DCA Vantage® Analzyer PEP to Go

SIEMENS Recall 08:13 AM 06/10/2007 W55789, Smith, Sara 14.0 - 12.5 - SIEMENS 10.5 - DCA Vantage" 8.5 - Analyzer 6.5= = 4.5 2.5 06/30/2005 06/03/2007 Print Recall Home Back Change DCA Vantage® Analyzer PEP to Go Answers for life. Effective date 06/09/2014 GPE15009.001 Table of Contents 1. Calibration 2. HbA1c Quality Control 3. HbA1c Sample Processing 4. Microalbumin/Creatinine Quality Control 5. Microalbumin/Creatinine Sample Processing 6. Weekly Maintenance 7. Quarterly Maintenance © Siemens AG 2013. All rights reserved. TOC Calibration Performing a Calibration 1. Scan the calibration card Barcode facing to the right • • Insert above the dot on the analyzer barcode track Hold the card against the right side and • smoothly slide down the track A"besp" sigrides a succeestá son. Lin "tip" sunsais que fopérations act alussie Ein Gigrattan bestäty die ertalreiche Speicherag. Un"Dio" segnala il buon esito doña lemanz. Un acnido corto indica que la lectura ha sido correctat 2. An audible beep will sound when successful Ues"apito" significa uma leitura bem sucedida. En velyexal iySasning ettertalpes af et"bio". En"pi" anger aff asilesningen utters. En piosbet angir at astagingen er cádig 3. Select OK to return to the main menu LOT 2013-06 0975 Note: Scan the calibration card, only once, with a new lot of reagent. TOC Calibration HbA1c Quality Controls Preparing the Quality Control 1. Gently tap the bottom of the control bottle on the ---- counter to collect material on bottom of the bottle 2. Carefully remove the cap -3714363 (5068A) 3. Add six (6) drops of Reconstitution Fluid into the SIEMENS --- DCA Systems ---- control bottle 9. 2013-00 Note: Discard the first drop to ensure constant volume JEMENS EMENS 4. Replace the cap (not the dropper) and swirl the control bottle several times SIEMENS DCA Syste Systems 5. Let stand at room temperature for 15 minutes .......... 6. After 15 minutes, swirl the control bottle again - several times 7. Remove and properly discard the cap, replace with dropper cap 8. Return to refrigerator for proper storage within 30 minutes HbA1c TOC Quality Control HbA1c Quality Controls Running Quality Control Running Quality Control 1. Prepare the Normal and Abnormal quality 8. Carefully remove excess control solution with a control materials lint-free tissue 2. Remove the quality control value card from the 9. Insert the capillary holder into the cartridge until it HbA1c quality control kit snaps into place 3. Scan the correct control card values prior to 10. Scan the cartridge testing Barcode facing to the right • Barcode facing to the right Insert into barcode track above the dot • • Insert into barcode track above the dot Slide cartridge smoothly down track • • Slide card smoothly down track • 10. Audible beep sounds when successful Insert the cartridge into the analyzer • Barcode facing to the right • 4. Remove and unwrap the capillary holder Insert cartridge until a click is heard • Slowly and firmly pull the flexible tab • 5. Mix the sample well by manually mixing the vial back and forth 11. Close the door 6. Open the control bottle and carefully aspirate 12. Remove and discard the cartridge when the test is control material without introducing air into complete the vial Press and hold the plastic tab with the left hand • • 7. Add 1uL of control sample to the capillary by Gently push down and to the right to unlock touching on the tip of the control solution 11. Record the QC results If an air bubble(s) is present in the capillary • tube, discard and repeat © Siemens AG 2013. All rights reserved. © Siemens AG 2013. All rights reserved. TOC HbA1c Sample Processing Performing a Hemoglobin A1c Test Running Quality Control 1. Touch the tip of the capillary to the blood 8. Remove and discard the cartridge sample until the capillary is filled • Select Next, then open the door 2. Wipe the side of the capillary tube with a lint- Press and hold the plastic tab with the left hand • free tissue Gently push down and to the right to unlock • If an air bubble(s) is present in the capillary • tube, discard and repeat 3. Insert the capillary holder into the cartridge until it snaps into place 4. Scan the cartridge DCA Vantage" - Barcode facing to the right • SIEMENS Insert into barcode track above the dot • Slide cartridge smoothly down track • Audible beep sounds when successful • 5. Insert the cartridge Barcode facing to the right SIEMENS • DCA Systems CE Insert cartridge until a click is heard LOT • Slowly and firmly pull flexible tab • 6. Close the compartment door 7. Record the results HbA1c © Siemens AG 2013. All rights reserved. TOC Sample Processing Microalbumin/Creatinine Quality Controls Preparing the Quality Control 1. Gently tap the bottom of the control bottle on the counter to collect material on bottom of the bottle 2. Carefully remove the foil crimp and stopper SIEMENS DCA 2000 NEP 6012A 3. Transfer the entire contents of the Reconstitution Fluid control vial using the pipette Note: Do not draw control back into the pipette 4. Replace the control vial stopper and swirl the MEMENS HEMENS SIEMENS control bottle several times SIEMENS DCA Systems 5. Let stand at room temperature for 15 minutes 6. After 15 minutes, swirl the control bottle again several times 7. Remove and properly discard the stopper, replace with dropper tip assembly Micro/Creat © Siemens AG 2013. All rights reserved. TOC Quality Control Microalbumin/Creatinine Quality Controls Running Quality Control Running Quality Control 1. Prepare the Normal and Abnormal quality 8. Insert capillary holder into the cartridge until it control materials snaps into place 2. Remove the quality control value card from the 9. Scan the cartridge using the barcode scanner quality control kit track 3. Scan the correct control card values prior to Barcode facing to the right • testing Insert into barcode track above the dot • Barcode facing to the right Slide cartridge smoothly down track • • Insert into barcode track above the dot Audible beep sounds when successful • • Slide card smoothly down track Insert the cartridge into the analyzer • 10. Audible beep sounds when successful Barcode facing to the right • • 4. Remove and unwrap the capillary holder Insert cartridge until a snap is heard • 5. Fill the control solution dropper, squeeze air 11. Depress the plunger into the cartridge bubbles out of the dropper 12. Slowly and firmly remove the flexible tab 6. Insert and fill the glass capillary into the tip of 13. Remove the cartridge when the test is complete the dropper, while gently squeezing Press and hold the plastic tab with the left • Discard and start over if a bubble is present • hand in the capillary tube Gently push down and to the right to unlock • 7. Carefully remove excess control material with a 14. Record QC results lint-free tissue © Siemens AG 2013. All rights reserved. TOC Microalbumin/Creatinine Sample Processing Running a Microalbumin/Creatinine Test Running Quality Control 1. Insert the tip of the capillary tube into a room 8. Close the compartment door temperature, well mixed urine sample to a level just above the starch plug 9. Record the results 2. Wipe the side of the capillary tube with a lint- 10. Remove and discard the cartridge • free tissue Press and hold the plastic tab with the left hand If an air bubble(s) is present in the capillary Gently push down and to the right to unlock • • tube, discard and repeat 3. Insert the capillary holder into the cartridge until it snaps into place 4. Scan the cartridge Barcode facing to the right • Insert into barcode track above the dot • Slide cartridge smoothly down track • Audible beep sounds when successful • 5. Insert the cartridge Barcode facing to the right • Insert cartridge until a click is heard • 6. Depress the plunger into the cartridge LOT 0073 € 7. Slowly and firmly remove the flexible pull tab ams Micro/Creat TOC Sample Processing Weekly Maintenance Cleaning the Barcode Window Cleaning the Analyzer Exterior 1. Turn the power OFF and disconnect the power 1. Turn the power OFF and disconnect the power cord cord 2. Wipe down the barcode window 2. Clean the exterior of the analyzer Lint-free cloth Lint-free cloth • • Dampened with water or ethanol Dampened with water or ethanol • • 3. Ensure the area is completely dry 3. Optional: Disinfect the exterior of the analyzer 4. Connect the power cord and turn the power using 0.5% sodium hypochlorite ON Remove any blood prior to disinfecting • Do not allow liquid to drip into the system • Allow the analyzer to disinfect for 10 • minutes 4. Connect the power cord and turn the power ON after the exterior is clean and dry Weekly © Siemens AG 2013. All rights reserved. TOC Maintenance Quarterly Maintenance Running an Optical Test 1. Scan the optical test cartridge Barcode facing to the right • Insert the cartridge above the track dot • Smoothly slide the cartridge down the track • Audible beep will sound when successful • 2. Insert the optical test cartridge SIEMENS Barcode facing to the right DCA Systems 123237 Fez. A. 2007-01 100000000007 • OPTICAL TEST CARTRIDGE Insert cartridge until a click is heard • 3. Close the compartment door 4. Test will run for approximately 10 minutes 5. Print and record the optical test values 6. Remove the optical test cartridge • Open the compartment door Press and hold the button located on the right • side Gently push the cartridge tab to the right • Note: Do not discard the optical test cartridge. Store in a safe, dry place. Quarterly TOC Maintenance Quarterly Maintenance Cleaning the Cartridge Compartment Cleaning the Cartridge Compartment 1. Power OFF the analyzer, and open the 8. Clean the cartridge return spring compartment door Warm, mild detergent solution and water or • 2. Wipe the inside of the compartment door and lint-free cloth with dampened with water or inside surfaces ethanol Lint-free cloth 9. Dry the cartridge return spring • Dampened with water or ethanol • 10. Remove any spilled liquid from the cartridge holder 3. Dry the surface using a clean, dry, lint-free 11. Rotate cartridge holder to locate and remove any cloth additional liquid 4. Insert a straightened paper clip (or like device) into the top hole of the spring 12. Clean the cartridge holder by rotating the cartridge holder as necessary 5. Gently pull the metal end towards the center of Dampen a sponge swab with water or ethanol • the cartridge compartment to release one side of the spring from the holder 13. Locate the vertical grooves inside the compartment 6. Repeat the above steps to release the other side of the cartridge holder spring 14. Locate back and front slots near the top of the compartment 7. Pull the cartridge return spring completely out of the system 15. Locate the leaf spring on the one side of the cartridge return spring 16. Lower the leaf spring back into the compartment © Siemens AG 2013. All rights reserved. TOC Quarterly Maintenance Changing the Air Filter 1. Remove the air filter Located at the back of the system • SIES Pull the holder from the top • 2. Remove and dispose the old air filter 3. Place the new air filter into the holder 4. Place the filter holder back onto the system © Siemens AG 2013. All rights reserved. TOC 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. 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