Atellica® 1500 Automated Urinalysis Analyzer PEP to Go

SIEMENS Healthineers SIEMENS Healthineers SIEMENS -- -- - --- CLINITEK Novus A Atellica 1500 Atellica™ 1500 Automated Urinalysis Analyzer PEP to Go *Not available for sale in the U.S. Product availability varies by country. Page 1 HOOD05162002594191 Effective date: 6/16/2017 Table of Contents SIEMENS Healthineers Hardware Overview……………………….…….….. 3 Software Overview……………………………….….. 8 Routine Operations SIEMENS Daily Maintenance.….…………………………. 10 System Preparation.……..………………….…. 18 Healthineers Sample Processing………….……………..……. 24 Reviewing Results.................................... 25 Printing Results........................................ 28 Calibration (CLINITEK Novus® Analyzer)...... 29 Quality Control…............................................ 30 Maintenance…………………………………………… 33 Monthly Maintenance.................................. 35 Periodic Maintenance................................. 37 Database Backup......................................... 39 2 © Siemens AG 2013. All rights reserved. Page 2 Hardware Overview – Atellica™ 1500 Analyzer SIEMENS Healthineers Atellica™ 1500 Automated Urinalysis Analyzer is composed of: 1. Atellica™ UAS 800 Analyzer 2. CLINITEK Novus® Automated Urine Chemistry Analyzer 3. Sample rack handler 2 1 3 3 Hardware Overview © Siemens AG 2013. All rights reserved. Page 3 Hardware Overview – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Atellica™ UAS 800 Analyzer External Components 3 1. Sample rack handler • Up to 10 racks can be loaded SIEMENS 2. Sampling area Healthineers 7 • Samples are mixed and aspirated 3. Cuvette waste bin 5 2 6 1 • Holds used cuvette cartridges Abillar wage 4. Wash and waste bottles • Utilized for cleaning of the analyzer 5. On/off button (on left side of analyzer) WASTE 4 WASH 6. Monitor, keyboard, mouse • Used to navigate the software 7. Serial number (on back of instrument, not shown) 4 © Siemens AG 2013. All rights reserved. Page 4 Hardware Overview – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Atellica™ UAS 800 Analyzer Internal Components Cuvette carousel • holds up to 12 cuvette cartridges, each contains up to 50 cuvettes Not visible in this image: Pipette • Used to mix, aspirate and dispense urine sample IT Front and rear cuvette guides Cuvette • Used to transport cuvette Centrifuge carousel • Spins cuvette to bank the particles on one plane Microscope and high-resolution camera • Used to analyze the urine sample A 5 © Siemens AG 2013. All rights reserved. Page 5 Hardware Overview – CLINITEK Novus® Analyzer SIEMENS Healthineers CLINITEK Novus® Automated Urine Chemistry Analyzer External Components 1. Sample rack handler • Up to 10 racks can be loaded 2. Display SIEMENS • Used to navigate the software 2 Healthingers 3 3. Sampling area 5 • Aspirates urine sample 4 6 • Barcode reader Card waste drawer 1 4. • Holds used cards Atellica 1500 5. Waste bottle 6. Rinse bottle 7. On button (on side of instrument, not visible) 8. Serial number (on back of instrument, not visible) 6 © Siemens AG 2013. All rights reserved. Page 6 Hardware Overview – CLINITEK Novus® Analyzer SIEMENS Healthineers CLINITEK Novus® Automated Urine Chemistry Analyzer Internal Components 1. Pipette (not visible) • Dispenses urine sample on test pads and into SG well 2. Cassette compartment door • Holds a reagent cassette and keeps it away from moisture 3. Card Platform 4 • Holds test card during processing 4. Syringe • Aspirates and dispenses urine sample through pipette 3 2 5. SG well (not visible) • Used to measure specific gravity and report clarity 7 © Siemens AG 2013. All rights reserved. Page 7 Software Overview – Atellica™ UAS 800 Analyzer SIEMENS Healthineers 1 Atellica™ UAS 800 Analyzer Screen Overview Atellica UAS 800: Automated Urine Sediment Analyzer 4.0 V ? i 1. Title bar 2 Measure Database Quality Control Help Info Logout Shut Down Displays device name and software version Measure List | 25 samples • Date & Time Rack Tube ID Name status 2. Menu bar 3/27/2017 1:56:22 PM 02 01 8001010 V Completed • Displays icons used to perform a task, including Shut 3/27/2017 1:56:42 PM V Completed Down and Logout 3/27/2017 1:57:11 PM 02 8001006 3 V Completed 3/27/2017 1:57:42 PM 04 8001025 Completed 3. Workspace 3/27/2017 1:58:15 PM 02 05 8001007 Completed 3/27/2017 1:58:48 PM 02 06 8001022 V Completed • Displays information and messages for the current task 3/27/2017 1:59:20 PM 02 07 8001015 V Completed 3/27/2017 1:59:54 PM 02 08 8001005 Completed 4. System Function bar 3/27/2017 2:00:26 PM 09 8001021 V Completed • Used to perform actions on the current screen 3/27/2017 2:01:00 PM 02 800.001 V Completed 3/27/2017 2:16:48 PM 03 07 8001010 V Completed 5. Status bar 3/27/2017 2:17:09 PM 03 02 8001003 Completed Displays task and system indicators 3/27/2017 2:17:37 PM 03 8001006 V Completed • 3/27/2017 2:18:10 PM 03 04 8001025 V Completed 486 4 O A M Initialize Rack Out Clear List Cuvette Reg STAT Test Automatic Manual Start Online Operator 1 Particle Classes: 14 Recognition Threads: Waiting 0 Waste bin: 114| Waste tank Ok Water tank Ok 3/27/2017 3:57:24 PM 5 8 Software Overview © Siemens AG 2013. All rights reserved. Page 8 Software Overview – CLINITEK Novus® Analyzer SIEMENS Healthineers 1 CLINITEK Novus® Analyzer Screen Overview SIEMENS Status: Ready CLINITEK Novus 2 Home 09 51 AM 05/17/2012 1. Status bar Displays system status indicators Tests Remaining 368 Status Log • 3 Cassette 10 Test Page Cassette Lot 1022001 2. Title bar 7 Onboard Stability 13 Days 1/1 Next Sample 0-00172 • Displays current screen name, date, and time Next STAT S-00001 A 3. Cassette Status Displays status of loaded cassette V • 4. Off button • Shuts down software and powers down hardware 5. Navigation bar 8 • Displays task and system indicators 20% 100% 6. System function bar 4 • Displays menus to complete tasks 7. Status log System Setup Results Start • Displays system messages 8. System indicators 5 6 • Displays status of waste and rinse 9 Software Overview © Siemens AG 2013. All rights reserved. Page 9 Daily Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Empty and clean the cuvette waste bin Clean the sample rack handler 1. Remove the cuvette waste bin. 1. Wipe the sample rack handler with a cloth moistened with a 2. Empty cuvette waste bin according to your facility’s disposal guidelines. 1:10 bleach solution. 3. Clean the cuvette waste bin with 1:10 solution of bleach. 2. Wipe the sample rack handler with water and dry. 4. Rinse with water and dry. 5. Replace the cuvette waste bin. Note: The cuvette counter resets to 0 when it is replaced. G CLINITEK NovUs A UAS 800 rack handler ********************** 10 Daily © Siemens AG 2013. All rights reserved. Page 10 Maintenance Daily Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Clean the front cuvette guide 1. Open the front cover. 2. Remove the front cuvette guide holding it at a slight angle to avoid bumping the cuvette carousel. 3. Wipe the guide with 70% isopropyl alcohol. 4. Wipe the guide with water and dry. 5. Clean the supporting plate and the pins where the guide is installed with a cloth moistened with 70% isopropyl alcohol. 6. Replace the front cuvette guide at a slight angle. Align the holes on the guide with the supporting pins. Confirm there is no gap when the guide is seated on the supporting pins. 7. Close the front cover. 11 Daily © Siemens AG 2013. All rights reserved. Page 11 Maintenance Daily Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Clean the rear cuvette guide 2 1. Open the front cover. 2. Turn the microscope arm toward the front of the analyzer. Do not remove the securing screw. 3. Hold the rear cuvette guide at a slight angle and remove it from the analyzer. 4. Wipe the guide with 70% isopropyl alcohol, wipe with water and dry. 5. Clean the supporting plate and the pins where the guide is installed with a cloth moistened with 70% isopropyl alcohol. #### 6. Replace the rear cuvette guide at a slight angle. Align the holes on the guide with the supporting pins in the analyzer. 7. Turn the microscope arm back to its original location. 8. Close the front cover. 12 © Siemens AG 2013. All rights reserved. Page 12 Daily Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Check the washing liquid bottle 1. Check the washing liquid bottle level in the status bar or by visual Waste bin: 114 Waste tank Ok Water tank Ok inspection. 2. Refill the bottle if it is almost empty. Do not perform this task when the analyzer is running. BERNSTEIN 3. Remove the cap with attached sensor and place it on a clean surface. 4. Fill the bottle with deionized water. 5. Replace the cap on the bottle. Note: Ensure the tubing is inserted into the cap until the “Push Until” label on the tubing is almost covered. WASH 13 © Siemens AG 2013. All rights reserved. Page 13 Daily Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Empty and clean the waste water bottle 1. Check the waste water bottle level in the status bar or by visual Waste bin: 114 Waste tank Ok Water tank Ok inspection. 2. Remove the cap with attached sensor. 3. Empty the bottle according to the lab’s waste disposal guidelines. BERNSTEIN 4. Clean the bottle with a 1:10 solution of bleach. 5. Replace the cap with attached sensor. Note: Allowing the floater to stay in contact with the tubes inside the bottle could result in an erroneous waste status. WASTE 14 © Siemens AG 2013. All rights reserved. Page 14 Daily Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Perform daily disinfecting rinse Shut Down (49) 1. Confirm the analyzer is in the Online status. 2. Remove all racks from the rack handler. 5 Are you sure you want to shut down the Atellica UAS 800 Automated Urine Sediment Analyzer? 3. Pour 6 mL of 2% bleach solution into a test tube. Place the test tube in Position 1 of an empty rack. × 4. Select the Shut Down button on the software. 5. Select the check to confirm you want to shut down the analyzer. Do you want to begin the daily disinfecting rinse? (35) 6. Select the check to confirm you want to start the procedure. 6 7. Open the front cover. X 8. Remove the front cuvette guide holding it at a slight angle to avoid bumping the cuvette carousel. Starting Daily Disinfection Wash 9. Close the front cover and select the check to start the rinse. - Place rack with a test tube of 6 ml 2% bleach solution - Remove front cuvette guide 10. After the disinfecting rinse is finished and the instrument is powered off - Close instrument door - Click green check to continue. (120) automatically, replace the front cuvette guide at a slight angle. Align the 9 holes on the guide with the supporting pin. × 11. Close the front cover. 15 © Siemens AG 2013. All rights reserved. Page 15 Daily Maintenance – CLINITEK Novus® Analyzer SIEMENS Healthineers Clean the SG well SIEMENS À Status: Not Ready CLINITEK Novus 1. Pour at least 2 mL of 5.25% sodium hypochlorite into a tube labeled System 01:30 PM 07/29/2013 Bleach. Calibration Diagnostics 2. Place the tube into the first position of a sample rack. Control System Management 3. Load the rack onto the system. Clean SG Well About the System 4. Select System. Prime Pump 5. Select Clean SG Well. 6. Select Start. Load & Unload Clean the sample rack handler ? 1. Use a germicidal wipe to clean the sample rack handler. System Setup Results Start 16 © Siemens AG 2013. All rights reserved. Page 16 Daily Maintenance – CLINITEK Novus® Analyzer SIEMENS Healthineers Empty the waste bottle (External bottle) Empty the waste bottle (Internal bottle) 1. Disconnect the tubing from the bottle. 1. Remove racks from the sample rack handler. 2. Empty the waste according to your facility’s disposal guidelines. 2. Press the latch and pull the waste bottle drawer out of the 3. Reconnect the tubing. slot. 3. Turn the bottle cap counterclockwise and remove it. 4. Empty the waste according to your facility’s disposal guidelines. 5. Replace the cap and turn it clockwise, finger tight. 6. Wipe off any spillage on the bottle. 7. Slide the waste bottle drawer into the slot until it is latched. 17 © Siemens AG 2013. All rights reserved. Page 17 SIEMENS System Preparation – Atellica™ UAS 800 Analyzer Healthineers Logging on 1. Press the power button on the analyzer. 2. Turn on the personal computer (PC). 3. When the dialog box appears, type in login name and SIEMENS Healthineers password. Atellica UAS 800 4. Select OK. Automated Urine Sediment Analyzer Username Password Logging off Ok 1. Select Logout in the Menu bar. Version 4.0.72 | @ 2015 Siemens AG 18 System © Siemens AG 2013. All rights reserved. Page 18 Preparation SIEMENS System Preparation – Atellica™ UAS 800 Analyzer Healthineers Loading cuvettes CE IVD 1. Open the front cover. CE [IVDI CE [IVD] CE LIVO LOT 2. Rotate wing screw to the left on top of cuvette carousel. 2019-04-23 8 2019-04-23 LOT] 100429516 160429512 3 2019-04-23 LOT] 160429616 LOT 2019-04-23 160429616 Atellica URS 800 3. Lift and remove top of cuvette carousel. TEZ Ovettes Areilica URS 800 Eso queries Atellica UAS 800 Areilica UAS 200 50 4. Open cuvettes carton and remove registration card. Ouvettes 5. Load a single cuvette cartridge into the carousel. Image of cuvettes carton 6. Turn the carousel clockwise to the next empty slot. 7. Load cuvette cartridges until the carousel is full. 8. Replace top on carousel and tighten wing screw. 9. Remove tape at the bottom of each cuvette cartridge. 10. Close the front cover. Note: Cuvettes must be registered with the system before processing samples. 19 © Siemens AG 2013. All rights reserved. Page 19 SIEMENS System Preparation – Atellica™ UAS 800 Analyzer Healthineers Cuvette Registration (44) Registering cuvettes You must register cuvettes before using them on the analyzer. 1. Select the Measure icon. Remove the registration card from the front of the cuvette box and 2. Select the Cuvette Reg button. then click the green check button. Insert the cuvette registration card into the barcode scanner slot 3. Press the check. when prompted. Insert the registration card in the sampling area with barcode . To cancel registration click the red X button. 4. facing the reader. 3 × 5. Select the check to return to the Measure screen. Barcode scan successful. (69) Cuvette registration complete. 5 Cuvette Reg 20 © Siemens AG 2013. All rights reserved. Page 20 System Preparation – CLINITEK Novus® Analyzer SIEMENS Healthineers Loading reagent cassette 1. Select System. 2. Select Load & Unload. 3. Select Yes. 4. Open the front cover. 5. Unlock and open the cassette door. 6. Remove the cassette. 7. Load the new cassette. 8. Close and lock the cassette door. 9. Close the front cover. Note: The system reads the lot number and expiration date of the reagent cassette when the front cover is closed. 21 © Siemens AG 2013. All rights reserved. Page 21 SIEMENS System Preparation – CLINITEK Novus® Analyzer Healthineers Empty and fill rinse bottle 1. Remove racks from the sample rack handler. 2. Press the latch forward and pull the rinse drawer out of the slot. 3. Turn the bottle cap counter clockwise to remove it. 4. Empty the rinse solution according to your facility’s disposal guidelines. 5. Fill the rinse bottle with 1000 mL of distilled or deionized water. 6. Add 2 mL of CLINITEK Novus Rinse Additive. 7. Gently swirl the bottle six times. 8. Replace the cap and turn it clockwise, finger tight. 9. Slide the rinse drawer into the slot until it is latched. 10. Select System. 11. Select Prime Pump. 22 © Siemens AG 2013. All rights reserved. Page 22 System Preparation – CLINITEK Novus® Analyzer SIEMENS Healthineers Empty card waste drawer 1. Remove racks from the sample rack handler. 2. Press the latch forward and pull the card waste drawer out of the slot. 3. Empty the cards according to your facility’s disposal guidelines. 4. Remove and clean the internal liner with isopropyl alcohol. 5. Replace the internal liner. 6. Slide the card waste drawer into the slot until it is latched. 23 © Siemens AG 2013. All rights reserved. Page 23 Sample Processing – Atellica™ 1500 Analyzer SIEMENS Healthineers Loading barcoded sample tubes 1. Place sample into the rack starting with position 1. 2. Tilt the rack at an angle to the right, align the rack slot with CLINITEK Novus' the retaining rail and load on the CLINITEK Novus® Analyzer sample rack handler. Ensure the barcodes are facing the system. 3. Select Start on the CLINITEK Novus screen. When sampling on the CLINITEK Novus Analyzer is complete, the rack moves along the sample rack handler to the Atellica™ UAS 800 Analyzer. Note: The minimum volume required to run the sample on both systems is 2.6 mL Samples to avoid for CLINITEK Novus® analyzer: visibly bloody, mucoid or foamy samples Samples to avoid for Atellica™ UAS 800 analyzer: foamy samples 24 Sample © Siemens AG 2013. All rights reserved. Page 24 Processing Sample Processing - Atellica™ 1500 Analyzer SIEMENS Healthineers Reviewing Results Atellica UAS 800: Automated Urine Sediment Analyzer 4.0 F Date Range 3/27/2016 3/27/2017 V ? i - 1. Select Database on the Atellica™ UAS 800 Measure Database Quality Control Help Info Logout Shut Down Sediment Result Sample List | 42 samples Selected Sample | Date: 3/27/2017 Name: - ID: 00102 software. Not Invalid Ft Review Y Filter Dilution: 1.0 Status: + Positive omments: Fl Invalid F Has Valid Image Date&Time ID Name /- Manual Eval Particl Category Ref. (p/p Not Empty Cuvette F. No Valid Image 3/27/2017 11:05:12 AM 2. Select a sample from the Sample List. N/A Invalid No 00/00 RB 0 .. 5 Empty Cuvette E Negative 3/27/2017 11:23:03 AM 8001004 N/A Invalid No 00/00 WBC <3 1 .. 9 ET Low Sample Level El Positive 3/27/2017 11:25:50 AM 00102 Positive No 15/15 WBCC O .. 9 3. Results are displayed in the Selected Sample El Normal Sample Level QC Failed 3/27/2017 11:26:03 AM 8001013 + Positive No 15/15 Has Result QC Passed CRY O .. 3/27/2017 11:35:15 AM 8001010 + Positive No 15/15 area. FI No Result F Validated HYA O .. 3/27/2017 11:35:35 AM 8001003 + Positive No 15/15 FI Measured Not Validated PAT D .. 1.5 3/27/2017 11:36:05 AM 8001006 Positive No 15/15 4. Use the Filter to narrow results. ET Not Measured ET To Confirm NEC o .. 3/27/2017 11:36:36 AM 8001025 Positive NO 15/15 Not Review Not To Confirm EPI o .. 5 Image for review Checked Valid 3/27/2017 11:37:10 AM Positive No 15/15 YEA O .. 01 No No Microscopy mode 3/27/2017 11:37:44 AM 8001022 + Positive No 15/15 BAC 0 .. 130 O No No No Manual El Automatic 3/27/2017 11:38:14 AM 8001015 + Positive No 15/15 .BACr 0 .. 130 03 N No No 3/27/2017 11:38:48 AM 8001005 + Positive No 15/15 0 .. 130 04 No Vo Chemical Result BACK NO 3/27/2017 11:39:22 AM 8001021 + Positive No 15/15 MUC O .. 264 05 No No El Abnormal ET No Result 3/27/2017 11:39:55 AM + Positive No 15/15 SPRM 0 .. 12 06 No Nc Normal F Has Result 3/27/2017 1:56:22 PM 8001010 + Positive No 15/15 07 No El Error No 3/27/2017 1:56:42 PM 8001003 + Positive NO 15/15 NO No 3/27/2017 1:57:11 PM 800100 Positive No 15/15 Edit Recalculate Add note Reset Apply ARME Delete Modify Comment Validate Outputs ID Errors Worklist Rerun Data View Gallery Online Operator Particle Classes: 14 Recognition Threads: Waiting 0 Waste bin: 114| Waste tank Ok Water tank Ok 3/27/2017 3:58:19 PM 25 © Siemens AG 2013. All rights reserved. Page 25 Sample Processing - Atellica™ 1500 Analyzer SIEMENS Healthineers Result Flags Flag Description Review Review is necessary Invalid Invalid sample Empty Empty cuvette ! Low level sample Skip Skipped To confirm. Sample requires manual review based on custom rule. QC passed QC failed 26 © Siemens AG 2013. All rights reserved. Page 26 Sample Processing - Atellica™ 1500 Analyzer SIEMENS Healthineers Atellica UAS 800: Automated Urine Sediment Analyzer 4.0 V ? Rerunning a sample Measure Database Quality Contro Help Logout Shut Down Sample List | 42 samples Selected Sample | Date: 3/27/2017 Name : ID: 00102 Y Filter Comments: Dilution: 1.0 us : + Positive 1. Select a sample on the Database screen. Date&Time ID Name +/- Manual Eval Particle Category p/pl Ref. (p/ul ) 3/27/2017 11:05:12 AM N/A Invalid 00/00 RBC 0 .. 5 3/27/2017 11:23- 8001004 N/A Invalid NO 00/00 WBC 0 .. 9 2. Select Rerun. 3/27/2017 11:25:50 AM 00102 + Positive No 15/15 .WBCC 3/27/2017 11:26:03 AM 8001013 Positive NO 15/15 CRY 312712017 11:35:15 AM 8001010 + Positive NO 3. If diluting the sample, choose dilution factor. 15/15 HYA O .. 2 3/27/2017 11:35:35 AM 8001003 Positive N 15/15 PAT 0 .. 1.5 3/27/2017 11:36:05 AM 8001006 No 15/15 NEC o .. 2 4. Place the sample on the CLINITEK Novus® Analyzer sample 312712017 11:36:36 AM 8001025 Positive 15/15 EPI 0 .. 5 Image| For review Checked Modified Valid /27/2017 11:37-10 AM 8001007 Positive 15/15 YEA 0 ... 3 07 No No No rack handler. 3/27/2017 11:37:44 AM 8001022 Positive NO 15/15 BAC .. 130 3/27/2017 11:38:14 AM 8001015 Positive N 15/15 . BACK 0 .. 13 3 5. Select Start on the CLINITEK Novus screen. 12017 11:38:48 AM 8001005 + Positive N 15/15 . BACC .. 130 No N No 3/27/2017 11:39:22 AM 8001021 Positive NO 15/15 MUC 0 .. 264 05 NO N No 3/27/2017 11:39:55 AM 8001001 NO 15/15 SPRM 0 . 12 06 N No When sampling on the CLINITEK Novus is complete, the rack 3/2712017 1:56:22 PM 8001010 Positive 15/15 No No No 3/2712017 1:56:42 PM 8001003 Positive NO 15/15 08 No No No moves along the sample rack handler to the Atellica™ UAS 800 3/27/2017 1:57:11 PM 8001006 Positive N 5/15 Edit Recalculate Add note Analyzer. Delete Modify Comment Validate Output ID Errors Worklist Rerun Data View Gallery Online Operator Particle Classes: 14 Recognition Threads: Waiting O Waste bin: 114| Waste tank Ok Water tank Ok 3/27/2017 3:58:19 PM Note: The minimum volume required to run the sample on Rerun both systems is 2.6 mL Date: 3/27/2017 Name: - ID: 8001004 Dilution Factor: 1.0 × 27 © Siemens AG 2013. All rights reserved. Page 27 Sample Processing - Atellica™ 1500 Analyzer SIEMENS Healthineers Atellica UAS 800: Automated Urine Sediment Analyzer 4.0 Printing sample and QC results V ? i Measure Database Quality Control Info Logout Shut Down 1. Select sample(s) on the Atellica™ UAS 800 Database screen. Sample List | 42 samples Selected Sample | Date: 3/27/2017 Name: - ID: 00102 Dilution : 1.0 Status : + Positive Q Filter Comments : 2. Select Outputs. Date&Time A ID Name Manual Eval Particle Category pul ef. (p/ul) 3/27/2017 11:05:12 AM N/A Invalid NO RBC <4 0 .. 5 3/27/2017 11:23:03 AM 8001004 N/A Invalic N 00/00 3. Select Print. WBC <3 0 .. 9 3/27/2017 11:25:50 AM 0010: + Positive No 15/15 .WBCC 0 .. 9 Outputs 3/27/2017 11:26:03 AM 8001013 + Positive No 15/15 CRY 0 .. 6 4. Select the check. Date: 3/27/2017 3/27/2017 11:35:15 AM 8001010 + Positive No 15/15 HYA 0 .. 2 3/27/2017 11:35:35 AM 8001003 + Positive 15/15 PAT O .. 1.5 3 Selected Sample: 3/27/2017 11:36:05 AM 8001006 + Positive NO 15/15 NEC O .. 3/27/2017 11:36:36 AM 8001025 + Positive NO 15/15 EPI 0 .. 5 Image For review Checked Modified Valid 3/27/2017 11:37:10 AM 8001007 + Positive NO 15/15 YEA 0 .. 3 01 No No No 15/15 Print Send To 3/27/2017 11:37:44 AM 8001022 + Positive NO Save BAC 0 .. 130 02 No No No 3/27/2017 11:38:14 AM 8001015 + Positive NO 15/15 .BACr 0 .. 130 03 No NO N Database Backup: 3/27/2017 11:38:48 AM 8001005 + Positive NO 15/15 . BAC 0 .. 130 04 No No No 3/27/2017 11:39:22 AM 8001021 + Positive NO 15/15 MUC 0 .. 264 05 No No No 3/27/2017 11:39:55 AM 8001001 Positive NO 15/15 SPRM 0 .. 12 06 No 3 3/2/12017 1:56:22 PM 8001010 + Positive NO 15/15 Full Anonymized 07 No NO NO 3/27/2017 1:56:42 PM 8001003 Positive No 15/15 08 NO NO NO 3/27/2017 1:57:11 PM 8001006 + Positive 15/15 Edit Recalculate Add note anmans × V Delete Modify Comment Validate Outputs ID Errors Worklist Rerun Data View Gallery Online Operator 1 Particle Classes: 14 Recognition Threads: Waiting 0 Waste bin: 114| Waste tank Ok Water tank Ok 3/27/2017 3:58:19 PM 28 © Siemens AG 2013. All rights reserved. Page 28 Calibration – CLINITEK Novus® Analyzer SIEMENS Healthineers Preparing Calibrator Rack Performing Calibration Rack Position Calibrator 1. Select System. SIEMENS Status: Ready CLINITEK Novus 2. Select Calibration. System > Calibration 10 25 AM 03/27/2012 1 Bleach The calibration passed. 3. To add a new lot select Change. Calibration Date & Time 03/27/2012 10:20 AM 2 CAL #4 Select Add. CAL 1 Lot 2106 • CAL 2 Lot 2106A CAL 3 Lot • Enter a lot. 2106B 3 CAL #1 CAL 4 Lot 2106C Print Select an expiration date. Cassette 10 Test • Cassette Lot 1022001 Calibration Temperature Send 4 CAL #2 23.2 ºC 4. Select Next. 5 CAL #3 5. Select Start. Exit 6. The calibration status of passed or Note: Allow calibrators to equilibrate failed will display at the end of the run. to room temperature before using. Reviewing Calibration Results 1. Select Results. 2. Select Calibration. 3. Select All Results. 29 © Siemens AG 2013. All rights reserved. Calibration Page 29 Quality Control – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Adding new QC lot information Running a QC test 1. Select Quality Control. 1. Follow QC vendor instruction to mix the QC material in its container. 2. Select Add in the Low or High Level Lots List pane. 2. Pour at least 2 mL of low and high level control solutions into 3. Select the Liquid type. appropriately labeled test tubes. 4. Enter the lot number. 3. Place the test tubes in a rack. Low level control solution in position 1 and high level control solution in position 2. 5. Select the Expiration date. 4. Place the rack on the sample rack handler. 6. Enter the RBC and WBC limit ranges. 5. On the QC Settings screen, select Low Level Lot and High Level Lot 7. Select the check. checkboxes for the appropriate lots. 6. Select Start QC. 7. Select the check. 8. When testing is complete, a message appears indicating QC Passed or QC Failed. 30 © Siemens AG 2013. All rights reserved. Quality Control Page 30 Quality Control – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Reviewing QC results Atellica UAS 800: Automated Urine Sediment Analyzer 4.0 V Select Database. Measure Database Quality Control Settings Help Logout hut Down 1. QC Settings QC Graphs 2. Select Data view or Gallery on the lower-right for more details. QC Conditions O Last 8 weeks @ Between 8/16/2016 8/26/2016 Update Upper and Lower Limits Category Low Level High Level Low level RBC High level RBC Lot ID 79581 79582 320 300 iquid Type Bio-Rad qUAntify Plus Bio-Rad q 280 Expiration Date 5/13/2017 5/13/2017 35 260 243.76 30 28.16 240224.4 218.24 221.76 227.04 First - Last Meas . Date 8/16/2016 - 8/23/2016 8/16/2016 22 21.12 24.64 220 201 62 208 28 25 20.24 195.36 200 194.48 Reviewing QC graphs Measure Count 11 10 20 13.2 14.96 180 160 RBC Limits (p/ul) 0-50 105-316 140 RBC Average (p/pl) 20.00 213.58 120 1. Select Quality Control. RBC SD (p/ul) 4.97 15.18 12:00: 140:00 12:01 18 400:00 12:0/19 400:00 12:00:00 12:00. 00:00 2.022 AM O 12:003 12:007 00:00 12.8/18 :00:00 AMO 400:00 12021 419:00 2:00:00 2:00:00 AM BC CV (%) 24.83 7.11 WBC Limits (p/ul) Low level WBC High level WBC 0 -25 55 - 167 2. Select QC Graphs. 170- WBC Average (p/jul) 0.00 107.58 24 160 22 150 WBC SD (p/ul) 0.00 20 8.31 18 140 3. Select the date range from the drop-down calendar. VBC CV (%) 0.00 7.72 16 180124.74 14 120 114.18 112.86 111.54 105.6 109.56 12 110 103.62 58:340 10 100 96.36 8 90 6 80 4. Select Update. 70 2 0 0 O 60 O O O 8/17 8/18 8/19 8/22 8/23 8/18 12:00:00 12:00:00 12:00:00 2:00:0 12:00:00 12:00:00 2.000 12:00:00 12:00-0 Output 12:020 12:0000 12:00:00 AM AM AM AM AM 2.00:00 00:00 Online 800Service article Classes: 14 Recognition Threads: Waiting 0 Waste bin: 46 | Waste tank Ok Water tank Ok 4/13/2017 5:35:36 AM 31 © Siemens AG 2013. All rights reserved. Page 31 Quality Control – CLINITEK Novus® Analyzer SIEMENS Healthineers Running a QC test Reviewing QC results at the end of a run 1. Pour at least 2 mL of each control into appropriately labeled test 1. Results automatically appear when the QC run is complete. tubes. 2. Use the scroll buttons to review details at the top of the screen. 2. Place the test tubes in a rack. Control 1 in position 1, Control 2 in position 2, Control 3 in Position 3. 3. Use the navigation bar to proceed to the next control. 3. Place the rack on the sample rack handler. Reviewing QC results for monthly review 4. Select System. 1. Select Results from the Home screen. 5. Select Control. 2. Select Control. 6. Verify the onscreen control lots are correct. 3. Enter search criteria. 7. To add a new lot, select Change. Reviewing QC Graphs for monthly review 1. Select Results from the Home screen. • Select Add. Enter the control lot and select Enter. 2. Select Control. • • Enter the expiration date and select Enter. 3. To graph all results, select All Results and then Graph. 8. Select Next. 4. To graph specific analytes or controls, select the analyte/control and select Enter. 9. Select Start. 32 © Siemens AG 2013. All rights reserved. Page 32 SIEMENS Maintenance – Atellica™ 1500 Analyzer Healthineers Interval Maintenance Task Instrument User Guide Daily Empty and clean cuvette bin Atellica™ UAS 800 Analyzer Chapter 7 Clean the sample rack handler Both Chapter 7 Clean the front and rear cuvette guides Atellica™ UAS 800 Analyzer Chapter 7 Check the washing liquid bottle Atellica™ UAS 800 Analyzer Chapter 7 Empty and clean the waste water bottle Atellica™ UAS 800 Analyzer Chapter 7 Perform daily disinfecting rinse Atellica™ UAS 800 Analyzer Chapter 7 Clean the SG well CLINITEK Novus® Analyzer Chapter 4 Empty the liquid waste bottle CLINITEK Novus® Analyzer Chapter 4 Monthly Clean the microscope objective Atellica™ UAS 800 Analyzer Chapter 7 Clean the centrifuge door and centrifuge arm Atellica™ UAS 800 Analyzer Chapter 7 33 Maintenance Maintenance © Siemens AG 2013. All rights reserved. Page 33 SIEMENS Maintenance – Atellica™ 1500 Analyzer Healthineers Interval Maintenance Task Instrument User Guide Periodic Clean the analyzer exterior Atellica™ UAS 800 Analyzer Chapter 7 Clean the drip tray Atellica™ UAS 800 Analyzer Chapter 7 Rinse the washing liquid bottle Atellica™ UAS 800 Analyzer Chapter 7 Remove empty cuvette cartridges Atellica™ UAS 800 Analyzer Chapter 7 Clean the washing liquid bottle Atellica™ UAS 800 Analyzer Chapter 7 Prime the pump CLINITEK Novus® Analyzer Chapter 4 Clean the card platform CLINITEK Novus® Analyzer Chapter 4 Clean the card grippers CLINITEK Novus® Analyzer Chapter 4 Clean the racks CLINITEK Novus® Analyzer Chapter 4 Clean the rack sensors CLINITEK Novus® Analyzer Chapter 4 Clean the pad sensor CLINITEK Novus® Analyzer Chapter 4 34 Maintenance © Siemens AG 2013. All rights reserved. Page 34 Monthly Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Clean the microscope objective 2 3 & 4 1. Open the front cover. 2. Turn the microscope arm toward the front of the analyzer. Do not remove the securing screw. 3. Gently wipe the microscope objective with a cloth dipped in 70% isopropyl alcohol. 4. Dry the objective with a clean cloth. 5. Turn the microscope arm back to its original location. 6. Close the front cover. 35 Monthly © Siemens AG 2013. All rights reserved. Page 35 Maintenance Monthly Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Clean the centrifuge cover and centrifuge arm 1. Open the front cover. 2. Remove the front cuvette guide holding it at a slight angle to avoid bumping the cuvette carousel. 3 3. Pull the black knob on the centrifuge cover to release the cover. 4. Remove the centrifuge cover. 5. Grasp the center of the centrifuge arm and carefully pull to remove it. 6. Wipe the centrifuge cover and arm with 70% isopropyl alcohol. 7. Rinse the centrifuge cover and arm with water and dry them. 8. Replace the centrifuge arm by aligning it with the magnet. The magnet will pull the arm into place. KIDS 9. Replace the centrifuge cover by aligning the pin on the knob with the clot on the door. 10.Replace the front cuvette guide. 11.Close the front cover. 5 36 © Siemens AG 2013. All rights reserved. Page 36 Periodic Maintenance – Atellica™ UAS 800 Analyzer SIEMENS Healthineers Performing periodic maintenance tasks Refer to the Atellica™ UAS 800 Analyzer User Guide for detailed instructions for each task. 1. Clean the analyzer exterior. 2. Clean the drip tray. 3. Rinse the washing liquid bottle. 4. Remove empty cuvette cartridges. 5. Clean the washing liquid bottle. 37 Periodic © Siemens AG 2013. All rights reserved. Page 37 Maintenance Periodic Maintenance – CLINITEK Novus® Analyzer SIEMENS Healthineers Performing periodic maintenance tasks Refer to the CLINITEK Novus® Analyzer Operator’s Guide for detailed instructions for each task. 1. Prime the pump. 2. Clean the card platform. 3. Clean the card grippers. 4. Clean the racks. 5. Clean the rack sensors. 6. Clean the pad sensor. 7. Clean the barcode reader. 38 © Siemens AG 2013. All rights reserved. Page 38 Database Backup - Atellica™ 1500 Analyzer SIEMENS Healthineers Atellica UAS 800: Automated Urine Sediment Analyzer 4.0 Perform database backup V ? i Outputs Measure Database Quality Control Info Logout Shut Down 1. Select Database. Sample List | 42 samples Selected Sample | Date: 3/27/2017 Name: - ID: 00102 Date: 3/27/2017 Dilution : 1.0 Status : + Positive Q Filter Comments : 2. Select Outputs. Date&Time ID Name Manual Eval Particle Category pul ef. (p/ul) Selected Sample: 3/27/2017 11:05:12 AM N/A Invalid NO RBC <4 0 .. 5 3/27/2017 11:23:03 AM 8001004 N/A Invalic N 00/00 3. Select Full or Anonymized. WBC <3 0 .. 9 3/27/2017 11:25:50 AM 0010: + Positive No 15/15 .WBCC 0 .. 9 Save Print Send To V 3/27/2017 11:26:03 AM 8001013 + Positive No 15/15 CRY 0 .. 6 4. Select the target location. 3/27/2017 11:35:15 AM 8001010 + Positive No 15/15 HYA 0 .. 2 Database Backup: 3/27/2017 11:35:35 AM 8001003 + Positive 15/15 PAT O .. 1.5 3 5. Select the check to confirm. 3/27/2017 11:36:05 AM 8001006 + Positive NO 15/15 NEC O .. 3/27/2017 11:36:36 AM 8001025 + Positive NO 15/15 EPI 0 .. 5 Image For review Checked Modified Valid 8001007 6. Select the check to save. Full Anonymized 3/27/2017 11:37:10 AM + Positive NO 15/15 YEA 0 .. 3 01 No No No 3/27/2017 11:37:44 AM 8001022 + Positive NO 15/15 BAC 0 .. 130 02 No No No 3/27/2017 11:38:14 AM 8001015 + Positive NO 15/15 .BACr 0 .. 130 03 No NO N 7. Select the x to close the window. 3/27/2017 11:38:48 AM 8001005 + Positive NO 15/15 × . BAC 0 .. 130 04 No No No 3/27/2017 11:39:22 AM 8001021 + Positive NO 15/15 MUC 0 .. 264 05 No No No 3/27/2017 11:39:55 AM 8001001 Positive NO 15/15 SPRM 0 .. 12 06 No 3 312/12017 1:56:22 PM 8001010 + Positive NO 15/15 07 No NO NO 3/27/2017 1:56:42 PM 8001003 Positive No 15/15 08 NO NO NO 3/27/2017 1:57:11 PM 8001006 + Positive 15/15 Edit Recalculate Add note anmans V Delete Modify Comment Validate Outputs ID Errors Worklist Rerun Data View Gallery Online Operator 1 Particle Classes: 14 Recognition Threads: Waiting 0 Waste bin: 114 @ Waste tank Ok Water tank Ok 3/27/2017 3:58:19 PM 39 © Siemens AG 2013. All rights reserved. Page 39 SIEMENS Training Checklist – Atellica™ 1500 Analyzer Healthineers To document that a facilitation event occurred, work with the learners to complete the following checklist for your records only. This does not serve as the final sign off for the customer. It is up to the facility to determine competency for their employees. Competency Objectives Complete Competency Objectives Complete System Overview Identify major hardware components Maintenance Perform daily maintenance Navigate the software Perform monthly maintenance Routine Operations Log into the software Perform periodic maintenance Determine the status of supplies Perform database backup Load supplies and empty waste Calibration (CLINITEK Prepare calibrators Novus® Analyzer) Process patient samples Process a calibration View patient results Review calibration results Print sample results Quality Control Add new QC lot information Process QC samples View QC data Observer: ______________________________________ Operator: ______________________________________ Date: _________________________________________ Training Checklist Page 40 © 2017 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 Inc. Atellica, CLINITEK Novus and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks are the property of their respective owners. Not available for sale in the U.S. Product HOOD05162002594191 Effective date: 6/16/2017 availability may vary from country to country and is subject to varying regulatory requirements. Note: This document is for supplemental Please contact your local representative for use only and is not intended to be used in availability. place of primary technical materials. Global Siemens Headquarters Global Siemens Healthcare Headquarters Siemens Healthineers Laboratory Diagnostics Siemens AG Siemens Healthcare GmbH Siemens Healthcare Diagnostics Inc. Wittelsbacherplatz 2 Henkestr. 127 511 Benedict Avenue 80333 Muenchen 91052 Erlangen Tarrytown, NY 10591-5005 Germany Federal Republic of Germany USA www.healthcare.siemens.com/laboratory-diagnostics Page 41 TOC SIEMENS Healthineers Now’s our time to inspire the future of healthcare together Engineering success. Pioneering healthcare. © Siemens Healthcare Diagnostics Inc., 2017 All rights reserved. Page 42