Bayer HealthCare ESPRIT Blood Glucose Meter User Manual
Contents
1. SOLUTION E Check Battery Capsule to be sure it is tightly in place If Battery Capsule is secure and display is still blank replace batteries two lithium CR2016 See page 26 E Call the Customer Service Department or 1 800 028 2511 toll free E Retest If the countdown fails to start call the Customer Service Department or 1 800 028 2511 toll free CHAPTER 1 4 Problem Solving Meter and Test Sensor PROBLEM 4 Control Test result is out of range too high or too low Causes Test Sensor or control solution passed expiration date or shelf life date e Deteriorated Test Sensor due to heat or cold Control solution not at room temperature e Not enough control solution drawn into Test Sensor SOLUTION M Make sure correct Programme Number has been entered Run another control test If still out of range retest with a new Test Sensor Disc and or control if needed with an acceptable expiration date and shelf life If still out of range call the Customer Service Department or 1 800 028 2571 toll free 33 1 5 CHAPTER Technical Information CUSTOMER SERVICE If attempts to correct a problem fail please call the Customer Service Department or 1 800 028 251 toll free We have trained specialists to assist you IMPORTANT M Speak to a Customer Service Representative before returning your Meter for any reason Information needed to resolve your problem co2. 99939679 Distributed by Bayer Bayer Australia Ltd A C N 000 138 714 875 Pacific Highway Pymble NSW 2073 Australia Telephone 1 800 028 251 1997 Bayer Corporation Printed in the U S A Rev 7 97 The most important function of your meter is to measure your blood glucose level The Glucometer Esprit system is designed to make this task as simple as possible The test is done in the TESTING MODE using a simple integrated step The system also provides for those who want more detailed information like averages and other special features All such options are provided in a separate mode called the FEATURES MODE The buttons on the instru ment are only used for the additional features Because the options of the FEATURES MODE take more time to learn than the use of the TESTING MODE we encourage you to go through the User Guide and decide what fea tures are right for you to make your diabetes more manageable Meter with Test Sensor T Disc inserted Meter Parts End Latch Test Sensor asap Capsule Pad lt gt moves left and right Slide Display NS orwar and back Button A Button B If you have any questions or concerns as you learn how to use the system see Customer Service page 34 Fold out this page for testing reference Programme Number Testing Materials i s 5 shinies WAF Test Sensor Carton Test Sensor Disc C
3. over waste container and move Slide back all the way to the end The Test Sensor is released to be discarded The Features Mode To Turn the Meter On in the Features Mode Move Slide forward Button A Allows you to move to the next setting Button B Allows you to change the setting Anytime you enter the Features Mode the following information is always displayed automatically and in this order 1 The number of remaining eave endl Test Sensors left in your Time 1 20 Meter appears with the Number of Test im present time and date Sensors remaining is 2 The last two test results appear with the time and date of the test NOTE If the Meter is new and no test results are stored in memory the Meter will display the number of remaining sensors only 3 After reviewing the above information turn the Meter off 12 13 CHAPTER CHAPTER 6 Set Time and Date Set Time and Date To set the time and date follow these directions SP ceed release Butor i 1 24 7 uN E the minute flashes Press Button B 1 Move Slide forward to enter to make a change Features Mode 2 Press and release Button A average displays if test results are in memory If no blood glucose test results are in memory the number of remain ing Test Sensors flashes _ If the number of Test Sensors is not correct press Button B to 4 Press and release Button A change and then go on to Step 3 the hour f
4. Figure 1 on the following page shows the comparison of the lay diabetic Glucometer Esprit System results with the whole blood glucose results The comparison of the healthcare professional results with the whole blood glucose results is shown in Figure 2 37 1 5 CHAPTER Technical Information CHAPTER 1 5 Technical Information Patient Use Clinical Study Results Figure 1 Glucometer ESPRIT System Results Obtained By 61 Lay Diabetics Figure 2 Glucometer ESPRIT System Results Obtained By 6 Healthcare Professionals 38 Meter Glucose mg dL and mmol L Whole Blood Referenced Meter Glucose mg dL and mmol L Whole Blood Referenced nN 328 y 1 6mg dL 1 02x 0 09mmai L of r 0 98 oO 4 0 200 300 400 500 600 6 8 11 13 16 7 22 2 27 8 33 3 Mean Whole Blood Glucose mg dL and mmol L GOO 33 3 J n 330 500 4 Y 0 3mg dL 1 04x g 27 8 0 02mmol L ay 4004 7098 cope 22 2 o Bye 300 pt 16 7 200 11 1 100 5 6 O 100 200 300 400 500 GC 6 11 1 16 7 22 2 27 8 ne e Mean Whole Blood Glucose mg dL and mmol L Glucometer Esprit System Whole Blood Referenced 2 Precision Precision Results for Whole Blood Specimens EDTA anticoagulated glycolyzed whole blood pools were supplemented with glucose to obtain five glucose levels Multiple replicates of the whole blood were tested on one day by multiple operators using multiple Glucometer Esprit mete
5. continue changes for A 2 A 3 and A 4 repeat steps 5 through 6 Then move Slide back to turn Meter off 765 ni RAE ni of bik If you only want to change a specific time s press Button A repeatedly to scroll to that display 17 CHAPTER CHAPTER Reset Basic Features optional Reset Basic Features optional The basic features are preset but may be reset to BEEPER SETTING fit your needs 4 Press Button B to E from beeper on to beeper off oy acs a areal beeper E from mmol L to mg dL blood glucose units Butt Ne ot off E from a 24 hour to a 12 hour am pm time clock pisss rea a gt i E E from Celsius C to Fahrenheit F temperature units Ee ary ene weer ee i __ a A PROCEDURE OPTIONAL SETTINGS 1 Move Slide forward to enter Features Mode Repeat 4 to change settings If a Programme Number appears and needs to be E Blood Glucose Units q a too Be mi as changed see page 4 5 a e g gl 2 Press and hold Button A ae E i PHH l2 H four times Time Clock 3 Then press and hold on Button A until b sF T beeper appears Release Button A and a Temperature go on to Step 3 next page 5 Move Slide back to turn Meter off 18 19 CHAPTER Review Time Specific Averages TIME SPECIFIC AVERAGES The average of all blood glucose results and the time specific averages are based on a two week testing period A minimum of three tests must be run within a tw
6. Meter off and then close the End Latch 29 CHAPTER 1 4 1 4 Problem Solving Warning Codes CODE CAUSE SOLUTION Hel Test Result is below 0 6 mmol L li tee WE Meter has detected an error aS Repeat the test and make sure Test Sensor is filled Heel Test Result is above 33 3 mmol L Lt H mal W Repeat the test If still high contact your physician or diabetes educator regarding a possible hyperglycemic condition high blood sugar 30 Problem Solving Warning Codes CODE LOC HIC CAUSE SOLUTION Temperature is too low between 0 and 10 C and could affect test results E Test within operating temperature range 10 to 40 C Temperature is too high between 40 to 50 C and could affect test results E Test within operating temperature range 10 to 40 C Deleted Test Result E if the temperature is too low or too high the test result is marked with an X and deleted from the average Low Batteries E Replace batteries within one week or 20 readings 31 1 71 ale Problem Solving Meter and Test Sensor PROBLEM 1 The display goes blank when the Meter is turned on NOTE Display goes blank if Meter is left on for 3 minutes without sensor or 15 minutes with sensor and no activity 2 Some display segments do not appear in the full display when the Meter is turned on 3 Meter fails to start countdown after blood is applied 32
7. ctify the defect under the Trade Practices Act warranties and iii the warranty card is completed and returned to Bayer Australia Ltd within 10 days after purchase then Bayer Australia Ltd will at its discretion repair or replace the equipment or supply equivalent goods free of charge The Purchaser should note that the requirement to return the warranty card relates only to the additional Bayer Australia Ltd warranty and is NOT a requirement for the Purchaser s warranties rights and remedies under the Trade Practices Act The liability of Bayer Australia Ltd for breach of the additional Bayer Australia Ltd warranty is limited to the replacement or repair of the equipment or the supply of equivalent equipment and liability for consequential damage is expressly excluded Should you require service for your Glucometer Esprit Blood Glucose Meter please ensure that it has been maintained as recommended in the User Guide If BAYER AUSTRALIA LTD finds any malfunction due to the accumu lation of dried blood serum or any foreign matter in or on the meter resulting from the failure of the Purchaser or user to adequately maintain the Glucometer Esprit meter a minimum of 60 00 will be charged for cleaning and servicing Bayer Australia Ltd ACN 000 138 714 875 Pacific Hwy Pymble NSW 2073 Australia 40
8. d Microlet Device with Endcap Glucolanz Lancet 1 Remove the endcap 2 Insert lancet firmly until the lancet comes to a full stop then twist off lancet cap 3 Replace the endcap NOTE See Microlet package insert for complete instructions 4 Wash your hands with warm soapy water Rinse and dry thoroughly Before running a test be sure e The Test Sensor Disc is inserted See page 1 e The date and time are set if you want correct date or time stored in memory with test result See page 14 Materials Needed Meter with Test Sensor Disc inserted 1 To enter the Test Mode move Pad left and hold while moving the Slide for ward Be sure Slide is moved all the way to the end A Test Sensor appears and the display prompts blood application with a flashing drop If a Programme Number P1 to P62 appears press Button B to change if needed and then Button A to continue If no change press Button A to prompt blood application Programme Number appears in display if Meter has been opened since last used 2 Prick your finger with the Microlet Device and form a small drop of blood CHAPTER Blood Glucose Test 3 Hold your fin ger level with the drop of blood on top Bring the Meter in from the side to the drop of blood 4 The test result displays after 30 seconds 8 Let the entire front edge of the Test Sensor touch the surfac
9. e of the blood drop Blood is auto matically drawn into the inside of the Test Sensor Hold there until Test Sensor is filled and you hear a beep Do not apply blood directly from an above position CHAPTER 3 Blood Glucose Test If you do not wish to store a result then press Button B before closing the Slide An X appears on the display Deleted results appear in the memory marked with an X These results are deleted from the average of stored test results 5 Point Meter down over waste container and move Slide back all the way to the end The Test Sensor is released NOTE Test results are stored automatically when Slide is closed Note The Meter automatically turns off if it is left on for 3 minutes without sensor or 15 minutes with sensor with no activity To preserve the battery life remember to turn off the Meter after you have used it IMPORTANT If your glucose level is below 2 8 mmol L or above 13 9 mmol L test again If your glucose level is still below 2 8 mmol L or above 13 9 mmol L it may indicate a potentially serious medical condition We recommend you consult your physician or healthcare professional immediately CHAPTER Control Test CHAPTER Control Test WHEN Anytime you want to check performance of the system Meter Test Sensor Disc or your testing technique WHY If the test result is not within range there may be a problem with the Test Sensor o
10. g the e Fach Test Sensor Disc has ten Test Sensors disc bumpy side up note e Each disc is assigned a Programme Number to the two blue Meter Tabs assure accuracy in test results when the Meter is he insi f the Meter set to match that number on the inside of the Mete Materials Needed Meter Test Sensor Disc Gently press the disc into place under the two Meter Tabs Please note the Programme Number on your Test Sensor Disc 1 Open the Meter by releasing the End Latch 2 Remove the Test Sensor Disc from the Paper Pak 2 CHAPTER Inserting a Test Sensor Disc 4 Close the Meter and fasten the End Latch You may now run ten tests before replacing the Test Sensor Disc 5 After inserting a Test Sensor Disc set the Programme Number Move Slide forward to enter Features Mode The Programme Number flashes in the display Press Button B to the Programme Number P1 to P62 that matches the number you noted on the Test Sensor Disc see cover foldout exam ple or end flap on Test Sensor Carton Press Button A to continue set time date or move Slide back to turn Meter off 4 Inserting a Test Sensor Disc To Remove the Used Test Sensor Disc Open the Meter and lift the edge of the used Test Sensor Disc out from under the two blue Tabs and remove from the Meter CHAPTER Blood Glucose Test CHAPTER 3 Blood Glucose Test Prepare for the Finger Puncture Materials Neede
11. l Information CHAPTER 1 5 Technical Information REPLACEMENT PRODUCTS When calling number with Part Number 40030032 99939679 50184147 or writing for supplies be sure to include the the name of the replacement part or product Item 3 volt Lithium Battery DL or CR 2016 2 Available at most stores Glucometer Esprit User Guide Glucometer Esprit Quick Reference Guide Part Numbers subject to change without notice Product Number 3616 3649 3650 3651 6541 5970 6555 6559 Product Name Glucometer Esprit Test Sensor Discs 50s Glucometer Esprit Low Control Glucometer Esprit Normal Control Glucometer Esprit High Control Microlet Automatic Lancing Device Glucolanz Lancets 200s Microlet Endcaps Regular 10s Microlet Endcaps Super 10s Replacement products may be obtained from Diabetes Care Centers or your local pharmacy 36 Glucometer Esprit System Whole Blood Referenced 1 Accuracy A patient use clinical study was performed at diabetes care centers in three different locations Glucose levels were measured with the Glucometer Esprit System on over 300 fresh capillary blood specimens by 61 persons with diabetes and six healthcare professionals The results were compared with the whole blood glucose results of the YSI 2300 Stat Plus Yellow Springs Instrument Co Inc Yellow Springs OH a glucose oxidase electrode system
12. lashes Press Button B to make a change If test results are in memory press and hold Button A The number of z iz remaining Test Sensors flashes 5 Repeat step 4 to set ee Press Button B if you want to ane meN change the number and then go m year y ki on to Step 3 6 Move the Slide back to turn Meter off 14 15 CHAPTER Reset Time Specific Averages The Meter calculates four time specific averages identified as A 1 A 2 A 3 and A 4 These times are preset for meal times but may be changed to meet your schedule To be included in the average the testing time must occur within one hour before or after the specific set time The preset times are i PROCEDURE 1 Move Slide forward to enter Features Mode 2 Press and release Button A Average dis ay plays if three test results iN have been stored Press and hold Button A until number of remaining lt _ u sensors appears Press and release Button A time Son appears 7 3 Press and hold Button Pe LI A until A 1 appears a l E Release Button A The minute flashes 4 Press Button B to change the minute for the A 1 Time Specific Average 16 CHAPTER T Reset Time Specific Averages 5 Press and release Button A The hour flashes Then press Button B to change the hour 6 Press and release Button A again and move to A 2 Average Press Button B to change the minute If you want to
13. o reset date and time before running another test See page 14 for directions WARNING Keep batteries away from children Lithium batteries are poisonous e If swallowed immediately contact your physician e Discard batteries according to your local environmental regulations 27 CHAPTER 1 4 Problem Solving Error Codes 1 2 seen Problem Solving Error Codes CODE CAUSE SOLUTION CODE CAUSE SOLUTION E Battery life has ended E Meter has detected an error E Replace batteries two lithium D accurate results not possible LII batteries size CR2016 See LII E Test Sensor Guide is wet Clean directions page 26 inside of Meter page 25 Be sure inside is dry before reuse os possible i Eg Temperature causes M Blood applied before Meter is Z too cold below 0 C ready Repeat test making sure S ee too hot above 50 C blood icon displays E Use Meter in an area of correct E Test Sensor has been damaged operating temperature 10 to due to intense heat exposure 40 C If problem cannot be corrected call the Customer Service EY Test Sensor removed during the test rie pha ee eo 22 j Cr E Move Slide back to turn the Meter off and then repeat the test E50 Meter has malfunctioned ES Meter is turned on when the End C se Call the Customer Service E am Latch is open LII Department or 1 800 028 251 LII E Move Slide back close to turn toll free the
14. o week period to give an average For example if three tests are run within two weeks for A 1 and A 4 time periods only then A 2 and A 3 will not display in your review 1 Move Slide forward to enter Features Mode The number of remaining Test Sensors displays and the last two test results 2 Press and hold Button A The first display shows the two week average of all glucose results 3 Press Button B two displays follow showing the A 1 average test result 20 CHAPTER 9 Review Time Specific Averages 4 Press Button B again and the A 2 average displays Continue to press Button B after each two successive displays to show the remaining averages 5 Move Slide back to turn the Meter off or continue to review stored test results See next page step 3 NOTE E f no average is available for a specific time there must be at least 3 stored blood glucose test results in the last two weeks the display scrolls to the next available Time Specific Average If there are no averages stored the first result shown will be the last test result see Chapter 10 21 1 O CHAPTER Review Test Results CHAPTER 1 1 Erase All Test Results TEST RESULTS 1 Move Slide forward to enter Features Mode 2 Press and hold Button A A average displays l 3 Press Button B to ib a review any average results 10 00 and all other stored test results beginning with the H H r j oo latest re
15. ontains ten Test Sensors Control Solution Microlet or Glucolanz Lancet _ CAUTION Before using any product to test your blood glucose sugar read all instructions and practice the test Do all quality control checks as directed and consult with a diabetes health professional These recommendations apply to all blood glucose monitoring systems and are supported by the American Association of Diabetes Educators the American Diabetes Association the Food and Drug Administration and the Health Industry Manfacturers Association Table of Contents CHAPTER 1 OOo 8 PAGE Preview 00 cece eeee 1 e Testing Mode e Features Mode Inserting a Test Sensor Disc 2 Enter Programme Number 4 Blood Glucose Test 6 Prepare for the Finger Puncture 6 Blood Glucose Test 7 Control Test 000 10 Enter Features Mode 13 Test Sensor Count 13 Last Test Results 13 Set Time and Date 14 Reset Time Specific Averages 16 Reset Basic Features optional 18 BOOD aucesuteeensaceentawe ness 19 Blood Units mmol L to mg dL 19 Clock Format 24 hour to 12 hour 19 Temperature Format C to F 19 Table of Contents CHAPTER PAGE cy Review Time Specific Averages 20 Review Test Results 22 Erase All Test Result
16. r the Meter See page 33 Materials Needed Control Meter with Test Sensor Test Sensor Carton with Control Range Solution Disc inserted 1 Move Pad left and hold while moving the Slide forward Be sure Slide is moved all the way to the end A Test Sensor appears and the display prompts for application of the sample with a flashing drop If a Programme Number appears press Button B to change if needed and then Button A to continue If no change press Button A to prompt sample application Programme Number appears in display if Meter has been opened since last used 10 2 Squeeze a drop of control solution onto a clean surface Do not fill Test Sensor directly from bottle 3 Bring the Meter in from the side to the drop of control solution Let the entire front edge of the Test Sensor touch the surface of the control solution drop Hold there until the Test Sensor is filled with solution you will hear a beep 4 The test result displays after 30 seconds Press the B Button twice to mark the test result with a tick VY when stored in the memory Marked control tests will not be included in any averages Compare the test result to the range listed on the end flap of the specific Test Sensor carton being used Note The Control Solution contains a red dye which may stain 11 CHAPTER CHAPTER 5 Control Test Enter Features Mode 5 Point the Meter down
17. rrectly and efficiently will be provided E Have your Glucometer Esprit Meter ready for testing when you phone It would also be helpful to have a bottle of Glucometer Esprit Normal Control available E Fill out the following check list before calling CHECK LIST 1 The meter serial number is 2 The date and time the problem occurred was 3 have tested with the Normal Control Yes No The Normal Control result was Lot Number Exp Date 4 Please include the lot number and expiration date of the Test Sensor Disc currently being used This information is printed on the Test Sensor and the Test Sensor Disc Carton Lot Number 34 Exp Date Test Sample Size Operating Range Testing Time Memory Features Temperature Humidity Power Source Battery Life CE Certification CHAPTER 1 5 Technical Information SPECIFICATIONS Capillary blood glucose Referenced to whole blood Approximately 3 4 uL 0 6 33 3 mmol L 30 seconds Stores last 100 test results Note If 100 test results are stored in memory and a new one is added the oldest test result is automatically discarded 10 to 40 C 10 to 80 RH Two 3 volt lithium batteries CR2016 Approximately 1000 tests This device conforms to EMC Directive 89 336 amendment 92 31 EEC Patent 5 429 735 MSE 1866 EPO Appl 951091990 Patent 5 575 403 MSE 1868 EPO Appl 961002086 35 1 5 CHAPTER Technica
18. rs and one lot of sensors The whole blood glucose levels of the blood specimens were also tested using the YSI 2300 Stat Plus Glucose Analyzer a glucose oxidase method The accuracy of the YSI was verified using control sera assayed using a modification of the CDC hexokinase reference procedure HEW publication no CDC 77 8330 YSI Glucometer Esprit Results Mean Whole Blood Glucose No of mg dL mmol L Tests not ia Bias no en oy 2 mg dL or 2 6 0 11 mmol L 1 8 0 9 0 0 1 6 4 8 Precision Results for Controls The Glucometer Esprit Control solu tions were tested in triplicate twice per day for ten days by one opera tor using one meter and one lot of sensors The following precision results were obtained Glucometer Esprit Within run SD mg dL mmol L not mmol L Mean Control mg dL mmol L Low 69 3 83 2 7 0 15 0 19 Normal 127 7 05 4 7 0 26 l 5 7 0 32 High 372 20 64 5 7 0 32 7 1 0 34 1 CHAPTER Warranty Information TRADE PRACTICES ACT WARRANTIES The Purchaser of this equipment is entitled to broad warranties rights and remedies conferred on consumers by the Trade Practices Act which cannot be restricted modified or excluded ADDITIONAL BAYER AUSTRALIA LTD WARRANTY If i a defect in workmanship or materials not due to acci dent abuse or use of unauthorized attachment occurs within five years of purchase and ii Bayer Australia Ltd is not already obligated to re
19. s 23 Transfer to a Computer 24 Meter Maintenance 25 Cleaning Procedure 25 Battery Replacement 26 Problem Solving 28 Error CodeS goede ha 4 4 4 oh dea tod 28 Warning Codes 00005 30 Meter and Test Sensor 32 Technical Information 34 Customer Service 005 34 Specifications 2 4n40c0chedeee goa ee 35 Replacement Products 36 Technical Information 37 Warranty Information 40 CHAPTER Preview There are two operation modes The Testing Mode To Turn the Meter On in the Testing Mode Move Pad left hold then move Slide forward The Testing Mode is used to W run a blood glucose test W run a control test CHAPTER 1 The Features Mode To Turn the Meter On in the Features Mode Move Slide forward Button A Allows you to move to the next setting Button B Allows you to change the setting Button B The Features Mode is used to HM set time date set specific average times reset meter options review results erase test results WE transfer to a computer NOTE You can turn off Meter move Slide back at any time in Features Mode any settings that have been changed are stored 2 CHAPTER CHAPTER 2 Inserting a Test Sensor Disc Inserting a Test Sensor Disc Important to know 3 Before insertin
20. sult Continue to 7 Ne press and release Button B o_o or hold to scroll through all stored test results A beep signals the last test result and returns to original display 22 ERASE ALL TEST RESULTS You can erase all test results stored in the Meter if you press and hold both l L HE A and B Buttons while a a reviewing stored test m LS results 3 Chapter WJ However you must press the buttons before the beep signals the last test result Press and hold both Buttons until 000 appears about 5 seconds If you change your mind to cancel erasing press either Button before closing the Slide When the Slide is moved back all stored test results are erased 23 CHAPTER 1 3 Meter Maintenance 1 2 CHAPTER Transfer to a Computer e Your Meter can transfer test results to a computer where results can be electronically summarized in a logbook report graph or chart e To make use of this feature you need special soft ware and a connecting cable e For more information relating to this program contact your nearest Bayer Diagnostics office 24 EXTERIOR CLEANING PROCEDURE The exterior of the Meter can be cleaned using a moist not wet lint free tissue with a mild detergent or disinfecting solution Wipe dry with lint free tissue after cleaning 1 part bleach mixed with 9 parts water INTERIOR CLEANING PROCEDURE The Latch Open Meter and wipe inside of Latch with moist
21. tissue and dry thoroughly The Test Sensor Guide Gently wipe any moist area on Test Sensor Guide and nearby areas with dry tissue It is important to avoid an AN excessive water The electronics T k est Sensor may be affected Guide WARNING POTENTIAL BIOHAZARD Healthcare professionals using this system on multiple persons should be aware of the follow ing and should follow the infection control procedure approved by their laboratory facility All products or objects which come into con tact with human blood even after cleaning should be handled as if capable of transmitting viral diseases The user should follow the recommendations for prevention of blood borne transmissible diseases in healthcare settings as recom mended for potentially infectious human blood specimens in the Health Service Guidelines on Decontamination of Equipment prior to inspection service or repair Ref HSG 93 26 25 1 3 CHAPTER Meter Maintenance CHAPTER 1 3 Meter Maintenance BATTERY REPLACEMENT 1 Locate the Battery Capsule 2 Using a fingernail thin coin or similar object pry the capsule loose and lift from Meter 3 Push through the small semicircular hole to release the two batteries 26 4 Insert two new lithium batteries CR2016 into the Battery Capsule with the side on top Push down gently to lock them into place 5 Replace the Battery Capsule IMPORTANT Remember t
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