CLINITEK Status® + Analyzer PEP to Go

SIEMENS tive Strip fost CLINITEK Status+ Analyzer SIEMENS CLINITEK Status® + Analyzer PEP to Go Answers for life. GPE15004.033 Effective Date: 02/14/2014 Table of Contents 1. System Overview 2. Urinalysis Strip Test 3. CLINITEK hCG Test 4. Urinalysis Quality Control 5. CLINITEK hCG Quality Control 6. Stored Results 7. Maintenance Cintesto © Siemens AG 2013. All rights reserved. System Overview Key Components and Features 1. On/Off Button Powers the analyzer On and Off 2. Touch Screen Displays instructions and prompts you through 6 3 operation Clinitest 3. Printer HCG 2 Prints results upon completion 4 CUNITEK Statur+ SIEMENS 1 4. Test Strips 1 Multistix Provide semi -quantitative urinalysis results SIEMENS - 5. Test Table & Insert Positions the test strips/cassettes in the analyzers read area 5 6. Cassette Provides qualitative results for hCG pregnancy tests 7. Calibration Bar (*not pictured) Calibrates every time the analyzer is powered on System Overview © Siemens AG 2013. All rights reserved. Urinalysis Strip Test Preforming a Quick Test 1. Select Strip Test 2. Adjust test table for strip tests 3. Select START Dip the reagent strip into the urine sample, • wetting all pads. Immediately remove the strip Drag the edge of the strip against the side of • the sample container as it is removed Blot the edge of the strip to the paper towel • Place the reagent strip in the table channel, • pads facing up. Slide the strip to the end of the channel 5. The test table and strip will automatically be pulled into the analyzer CLINITEK Status"+ 6. When complete, remove and dispose the test strip per laboratory procedure SIEMENS Urinalysis Strip Test © Siemens AG 2013. All rights reserved. Urinalysis Strip Test Preforming a Full Test 1. Select Strip Test 6. Select Appearance • 2. Select Last Operator or Enter New Operator ID Select Yellow and Clear or Other Use the touchscreen to enter the information Select a color and clarity. Select Next to • • and select Enter to continue continue 3. Select Recall Patient or Enter New Patient 7. The test table and strip will automatically be Select previous patient or enter new pulled into the analyzer • information using the touchscreen. Select 8. When complete, remove and dispose the test Enter to continue strip per laboratory procedure 4. Adjust test table for strip tests 5. Select START Dip the reagent strip into the urine sample, • wetting all pads. Immediately remove the strip Drag the edge of the strip against the side of • the sample container as it is removed Blot the edge of the strip to the paper towel • Place the reagent strip in the table channel, • pads facing up. Slide the strip to the end of the channel © Siemens AG 2013. All rights reserved. CLINITEK hCG Pregnancy Test Preforming a Quick Test 1. Verify the test table insert is in position for a Clinitest cassette test 2. Select Cassette Test 4. Select CLINITEK® hCG cassette 5. Remove test cassette and place on the test table 6. Select START 7. Add sample using the pipette into the sample well (approximately 0.2 mL) SIEMENS Excess sample in overflow chamber is • acceptable – do not squeeze overflow amount into the sample well Bring sample to room temperature if • refrigerated Specimens collected at any time of the day may • be used 8. The test table and cassette will automatically be pulled into the analyzer 9. When complete, remove and dispose the test cassette per laboratory procedure hCG Cassette © Siemens AG 2013. All rights reserved. Test CLINITEK hCG Pregnancy Test Preforming a Full Test 1. Verify the test table insert is in position for a cassette 10. The test table and cassette will automatically be pulled test into the analyzer 2. Select Cassette Test 11. When complete, remove and dispose the test cassette 3. Select Last Operator or Enter New Operator ID per laboratory procedure Use the keyboard to enter the information and • select Enter to continue 5. Select Recall Patient or Enter New Patient Select previous patient or enter new information • using the touchscreen. Select Enter to continue 6. Select CLINITEK® hCG cassette 7. Remove test cassette from package and place on the test table 8. Select START 9. Add sample, using the pipette into the sample well (approximately 0.2 mL) Excess sample in overflow chamber is acceptable – • do not squeeze overflow amount into the sample well Bring sample to room temperature if refrigerated • Specimens collected at any time of the day may be • used © Siemens AG 2013. All rights reserved. Urinalysis Quality Control Preparing Quality Control Preforming Quality Control (Connect System) 1. Add 12 mL distilled or DI H20 into an 1. Select QC Test appropriately labeled tube Prepare a Positive and Negative control 2. Select QC Strip Test • 2. Remove a Chek-Stix® control test strip 3. Select Last Operator or Enter New Operator ID Use the touchscreen to enter the information • 3. Place the control test trip into the appropriate and select Enter to continue tube 4. Select Use Last Lot or Enter new lot and 4. Cap the tube and invert gently for 2 minutes expiration 5. Allow the tube to stand for 30 minutes Enter the lot information using the touchscreen • and select Enter to continue 6. Invert the tube 1 more time 5. Enter the lot information for the test strip to test 7. Uncap the tube and discard the control strip the controls per laboratory procedure Enter the lot information using the touchscreen • 8. Repeat steps for the other control and select Enter to continue 6. Select START Dip the test strip into the control solution • Place the test strip in the table channel, pads • facing up. Slide the strip to the end of the channel Test stable will automatically pull in strip • 7. Remove and dispose the test cassette per laboratory procedure 8. Repeat for the other control Urinalysis © Siemens AG 2013. All rights reserved. Quality Control CLINITEK hCG Quality Control Preforming Quality Control (Connect System) 1. Verify the test table insert is in position for a cassette test 2. Select QC Test 2. Select QC Cassette Test Required 4. Select Enter lot and expiration date Enter the lot information using the touchscreen • and select Enter to continue 5. Place hCG cassette into the test table 6. Select START 7. Add control (to marked line, approximately 0.2 mL) into the sample well 8. The test table and cassette will automatically be pulled into the analyzer 9. Review if QC Test displays Pass or Fail 10. When complete, remove and dispose the test cassette per laboratory procedure hCG Quality Control Stored Results Recalling Patient Results Recalling Quality Control Results 1. Select Recall Results 1. Select Recall Results 2. Highlight Recall Patient Tests or QC Tests and 2. Highlight Recall Patient Tests or QC Tests and press Select press Select 3. Select Patient tests 3. Select QC tests 4. Select Next 4. Select Next 5. Recall Results 5. Recall QC Results Search by name – enter name using the • • Search by? keyboard and select Enter to continue • Other? Search by ID – enter ID using keyboard and • select Enter to continue 6. Highlight a result and press Select Search by date – enter earliest date and latest 7. When complete select Done • date. Select Search to continue 6. Highlight a result and press Select 7. When complete select Done Stored Results © Siemens AG 2013. All rights reserved. Maintenance 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 Maintenance Maintenance Disinfecting the Test Table and Insert Cleaning the Calibration Bar 1. Prepare appropriate solution per laboratory 1. Remove the insert from the test table by procedure slowly pulling 2. Place the insert and/or test table into the solution 2. Check the white calibration bar for dirt or Make sure the white calibration bar remains discoloration • above the solution If clean and unmarked – replace table into • 3. Soak table and insert analyzer Minimum of 2 minutes to a maximum of 10 • 3. If the calibration bar is dirty or discolored, minutes gently wipe it with a new cotton-tipped swab Do not exceed 10 minutes or lint-free cloth with distilled water • 4. Rinse the test table and insert thoroughly with 4. Allow calibration bar to air dry water 5. Inspect the surface for dust, foreign material, 5. Dry with a soft cloth and replace test table and scratches or scuffs insert Replace entire test table if any marks are • visible 6. Reinsert test table into analyzer Note: This document is for supplemental use only, and not meant to be used in place of primary technical materials. © 2014 Siemens Healthcare Diagnostics Inc. All rights reserved. This guide and the software described within, are copyrighted. No part of this may be copied, reproduced, translated, or reduced to any electronic medium or machine-readable form without the prior written consent of Siemens Healthcare Diagnostics. All trademarks are the property of their respective owners. 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