CLINITEK Status® Quick Guide

SIEMENS Healthineers CLINITEK STATUS + Analyzer Restricted © Siemens Healthineers, 2019 CLINITEK STATUS + Analyzer SIEMENS Healthineers .. • Reads Urinalysis test strip to Fet up 4:28PM 03-18-2008 assess metabolic states and Cassette fest Strip Tout detects urinary tract CLINITEK Status+ infections and other disorders. SIEMENS • Uses Clinitest Immunoassay cassettes to perform qualitative hCG pregnancy test. 2 Restricted © Siemens Healthineers, 2019 CLINITEK STATUS + Analyzer SIEMENS Healthineers .. PRINCIPLE: Reflectance Photometry –Consist of six light emitting diodes, light guide, mirror, lens and detector. CLINITEK Status+ • Lights from the LED travels along the guide and reflects off the calibration bar, strip pad onto the mirror at specific wavelengths (470nm, 525nm, 565nm, 625nm, 660nm and SIEMENS 845nm). • Intensity of the reflected light is dependent upon the degree of color change in the test pad and is directly related to the concentration of the analyte being tested. • Detected light intensity is converted into electrical impulse and converted into clinical results. 3 Restricted © Siemens Healthineers, 2019 KEY FEATURES: SIEMENS Healthineers .. • Easy operation touch screen. • Self Calibration. STREAMLINING OPERATIONS: BROAD CLINICAL EXPERTISE: • Data storage - 950 patient results. Customized and automated A robust menu of assays workflows designed to 700 operator IDs. covering nearly every organ improve productivity and disease Convenience – electric outlet / 6 AA batteries (100 tests). • • Standardization DIGITALIZING LABS: PARTNERING FOR Integrated data, process and PERFORMANCE: • Auto check inventory management tools for Innovative performance- better workflow and based partnerships with clinical outcomes Automatic test strip ID comprehensive service offerings • • Security 4 Restricted © Siemens Healthineers, 2019 KEY COMPONENTS SIEMENS Healthineers .. •ON and OFF Button CLINITEK Status+ Analyzer SIEMENS 5 Restricted © Siemens Healthineers, 2019 SIEMENS Healthineers .. KEY COMPONENTS • Test Strips SIEMENS 2161 Multistix® SIEMENS 2161 10 SG Reagent Strips Multistix* 10 SG for Urinalysis Ketone 25 Uroblinogen Note LINPoches For - Diagnostic Use 100 Strips 6 Restricted © Siemens Healthineers, 2019 KEY COMPONENTS SIEMENS Healthineers .. • Test Table and Insert 7 Restricted © Siemens Healthineers, 2019 KEY COMPONENTS SIEMENS Healthineers .. •Calibration Bar 8 Restricted © Siemens Healthineers, 2019 KEY COMPONENTS SIEMENS Healthineers .. • Touch Screen and Printer 9 Restricted © Siemens Healthineers, 2019 SIEMENS CLINITEK STATUS + Analyzer Healthineers : Input Settings •Quick Test Select one of the options Quick Test Full Test Permit test sequence Permit test sequence without entering after entering: operator or patient - operator name information - patient name • Full Test - patient ID sample appearance Custom Set Up Next •Custom Set up 10 Restricted © Siemens Healthineers, 2019 QC RUNNING SIEMENS Healthineers .. QUALITY CONTROL - • Helps ensure that the urinalysis strips are performing correctly and that the analyzer is accurately reading them. • QC also helps detect errors that result from user techniques. SIEMENS 11 Restricted © Siemens Healthineers, 2019 QC RUNNING SIEMENS Healthineers .. PREPARING QUALITY CONTROL: - 1. Add 12 ml distilled or DI H2O into an appropriately labeled tube. (Prepare a Positive and Negative control). 2. Remove a Chek-Stix control test strip. 3. Place the control test strip into the appropriate tube. 4. Cap the tube and invert gently for 2 minutes. 5. Allow the tube and invert gently for 2 minutes. 6. Allow the tube to stand for 30 minutes. 7. Uncap the tube and discard the control strip per SIEMENS laboratory procedure. 8. Repeat steps for the other control. 12 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. • Select QC Test Select Ready 10:02 10-14-2009 Instrument Recall Results Set Up QC Test QC Cassette Test Strip Test 13 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers : •Select QC Strip Test QC Test QC Select type of test QC Strip Test QC Cassette Test 14 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. •Select Last Qc Operator Name Operator or Enter New Operator ID. • Use the touchscreen to enter the - information and select enter to continue.. Enter New Operator Name JECYLL S. DAYANGHIRANG, M.D. | SHS AP ASN PHI DX 15 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. Qc Control Lot • Select Use Last Lot or Enter new lot and X expiration. A B CDEF G IH • Enter the lot information using the 1 J KLMNOP touchscreen and select ENTER to continue. QR S T U VWX Y Z - Enter ac Control Expiration 09 10 14 YY MM DD AA lv Previous Ente 16 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. •Select Enter new lot and expiration date. Qc Strip Lot Multistix@ 10 SG Enter new lot and expiration date JECYLL S. DAYANGHIRANG, M.D. | SHS AP ASN PHI DX 17 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers : Qc Strip Lot • Enter the lot information for the test strip to 123 test the controls. ABCDEFGH • Enter the lot information using the IJ KLMNOP QR S T U VWX touchscreen and select ENTER to continue. OY Z . - - Enter Qc Strip Expiration 09 YY MM Previous Enter 18 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers : •Select START Prepare Test QC Multistix@ 10 SG Touch START to begin Control: CHEK-STIX Level: START NEGATIVE 19 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. • Dip the test strip into the control solution. • Blot the strip to a clean paper towel. SIEMENS 20 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. • Place the strip in the table channel, pads facing up. Slide the test strip to the end of the channel. • Test table will automatically pull in strip. • Remove and dispose the test cassette per laboratory procedure. O SIEMENS 21 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. • QC Result will display on the screen and a test report will be printed. Qc Results QC Test: FAIL 1 of 2 GIUCOSE ......... Negative Bilirubin ........... Negative More Kotone .............. Negative ISpecific Gravity ... <=1.0051 Add QC Blood. Negative notes IpH ...... 5.5! O Protein ........... ........ Negative Print Urobilinogen. 0.2 E.U./dL Nitrite ............ Negative Leukocytes .. Negative Done SIEMENS 22 Restricted © Siemens Healthineers, 2019 QC Running SIEMENS Healthineers .. • Press DONE when completed. • Repeat for the other control. Results Patient: SARA SMITH Clinitest@ hca .............. Negative Test date ................. 10-14-2009 Time ............. ................ 08:1 9 Operator Name. 120004128004 Print Done 23 Restricted © Siemens Healthineers, 2019 Patient Sample Running (FULL TEST) SIEMENS Healthineers .. SIEMENS Running Full Strip Tests 24 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • Select Strip Test Select Ready 09:05 10-14-2009 Instrument Recall Results Set Up QC Test QC Cassette Test Strip Test 25 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • Select Last Operator or New Operator ID Operator Name Enter New Operator Name 26 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers : • Use the touchscreen to enter the information and select ENTER to continue. Enter Operator Name 123 X A B C D E F G H J KL MN O P - Q R ST U V WIX Y Z - - Enter 27 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers : • Select Recall Patient or Enter New Patient. • Select previous patient or enter new information Patient Information using the touchscreen. Recall Patient Enter New Patient 28 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • Key in Patient Name or ID Enter Patient Name 123 X ABCDEFGH J K L M NO - QR Y 29 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • Select START Prepare Test 0000m Multistix@ 10 SG Touch START to Help begin ? START 30 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers : • Dip the reagent strip into the urine sample, wetting all pads. Immediately remove the strip Prepare Test • Drag the edge of the strip against the side of the sample container as it is removed. 1. Dip test strip in sample • Blot the edge of the strip to the paper towel. 2. Remove excess 3. Blot strip 4. Place on test table 00:08 31 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers : • Place the reagent strip in the table channel, pads facing up. Slide the strip to the end of the channel. MENS 32 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • The system will perform self calibration sample testing. Calibrating Please wait Clinitek Status@ is Calibrating 33 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers : • Select Appearnace. • Select Yellow and Clear or Other Select Appearance Test in progress • Select a color and clarity . Select Color and Clarity of urine sample • Select Next to continue. Yellow and Clear Other 34 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • Running time will appear on the screen. Analyzing In progress 00:43 35 Restricted © Siemens Healthineers, 2019 SIEMENS Patient Sample Running Healthineers .. • The test table and strip will automatically be pulled into the analyzer. • Result will be shown on the screen. • When complete, remove and dispose the test strip per laboratory procedure. SIEMENS Results Patient: SARA SMITH 1 of 2 Glucose .... ........ 100 mg/dl Bilirubin. .... Small More Ketone .... 80 mg/dl Specific Gravity ... <=1.005 Blood ... . Large PH .... ... 5.5 Protein ... 30 mg/dl Print Urobilinogen ...... 2.0 E.U./dL Nitrite ........ .. Positive Leukocytes ..... Moderate Done JECYLL S. DAYANGHIRANG, M.D. | SHS AP ASN PHI DX 36 Restricted © Siemens Healthineers, 2019 Patient Sample Running (Quick Test) SIEMENS Healthineers : SIEMENS Running Quick Strip Tests JECYLL S. DAYANGHIRANG, M.D. | SHS AP ASN PHI DX 37 Restricted © Siemens Healthineers, 2019 Patient Sample Running (Quick Test) SIEMENS Healthineers .. • Select Strip Test Select • Adjust test table for strip tests. Ready 09:05 10-14-2009 Instrument Recall Results Set Up QC Test QC Cassette Test Strip Test 38 Restricted © Siemens Healthineers, 2019 Patient Sample Running (Quick Test) SIEMENS Healthineers .. • Select START Prepare Test Multistix@ 10 SG Touch START to Help begin ? START 39 Restricted © Siemens Healthineers, 2019 Patient Sample Running of the SIEMENS Healthineers : (Quick Test) • Dip the reagent strip into the urine sample, wetting all pads. Immediately remove the strip . Prepare Test • Drag the edge of the strip against the side of the sample container as it is removed. 1. Dip test strip in sample • Blot the edge of the strip to the paper towel. 2. Remove excess 3. Blot strip 4. Place on test table 00:08 40 Restricted © Siemens Healthineers, 2019 Patient Sample Running (Quick Test) SIEMENS Healthineers .. • Place the reagent strip in the table channel, pads facing up. Slide the strip to the end of the channel. MENS 41 Restricted © Siemens Healthineers, 2019 Patient Sample Running (Quick Test) SIEMENS Healthineers .. Calibrating Analyzing Please wait In progress Clinitek Status@ is Calibrating 00:43 42 Restricted © Siemens Healthineers, 2019 Patient Sample Running (Quick Test) SIEMENS Healthineers .. • Test strip ejected automatically. SIEMENS •Results Results Patient: SARA SMITH 1 of 2 Glucose .... ........ 100 mg/dl Bilirubin. .... Small More Ketone .... 80 mg/dl Specific Gravity ... <=1.005 Blood ... . Large PH .... ... 5.5 Protein ... 30 mg/dl Print Urobilinogen ...... 2.0 E.U./dL Nitrite ........ .. Positive Leukocytes ..... Moderate Done JECYLL S. DAYANGHIRANG, M.D. | SHS AP ASN PHI DX 43 Restricted © Siemens Healthineers, 2019 SIEMENS Healthineers .. Recalling Stored Results Select -18-2009 Instrument Recall set Up Cassette Test Strip Test CLINITEK Status"+ SIEMENS 44 Restricted © Siemens Healthineers, 2019 Recalling Stored Results SIEMENS Healthineers .. •Select Recall Results Select Ready 11:23AM 12-29-2009 Instrument Recall Results Set Up QC Test QC Cassette Test Strip Test 45 Restricted © Siemens Healthineers, 2019 Recalling Stored Results SIEMENS Healthineers : •Click Select Recall Options Recall Patient Tests or QC Tests Delete Records Done Select 46 Restricted © Siemens Healthineers, 2019 Recalling Stored Results SIEMENS Healthineers .. •Click Next Recall Results Choose which Patient tests results to search QC tests Previous Next RRRRR 47 Restricted © Siemens Healthineers, 2019 Recalling Stored Results SIEMENS Healthineers .. Recall Results Search by name or ID RRRRRRRRRRRRARR Search by date Previous View all results 48 Restricted © Siemens Healthineers, 2019 Recalling Stored Results SIEMENS Healthineers .. Recall Results Recall Results Recall Results Enter name or ID Search by date Search Results 123 X Enter earliest date Enter latest date 11:21AM 12-29-2009 0352 11:20AM 12-29-2009 0351 A 4:20PM 11-30-2009 .. 0350 B C D E F G H 12 29 09 12 29 09 5:16PM 11-28-2009 .. 0349 MM DD MM DD 3:15PM 12-29-2009 0348 RRRRRRRR J K L M N O P 9:41PM 12-10-2009 0347 9:40PM 12-10-2009 0346 RRRRRRRR RIS T WIRRRRRRRRRR 9:39PM 12-10-2009. RRRRRRRRRAY .. 0345 Q JU V WIX 4:33PM 06-23-2009. 0172 4:33PM 06-23-2009 0171 YZ - Enter Previous Search Back Send all Print all Select 49 Restricted © Siemens Healthineers, 2019 SIEMENS Healthineers .. Instrument Set-up Select Ready 05-18-2009 Instrument Set Up Recall Results Cassette Test Strip Test CLINITEK Status"+ SIEMENS 50 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers : •Select Instrument Select Ready 11:23AM 12-29-2009 Set up Instrument Recall Results Set Up QC Test QC Cassette Test Strip Test 51 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers .. •Select Operator and Choose Settings Patient Information. Language Settings Set Password Operator and Patient information Date and Time Settings •Click Select. Test sequence number Instrument Settings Restore Default Settings Diagnostics System Information Sample Interference Notes Done Select 52 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers .. •Quick Test Input Settings Select one of the options •Full Test Quick Test Full Test Permit test sequence Permit test sequence •Custom Set Up without entering after entering: operator or patient - operator name information - patient name - patient ID - sample appearance •Click Next Custom Set Up Next 53 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers .. Select Choose Settings Ready 11:23AM 12-29-2009 Instrument Recall Results Language Settings Set Up Set Password V QC Test Operator and Patient information QC Date and Time Settings Test sequence number Cassette Test Strip Test Instrument Settings Restore Default Settings Diagnostics System Information Sample Interference Notes Done Select 54 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers : Instrument Settings Choose Format 1 of 2 Results Format Units Selection Plus System System Settings Display Contrast Connectivity Conventional Enabled Urinalysis Test Settings Authorized Operator SI Disabled Printer Settings QC Settings Software Update Nordic Done Select Next 55 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers .. Choose Format 2 of 2 Mark Positive Yes Results No Store instrument Yes serial number in patient records No Done 56 Restricted © Siemens Healthineers, 2019 SIEMENS Instrument Set-up Healthineers .. Urinalysis Test Enter strip lot Enabled number and expiration date before each test. Disabled Previous Done 57 Restricted © Siemens Healthineers, 2019 SIEMENS Maintenance Healthineers : Cleaning the Instrument 1. Turn the analyzer Off 2. Use a damp cloth with a mild detergent 3. Wipe the outside, including the display area Routine Cleaning of Test Table Insert 1. Remove the insert 2. Rinse both sides of the table insert under running SIEMENS water 3. Dry and replace insert Periodic Cleaning of Test Table Insert 1. Remove the test table by pulling slowly out of the analyzer 2. Drain the drip tray if necessary 3. Wet a cotton-tipped swab with water and carefully clean the test table (except for the white calibration bar) 4. Dry the test table thoroughly with a soft cloth or lint-free tissue 5. Replace the test table insert 58 Restricted © Siemens Healthineers, 2019