime the reagent and Prime  perform a blank run Lyse Level: 94%  To prime the reagent, navigate to: Exp.: 05/25/2015 LOT: S20111651014N 1. Home 2. Maintenance Prime 3. Reagent status 4. Prime (located within each individual Cleaner Level: 78% reagent box) or Prime all (located at Exp.: 05/12/2015 LOT: S501111109149 the bottom of the screen) Prime Waste Level: 28% ON tracking Empty waste Measurement credits Volume Replace Calibrate sensors Prime all View log Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 17 2014-07-22 Global Product Education Daily Setup Exit 01:08 PM Perform a Daily Shutdown / Cleaning:  Initiate a Shutdown of the system from the Shutdown Home screen by selecting Exit > Shutdown  Turn off the power via the power switch when the system displays a warning and emits a Preparing for shipment sustained tone Warning 5905  During a shutdown, the system: 1. First, saves data and settings, and Are you sure ? closes the databases 2. Then, automatically cleans and flushes debris from the system to OK Cancel prevent clogs and contamination 3. Lastly, moves mechanical parts (sample needle, syringe pumps, and valves) into their home positions Warning: Do not turn off the instrument by flipping the power switch on the back panel. Doing so may result in erroneous operating, loss of data, or a prolonged start-up cycle during later use. Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 18 2014-07-22 Global Product Education New sample 01:09 PM Sample Processing Sample ID AUTO_00038 Type Human Run a Patient Sample (Barcoded and Non- Barcoded) Patient ID 1. Mix sample gently by inverting 8 – 11 times Name 2. Navigate to Home > Measure > New Sample Birthdate 3. Select a sample type (Human, Male, Female, Profile 1 – 7) Sex --- 4. Identify the sample (Sample ID) by scanning Doctor the sample barcode or manually entering Sample ID 5. Insert the sample tube into the Sample rotor 6. Select Run 7. During this time the status light turns red, the sample rotor rotates the sample into the system for aspiration (100µL). After a few seconds, the sample rotor rotates back out to its original position Run Blank Normal ranges 8. When sampling is complete, the status light turns green indicating that the system is ready EMR(LIS) Cancel for the next sample Note: If a Blank was not performed before running a sample, a Important: If QC was not performed, perform QC message appears: “There is no valid blank prior to running a patient sample. measurement. Press OK to measure a blank first”. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Sample Processing © Siemens AG 2013. All rights reserved. Page 19 2014-07-22 Global Product Education Sample Processing Measure 01:14 PM Interpret Patient Results: PID 03/09/2015 01:13 PM Type  Results display in the Measure screen (Home > SID AUTO_00039 Human Measure)  Results are divided into three categories: Normal Ranges Tech Details 1. Parameters Parameters 2. Normal Ranges WBC 5.15 103/ul WBC 3. Tech Details LYM 2.17 103/ul MID 0.56 103/ul 42.1 % 10.9 % GRA 2.42 103ul 47.0 % ................ The ID header displays: HGB 13.5 g/dl . ..................  21 78 129 400fl  PID – Patient ID, date and time of MCH 30.3 pg sample run MCHC 32.9 g/dl RBC 4.46 106/ul RBC  SID – Sample ID and sample Type MCV  Warning flags when appropriate 92.1 fil RDW 16.2 % HCT 41.07 % 200fl  Results screen – Parameters PLT 232 103/ul ......................  Values within normal range are white MPV 9.8 fl PLT  Values outside of the normal range are red and flag as L or H  Histograms display graphical 50fl ........................ information about volume distribution of WBC, RBC, PLT  Discriminators are indicated by vertical lines that separate different cell New sample Re-run Print populations Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 20 2014-07-22 Global Product Education Sample Processing Measure 01:15 PM Review Patient Results: PID 03/09/2015 01:13 PM  Results screen – Normal Ranges SID AUTO_00039 Type Human  Normal ranges display in a graphical format on the right of the screen  Each value is indicated by a downward- Parameters Normal Ranges Tech Details pointing white arrowhead within the WBC 5.15 103/ul 4.00 11.70 LYM% 42.1 % 10.8 45.4 normal range graphics MID% 10.9 % 1.8 17.0 GRA% 47.0 % 44.0 80.9 LYM 2.17 103/ul 0.80 3.30  Low and high limits of the normal MID 0.56 103/ul 0.30 1.70 range display on either side of the GRA 2.42 103/ul 2.30 8.80 8.8 range line HGB 13.5 g/dl 16.5 MCH 30.3 pg 23.3 36.1 MCHC 32.9 g/dl 29.7 36.8 RBC 4.46 106/ul 2.76 5.74 MCV 92.1 fil 76.4 102.0 RDW 16.2 % 11.3 16.7 HCT 41.07 %_ 26.10 49.60 PLT 232 103/ul 97 390 MPV 9.8 fil 7.5 13.1 New sample Re-run Print Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 21 2014-07-22 Global Product Education Sample Processing Measure 01:15 PM Review Patient Results: PID 03/09/2015 01:13 PM Results screen – Tech Details SID AUTO_00039 Type  Human  Probe voltage: shows electrode voltages for WBC and RBC counts  WBC lyse volume: default value = 0.9  Diagnostic flags: shows evaluations Parameters Normal Ranges Tech Details made by the system based on results Probe voltage Max  Warning flags display for the Min WBC 277 279 measurement RBC 307 309 WBC Lyse volume 0.90 ml Diagnostic flags Warning flags New sample Re-run Print Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 22 2014-07-22 Global Product Education Sample Processing Measure 01:11 PM Review Patient Results: PID 03/09/2015 01:09 PM  Flags SID AUTO_00038 Type Human  Out of Normal Range Flags Warning dDEW • Parameters are highlighted in red and display an L flag if under the normal range, and an H flag Parameters Normal Ranges Tech Details if above the normal range WBC 0.01 103/ul L WBC LYM 103/ul E 103/ul E % E MID  Measurement Condition Flags GRA 103/ul E If the system cannot interpret HGB 0.0 g/dl L ........................ • MCH 62 400fl measurements, condition flags E MCHC pg are attached to the result and g/dl RBC 0.00 106/ul L RBC display in the header of the MCV E Measure screen with a Warning, - fl RDW % and in the Tech Details screen HCT ...................... PLT 6 103/ul L 29 200fl with a brief explanation. MPV 9.8 fl PLT 29 50fl New sample Re-run Print Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 23 2014-07-22 Global Product Education Sample Processing Measure 01:11 PM Review Patient Results: PID 03/09/2015 01:09 PM  Flags SID Type O  Blank Cycle Flagging Warning BEW • The system flags parameter values if a high Blank has been accepted Parameters Normal Ranges Tech Details Associated value is WBC 0.01 103/ul L WBC • displayed but flagged LYM 103/ul E % E MID 103/ul E % E with an asterisk (*) GRA 103/ul E % E Associated value is HGB 0.0 g/dl L .......................... • 400fl pg E 62 dashed out (---) and MCH flagged by an E flag MCHC g/dl RBC 0.00 106/ul L RBC MCV E RDW HCT % PLT 6 103/ul L 29 200fl MPV 9.8 fl PLT Note: Refer to the tables titled Flagging on WBC and HGB channels, Flagging on RBC/PLT channel, and Warning 29 50fl Flags of Differential Parameters in the Sample Measurement and Interpretations of Results section of the Operator’s Guide, for more information New sample Re-run Print regarding flag symbols, their meaning, and explanation and recommended actions. Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 24 2014-07-22 Global Product Education Technologies Measurement Methods:  Photometric Light Absorbance Method  Measures the WBC dilution to ....... determine the hemoglobin (HGB) concentration of the erythrocytes (RBC)  Volumetric Impedance Method  Measures the cellular concentrations and volume distributions of RBCs and PLTs from RBC dilution  A lytic reagent is used to determine the distribution of leukocytes (WBC), and O their three sub-populations (LYM, MID, GRA)  3-Part Differential Analysis Method  Counts and simultaneously size- differentiates the white blood cells by using a WBC lytic process © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Technologies Page 25 2014-07-22 Global Product Education Technologies Measurement Sequence: 1. The sampling needle moves into the sample 6. The WBC cell counting is performed, followed vial and aspirates 100µL of EDTA anti- by an HGB measurement coagulated whole blood sample 7. Then an RBC and PLT counting is performed 2. 25µL of this sample is separated in the 8. The system drains and cleans the measuring sampler head while the remaining 75µL is chambers and related tubing, and prepares for disposed of through the sampling needle into the next blood sample. Apertures are cleaned a dedicated washing chamber with high-voltage burning pulses 3. The 25µL whole blood sample is transported to the mixing chamber through the sampling needle with an addition of 4mL of diluent to make a 1:160 primary dilution 4. 25µL of the diluted sample is aspirated into the sampler head and then mixed with another 4mL of diluent which is dispensed into the RBC chamber forming a 1:25,000 overall RBC dilution 5. The remaining mix dilution is moved to the WBC chamber where 0.9mL of lysing reagent is added. Bubbles are used to mix the lyse and Note: Measuring times: the mix dilution. This creates a dilution of WBC count (adaptive) 2 – 6 seconds 1:196 which is suitable for photometric HGB measurement 2 seconds measurement and WBC counting RBC/PLT count 8 seconds © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. © Siemens AG 2013. All rights reserved. Page 26 2014-07-22 Global Product Education Calibration Maintenance 01:18 PM Prepare and Perform a Calibration: 1. Prior to performing a Calibration, run a Self- Cleaning test and a Blank measurement:  To perform a Self-test navigate to: Calibration 1. Home 2. Maintenance 3. Diagnostics Diagnostics 4. Self Test 5. Start Reagent status 2. Run a Blank measurement (Refer to the section titled Daily Startup in this documentation for instructions) 3. To perform a calibration navigate to: 1. Home 2. Maintenance 3. Calibration 4. Calibration with measurement Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Calibration Maintenance Page 27 2014-07-22 Global Product Education Calibration measure 01:20 PM Calibration PIC PLUS025 03/09/2015 01:19 PM SID CAL7/1 Type Control Warning W Runs 1 of 3 Prepare and Perform a Calibration: 4. If using a new lot of calibrator, scan the Parameters Normal Ranges Tech Details barcode on the assay sheet to upload the lot WBC 10.35 103/ul number, expiration date, and target values for WBC LYM 0.62 103/ul 6.0 % the calibrator MID 0.25 103/ul 2.4 % GRA 9.48 103/ul 91.6 % 5. Select the number of runs desired: 3 or 7 and HGB 15.2 g/dl 43 ..................... 400fl select Accept MCH 29.5 pg 162 189 MCHC 30.5 g/dl 6. Mix the calibrator material, insert the tube into RBC 5.17 106/ul RBC the sample adaptor, and select Run MCV 96.8 fl RDW 15.8 % 1. The system rotates the sample for HCT 50.05 % aspiration and begins measuring PLT 145 103/ul 200fl (Status light turns red) MPV 9.8 A PLT 2. The system rotates the sample to the original position once aspiration is complete 27 50fl 7. If the results look good, and there are no warning flags, run Calibration with Measurement again until you reach the Run Evaluate Print required number of runs: 3 or 7 Discard Back 8. If a warning flag is displayed (C or c, clogging) select Discard to delete that particular calibration run, then run Calibration with Note: Mix the calibrator sample thoroughly in measurement again between runs © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 28 2014-07-22 Global Product Education Calibration Calibration measure 01:18 PM Review and Interpret Calibration Results: PID PLUS025 00/00/0000 12:00 AM After performing all the runs, the results SID CAL7/1 Type Control  display showing statistical evaluation of Runs 1 of 3 calibration runs Parameters Normal Ranges Tech Details WBC 6.79 103/ul WBC  Each calibration factor must be within 1.00 +/- LYM 2.30 10%ul 33.8 % 0.20 limits MID 0.56 103/ul 8.3 % GRA 3.93 103/ul 57.9 % HGB 12.5 g/dl ................ MCH 28.9 pg 20 79 129 400fl  If a calibration is outside this range, it is highlighted in red MCHC 31.7 g/dl RBC 4.32 106/ul RBC MCV 91.4 f RDW 16.3 % The left part of the screen displays: Target HCT 39.48 %  values, Mean Values of Runs, CV%, and the PLT 250 103/ul 30 200fl newly calculated calibration factors MPV 10.0 fl PLT  If the CV% values and the new factors are 30 50fl satisfactory, select Evaluate > Accept If the results are not acceptable, select Cancel. Run Print  Discard Back  Repeat the calibration process using a new vial of calibration material © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 29 2014-07-22 Global Product Education Calibration Calibration history 01:39 PM View Calibration History and Database Date WBC RBC HGB  To view the history of calibration events by factors, navigate to: 02/13/2015 09:19 AM 1.00 1.03 1.02 1. Home 02/11/2015 03:54 PM 1.00 1.00 1.01 2. Maintenance 01/27/2015 03:44 PM 0.98 0.99 1.00 3. Calibration 01/22/2015 01:36 PM 0.98 0.99 1.01 4. History  The Calibration History screen shows the calibration factors that were generated by each calibration Print Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 30 2014-07-22 Global Product Education Calibration Calibration database 01:39 PM View Calibration History and Database Sample ID Date LOT  To view the calibration database, navigate to: CAL5/1 02/11/2015 PLUS ... 1. Home CAL5/2 02/11/2015 PLUS ... 2. Maintenance CAL5/3 02/11/2015 PLUS ... 3. Calibration CAL6/1 02/13/2015 PLUS ... 4. Database CAL6/2 02/13/2015 PLUS ... CAL6/3 02/13/2015 PLUS ...  The calibration database screen shows the details of each calibration run CAL7/1 03/09/2015 PLUS .. CAL7/2 03/09/2015 PLUS ... CAL8/1 03/09/2015 PLUS ... CAL8/2 03/09/2015 PLUS ... CAL8/3 03/09/2015 PLUS ... Records 22 | Selected 0 Details Print Filter Statistics Manage Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 31 2014-07-22 Global Product Education Quality Control New LOT 01:40 PM Enter a New Lot of QC Material: 1. Navigate to Home > Quality control > New LOT Lot Level Normal 2. Scan the QR code located on the Assay sheet Expiration-date shipped with your control materials, to load the Lot information, expiration date, and Target Range target and range values WBC [103/ul] 0.00 +/- 0.00 3. Allow time for the prompt “Do you want to install controls…?” to appear RBC [108/ul] 0.00 +/- 0.00 HGB [g/dl] 4. Select Yes 0.0 +/- 0.0 HCT [%] 0.00 +/- 0.00 MCV [fl] 0.0 +/- 0.0 MCH [pg] 0.0 +/- 0.0 MCHC [g/dl] 0.0 +/- 0.0 RDW [%] 0.0 +/- 0.0 PLT [103/ul] +/- O O MPV [fl] 0.0 +/- 0.0 Accept Load Cancel © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Quality Control Maintenance Page 32 2014-07-22 Global Product Education Quality Control New LOT 01:40 PM View QC Reference Values: 1. Select Quality control LOT 2. Select > next to the expiration date for that Level Normal control Expiration-date 3. Select References Target Range WBC [103/ul] 0.00 +/- 0.00 RBC [108/ul] 0.00 +/- 0.00 HGB [g/dl] 0.0 +/- 0.0 HCT [%] 0.00 +/- 0.00 MCV [fl] 0.0 +/- 0.0 MCH [pg] 0.0 +/- 0.0 MCHC [g/dl] 0.0 +/- 0.0 RDW [%] 0.0 +/- 0.0 PLT [103/ul] +/- O O MPV [fl] 0.0 +/- 0.0 Accept Load Cancel © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Quality Control Maintenance Page 33 2014-07-22 Global Product Education QC Normal LOT B025N 01:41 PM Quality Control PID 00/00/0000 12:00 AM SID Type QC Normal Run a Quality Control Sample 1. To measure QC (all levels), navigate to: Parameters Normal Ranges Tech Details 1. Quality control WBC 103/ul WBC LYM 103/ul 2. Select the check box in front of the Lot MID 103/u % % number and level of QC you wish to run GRA 103/ul HGB g/dl 3. Select > next to the expiration date for MCH 400fl MCHC pg that control g/dl RBC 106/ul RBC 4. Select Measure MCV 5. Mix the control material, insert the tube RDW HCT % into the sample adaptor, and select Run PLT 103/ul 200fl 6. The system rotates the sample for MPV fl PLT aspiration and begins the QC measurement (Status light turns orange and then red) 50fl 7. The system rotates the sample to the original position once aspiration is complete Run Print 8. The QC results display and the system beeps when the measurement is Discard Back complete Important: Verify that a valid Blank has been 9. Select Run to rerun QC, Discard to performed and accepted prior to running QC. discard the QC results, and Print to print the results © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 34 2014-07-22 Global Product Education Quality Control QC Normal LOT B025N 01:43 PM Review and Interpret QC Results PID B025N 03/09/2015 01:42 PM 005 Type QC Normal  Results display in the QC screen (Home > SID Quality control) Parameters Normal Ranges Tech Details  Results are divided into three categories: WBC 6.79 103/ul LYM 2.30 103/ul WBC 1. Parameters 33.8 % MID 0.56 103/ul 8.3 % 2. Normal Ranges GRA 3.93 103/ul 57.9 % HGB 12.5 g/dl ................ 3. Tech Details MCH 28.9 pg 20 79 129 400fl MCHC 31.7 g/dl RBC 4.32 106/ul RBC  The Lot number, date and time of run, sample ID and sample type display in the header MCV 91.4 fl RDW 16.3 % HCT 39.48 % L PLT 250 103/ul 200fl  Results screen – Parameters  Values within normal range are white MPV 10.0 fl PLT  Values outside of the normal range are red and flag as L or H  Histograms display graphical 30 50fl information about volume distribution of WBC, RBC, PLT  Discriminators are indicated by vertical lines that separate different cell Run Print populations Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 35 2014-07-22 Global Product Education Quality Control QC Normal LOT B025N 01:44 PM Review and Interpret QC Results PID B025N 03/09/2015 01:42 PM Results screen – Normal Ranges SID 005 Type QC Normal   Normal ranges display in a graphical format on the right of the screen Parameters Normal Ranges Tech Details  Each value is indicated by a downward- WBC 6.79 103/ul 6.40 8.80 pointing white arrowhead within the LYM% 33.8 % 24.5 38.5 normal range graphics MID% 8.3 % 3.0 15.0 GRA% 57.9 % 51.5 67.5 LYM 2.30 103/ul 1.80 3.00  Low and high limits of the normal range MID 0.56 103/ul 0.20 1.20 GRA 3.93 103/ul 3.80 5.20 display on either side of the range line HGB 12.5 g/dl 12.9 14.5 MCH 28.9 pg 27.0 32.6 MCHC 31.7 g/dl 29.5 35.5 RBC 4.32 106/ul 4.30 4.90 MCV 91.4 fl 86.5 96.5 RDW 16.3 % 11.5 21.5 HCT 39.48 % L 39.70 44.50 PLT 250 103/jul 190 290 MPV 10.0 f 6.1 12.1 Run Print Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 36 2014-07-22 Global Product Education Quality Control Measure 01:15 PM Review and Interpret QC Results PID 03/09/2015 01:13 PM Results screen – Tech Details SID AUTO_00039 Type Human   Probe voltage: shows electrode voltages for WBC and RBC counts  WBC lyse volume: default value = 0.9 Parameters Normal Ranges Tech Details  Diagnostic flags: shows evaluations Probe voltage made by the system based on results Min Max  Warning flags display for the WBC 277 RBC 307 279 309 measurement WBC Lyse volume 0.90 ml Diagnostic flags Warning flags New sample Re-run Print Discard Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 37 2014-07-22 Global Product Education Quality Control B025N (QC Normal) 04:11 PM To Display QC Results in Database (Table) View: Sample ID HGB HCT MCV 1. Select Quality control 004 13.9 41.74 91.0 2. Select the check box to the left of the Lot file 005 12.5 L 39.48 L 91.4 that you wish to view 006 13.5 42.15 91.6 3. Select > next to the expiration date for that control 4. Select Database at the bottom of the screen 5. Navigate through all the parameters by selecting the left/right arrows at the bottom of the screen Records 3 | Selected 3 Details Print Filter Manage Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 38 2014-07-22 Global Product Education Quality Control QC Monthly View 01:48 PM View, Print, or Export Control Lot Data Files QC lots that were measured in 1. Navigate to Home > Quality Control 02/2015 2. Select the check box to the left of the Lot file that you wish to view Lot name Level Exp. date 3. Select Monthly View at the bottom of the B025L QC Low 05/05/2015 V screen Navigate through the months (mm/yyyy) B025N QC Normal 05/05/2015 4. V using the arrows at the top of the screen 5. Select Print or Export for the selected file(s) Important: Selecting Export writes the selected records as an ASCII file (.txt) to the USB storage device if a USB device is present in the USB port, otherwise the system requests that the USB device be inserted. Print Export Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 39 2014-07-22 Global Product Education Quality Control B025N (exp. 05/05/2015) 01:49 PM View a Levey-Jennings Chat WBC 7.11 103/ul, N=3, CV=5.3, SD=0.38, MEAN=7.15 1. Navigate to Home > Quality Control ........................................................................................................................................................................... 8.80 2. Select the check box to the left of the Lot file 7.60 O that you wish to view O ........................................ .... 6.40 3. Select > to the right of the expiration date so RBC 4.60 10%ul, N=3, CV=3.5, SD=0.16, MEAN=4.50 that the Levey-Jennings chart displays ........................................................................................................................................ 4.90 4. To navigate through the chart to view the 4.60 results for the different parameters, select the ............................................................................................................................................................................. 4.30 up and down arrows towards the bottom of HGB 13.5 g/dl, N=3, CV=5.3, SD=0.7, MEAN=13.3 the screen 7 .......... 14.5 5. To display results for a specific measurement o 13.7 point, select the Left/Right arrows on either 12.9 side of the View option, to move the white triangle pointer to the specific measurement HCT 42.15 %, N=3, CV=3.5, SD=1.44, MEAN=41.12 ................................................................................................................. ........................ 44.50 you wish to view 42.10 6. Select View .... 39.70 7. Select Normal ranges and Tech Details to view those results for that particular View measurement Important: Any QC that has been measured via the Database Print References Measure screen will not be included in the statistical data. Measure Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 40 2014-07-22 Global Product Education Maintenance Cleaning 01:49 PM Daily Maintenance: Cleaning  Perform a Daily Shutdown / Cleaning: 1. To shut down the system select Exit > Shutdown Hard cleaning • The software initiates a Cleaning sequence 2. When the system displays a warning message and emits a sustained tone, it Drain chamber is safe to turn off the power 3. Power off the system by pressing the Power switch  Perform a Daily Startup: 1. Power on all external devices (Printer) if installed 2. Power on the system by pressing the Power switch (Wait 5 minutes before initiating any measuring processes to allow system to warm up) 3. Follow Startup as per laboratory policy Home Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Maintenance Page 41 2014-07-22 Global Product Education Maintenance Cleaning 01:49 PM Weekly Maintenance:  Perform a Hard Cleaning Cleaning  Put 1 mL of the ADVIA Hypoclean solution into a sample tube Hard cleaning  Run the Hard Cleaning function by navigating to: 1. Home Drain chamber 2. Maintenance 3. Cleaning 4. Hard Cleaning  Repeat blank and select Accept if in range  Check Tubing System  Open the side door and check for any leaks Warning: The sharp tip of the piercing needle can cause injury. Always use rubber gloves and a cotton swab to clean the wash head. Home Back © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 42 2014-07-22 Global Product Education Maintenance Weekly Maintenance:  Clean the Needle Wash Head 1. Run the shut-down procedure and power down the system 2. Open the side door 3. Use a moistened cotton swab with deionized water to remove salt and blood residuals from the bottom of the wash head 4. Power on the system by pressing the Power switch 5. Follow Startup as per laboratory policy Warning: The sharp tip of the piercing needle can cause injury. Always use rubber gloves and a cotton swab to clean the wash head. © Siemens Healthcare Diagnostics Inc. 2015 All rights reserved. Page 43 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 44 2014-07-22 Global Product Education