LDX Users Manual
Contents
1. Using Your MiniPet Pipettes pages 22 25 for additional information 18 Alere Cholestech LDX System User Manual NOTE Fingerstick sample must be applied within minutes after collection or the blood will clot Check the package insert for the test cassette you are using to determine the exact number of minutes x 7 Keep the cassette level after the sample has been applied WARNING Allowing the sample to sit in the cassette will cause inaccurate results Immediately place the cassette into the drawer of the analyzer The black reaction bar must face toward the analyzer The brown magnetic stripe must be on the right The cassette should be placed in the center of the drawer 8 DO NOT PUSH IN THE DRAWER Press RUN The drawer will close During the test the screen will display Test Hameces Runn i pages 9 Put everything that came into contact with the blood samples or control calibration verification or proficiency testing material into a biohazardous waste container Alere Cholestech LDX System User Manual 19 10 11 12 13 14 15 16 17 When the test is complete the analyzer will beep and the screen will display Press DATA to view the additional results When the results are outside the measuring range of the test the screen will display or If there is a problem with the test a message will appear on the screen See the Trouble2. Cholestech LDX System User Manual Cholestech LDX System User Manual Read Me First Congratulations on the purchase of your Alere Cholestech LDX System Please take a few minutes to examine the contents of your package to be sure that nothing has been damaged in shipment Be sure to read the instructions in this user manual before operating the Alere Cholestech LDX Analyzer If you have any questions now or in the future please contact Alere Table of Contents Introduction 2 ceececeeeeeeneeeeeeeenseeeeeeeseuseeeeeeesensenseeeeeaesensaees 4 Examining Your Package Content ecsceceeeesteeeeeeeseeeeeeeeaes 5 How the Alere Cholestech LDX Analyzer WorkS s s scsesees 6 Getting Started csceeceeeseeeeeeeeeeeseeseeseeeeeseseeseeeeneaneeeeen 10 Setting the Configuration Menu eeeeceeeeeeeeeeeeeeeeeteeeeeeeeneeeees 12 Configuration Menu FIOWChAart ee eeeeeeeeeeeeeeeeeseenneeeeeeeenneeees 14 Alere Cholestech LDX Optics Check c cccccceeseseseseeeteeeees 16 Optics Check Cassette Test Procedure eeeeeeeeeeeeeeees 17 Testing ProCeCure 1 scssceseeeenceeeeseeeeneeeeeneaseeseeeeeeenenseoes 18 Ranning AT OSE cs ssstecse cts s seccedesa eked seria chce scedh nEaN IR ENA 18 Performing a FINQerstiCk cccceeeeeeseeeeeeeenneeeeeeeeneeeeeeeseeeeeetee 22 Using Your MiniPet Pipettes ccccccccsseessssseseetsseseeteeeseseeess 25 Quality Control sasi
3. Begin Testing Are Results within of quality control material Acceptable Limits Yes No RECORD results on Verify expiration date on Quality Control Log Quality control material Cassette RETEST with sample from same control vial using NEW cassette CONTINUE TESTING Within patient samples Yes Limits Me RETEST with sample from a NEW control vial using a NEW cassette Within Yes Limits Call Alere Alere Cholestech LDX System User Manual 29 Moderate Complex Tests If you are running a test cassette that is categorized as moderate complexity nonwaived under CLIA note the following Sample Type Any appropriate sample type may be used fingerstick capillary or venous whole blood serum or heparinized plasma Check the package insert for the test cassette you are using to determine the appropriate sample type s When running serum or plasma change the SAMPLE mode in the Configuration Menu to Serum Quality Control Recommendations Controls should be tested e With each new lot of cassettes e With every new shipment of cassettes even if the lot has been received previously e When reagents may have been stored or handled in a way that can degrade their performance e As otherwise required by your laboratory s standard quality control procedures e As otherwise required by federal state and local guidelines Optics Check Cassette The Optics Check Cassette should be run each
4. Check the package insert for the test cassette you are using to determine the volume for the controls e Run the Alere Cholestech LDX Analyzer in the appropriate SAMPLE mode See Setting the Configuration Menu on page 12 Check the package insert for the test cassette you are using to determine the SAMPLE mode for quality control material e See Running a Test for the procedure 26 Alere Cholestech LDX System User Manual External Quality Control External quality control material should be used to demonstrate that the reagents and the assay procedure perform properly Good Laboratory Practice principles suggest that controls should be run whenever the laboratory director has any question about test system integrity reagent storage conditions or the reliability of any test result If the controls do not perform as expected repeat the test or contact Alere before testing patient samples Controls should be tested e With each new lot of cassettes e With every new shipment of cassettes even if the lot has been received previously e When reagents may have been stored or handled in a way that can degrade their performance e As otherwise required by your laboratory s standard quality control procedures e As otherwise required by federal state and local guidelines Record the results in a Quality Control Log The quality control results should be in range before testing patient samples See Results Outs
5. Manual 45 Symbols In vitro diagnostic Medical Device PAN Caution Consult accompanying Documents M This Direction Up i Temperature Limitation Biohazard CE BH CE Mark Consult Instructions for Use w amp Manufacturer Biological Risks X Direct Current Waste Electrical amp Electronic Equipment 9 Fragile Keep Dry Sufficient for lt n gt Telephone CRMLN Certified 46 Alere Cholestech LDX System User Manual Symbols LOT Contents Catalogue Number Batch Code Control Calibration Verifcation Restriction of Use Indicates compliance T V Rheinland of Hazardous of CAN CSA C22 2 Product Safety Substance No 6110 1 2nd Certifcate for USA Compliance edition including and Canada Amendment 1 Printer Port Authorized Representative in the European Community PROFESSIONAL USE ONLY For Professional Use Only T v Rheinland Product Safety T V Rheinland Product Safety Certificate demonstrating full compliance with the GPSG German equipment safety law for Germany but it also demonstrates compliance to the LVD minimum EU requirement Alere Cholestech LDX System User Manual 47 12 298 Alere San Diego Inc EC REP MDSS GmbH weal 9975 Summers Ridge Road LEC REP Schiffgraben 41 San Diego CA 92121 USA 30175 Hannover www alere com Germany The Alere Logo Alere and Cholestech LDX are trademarks of the Alere group of companies MiniPet is a trademark of Tr
6. a sample to the cassette and place it into the analyzer In a few minutes the results will appear on the screen The Alere Cholestech LDX System is for in vitro diagnostic use only This manual contains all the information you need to operate and care for the Alere Cholestech LDX Analyzer Please read this entire manual before you use the analyzer Alere Product Support and Customer Service Alere will provide every customer with the product support and training needed to properly use the Alere Cholestech LDX System We maintain a staff of qualified Product Support Specialists available 24 hours a day seven days a week 4 Alere Cholestech LDX System User Manual Examining Your Package Contents When you receive your Alere Cholestech LDX Analyzer open the shipping box and check the contents against the packing list Please save the shipping box for reuse if you plan to send the Alere Cholestech LDX Analyzer and supplies to other sites The Alere Cholestech LDX System Includes e Alere Cholestech LDX Analyzer e Power Supply e Optics Check Cassette e User Manual e Accessory Tray e Capillary Tubes e Capillary Plungers e Single use Lancets e MiniPet Pipette e Pipette Tips e Alere Thermal Printer and Cable Assembly A carrying case is available as an optional accessory The carrying case is not intended for shipping the Alere Cholestech LDX Analyzer In addition to these supplies you may need the fo
7. and DATA button is pushed twice after results appear 2 Framingham risk is on and the STOP button is pushed when Risk RUN yes STOP no appears Check calendar in the analyzer to make sure it is set correctly Check expiration date on cassette pouch or box Low Battery Internal battery Call Alere Internal battery voltage is too low is not user serviceable Mag Read Unable to read 1 Wipe magnetic stripe Error magnetic stripe on with a soft tissue and See iser the cassette Handal RUN button pushed without restart test If second test fails repeat test using a new cassette 2 Check cassette position magnetic stripe must be on the right 3 If message reappears call Alere Place cassette in drawer before pushing RUN cassette in drawer button Alere Cholestech LDX System User Manual 39 Error Message Qetice Test Fail See User Handal Reaction Dig Hoi Dogu Ep EH Sensas Fail Problem A problem with the optical system of the analyzer or a faulty Optics Check Cassette Insufficient sample volume was applied to the cassette due to air bubbles or incompletely filled capillary tube or pipetting error Insufficient sample volume reached reaction pads due to high hematocrit of sample Improper sample collection Sample clotted because it was left in capillary tube too long Improper sample collection Finger was milked to obtain sample or ca
8. any warranty of merchantability fitness for a particular purpose and non infringement regarding the product Alere s maximum liability with any customer claim shall not exceed the net product price paid by customer Neither party shall be liable to the other party for special incidental or consequential damages including without limitation loss of business profits data or revenue even if a party receives notice in advance that these kinds of damages might result 42 Alere Cholestech LDX System User Manual The Limited Warranty above shall not apply if the Customer has subjected the Product to physical abuse misuse abnormal use use inconsistent with the Product Manual or Insert fraud tampering unusual physical stress negligence or accidents Any warranty claim by Customer pursuant to the Limited Warranty shall be made in writing within the applicable Limited Warranty period General Specifications Normal Environmental Conditions Operating Voltage e 9 volt DC at 1 amp Environmental Conditions e Indoor use e Altitude up to 6 561 feet 2 000 meters e Temperature 68 87 F 20 31 C e Relative humidity from 20 to 80 e Pollution degree Class 2 If the equipment Alere Cholestech LDX Analyzer is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Alere Cholestech LDX System User Manual 43 Glossary of Terms ALT GPT Alanine Aminotransfer
9. as far as you can Place the pipette tip into the sample and slowly release the plunger Confirm that no air bubbles are in the pipette tip 3 Place the pipette tip into the cassette sample well Dispense the sample by pressing the plunger down Move the pipette tip out of the sample well before releasing the plunger again 4 Remove the pipette tip and put it into a biohazardous waste container NOTE If the plunger is released before the pipette tip is removed from the sample well the sample may be drawn back into the pipette tip NOTE Keep the cassette level at all times after applying the sample For additional information about proper handling of blood specimens see the package insert for the test cassette you are using Alere Cholestech LDX System User Manual 25 Quality Control External quality control material should be run routinely to show that your system is giving accurate results Alere recommends the following quality control procedures for the Alere Cholestech LDX System Choosing Quality Control Materials Liquid Level 1 and Level 2 controls that work well with the Alere Cholestech LDX System are available If you use other controls you will need to establish ranges for the Alere Cholestech LDX System Handling Controls e Follow the instructions that come with your controls e Check the expiration date before using Do not use expired control material e Use the appropriate MiniPet Pipette
10. either hand To help increase blood flow the fingers and hands should be warm to the touch To warm the hand you can Preferred Wash the patient s hand with fingerstick site warm water or Apply a warm not hot compress to the hand for several minutes Or Gently massage the finger from the base to the tip several times to bring the blood to the fingertip 4 Clean the site with an alcohol swab Dry thoroughly with a gauze pad before pricking the finger 5 Firmly prick the selected site with a single use lancet 22 Alere Cholestech LDX System User Manual Squeeze the finger gently to obtain a large drop of blood Wipe away this first drop of blood as it may contain tissue fluid eee SPE aie Ndi Squeeze the finger gently again while holding it downward until a second large drop of blood forms Do not milk the finger The puncture should provide a free flowing drop of blood Hold the capillary tube horizontally or at a slightly descending angle by the end with the plunger Touch it to the drop of blood without touching the skin The tube will fill by capillary action up to the black mark Do not collect air bubbles If it is necessary to collect another drop of blood wipe the finger with gauze then massage again from base to tip until a large drop of blood forms Fill the capillary tube within 10 seconds Wipe off any excess blood from the finger and
11. have the patient apply pressure to the puncture until the bleeding stops Alere Cholestech LDX System User Manual 23 Follow these suggestions to help you consistently perform good fingersticks Suggestion Perform a deep and firm An adequate puncture puncture is crucial to obtaining a free flowing drop of blood Keep the patient s hand below This will improve the the level of his or her heart blood flow Hold the capillary tube at a This will make the capillary slight descending angle to the tube fill faster drop of blood Fill the capillary in less than This will ensure proper mixing 10 seconds of blood and anticoagulant which prevents clotting Dispense blood from the After five minutes the blood capillary tube in less than may begin to clot in the five minutes capillary tube If blood stops flowing wipe You can improve blood flow by finger firmly with gauze reopening the puncture WARNING Squeezing the finger excessively may cause inaccurate test results 24 Alere Cholestech LDX System User Manual Using Your MiniPet Pipettes Use this procedure to apply a sample of venous serum plasma or whole blood or control calibration verification or proficiency testing material to the cassette See cassette specific package insert for volume amount 1 Firmly attach the pipette tip to the end of the MiniPet Pipette Use a new tip for each sample 2 To fill the pipette push the plunger down
12. to the RISK ASSESSMENT PROGRAM Press RUN to move to risk factors screens 1a Yeap CHO Percentage risk of developing CHD within 10 years is displayed Risk 1h CHO risk dete Press DATA to select AGE range from 20 34 Aige 40 d4 35 39 40 44 45 49 50 54 55 59 60 64 65 69 70 74 and 75 79 CHD Risk Assessment Modeling Press RUN to advance to the next risk factor After running a test and performing an initial risk assessment screen the Alere Cholestech LDX CHD Risk Assessment Program F allows you to change the information in the file to see how these POSS FUN fo VAr 10 Wie Eear changes will impact the patient s risk of CHD This helps to screen 3 k illustrate the effect that lifestyle changes can have Only manually CHO risk data Press DATA to select GENDER entered items can be modified ec Male or Female ge 1 Recall the patient s test results by pressing DATA Press RUN to advance to the next risk factor screen 2 Press the DATA button until the CHD Risk Assessment Program screen appears The screen will display CHO risk data Press DATA to select SMOKING option 9 ppea play Smoke Ho Yes Cigarette smoker or quit within the last Risk year or RUN yes STOP rin No 3 Press the RUN button to advance to the risk factor data Press RUN to advance to the next risk factor screen you wish to modify Follow the same instructions for performing a CHD risk assessment CHO risk data Press DATA until
13. you reach the desired 4 When finished the new percentage risk of developing SpP 100 109 SYSTOLIC BLOOD PRESSURE LEVEL CHD providing the patient makes the identified changes range from lt 120 120 129 130 139 will be displayed 140 159 and gt 160 5 To exit the CHD Risk Assessment Program press STOP Press RUN to advance to the next risk factor screen 34 Alere Cholestech LDX System User Manual Alere Cholestech LDX System User Manual 35 Troubleshooting amp Maintenance Cleaning NOTE Unplug Alere Cholestech LDX Analyzer prior to cleaning e Nomaintenance is required other than routine cleaning e Routine cleaning e Clean the outside of the Alere Cholestech LDX Analyzer case with a clean damp cloth If necessary a mild detergent or disinfectant such as a 5 bleach solution may be used Do not immerse the analyzer in water or other cleaning fluid Do not use any abrasive cleanser e When necessary clean inside the cassette drawer with a cotton swab moistened with water a 70 isopropyl alcohol solution a 5 bleach solution or disinfectant Dry with a second unused cotton swab 36 Alere Cholestech LDX System User Manual Precautions and Warnings Always press STOP Make sure that the cassette drawer is closed and the screen is blank before unplugging the power supply Do not remove the ROM pack while the analyzer is plugged in Do not allow any liquid except the sample in a cassette in
14. 1 year CHO Fisk 12 32 Alere Cholestech LDX System User Manual Press the DATA button to move to the next screen If print option in the Configuration Menu has been set to On the screen will display Print RUNS yes STOR ria If print option in the Configuration Menu has been set to Off the screen will display End of Data Info If print option in the Configuration Menu has been set to On and the answer to Print is yes the Risk Assessment result will be printed along with the regular test results If the answer to Print is no only regular test results will be printed You may exit the CHD Risk Assessment Program by pressing STOP at any time during the program The result will be N A Alere Cholestech LDX System User Manual 33 Risk Assessment Flowchart The Alere Cholestech LDX Analyzer allows you to access a CHD Risk Assessment Program based on the Framingham Study To access this program you must first run a patient sample on a test cassette that includes both total cholesterol TC and HDL cholesterol LCD Display To Access the Program CHO risk cata Press DATA to select BLOOD PRESSURE BP Treatecd Mo Treatment Yes or No Press RUN to advance to the risk assessment result screen LCD Display To Access the Program TCsFEl H LE When the RESULTS appear on the screen non HDL 143 press DATA to move to the next screen TE HDL 5 1 Press DATA again to move
15. ase glutamic pyruvic transaminase AST GOT Aspartate Aminotransferase glutamic oxalacetic transaminase CLIA Clinical laboratory improvement amendments HDL High density lipoprotein hsCRP High sensitivity C Reactive protein In Vitro Diagnostic A diagnostic test done outside the body ROM Read only memory Return Policy Please contact Alere Product Support prior to returning any defective components Refer to the Contact Alere section for additional information 44 Alere Cholestech LDX System User Manual Contact Alere Alere Product Support Contact one of the following Alere Product Support Care Centers or your local distributor if you have any questions regarding the use of your Alere product You may also contact us at www alere com Europe amp Middle East 44 161 483 9032 EMEproductsupport alere com Asia Pacific 61 7 3363 7711 APproductsupport alere com Africa Russia amp CIS 972 8 9429 683 ARCISproductsupport alere com Latin America 57 01800 094 9393 LAproductsupport alere com Canada 1 613 271 1144 CANproductsupport alere com US 1 877 308 8289 USproductsupport alere com Alere Customer Service Contact the following Alere Service Care Center or your local distributor for order and billing assistance You may also contact us at www alere com Phone E Mail Address 1 877 441 7440 clientservices alere com Alere Cholestech LDX System User
16. ation Menu when used with the DATA button DATA 1 Allows you to review the results from the last cassette tested 2 Allows you to enter information into the Risk Assessment Program 3 Allows you to change settings in the Configuration Menu 1 Stops a test 2 Closes the drawer 3 Allows you to enter and exit the Configuration Menu of the analyzer The drawer will close and the screen will go blank after four minutes without use Alere Cholestech LDX System User Manual In the back of the analyzer are two ports a circular port for the power supply and a rectangular port used for connecting the analyzer to a printer There is also a ROM pack that contains upgradable firmware The power supply provides the analyzer with 9 volts DC at 1 amp A country specific power supply is included NOTE The Alere Cholestech LDX Analyzer contains a battery that cannot be replaced by the user Battery life is greatly reduced if the analyzer is left unplugged To conserve this battery we recommend plugging in the analyzer when not in use d must be disconngcted Cable Support before remgving Bees a g Port Identifications Power Socket ba o 238 O Connects power input supply to analyzer 9V 1A Print ROM Pack ROM Pack Contains upgradable firmware ROM Pack Clip 4 2 Printer Port Connects printer to analyzer 8 Alere Cholestech LDX System User Man
17. d Alere will send out a replacement Alere Cholestech LDX Analyzer Return the malfunctioning analyzer to Alere Note the return authorization number on both the shipping box and the airbill and send the analyzer back to Alere as soon as possible following receipt of the replacement analyzer Disposal Procedure The product may come into contact with blood during testing Used products therefore carry a risk of infection When disposing of an analyzer that has been utilized please do so in accordance to the regulations applicable in your country For information about correct disposal please contact your local council or authority The product falls outside the scope of the European Directive 2002 96 EC directive on Waste Electrical and Electronic Equipment WEEE For the applicable warranty period Alere warrants that each product shall be I of good quality and free of material defects Il function in accordance with the material specifications referenced in the product manual and Ill approved by the proper governmental agencies required for the sale of products for their intended use the Limited Warranty If the product fails to meet the requirement of the limited warranty then as a customer s sole remedy Alere shall either repair or replace at Alere s discretion the product Except for the limited warranty stated in this section Alere disclaims any and all warranties express or implied including but not limited to
18. day that patient samples are tested Proficiency Testing Proficiency testing is required when testing under CLIA moderately complex nonwaived status Call Alere for more information on proficiency testing agencies Calibration Verification Call Alere for recommended Calibration Verification material NOTE Read the package insert for the test cassettes you are using for any special instructions 30 Alere Cholestech LDX System User Manual Risk Assessment Coronary Heart Disease CHD Risk Assessment Program The Alere Cholestech LDX CHD Risk Assessment Program is based on data from the Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults The relationship between these risk factors and CHD is derived from the Framingham Study The Framingham Study documents and tracks the effects of variables involved in the development of CHD The age range for the study is 20 79 years and includes both men and women The risk assessment program may be used with any test cassette that provides results for both total cholesterol and HDL cholesterol This program calculates the percentage risk of developing coronary heart disease CHD over 10 years based on test results and the following risk factors e Sex male female e Smoking yes no e Age 20 79 e SBP systolic blood pressure e SBP has been treated or not treated e Th
19. e risk calculation is valid for persons 20 79 years of age who are currently free of CHD Although the effects of family medical history obesity and exercise may be relevant they were not included as separate risk factors in the risk assessment developed by the Framingham Study Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Executive summary of the Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel Ill JAMA 2001 285 2486 97 Alere Cholestech LDX System User Manual 31 Performing a CHD Risk Assessment See Setting the Configuration Menu pages 12 13 When Risk appears select CHD Risk 1 After a cassette is run that includes total cholesterol TC and HDL cholesterol results press the DATA button until CHD Risk Assessment Program screen appears The screen will display Risk RUM syes STOP ric 2 Press the RUN button to enter the CHD risk data screens These screens will look like this CHO risk date Smok esri 3 Press the DATA button to select patient risk factor data options Press the RUN button to enter your selection and advance to the next screen for the next patient risk factor data 4 After all patient risk factor data needed for the CHD Risk Assessment Program has been entered the result will be displayed like this
20. ges Only NOTE The translations that show on the Alere Cholestech LDX Analyzer screen do not include the language accents due to hardware limitations of the Alere Cholestech LDX Analyzer s display 10 Alere Cholestech LDX System User Manual NOTE If these messages do not appear check the power connections If these messages still do not appear or if the screen reads Calibration Fail eetlelil Tech Beru Contact Alere If the analyzer is not yet at the proper operating temperature warmed up the screen will display Initial Warm Us apka Alere Cholestech LDX System User Manual 11 Setting the Configuration Menu 1 To enter the Configuration Menu press and hold down Before using your Alere Cholestech LDX Analyzer you should the STOP button until the firmware version appears enter the Configuration Menu and set it to best meet your needs 2 The first item in the Configuration Menu then will be The following items can be customized displayed Language English Italian Soanish German French 3 The DATA button allows you to select choices for each mg dL milligrams per deciliter ai diate items is sp ane aa ate mmol L millimoles per liter utton enters your choice and advances you to the nex menu item NOTE U L units per liter and mg L milligrams per liter will be reported when the Configuration Menu is set for either UNITS mg dL or UNITS mmol L pa Whole B Venous or capillary whole blood Example The
21. iContinent Scientific Inc 2011 Alere All rights reserved PN 26189en Rev B 2011 03
22. ide the Control Range on page 28 if they are not Please call Alere to report any problems or if you have any questions about quality control Control Range Results for Alere controls should be within the ranges on the expected value card included with the control Results Within Control Range If results for all tests are within the expected ranges for both levels of controls patient samples may be tested and the results reported Alere Cholestech LDX System User Manual 27 Results Outside the Control Range If results of one or both levels of control tested are outside the established ranges 1 Verify that the lot number on the control vial and the assay sheet are the same 2 Check the expiration date for the test cassette and quality control materials Discard expired products 3 Retest the control level that is out of range using a new sample from the same control vial Pay careful attention to possible errors in technique If the control is within acceptable limits patient samples may be tested and results reported If the control is outside the acceptable limits retest with a sample of control from a new vial e If results are in range continue testing patient samples e f the control is still outside the acceptable limits contact Alere Do not use the analyzer for testing patient samples until the problem is resolved 28 Alere Cholestech LDX System User Manual Quality Control Flow Diagram
23. llowing materials that are not provided with your Alere Cholestech LDX System e Alere Cholestech LDX Test Cassettes e Alere Level 1 and 2 Controls e Biohazardous waste containers e Alcohol swabs e Gloves e Gauze sponges e Vacuum collection tubes needles and tube holders if the sample is to be collected by venipuncture Alere Cholestech LDX System User Manual How the Alere Cholestech LDX Analyzer Works The Alere Cholestech LDX Analyzer uses reflectance photometry the amount of light reflected from a solid surface to measure the amount of substances in blood The analyzer measures color changes of the four reagent pads The amount of color formed is converted by the analyzer to a concentration and the results are shown on the liquid crystal display LCD screen rim SP B Stop Button Data Button Liquid Crystal Display wn e N Run Button The Analyzer The Alere Cholestech LDX Analyzer has a 32 character display screen and three buttons that control all the steps needed for operation The three buttons are labeled RUN DATA and STOP 6 Alere Cholestech LDX System User Manual RUN 1 Opens the cassette drawer and activates the analyzer when the analyzer is hibernating 2 Starts a test Press the RUN button after a cassette is placed in the drawer to start a test 3 Allows you to enter information into the CHD Risk Assessment Program and change settings in the Configur
24. p AST was not linear Internal hardware problem Indicates a defective ROM pack An electrical problem occurred or the analyzer lost its optical calibration information 38 Alere Cholestech LDX System User Manual Action to Take Move the analyzer to another location or wait until the current location reaches acceptable temperature Check calendar in the analyzer to make sure it is set correctly Check expiration date on cassette pouch or box Repeat the test with a new cassette If message reappears call Alere Disconnect Reconnect analyzer from power supply If message reappears call Alere Unplug the analyzer Remove ROM pack and install a ROM pack from an analyzer that is functional If analyzer is functional with the ROM pack then the problem is the ROM pack and it will have to be replaced Call Alere Disconnect Reconnect analyzer from power supply If message reappears call Alere Error Message Problem Paca tole This is a normal empty message that appears End of data This is a normal info message that appears Cassette expiration date month has been reached Action to Take 1 When the optics check has been run and DATA button is pushed 2 A cassette has been run the power supply has been unplugged from the analyzer and DATA button is pushed 3 When an error message occurs i e Used Cassette and DATA button is pushed 1 CHD risk is off
25. pillary tube was filled too slowly The humidity sensor has become disconnected or has failed 40 Alere Cholestech LDX System User Manual Action to Take Repeat optics check with another Optics Check Cassette If the message reappears call Alere The analyzer will now be deactivated 1 Repeat test with a new cassette and new fingerstick sample 2 Repeat test with a new pipette tip and cassette Be sure pipette tip is firmly in place Repeat test with a new cassette and new fingerstick sample If message reappears test patient by alternate method Repeat test with a new cassette and new fingerstick sample Pay close attention to proper technique Repeat test with a new cassette and new fingerstick sample Pay close attention to proper technique The cassette is Repeat test with a new malfunctioning cassette Call Alere Error Message Selftest Fail Temp Too High See User Harnual or Temperature Dut of Kange Too Much Light See User Handal Tray Timeout See User Manual Used Cassette EPP Problem analyzer has lost internal memory temperature malfunction or hardware problem The analyzer is in an environment outside its proper temperature range The analyzer is in an environment with excessively bright light The cassette is jammed in the tray The microprocessor is confused because the buttons were pressed too quickly A previously used ca
26. r or allow it to become wet dirty or scratched Do not use a damaged or expired Alere Cholestech LDX Optics Check Cassette Run the Alere Cholestech LDX Optics Check Cassette e Once each day before patient samples are tested e After the Alere Cholestech LDX System has been moved or serviced 16 Alere Cholestech LDX System User Manual Optics Check Cassette Test Procedure Do not use an Alere Cholestech LDX Optics Check Cassette that has become damaged or altered in any way NOTE Do not place any blood sample on the cassette 1 Press the RUN button After verifying the Selftest OK message the drawer will open This message will display Load cassette ard press RUH 2 Place the Optics Check Cassette into the cassette drawer 3 Press the RUN button again and the analyzer will automatically perform the optics check The words Optics Check and four numbers will display on the screen one for each optical channel in the analyzer Qetics Check ohiil chiz chif chi4d 4 Check to see that the numbers are within the acceptable range which is printed on the Optics Check Cassette Record the results in the Optics Check Log 5 If the numbers are outside the printed range this message will display Qetics Test Fail chil chif chiS chi4 6 If an expired Optics Check Cassette is used this message will display Expired Cassette chil chif chif chi4 7 Ifan expired Optics Check Cassette is used and then a
27. rid SAMPLE thiole E LOL HOL ratio Cong merid Printer on To Access the Configuration Menu Press STOP on the analyzer and hold until the FIRMWARE VERSION appears The next display will appear automatically Press DATA to select LANGUAGE CHOICES English Italiano Espa ol Deutsch or Fran ais Press RUN to advance to the next option Press DATA to select UNITS mg dL or mmol L Press RUN to continue NOTE U L and mg L will be reported when the Configuration Menu is set for either UNITS mg dL or UNITS mmol L Press DATA to select SAMPLE MODE Whole B Venous or capillary whole blood samples or Serum Serum plasma or proficiency test material Press RUN to continue NOTE Check the package insert for the test cassette you are using to determine correct Sample option when testing quality control or calibration verification material Press DATA to select LDL HDL RATIO OPTION No reports TC HDL ratio Yes reports LDL HDL ratio Press RUN to continue Press DATA to select PRINTER OPTIONS On Printer function turned on or Off Printer function turned off Press RUN to continue 14 Alere Cholestech LDX System User Manual LCD Display Cong merid nam copies 1 Cong merid FRisk CHO Misk Cong merid ked Mar 2 Torii Merd HHIMP ISS Hn XX AM or PM z li To Access the Configuration Menu Press DATA to select COPY OPTIONS 1 One cop
28. screen will display 4 You can press STOP at any time to exit the Configuration Menu Serum Serum or plasma calibration verification or proficiency testing material Config marud NOTE Check the package insert for the test LUI Tesmer cassette you are using to determine the correct If you wish to change the units displayed press the DATA button SAMPLE mode when testing quality control or to change to calibration verification material LDL HDL ratio No LDL HDL function turned off TC HDL bemti mamu IHI TS mmoleL function turned on Yes LDL HDL function turned on TC HDL When the desired choice is displayed press the RUN button to function turned off enter the choice and to advance to the next item On printer function turned on Off printer function turned off Number of 1 1 printed label Copies 2 2 printed labels 3 3 printed labels CHD Risk Framingham Risk on Off Risk assessment option is turned off Day of week month day and year English Day of week day month and year Alternate language settings Hour minutes seconds AM PM English Hour minutes seconds 24 hour Alternate language settings 12 Alere Cholestech LDX System User Manual Alere Cholestech LDX System User Manual 13 Configuration Menu Flowchart The analyzer allows you to customize function settings in the Configuration Menu Med bb yo FV Firmuare Uers lor Config mer Lang English Cong menu UNTTS mgd Config me
29. shooting amp Maintenance section pages 36 41 for further instructions When the drawer opens remove the cassette and put it in a biohazardous waste container Leave the analyzer drawer empty when not in use Record the results on the appropriate form To run another test cassette press RUN once Repeat step 3 and steps 6 through 15 20 Alere Cholestech LDX System User Manual NOTE If you do not want to run another test and the drawer is open press STOP to close drawer 18 Otherwise after four minutes a beep will sound and the screen will display NOTE If the RUN button is not pushed within 15 seconds the drawer will close and the screen will go blank 19 If necessary press the DATA button to view the results from the last cassette tested NOTE Pressing the RUN button will erase the previous result Alere Cholestech LDX System User Manual 21 Performing a Fingerstick NOTE A warm and clean hand with good blood flow from the puncture site is essential to collect a good capillary sample Alere supplies a variety of capillary tube options Check the package insert for the test cassette you are using to determine the appropriate capillary tube 1 The patient should sit quietly for five minutes before the blood sample is collected 2 Puta capillary plunger into the end of an Alere capillary tube with the colored mark Set it aside 3 Choose a spot on the side of one of the center fingers of
30. side the analyzer case If a liquid is spilled on the analyzer unplug the power supply and call Alere at once The analyzer drawer must be left empty when not in use Do not store cassettes in the analyzer The analyzer must be handled carefully to avoid damage when moving from site to site Carry only one analyzer in an Alere Cholestech LDX Carrying Case Do not use the Alere Cholestech LDX Carrying Case to ship the analyzer Do not use the Alere Cholestech LDX Carrying Case for air travel as checked baggage The analyzer should be shipped in its original box There are no user adjustments in the analyzer Do not remove the cover of the analyzer This will void the warranty agreement Do not attach any printer or computer to the analyzer unless using the cable recommended by Alere Keep fingers clear of the cassette drawer when it moves in or out of the analyzer Protect cassettes from magnetic fields that could damage the magnetic stripe e g magnetic stirrer Refer to the package insert that accompanies Alere Cholestech LDX test cassettes for precautions specific for testing with each cassette Alere Cholestech LDX System User Manual 37 Corrective Action Error Message HARM i WARE 2 WARE F AAD Error Bad Checksum Calibration Fail Call Tech Seri ice Problem Unacceptable temperature variation during test run Cassette expiration date month has been reached Kinetic reaction for ALT am
31. ssette has been placed in the analyzer The cassette was placed in the drawer incorrectly Action to Take Disconnect Reconnect analyzer from power supply If message reappears call Alere Move the analyzer to another location or wait until the current location reaches acceptable temperature Move the analyzer to a location with less light When light level is acceptable it will again become operable Press RUN the drawer will come out Replace the cassette flat in the drawer and press RUN button Disconnect Reconnect analyzer from power supply Repeat test with a new cassette If message reappears call Alere Repeat test with a new cassette Dispose of used cassette appropriately Repeat test with a new cassette Call Alere if message reappears The cassette is Repeat test with a new malfunctioning cassette Alere Cholestech LDX System User Manual 41 Limited Warranty Should a malfunction occur contact Alere If Alere determines that the Alere Cholestech LDX Analyzer should be returned and the analyzer is within warranty you will be assigned a return authorization number and be provided shipping instructions If your analyzer is not in warranty replacement options will be made available to you Should you choose to exercise a replacement option through Alere a return authorization number and shipping instructions will be given to you Immediately after the return has been authorize
32. ssnsssssrinn 26 Results Outside the Control RAnge eecsecceeeeseeeeeeeeeneeeeeeee 28 Moderate Complex Tests ccsceseeseeeneeseneueeuenenseneneenenenae 30 Risk Assessment csceeeeeeeeeeeeeeeeeeeeeseeeeeeeseeseeeeeeeeseneeeee 31 Coronary Heart Disease CHD Risk Assessment Program 31 Performing a CHD Risk Assessment 32 Risk Assessment Flowchart ccccceceeeeeeeeeeeeceeeeeeeeeeeeeeeeeeeeee 34 Risk Assessment Modeling cccscceeeeenneeeeeeeeneeeeeeeneeeeeeee 35 2 Alere Cholestech LDX System User Manual Troubleshooting amp Maintenance s cesesseeeeeeeeeeeeneeens 36 NSAI E E T es snceh hoa AE A T ET 36 Precautions and WarningS cccecccceeessccceeeeeseeeeeeeeeeeeeeeeeees 37 Corrective ACTION ccccccccccceceeeeeeseceeeeeaueaeeeeesaesseseeeeseeeeeeeeeeeees 38 Limited Warranty cscccesssesceseseeenseecsenseesenenseseeenseeaeensess 42 General Specifications ccccscsccsessseneessseneeessenseseeeeensoees 43 Glossary Of Terms scccesescecnseeeseneesseeneesesenecessensesesessnsoees 44 Contact Ale re sccscccsccseecsensneceesensenseeneeeesenecnesensesseeesnsones 45 SYMDOINS secesceeeseseneeeeeesensesseenseeesensaeeeenseseeeeensosaeensesesonees 46 Alere Cholestech LDX System User Manual Introduction The Alere Cholestech LDX System is a small portable analyzer and test cassette system It is easy to use and gives fast and reliable results To run a test just add
33. test cassette is used this message will display following the test results Expired Qetlics Cassette Alere Cholestech LDX System User Manual 17 Testing Procedure Running a Test For more information see the test cassette package inserts The Quick Reference Guide gives a brief summary of the procedure NOTE Gloves should be worn whenever working with samples that are potentially biohazardous 1 Ifthe cassettes have been refrigerated allow them to come to room temperature at least 10 minutes before opening 2 Make sure the analyzer is plugged in 3 Remove the cassette from its pouch Hold the cassette by the short sides only Do not touch the black bar or the brown magnetic stripe Place the cassette on a flat surface 4 Press RUN The analyzer will do a selftest and the screen will display Selftest PUPPIE rH Selftesct OF 5 The cassette drawer will open and the screen will display Load cassette ard press RUM aaa Crd X Wors X indicates current sample setting W Whole Blood S Serum 6 Place the sample into the cassette well Use the Alere Cholestech LDX Capillary Tube for fingerstick samples Use an appropriate MiniPet Pipette for venous blood samples and quality control calibration verification and proficiency testing materials Check the package insert for the test cassette you are using to determine the volume for the sample type you are using See Performing a Fingerstick and
34. ual The Test Cassettes Cassette Type 1 is used for lipids glucose ALT and AST Cassette Type 2 is used for hsCRP only Each test cassette has two parts the main body and the reaction bar The main body contains a sample well where the blood sample is dispensed and a brown magnetic stripe The magnetic stripe contains the test names instructions to the analyzer for running the tests on the cassette and calibration information for converting the color reading to test concentration Cassette Type 1 Sample Well Main Body Magnetic Stripe born Il ll E _ See Cassette Type 2 Reaction Bar Sample Well Alere Cholestech LDX System User Manual Getting Started Use your Alere Cholestech LDX System in a location that has e Room temperature 68 87 F 20 31 C e Astable work surface NO centrifuges e No direct heat oven or room heater e No bright light sunlight or spotlight 1 Check that the ROM pack is completely inserted and the clip is in place NOTE Do not remove the ROM pack while the analyzer is plugged in The analyzer will lose its optical calibration and will no longer function 2 Insert the power supply plug into the round socket in the back of the analyzer 3 Plug the power supply into a surge protected power outlet The following messages will appear on the screen Testing memory Selftest running For Multi Langua
35. y of test results will print or 2 Two copies of test results will print or 3 Three copies of test results will print Press RUN to continue Press DATA to select CHD RISK ASSESSMENT PROGRAM OPTIONS On CHD Risk Assessment Program is turned on or Off CHD Risk Assessment Program is turned off Press RUN to continue NOTE f the CHD Risk option is selected the printer will not print test results until the assessment is complete Press DATA to select DAY OF WEEK Mon Sun Press RUN to continue Press DATA to select MONTH Jan Dec Press RUN to continue Press DATA to select DAY 1 31 Press RUN to continue Press DATA to select YEAR 1999 2030 Press RUN to continue Press DATA to select HOUR 1 12 Press RUN to continue Press DATA to select MINUTES SECONDS 0 59 Press RUN to exit Configuration Menu NOTE When English is the selected language AM or PM is displayed When any other language setting is selected the hours are shown in 24 hour format from 00 00 to 24 00 hours NOTE Press STOP at any time to exit the Configuration Menu Alere Cholestech LDX System User Manual 15 Alere Cholestech LDX Optics Check An Alere Cholestech LDX Optics Check Cassette is supplied with the analyzer It should be used to check the optical system of the analyzer Store the Alere Cholestech LDX Optics Check Cassette at room temperature in the case provided Do not touch the reaction ba
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