System User Manual
Contents
1. m n z D m i a o o m i i 7 m 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 lancet Lu D i Lu o i oa a So N Lu 20 TESTING PROCEDURE Cholestech LDX System User Manual 6 10 Squeeze the finger gently to obtain a large drop of blood Wipe away this first drop of blood as it may contain tissue fluid 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 have the patient apply pressure to the puncture until the bleeding stops Follow these suggestions to help you consistently perform good fingersticks Suggestion TESTING PROCEDURE Cholestech LDX System User Manual Reason 21 Perform a deep and firm puncture Keep the patient2. coal Hayward CA 94545 U S A Tel 1 877 441 7440 Fax 1 877 441 7441 www cholestech com LULU 25 001 12298 ARMED A Division of Quinties Ltd Runnymede Malthouse Business Centre off Hummer Road Cholestech LDX is a registered trademark of the Inverness Medical group of companies MiniPet is a trademark of TriContinent Scientific Inc Egham Surry TW20 9BD United Kingdom 2009 Inverness Medical All rights reserved ART12298 Rev E
3. Assessment 27 Coronary Heart Disease CHD CHD Risk Assessment Program 005 27 Performing a CHD Risk Assessment 28 CHD Risk Assessment Flowchart 30 CHD Risk Assessment Modeling 31 Maintenance amp Troubleshooting 32 Cleaning s namana mha renun ee eee Bua aes 32 Precautions and Warnings 000 eee 32 Troubleshooting piiri ka ei hg han ae ee ere GNYAN 34 General Specifications 36 Warranty and Service Cholestech guarantees that each Analyzer will be in good working order on the day it is installed and that it will conform to Cholestech s specifications Cholestech or its agent will provide service to keep or restore each Analyzer to good working order for two years at no additional charge to the purchaser Warranty service provided under this agreement does not assure uninterrupted operation of the Analyzer The Service provided by Cholestech under this agreement does not include 1 Repair or replacement made necessary because of the use of the equipment for other than the ordinary use for which it was designed as stated in Cholestech publications Repair or replacement made necessary because of accident disaster which includes but is not limited to fire flood earthquake water wind and lightning transportation neglect or misuse or alterations which include but are not limited to
4. any deviation from Cholestech s physical mechanical or electrical machine design INTRODUCTION 1 Cholestech LDX System User Manual z a Q i c o z Introduction The Cholestech LDX 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 a sample to the cassette and place it into the Analyzer In a few minutes the results will appear on the screen The Cholestech LDX System is for in vitro diagnostic use only This manual contains all the information you need to operate and care for the Cholestech LDX Analyzer Please read this entire manual before you use the Analyzer Technical and Customer Service Cholestech will provide every customer with the technical support and training needed to properly use the Cholestech LDX System We maintain a staff of qualified Technical Service Representatives available 24 hours a day seven days a week For current ordering information or any other customer service related questions our Customer Service department is available from 8 00 am to 8 00 Pm Eastern time Monday through Friday Please feel free to contact us at Cholestech 3347 Investment Blvd Hayward CA 94545 U S A Tel 1 877 441 7440 Fax 877 441 7441 ctec_support cholestech com 2 INTRODUCTION Cholestech LDX System User Manual 2 oOo D i Examining Your Package Contents When you receive
5. s hand below the level of his or her heart Hold the capillary tube horizontally or at a slightly descending angle to the drop of blood Fill the capillary in less than 10 seconds Dispense blood from the capillary tube in less than five minutes If blood stops flowing wipe finger firmly with gauze WARNING Squeezing the finger excessively may cause inaccurate test results An adequate puncture is crucial to obtaining a free flowing drop of blood This will improve the blood flow This will make the capillary tube fill faster This will ensure proper mixing of blood and anticoagulant which prevents clotting After five minutes the blood may begin to clot in the capillary tube You can improve blood flow by reopening the puncture m N z D 0 a o o m i i a m 22 TESTING PROCEDURE Cholestech LDX System User Manual Using Your MiniPet Pipettes See page 16 for proper pipette selection Use this procedure to apply a sample of venous serum plasma or whole blood or control calibration verification or proficiency testing materials 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 Tofill the pipette push the plunger down as far as you can Place the pipette tip midway into the sample and slowly release the plunger Confirm that no air bubbles are in the p
6. the drawer is open press STOP to close the drawer 18 Otherwise after four minutes a beep will sound and the screen will display IMPORTANT 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 IMPORTANT Pressing the RUN button will erase the previous result TESTING PROCEDURE 19 Cholestech LDX System User Manual Performing a Fingerstick IMPORTANT A warm and clean hand with good blood flow from the puncture site is essential to collect a good capillary sample Also Cholestech supplies two different capillary tubes 35 pL and 50 pL The 50 pL tube must be used with the hs CRP cassette The 35 pL tube is used with all other test cassettes 1 The patient should sit quietly for five minutes before the blood sample is collected 2 Puta capillary plunger into the end of a Cholestech Capillary Tube with the colored mark Set it aside 3 Choose a spot on the side of one of the center fingers of either hand To help increase blood flow the fingers and hands should be warm to the touch To warm the hand you can Prener COIN a Wash the patient s hand with warm water or NN b Apply a warm not hot a compress to the hand for several minutes or c Gently massage the finger from the base to the tip several times to bring the blood to the fingertip
7. your laboratory s standard quality control procedures e As otherwise required by federal state and local guidelines Optics Check Cassette Run the Optics Check Cassette each day that patient samples are tested Proficiency Testing Proficiency testing is required when testing under CLIA moderate complexity nonwaived status Call Cholestech Technical Service for more information on proficiency testing agencies Calibration Verification Call Cholestech Technical Service 1 877 441 7440 or 1 321 441 7200 for recommended calibration verification material IMPORTANT Read the package insert for the test cassettes you are using for any special instructions gt gt lt rr Q i o q 24 uu i CHD RISK ASSESSMENT 21 Cholestech LDX System User Manual Risk Assessment o TI i N a gt N N m n N m a Coronary Heart Disease CHD Risk Assessment Program The 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 assess
8. IDX LDX Y CHOLESTECH IDX System User Manual Read Me First Congratulations on the purchase of your 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 It is critical to fill out the warranty card enclosed to ensure a record of your one year warranty Be sure to read the instructions in this user manual before operating the Cholestech LDX If you have any questions now or in the future please contact Cholestech Technical Service at 1 877 441 7440 or 1 321 441 7200 by fax at 1 321 441 7400 or via e mail at ctec_support cholestech com TABLE OF CONTENTS Cholestech LDX System User Manual lable of Contents Introduction 0 0 0 0 0 00002000 1 Examining Your Package Contents 2 How the Cholestech LDX Works 4 Getting Started 0 0 00 aa 9 Setting the Configuration Menu 10 Configuration Menu Flowchart 0 12 Cholestech LDX Optics Check 13 Optics Check Cassette Test Procedure 13 Testing Procedure 00 15 Running a Test 0 a 15 Performing a Fingerstick 19 Using Your MiniPet Pipettes 22 Quality Control 0 23 Results Outside the Control Range 25 Moderate Complexity Tests 26 CHD Risk
9. TED 11 Cholestech LDX System User Manual 1 To enter the Configuration Menu press the STOP button and hold down until the firmware version appears 2 The first item in the Configuration Menu then will be displayed 3 The DATA button allows you to select choices for each of the menu items in the Configuration Menu The RUN button enters your choice and advances you to the next menu item D m D 4 gt a m o 4 You can press STOP at any time to exit the Configuration Menu Example The screen will display If you wish to change the units displayed press the DATA button to change to When the desired choice is displayed press the RUN button to enter the choice and to advance to the next item 12 GETTING STARTED Cholestech LDX System User Manual Configuration Menu Flowchart The Analyzer allows you to customize function settings in the Configuration Menu i Liu lt N oS Lu eS EYE Firmware Version To Access the Configuration Menu Press STOP on the Analyzer and hold until the FIRMWARE VERSION appears The next display will appear automatically Config merid Lang English Press DATA to select LANGUAGE OPTIONS English Italiano Espafiol Deutsch or Francais Press RUN to advance to the next option Config menu UNITSSmg dL Press DATA to select UNITS mg dL or mmol L Press RUN to continue Note
10. U L and mg L will be reported when the Configuration Menu is set for either UNITS mg dL or UNITS mmol L Config menu SAMPLEsWhole B Press DATA to select SAMPLE MODE Whole B Venous or capillary whole blood samples or Serum Serum plasma or proficiency testing 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 Config menu Printer on Press DATA to select PRINTER OPTIONS On Printer function turned on or Off Printer function turned off Press RUN to continue Config menu num copies 1 Press DATA to select COPY OPTIONS 1 One copy 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 Config mer Risk CHO Risk 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 If the CHD Risk option is selected the printer will not print test results until the assessment is complete Config mer Mon Aug 3 2665 Press DATA to select DAY OF WEEK Mon Sun Press RUN to continue Press DATA to select MONTH Jan Dec Pres
11. Works 4 he Cholestech LDX System 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 he liquid crystal display LCD screen Liquid Stotstcy Crystal DY Display THE ANALYZER The 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 INTRODUCTION 5 Cholestech LDX System User Manual z a Q i c o z RUN 1 Opens the cassette drawer or activates the Analyzer 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 Configuration 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 CHD Risk Assessment Program 3 Allows you to change settings in the Configuration Menu STOP 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
12. alyzer Do not remove the cover of the Analyzer This will void the warranty agreement Do not attach the printer or a computer to the Analyzer unless using the cable recommended by Cholestech 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 Cholestech test cassettes for precautions specific for testing with each cassette d ce a mm N Z ID d F p m zg e o Lad lt Lu lt TROUBLESHOOTING 34 Maintenance amp Troubleshooting Cholestech LDX System User Manual Troubleshooting Message Indication Corrective Action WARN 1 Unacceptable temperature Move the Analyzer to another location variation during test run or wait until the current location reaches acceptable temperature WARN 2 Cassette expiration date month Check calendar in the Analyzer to make has been reached sure it is set correctly Check expiration date on cassette pouch or box WARN 7 Kinetic reaction for ALT amp AST Repeat the test with a new cassette was not linear A D Error Internal hardware problem Disconnect reconnect Analyzer from power supply If message reappears call Cholestech Technical Service Bad Checksum Indicates a defective ROM pack Unplug the Analyzer Remove ROM pack and instal
13. amples until the problem is resolved QUALITY CONTROL FLOW DIAGRAM BEGIN TESTING of quality control material gt Are RESULTS within ACCEPTABLE LIMITS YES NO RECORD results in a VERIFY expiration date on Quality Control Log Quality control material Cassette RETEST with sample from SAME control vial using NEW cassette ee 4 YES WITHIN LIMITS NO TOULNOD ALITYND RETEST with sample from a NEW control vial using a NEW cassette YES WITHIN LIMITS NO CALL Cholestech Tech Service at 1 877 441 7440 or 1 321 441 7200 26 MODERATE COMPLEXITY TESTS Cholestech LDX System User Manual Moderate Complexity 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
14. color reading to test concentration Main Body Magnetic Stripe kaaa PAG RS ee Cassette Type 1 Sample Well Main Body Magnetic Stripe Cassette Type 2 GETTING STARTED 9 Cholestech LDX System User Manual Getting Started Use your Cholestech LDX System in a location that has Room temperature 68 87 F 20 31 C A stable work surface NO centrifuges No direct heat oven or room heater No bright light sunlight or spotlight 1 Check that the ROM pack is completely inserted and the clip is in place D m D 4 gt a m o IMPORTANT Do not remove the ROM pack while the Analyzer is plugged in The Analyzer may 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 display on the screen Testing memory Danita Ba Na A ameg pase st g pse sog SE LES En FOR MULTI LANGUAGES ONLY Note The translations that show on the Cholestech LDX Analyzer s screen do not include the language accents due to hardware limitations of the Cholestech LDX Analyzer s LCD e Me bt Fee a O LU s 10 GETTING STARTED Cholestech LDX System User Manual IMPORTANT If these messages do not appear check the power connections If these messages still do not appear or
15. ess the RUN button to enter the CHD risk data screens These screens will look like this 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 5 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 CHD RISK ASSESSMENT 29 Cholestech LDX System User Manual o i N a gt N N m n N m a If print option in the Configuration Menu has been set to Off the screen will display End of Data Info 6 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 30 CHD RISK ASSESSMENT Cholestech LDX System User Manual zZ Lu N 7e Lu N N lt x 2 24 I CHD Risk Assessment Flowchart The Analyzer allows you to access a CHD Risk Assess
16. essment result screen 18 Year CHO Figk 1ls Percentage risk of developing CHD within 10 years is displayed CHD RISK ASSESSMENT 31 Cholestech LDX System User Manual CHD Risk Assessment Modeling After running a test and performing an initial risk assessment the Cholestech LDX CHD Risk Assessment Program allows you to change the information in the file to see how these changes will impact the patient s risk of CHD This helps to illustrate the effect that lifestyle changes can have Only manually entered items can be modified 1 Recall the patient s test results by pressing DATA 2 Press the DATA button until the CHD Risk Assessment Program screen appears The screen will display 3 Press the RUN button to advance to the risk factor data you wish to modify Follow the same instructions for performing a CHD risk assessment 4 When finished the new percentage risk of developing CHD providing the patient makes the identified changes will be displayed 5 To exit the CHD Risk Assessment Program press STOP o TI N a gt N N m n N m a gt Lu z Lu TROUBLESHOOTING 32 MAINTENANCE amp TROUBLESHOOTING Cholestech LDX System User Manual Maintenance amp Troubleshooting Cleaning IMPORTANT Unplug Analyzer prior to cleaning No maintenance is required other than routine cleaning Routine cleaning Clean the outside
17. for the controls e Run the Cholestech LDX Analyzer in the appropriate SAMPLE mode See Setting the Configuration Menu on page 10 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 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 Cholestech Technical Service before testing patient samples i c gt lt o i 2 a 24 QUALITY CONTROL Cholestech LDX System User Manual 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 Outside the Con
18. if the screen reads Call Cholestech Technical Service If the Analyzer is not yet at the proper operating temperature warmed up the screen will display i Lu lt N So Lu Setting the Configuration Menu Before using your Cholestech LDX Analyzer you should enter the Configuration Menu and set it to best meet your needs The following items can be customized Language English Italian Spanish German French Units mg dL milligrams per deciliter mmol L millimoles per liter 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 Sample Whole B Venous or capillary whole blood Serum Serum plasma or proficiency testing material Note Check the package insert for the test cassette you are using to determine the correct SAMPLE mode when testing quality control or calibration verification material Printer On printer function turned on Off printer function turned off umber of 1 1 printed label 2 2 printed labels Copies 3 3 printed labels Risk CHD Risk CHD Risk Assessment Program is turned on Off CHD Risk Assessment Program is turned off Date Day of week month day and year English Day of week day month and year Alternate language settings Time Hour minutes seconds AM PM English Hour minutes seconds 24 hour Alternate language settings GETTING STAR
19. ipette 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 Lu i Lu o i oa a oS N Lul 4 Remove the pipette tip and put it into a biohazardous waste container IMPORTANT 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 IMPORTANT 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 QUALITY CONTROL 23 Cholestech LDX System User Manual Quality Control External quality control material should be run routinely to show that your system is giving accurate results Cholestech recommends the following quality control procedures for the Cholestech LDX System Choice of Material Liquid Level 1 and Level 2 controls that work well with the Cholestech LDX System are available from Cholestech If you use other controls you will need to establish ranges for the Cholestech LDX System Handling Controls e Follow the instructions that come with your controls e Check the expiration date before use Do not use if expired e Use an appropriate MiniPet Pipette Check the package insert for the test cassette you are using to determine the volume
20. l 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 Calibration Fail Call Tech Service An electrical problem occurred or the Analyzer lost its optical calibration information Cholestech Technical Service Disconnect Reconnect Analyzer from power supply If message reappears call Technical Service Data file empty This is a normal message that appears 1 When the optics check has been run and DATA button is pushed 2 Acassette 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 End of data info This is a normal message that appears 1 CHD risk is off and DATA button is pushed twice after results appear 2 CHD risk is on and the STOP button is pushed when Risk RUN yes STOP no appears Expired Cassette Cassette expiration date month has been reached Check calendar in the Analyzer to make sure it is set correctly Check expiration date on cassette pouch or box Low Battery Internal battery voltage is too low Call Cholestech Technical Service Internal battery is not user serviceable Mag Read Error See User Manual Unable to read magnetic stripe on the cassette 1 Wipe magnetic stripe with a soft tissue and restart te
21. le clotted because it was eft in capillary mproper samp Finger was milki sample or capi ube too long e collection ed to obtain lary tube was filled too slowly Repea 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 est with a new cassette and The cassette is malfunctioning Repeat test with a new cassette Selftest Fail Analyzer has lost internal memory temperature malfunction or hardware problem call Cholestech Technical Service Disconnect reconnect Analyzer from power supply If message reappears Temp Too High See User Manual or Temperature Out of Range The Analyzer is in an environment outside its proper temperature range or wait until the current location reaches acceptable temperature Move the Analyzer to another location Too Much Light See User Manual The Analyzer is in an environment with excessively bright light it will again become operable Move the Analyzer to a location with less light When light level is acceptable Tray Timeout See User Manual The cassette is jammed in the tray Replace the cassette flat in the drawer and press RUN button Press RUN the drawer will come out Buttons were pressed too quickly Cholestech Technical Service Disconnect reconnect Analyzer from power s
22. ment 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 NS ENE Tl 221 HOL roan HOL 193 To Access the Program When the RESULTS appear on the screen press DATA to move to the next screen TC HOLSE 1 Press DATA again to move to the CHD RISK ASSESSMENT PROGRAM RUN yes STOP pro Press RUN to move to CHD risk factor data screens CHO risk Ages4O 4q data CHO risk data Sesh Press DATA to select AGE range from 20 34 35 39 40 44 45 49 50 54 55 59 60 64 65 69 70 74 and 75 79 Press RUN to advance to the next risk factor data screen Press DATA to select GENDER Male or Female Press RUN to advance to the next risk factor data screen CHO risk data Smok es NG CHO risk data SEP 120 129 Press DATA to select SMOKING option Yes Cigarette smoker or quit within the last year or No Press RUN to advance to the next risk factor data screen Press DATA until you reach the desired SYSTOLIC BLOOD PRESSURE LEVEL range from lt 120 120 129 130 139 140 159 and gt 160 Press RUN to advance to the next risk factor data screen CHO risk data EP TreatedsNo Press DATA to select BLOOD PRESSURE Treatment Yes or No Press RUN to advance to the risk ass
23. ment 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 CHD over 10 years based on test results and the following risk factors Sex male female Smoking yes no Age 20 79 SBP systolic blood pressure SBP has been treated or not treated yes no The 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 III JAMA 2001 285 2486 97 28 CHD RISK ASSESSMENT Cholestech LDX System User Manual Lu N N Lu N N lt x 2 24 x Performing a CHD Risk Assessment See Setting the Configuration Menu pages 10 11 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 the CHD Risk Assessment Program screen appears The screen will display 2 Pr
24. of the 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 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 Precautions and Warnings Cholestech LDX Analyzer 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 inside the Analyzer case If a liquid is spilled on the Analyzer unplug the power supply and call Cholestech Technical Service at once MAINTENANCE 8 TROUBLESHOOTING 33 Cholestech LDX System User Manual The Analyzer drawer must be left empty when not in use Do not leave cassettes in the Analyzer The Analyzer must be handled carefully to avoid damage when moving from site to site Carry only one Analyzer in a Cholestech LDX Carrying Case Do not use the Cholestech LDX Carrying Case to ship the Analyzer Do not use the 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 An
25. results mmediately 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 8 DO NOT PUSH IN THE DRAWER Press RUN The drawer will close During the test the screen will display m N z ir vu a oO o m i i 7 m 9 Put everything that came into contact with the blood samples or control calibration verification or proficiency testing material into a biohazardous waste container 10 When the test is complete the Analyzer will beep and the screen will display 11 Press DATA to view the additional results 18 TESTING PROCEDURE Cholestech LDX System User Manual 12 When the results are outside the measuring range of the test the screen will display Pete tr 2 HAH or Bimenes TO O EHH naig To HAH 13 If there is a problem with the test a message will appear on the screen See the Troubleshooting amp Maintenance section pages 32 35 for further instructions 14 When the drawer opens remove the cassette and put it in a biohazardous waste container Leave the Analyzer drawer empty when not in use 15 Record the results on the appropriate form 16 To run another test cassette press RUN once Lu i Lu o i oe a oS N Lul 17 Repeat step 3 and steps 6 through 15 IMPORTANT If you do not want to run another test and
26. s 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 Config menu TIMEs9 685 23 AM 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 GETTING STARTED 13 Cholestech LDX System User Manual Cholestech LDX Optics Check A Cholestech LDX Optics Check Cassette is supplied with the Analyzer It should be used to check the optical system of the Analyzer Store the Cholestech LDX Optics Check Cassette at room temperature in the case provided Do not touch the reaction bar or allow it to become wet dirty or scratched Do not use a damaged or expired Cholestech LDX Optics Check Cassette D m D 4 gt a m o Run the Cholestech LDX Optics Check Cassette e Once each day before patient samples are tested e After the Cholestech LDX System has been moved or serviced Optics Check Cassette Test Procedure Do not use a Cholestech LDX Optics Check Cassette that has become damaged or altered in any way IMPORTANT Do not place any blood sample on the cassette 1 Pre
27. ss the RUN button After verifying the Selftest OK message the drawer will open This message will display spe ed Piha 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 i Lu lt N oS Lu o 14 GETTING STARTED Cholestech LDX System User Manual Check to see that the numbers are within the acceptable range 80 105 which is printed on the Optics Check Cassette Record the results in the Optics Check Log If the numbers are outside the printed range this message will display If an expired Optics Check Cassette is used this message will display If an expired Optics Check Cassette is used and then a test cassette is used this message will display following the test results TESTING PROCEDURE 15 Cholestech LDX System User Manual lesting Procedure Running a Test For more information see the test cassette package inserts The Quick Reference Guide gives a brief summary of the procedure IMPORTANT Gloves should be worn whenever working with samples that are potentially biohazardous 1 If the cassettes have been refrigerated allow them to come to room temperature at least 10 minutes before opening 2 Make sure
28. st 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 Cholestech Technical Service RUN button pushed without cassette in drawer Place cassette in drawer before pushing RUN button Note Do not try to run a cassette if you have been troubleshooting a problem with it for more than 30 seconds Evaporation of sample may cause inaccurate results Message Indication Maintenance amp Troubleshooting Cholestech LDX System User Manual Corrective Action 35 Optics Test Fail See User Manual A problem with the optical system of the Analyzer or a faulty Optics Check Cassette Repeat optics check with another Optics Check Cassette If the message reappears call Cholestech Technical Service The Analyzer will now be deactivated Reaction Did Not Occur nnnn Insufficient sample volume was applied to the cassette due to air bubbles or incompletely filled capillary tube or pipetting error 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 nsufficient sample volume reached reaction pads due to high hematocrit of sample test patient by alternate method Repeat test with a new cassette and new fingerstick sample If message reappears mproper sample collection Samp
29. the Analyzer is plugged in and has warmed up 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 m N z D o a o o m i i a m 4 Press RUN The Analyzer will do a selftest and the screen will display 5 The cassette drawer will open and the screen will display 16 TESTING PROCEDURE Cholestech LDX System User Manual 6 Place the sample into the cassette well Use a 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 Using Your MiniPet Pipette pages 19 22 for additional information IMPORTANT Fingerstick samples 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 Lu i Lu o i oa a oS N Lul TESTING PROCEDURE 17 Cholestech LDX System User Manual 7 Keep the cassette level after the sample has been applied WARNING Allowing the sample to sit in the cassette will cause inaccurate
30. trol Range on page 25 if they are not Please call Cholestech Technical Service at 1 877 441 7440 or 1 321 441 7200 to report any problems or if you have any questions about quality control Control Range Results for Cholestech controls should be within the ranges 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 Uo i gt mal lt D lt j QUALITY CONTROL 25 Cholestech LDX System User Manual 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 a If the control is within acceptable limits patient samples may be tested and results reported b If the control is outside the acceptable limits retest with a sample of control from a new vial e f results are in range continue testing patient samples e f the control is still outside the acceptable limits contact Cholestech Technical Service Do not use the Analyzer for testing patient s
31. upply Repeat test with a new cassette If message reappears call Used Cassette nnnn A previously used cassette has been placed in the Analyzer Repeat test with a new cassette Dispose of used cassette appropriately The cassette was placed in the drawer incorrectly Cholestech Technical Service if message reappears Repeat test with a new cassette Call The cassette is malfunctioning Repeat test with a new cassette a c w m N zZ lt r 2 m zZz P a iw m Ro N z O o Lu A N lt 24 Lu zZ Lu o 36 GENERAL SPECIFICATIONS Cholestech LDX System User Manual General Specifications Normal Environmental Conditions Operating Voltage 9 volt DC at 1 amp Environmental Conditions Indoor use Altitude up to 6 561 feet 2 000 meters Temperature 68 87 F 20 31 C Relative humidity 80 for temperature up to 87 F 31 C Pollution degree Class 2 If the equipment Cholestech LDX Analyzer is used in a manner not specified by the manufacturer Cholestech the protection provided by the equipment may be impaired In vitro diagnostic medical device Ah Biological risks f Read User Manual before using Cholestech LDX Analyzer CRMLN Certified NOTES 37 Cholestech LDX System User Manual Notes Cholestech LDX System User Manual CHOLESTECH m inverness medical 3347 Investment Blvd
32. use 2 gt D o i 6 INTRODUCTION 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 or to a computer 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 IMPORTANT The 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 keep the Analyzer plugged in when not in use Cable Support Port Identification O input 9V FFF 1A Power Socket 9V 1A Connects power supply to Analyzer Pri ROM Pack Contains upgradable firmware Printer Port Connects printer to Analyzer INTRODUCTION 1 Cholestech LDX System User Manual z a Q i c o z THE TEST CASSETTES Cassette Type 1 is used for lipids glucose ALT and AST Cassette Type 2 is used for hs CRP 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
33. your Cholestech LDX 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 Cholestech LDX Analyzer and supplies to other sites The Cholestech LDX System Includes Cholestech LDX Analyzer Power Supply Optics Check Cassette User Manual Procedure Manual CD Warranty Card Accessory Tray Capillary Tubes Capillary Plungers Lancets MiniPet Pipette Pipette Tips Printer and Cable Assembly Training Video INTRODUCTION 3 Cholestech LDX System User Manual z D Q i c o z A carrying case is available as an optional accessory The carrying case is not intended for shipping the Cholestech LDX Analyzer In addition to these supplies you may need the following materials that are not provided with your Cholestech LDX Analyzer Cholestech LDX Test Cassettes Cholestech Level 1 and 2 Controls Biohazardous waste containers Alcohol swabs Gloves Gauze sponges Vacuum collection tubes needles and tube holders if the sample is to be collected by venipuncture e Surge protector IMPORTANT If you haven t filled out the warranty card please do so now and mail it to Cholestech or you can do so online at www cholestech com support register htm Inverness Medical 9975 Summers Ridge Road San Diego CA 92121 U S A 4 INTRODUCTION Cholestech LDX System User Manual 2 o D o i How the Cholestech LDX
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