TysonBio_Evolve_UserManual
Contents
1. utes press M button To change the minutes press S button 038 To enter the minutes and move on to choose the third alarm setting press the M button Fig 6 9 To set the third alarm press the M button y If you press S Fig 6 button n it will be moved on to health management alarm YES m setting step 11 To change the hour press S button To e enter the hour and move on to change the minutes press val M button To change the minutes press S button To enter the minutes and move on to choose the fourth alarm setting a 3h press the M button Fig 7 i 10 To set the fourth alarm press the M button y If you 11 press S button n it will be moved on to health manage ment alarm setting step 11 To change the hour press S button To enter the hour and move on to change the minutes press M button To change the minutes press S button To enter the minutes and move on to health man agement HI alarm setting press the M button Fig 8 Note When the alarm is ringing press S or M button to turn off or alarm will turn off automatically after 30 sec To change the HI alarm setting press the S button To enter the HI alarm setting and move on to LO alarm set ting press M button Fig 9 12 To change the LO alarm setting press the S button Fur ther press M button to enter the LO alarm setting and finish the meter setting turn off the meter F2. Town ljsselburecht 3 Postbus 5486 Wuxi Jiangsu 214194 China 6802 EL Arnhem Netherlands TEL 86 510 379 3149 TEL 31 263 653 375 Limitations of the Procedure Caution The TysonBio EVOLVE System is designed for in vitro use only and is not intended to test on newborns The TysonBio EVOLVE Test Strips are designed for use with fresh capillary whole blood samples obtained from the fingertip palm and forearm False results may occur when performing the test while severely dehydrated se verely hypotensive in shock or in a hyperglycemic hyperosmolar state If you believe you are suffering from any of the above symptoms consult a health care professional immediately Service and Warranty IMPORTANT The TysonBio EVOLVE Blood Glucose Monitoring System is designed for in vitro diagnostic use only Tyson Bioresearch Inc cannot endorse the performance of the TysonBio EVOLVE System when used with Test Strips other than those designed for the TysonBio EVOLVE Meter The TysonBio EVOLVE System manufacturer warranty is valid only when used properly within the guidelines of the provided User s Manual and is invalid when the TysonBio EVOLVE System and TysonBio EVOLVE Test Strip are used improperly Manufacturer Warranty Tyson Bioresearch Inc guarantees that this device will be free of defects in materials and workmanship for a period of three years from the date of origi nal purchase During the stated three year period our company shall repa
3. be used only once The Test Strip consists of the following parts 1 Confirmation Window This is where you can confirm that enough blood has been applied to the target area 2 Target Area This is where blood is drawn into the Test Strip 3 Contact Bar This end of the Test Strip is inserted into the Test Port to activate the Meter white side face up About the TysonBio EVOLVE Test Strip Vial VIAL LABEL TEST STRIP VIAL EVOLVE Blood Glucose Test Strips Store at 4 30 C 39 86 F Do not refrigerate Use within 90 days after first opening a Do not store test strips outside this vial Use TysonBio EVOLVE meter only cose Test Strips Re cap immediately 3 WARNING Always close lid tightly Lot H8T121205 fil Hi rotae nal For testing of glucose in capillary whole blood EXP Aug 201 0 ely For in vitro diagnostic use gt na ii Control Solution Range pes lid tightly Tyson Bioresearch Inc mg dL mmol l pen abel whole blood 5F 22 Ke E Road Ill Science Based Industrial Park Chu Nan Low 31 61 1 7 3 4 Taiwan Tel 886 37 585998 Normal 84 144 4 7 8 0 50 TEST STRIPS High 348 438 19 3 24 3 Code Number Lot Number Control Solution Range Expiration Date About the Glucode Chip The Glucode Chip is used to ensure that your Meter provides you with accurate results Before performing the blood glucose test or starting a new strip vial please check your
4. erly in accordance with local state and federal law Applying Blood Sample to the Test Strip 1 After obtaining a blood sample place the drop onto the test well of the Test Strip Blood is automatically drawn into the Test Strip 2 AS soon as enough blood has filled the Confirmation Window see picture of the Test Strip the Meter will beep and begin counting down from 5 to 1 Your blood glucose result will appear on the LCD display and will be stored into the Meter memory automatically 523 032m 1404 Note To ensure accurate results make sure the Confirmation Window of the Test Strip is completely filled with your blood sample 3 After the test result appears if no further tests are performed the Meter will automatically shut off after 3 minutes After finishing the test you can push the strip eject button to remove the used strip or using a tissue paper to remove Test Strip from the Meter for proper disposal Warning Always discharge the used test strip into suitable waste container Please DO NOT point the test strip at people or animal when ejecting and avoid pointing at eyes nose and mouth while test strip is in load position amp 0 0 HI and LO Readings 1 The test results range between 20 to 600 mg dL 1 1 to 33 3 mmol l If a HI message appears on the display your Meter has detected that your blood glucose level is higher than 600 mg dL 33 3
5. mmol l It is suggested that you review your testing procedure and test again with a Fig 12 new Test Strip to confirm the result If the same result oc curs consult your healthcare professional immediately Fig 12 2 If a LO message appears on the display your Meter has detected that your blood glucose level is lower than 20 mg dL 1 1 mmol l It is suggested that you review your testing procedure and test again with a new Test Strip to confirm the result If the same result occurs con Fig 13 sult your healthcare professional immediately Fig 13 Ea eps a rr San an Loa 34 Memory Features The TysonBio EVOLVE Meter automatically stores the 300 most recent blood glucose results with date and time in its memory It also provides you with a consecutive 7 14 30 day average of your blood glucose test results 1 Press M button to turn on the Meter All segments of the LCD display will appear The date and time will appear first 2 Press S button the result of control solution will appear on display 3 Press S button the consecutive 7 day average will be shown 4 Press S button the consecutive 14 day average will be shown 5 Press S button the consecutive 30 day average will be shown Note If there is no test results during this stage it will directly appear the most recent test result Wk 523 908 I Sl LI lt mg dl 6 Press
6. system Data Port Connect interface cable to transfer data 10 Strip Ejection Button Push button to eject the used strip 11 Glucode Chip Insert the Glucode Chip for coding w iaia About the TysonBio EVOLVE Meter Display 1 Date 2 Time 3 Control Solution Test 5 0 Appears when doing a control 3 solution test and marking the pA gg Moi fo paN Lee as a control solution s x K if 4 Code Symbol CI O Appears with the code number E I H T n D of the Test Strips in use DA gil 5 Memory Symbol ARABI nimol Indicates in memory mode 6 Units of Measurement Unit Q of mmol I or mg dL will appear with the test result 7 Battery Symbol Appears when the battery is low or must be replaced 8 Blood Drop Symbol Flashes when it is ready to apply sample to Test Strip 9 Warning Symbol Appears when result is out of the range of your setting reference value 10 Alarm Function Symbol Appears when the clock alarm is set 11 Test Strip Symbol Appears to tell you when the meter is ready for test 12 Day Average Symbol Shows the average value of test results 13 Test Result Area Display test results 14 Temperature Message Appears if your meter is out of operating temperature range About the TysonBio EVOLVE Test Strip The TysonBio EVOLVE Test Strip is used to per form the blood glucose test in conjunction with the TysonBio EVOLVE Meter Each strip can
7. with e ait out inserting the Glucode Chip a 000 will appear on TRIPS the screen and then turn off automatically after 3 sec as 3 Match the code number on the Meter display with the code number on the Test Strip vial If the code matches you may press the M button to turn off the meter and begin to test lately If the meter code and vial code do not match please ask the store distributor to replace a new vial The Control Solution Test The Control Solution is used to check and ensure that the Meter and Test Strip are working together properly and that you are performing the test cor rectly When To Perform a Control Solution Test 1 When you are using your Blood Glucose Monitoring System for the first time 2 When you are using a new batch of Test Strips 3 Anytime you question the performance of the system or on a regular basis to ensure accuracy e g once a week 4 When you adjust your diabetic medication plans 5 When your blood glucose test result is lower or higher than your normal level Note Control Solutions are required but not supplied For order information please call Customer Service There are three Con trol Solutions at different desired range of aqueous glucose Low Normal or High For more information about the Control Solution please read your Control Solution package insert Two sets of control solution should be used a high level and a low level control solution of your choice To perf
8. Display Messages iu aria 38 Specificatii NS a iciscsacasasnsnencactearsnsaadesssannaie0iaceaanssannnnaaiaeesechavea RI 45 Limitations of the Procedure 47 Service and Warranty iii 47 Customer Service Important Information Available Alternative Sites Testing Palm and Forearm TysonBio EVOLVE Blood Glucose Monitoring System provides you alterna tive sites testing AST This system provides you to test on the palm and the forearm with the equivalent results to fingertip testing There are limitations for doing AST Please consult your healthcare professional before Pali you do AST Forearm Alternative site results differ from fingertip results when glucose levels are changing rapidly such as after a meal after taking insulin during exercise or when you are ill or under stress Use blood from a fingertip rather than an alternative site if e you think your blood glucose is low e you don t regularly have symptoms when your blood glucose is low or e how you feel doesn t match the results from the alternative site e when you have just taken insulin or any time during or after exercise e when there are unknown variables occurring in your day such as illness e whenever you are about to drive CAUTION 1 Physiologic differences in the circulation between the finger and other test sites like the forearm and palm may result in differences in blood gluc
9. Meter with the Glucode Chip to ensure proper performance further instructions for use of the Glucode Chip is provided on page 22 23 After checking your Meter the Glucode Chip is also used to code setting Note Code Number e Always use the Glucode Chip to ensure your Meter is performing properly e DO NOT misplace your Glucode Chip Installing Replacing the Battery When the battery is low the Meter will show a warning signal When this display appears it is time to replace a new battery When the low battery warning signal is b i shown the Meter will provide accurate results for ap gt proximately 50 more measurements How to Replace the Battery 1 From the back of the Meter gently slide and remove the battery cover 2 Turn over the battery cover and insert a 3 Volt Lithium battery CR 2032 with the side facing down 3 Slide battery cover back into place with the battery side facing down amp I p4 2 IX IX ze SE 5 3 RO GD I il Setting Up the Meter To turn the Meter on first insert a battery then press the reset button located at the back of the Meter and proceed with the following instructions Setting Up the Date Time 1 Press the M button to enter this mode Press and release S button to choose 24hr or 12hr display With your favorite clock mode press M button and the year setting Fig 1 will be appeare
10. S button the most recent test result will appear If it G53 ggg 35 has 14 day average result it will show under the screen at D gt the same time Each time you press the S button the meter dn m will recall the last 300 test results accordingly When the CURTE bi memory is full the oldest result is removed and replaced with the newest result 7 Press and release the S button to the end of the memory 000 will show Then press the S button again or press M button at anytime to turn off the meter Mem r E n n Nol ii Nei fd eed an Exiting the Memory Mode 1 Press the M button to turn off the meter 2 Meter will shut down automatically after 3 minutes with no further action Note The consecutive 7 14 30 day average is calculated from the blood glucose results obtained during the last consecutive 7 14 30 day To Record Your Results We have provided a log book for your recording convenience To learn more about how to record your results please refer to the log book for further instructions 36 Transfer Test Results to a Computer You can use your meter with TysonBio Link Health Management Software to transfer test results to your personal computer 1 Obtain the required software and cable For order information please call Tyson Bioresearch Inc Customer Ser vice or visit website of www tysonbio com 2 Install the software on a computer Follow the instructions provided with so
11. TysonBio Blood Glucose Monitoring System User s Manual For in vitro diagnostic use only area E VOLVE Table of Contents IMpoOrtant Information weiceccaienisinicniecccnnetsnaencenscensucnnentendidanntananncnadceececnniatendytn 3 Introduction isisisi aap a E 7 About the Product sasssa tetara EEA E ENERET 8 About the TysonBio EVOLVE Meter 9 About the TysonBio EVOLVE Meter Display 11 About the TysonBio EVOLVE Test Strip i 13 About the TysonBio EVOLVE Test Strip Vial iii 14 About the Glucode Chip nn 15 Installing Replacing the Battery eeeeeteeeeeeeteeeeeeeneeeeeeeaas 16 Setting Up the Meter riniiciininiin iii 17 Setting Up the Date Time rnern rr nnne ne 17 Setting Up Alarm Al alone audi 18 Unit Selection and Code Setting 21 Coding Your TysonBio EVOLVE Meter rrrriiiiiiene 22 The Control Solution Test iii 24 Testing Your Blood Glucose Level rrrriiiinne 28 Preparing the Test Strip ia aaa 29 Obtaining a Blood Sample aiaa 30 Applying Blood Sample to the Test Strip 31 Memory Features giiiii AARAA 34 Transfer Test Results to a Computer rriinn 36 Care and Storage iiiii iii 37
12. d Press and release the S_ Gra button until the correct year appears Fig 1 2 To enter the year and move on to choose the month press the M button To change Fig 2 the month press the S button Fig 2 3 To enter the month and move on to choose the day press the M button To change the day press the S button Fig 3 Fig 3 4 To enter the day and move on to choose the hour setting Bo press the M button Fig 3 5 To change the hour press the S button To enter the hour and move on to change the minutes press the M button Fig 4 6 To change the minutes press the S button To enter the an minutes and move on to choose the alarm setting press dES mu the M button Fig 4 a di Setting Up Alarm po 7 To set the first alarm press the M button y If you press one S button n it will be moved on to health manage 6 30 ment alarm setting step 11 To change the hour press a ff S button To enter the hour and move on to change the minutes press M button To change the minutes press S button To enter the minutes and move on to choose the Fig 5 second alarm setting press the M button Fig 5 8 To set the second alarm press the M button y If you ES 70 press S button n it will be moved on to health manage ment alarm setting step 11 To change the hour press S L button To enter the hour and move on to change the min
13. dicat ing a problem with the Test Strip An error message indicat ing a problem with the Meter setting 10 40 C or 50 104 F Wait 15 minutes before re testing Review the instructions and try again with a new Test Strip Press reset button and check the meter again with the Glucode Chip If the problem persists contact Customer Service for help DISPLAY WHAT IT MEANS ACTION Ke Battery power is low Meter will provide approximately 50 more measurements Battery power is too low for further usage All testing values recorded in the memory have been shown The setting alarm is ring ing to remind of doing the blood glucose test Replace with a new 3 Volt lithium battery CR 2032 Replace with a new 3 Volt lithium battery CR 2032 immediately Press M or S button or wait for 3 minutes to turn off the meter Press M or S button to shut off or the alarm will turn off automatically after 30 sec DISPLAY WHAT IT MEANS ACTION An error message indicat Check the meter again with ing a problem with the the Glucode Chip If the coding of Meter problem persists contact Customer Service for help Other problems that may occur ACTION The Test Strip has not been inserted into the Review the instructions and re insert the Test Meter properly Strip correctly white side face up Defective Test Strip Replace with a new Test Strip Insu
14. e levels obtained from the fingertip palm and forearm This is an over the counter OTC product Please read the entire User s Manual carefully before using this product ED About the Product Your TysonBio EVOLVE System is made up of several components This booklet is designed to guide you through the operation of the system with detailed directions and pictures Your TysonBio EVOLVE System contains TysonBio EVOLVE Meter One vial of TysonBio EVOLVE Test Strips 10 strips One Glucode Chip outside the strip vial One Lancing Device option Ten Lancets option One Control Solution One carrying case User s Manual Log book option Quick Reference Guide Note 25 50 test strips vial can be purchased individually About the TysonBio EVOLVE Meter E FRONT BACK C 0537 S N M05B13286 1 Display Your test results are displayed here The large easy to read screen guides you through the test by using numbers and symbols 2 M Button The M mode button is used to set time alarm enters the memory mode to show the consecutive 7 14 30 day average results and turns the Meter on and off S Button The S select set button is used to select year month day time memory of results and control solution mode Test Port This is where you insert the Test Strip into the Meter Unit Switch Switch for mmol l or mg dL 1 mmol l 18 mg dL Battery Cover Label Reset Button Press this button to re set the
15. fficient blood sample Repeat the test with new Test Strip Test Strip remains in the test port for more Meter will automatically turn off Re insert the LCD display on the Meter is blank when try Contact Customer Service for help Pai LS Specifications 45 Meter Operating Conditions Temperature 10 C 40 C 50 F 104 F Humidity 10 90 RH Hematocrit 35 55 Test Sample Capillary Whole Blood from Fingertip Palm and Forearm Sample Volume gt 0 5 pl Measuring Unit mg dL or mmol L Measuring Range 20 600 mg dL 1 1 33 3 mmol L Test Time 5 Sec Memory Capacity 300 most recent results Average 7 14 30 days average results External Output Standard RS232 PC interface Power supply 3 Volt lithium battery CR 2032 Battery Life Approximately 1000 tests Dimension and Weight 92 x58 x19 mm 60 g 46 m The TysonBio EVOLVE Meter TysonBio EVOLVE Test Strip and Con trol Solution are in conformity with the IVDD 98 79 EC The Lancing device is in conformity with the MDD 93 42 EEC Manufacturer EU authorized representative Tyson Bioresearch Inc Medical Device Safety Service GmbH 5F 22 Ke E Road III Science Based Schiffgraben 41 D 30175 Hannover Industrial Park Chu Nan Germany Taiwan R O C TEL 49 511 62628630 TEL 886 37 585998 m The Lancets are in conformity with the MDD 93 42 EEC Manufacturer EU authorized representative Wuxi Xinda Medical Device Co Ltd EMDAR BV No 42 Xixin Road Zhangjing
16. ftware to install the software Get ready to transfer test results Connect the interface cable to a serial port on your computer Then connect the other end of interface cable to the data port located on PE the side of the meter with the meter turned off PC will appear on the display indicating that the meter is in the communication mode 4 Transfer data Follow the instructions provided in the software to download the results from the meter After finishing the data transfer press M button to turn off the meter Note While in the communication mode you will be unable to perform a blood glucose test If the meter is not in the PC link mode it will not respond to computer commands o Care and Storage 1 Handle the Meter with care Dropping or throwing the Meter may cause damage to the device 2 Do not expose the Meter Test Strips and Control Solution to extreme con ditions such as high humidity heat freezing cold or dust Always wash hands with soap and water and rinse and dry completely be fore handling the Meter and Test Strips 4 When cleaning the Meter gently wipe the exterior surface using a damp soft cloth DO NOT USE ANY ORGANIC SOLVENT for cleaning 5 The Meter should be stored at room temperature in a dry and clean space DO NOT STORE IN DIRECT SUNLIGHT OR AREAS WITH HIGH HU MIDITY AND OR DUST It is advised that you store the Meter and its ac cessories into the provided carrying case F
17. ig 9 Unit Selection and Code Setting 1 Select unit mg dL or mmol l on the back 2 Plug the Glucode Chip into the connector for strip coding Note The mg dL is the standard unit in the United States Meters used in the United States must be set to read in mg dL mmol l mg dL 22 Checking the Performance of Your TysonBio EVOLVE Meter The Glucode Chip is used for checking and coding your TysonBio EVOLVE Meter To check your Meter 1 Insert the Glucode Chip into meter s Glucode Chip ba tag ta i ARAA n slot All segments of the LCD display will appear in I A vi l ads dicating that the Meter is functioning properly ki ct T DEL N ul 2 If you are a first time user or start a new strip vial M please continue the coding procedure TAAA m nt Coding Your TysonBio EVOLVE Meter Each batch of Test Strip is encoded with a number that must match one of the code numbers stored in the Meter In order to ensure an accurate result the code number on the display must also match the code number found on the Test Strip vial 1 Insert the Glucode Chip Conductive Bar s end first into the connector The Meter will automatically be turned on mer Note Code the Meter whenever you start a new test mt te strip vial 2 All segments of the LCD display will appear Then a beep er will sound followed by the code number _ Note If you are using the Meter for the first time
18. ir or replace any TysonBio EVOLVE Meter found defective with a new Tyson Bio EVOLVE Meter This warranty does not apply to the performance of a TysonBio EVOLVE Me ter that has been accidentally damaged altered misused tampered with or abused in any way In no event shall our company be liable to the purchaser or any other person for any incidental consequential or punitive damages arising from or in any way connected with the purchase or operation of the TysonBio EVOLVE Meter or its parts For manufacturer warranty services purchaser must contact Tyson Bioresearch Inc for help Customer Service If you have any questions or concerns regarding this product and or its operation or any attempt to correct a problem fails please call our Customer Service Our trained specialists will be happy to assist you train you or even reaffirm your results Customer Service Hotline 1 800 948 3894 U S 24 hours a day 886 37 585998 or E Mail us at service tysonbio com website www tysonbio com When you call our Customer Service please have your TysonBio EVOLVE Meter TysonBio EVOLVE Test Strip and all other system supplies available This will allow us to answer any of your questions with speed and efficiency Mi CE lt Keep away from sunlight di Keep dry Q Do not reuse 0537 30 C In Vitro Diagnostics Medical Device X Store at 4 C to 30 46 ID B03K106703 Revision 02 A Caution consult accompanying documents i Read Inst
19. irt or debris in or on the lancet and lancing device Preparing the Test Strip 1 Wash hands using soap and warm water Rinse and dry thor oughly 2 Pull out a Test Strip from the vial and re cap the vial immedi ately 3 Insert the Test Strip white side face up into the test port 4 A beep will sound and the code number will appear followed by a flashing symbol Now you are ready to obtain a blood sample Reminder Make sure that the code number on the display matches the code number displayed on the Test Strip vial If the code number on the display does not match the code number on the Test Strip vial code the Meter by using Glucode Chip accordingly See page 22 23 wil 30 Obtaining a Blood Sample SAMPLE MAY BE OBTAINED FROM FINGER PALM or FOREARM For further instructions please see the insert provided with lancing device 1 Unscrew and remove the endcap of the lancing device 2 Insert the lancet into the lancet holder 3 Twist and remove the protective lancet cover to expose the sterile needle tip 4 Recapping and screwing the endcap to the body of the lancing device 5 Pull back on the cocking mechanism until it comes to a stop 6 Place the lancing device firmly against the finger tip and press the release button 7 After sampling remove the endcap containing the used lancet carefully 8 Remove the lancet from the lancing device Discard the used lancet prop
20. mple For your reference or you can change the default setting value 100 mg dL according to page 20 Indicate the result is LOWER than the LO alarm setting of the health management Meter detects blood glu cose level is higher than 600 mg dL 33 3 mmol l Meter detects blood glu cose level is lower than 20 mg dL 1 1 mmol l DISPLAY WHAT IT MEANS ACTION Be tw A mg dl For your reference or you can change the default set ting value 70 mg dL accord ing to page 20 Indicates high blood glu cose level Repeat test If result still occurs consult your physician immediately Indicates low blood glucose level Repeat test If result still occurs consult your physician immediately Temperature is high during the test procedure Temperature is low during the test procedure Temperature is too high to perform the test Result may be larger varia tion Move to a cooler envi ronment 10 40 C or 50 104 F and wait 15 minutes before re testing Result may be larger varia tion Move to a warmer environment 10 40 C or 50 104 F and wait 15 minutes before re testing Repeat the test in a cooler setting 10 40 C or 50 104 F Wait 15 minutes before re testing DISPLAY WHAT IT MEANS ACTION Temperature is too low to Repeat the test in a warmer perform the test An error message in
21. olution test result will appear Caution Please remember that in order to prevent contamination follow the above instructions for performing the Control Solution test Comparing Control Solution Results The system is functioning properly if the result falls inside the specified range printed on the Test Strip vial If the test result falls outside the specified range repeat the test Results falling outside the specified range may be caused by Error in performing the test Control solution temperature is lower than 15 C 59 F or higher than 35 C 95 F Expired or contaminated Control Solution Expired or contaminated Test Strips Improper coding of the Meter Meter malfunction Note The result will not be incorporated into the average in the Control Solution test ctl mode DO NOT use the system if the problem persists Please call Tyson Bioresearch Inc Customer Service or website of www tysonbio com 28 Testing Your Blood Glucose Level Before testing blood glucose you need the following items 1 TysonBio EVOLVE Meter 2 TysonBio EVOLVE Test Strip 3 Adjustable Automatic Lancing Device 4 Sterile Lancet 5 Glucode Chip Caution To reduce the chances of infection e Never share a lancing device and lancet with another person e Always use a new and sterile lancet Lancets are for single use only e Always use a new Test Strip Test Strips are for single use only e Do not get lotion oil d
22. or healthcare professionals using this system on multiple patient please be aware that all items that come in contact with human blood should be handled as potential biohazards Users should follow the guidelines for prevention of blood borne transmittable diseases in a healthcare setting for potentially infectious human blood specimens as recommended in the oO National Committee for Clinical Laboratory Standards Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline NCCLS document M29 A ISBN 1 56238 339 6 38 Display Messages DISPLAY WHAT IT MEANS ACTION Da pagaia vitata tata IA lea Tra ope apr fai 4M BB PA System check for verifying that all segments of the Meter are functioning This message appears im mediately if your Meter has not been encoded This is the current code number in use No Action Necessary Code Meter see page 22 Coding Your TysonBio EVOLVE Meter This code number should match the code number printed on your Test Strip vial The system is ready to ac cept a blood sample The system is ready to accept a Control Solution sample Indicate the result is HIGHER than the HI alarm setting of the health management DISPLAY WHAT IT MEANS ACTION You may now apply a blood sample You may now apply a drop of Control Solution sa
23. orm a Control Solution test 25 1 Make sure the Control Solution is at room temperature 15 C to 35 C or 59 F to 95 F prior to testing 2 Insert a Test Strip white side face up Contact Bar s end first into the test port The Meter will automatically turn on All segments of the LCD display will appear a beep will sound and the code number will appear followed by a flash ing symbol Be sure the code number on the display matches the code number on the Test Strip vial If the code numbers do not match code the Meter by using Glucode nell Chip accordingly Fig 10 i 4 After the symbol appears press the S button for 3 sec Fig 10 to switch control solution mode The ctl symbol indicates Code 365 that the Meter will mark your current test as a Control Solu tion test Now you are ready to apply the Control Solution nil Fig 11 oO Code 966 e Fig 11 5 Discard the first drop of Control Solution and squeeze a small drop of Control Solution on a clean nonabsorbent surface such as a clean piece of wax paper Do not apply Control Solution to the Test Strip directly from the bottle 6 Bring the tip of the Test Strip to lightly touch the drop of Control Solution Control Solution is automatically pulled into the strip through the tip Hold until the meter beeps ti 1 The meter will now being counting down from 5 to 1 and a i the Control S
24. ose measurements from the other test sites and your fingertips Changes in blood glucose may be observed in finger blood samples sooner than blood samples from the forearm and other alternate sites Rub the alternate test sites about 20 seconds before lancing If you are testing for hypoglycemia low blood glucose or if you suffer from hypoglycemia unawareness we recommend that you test on your fingertips 2 Talk to your doctor to see if alternative site testing is right for you With a little bit of education you can give your fingertips a rest and maybe test more often than you do now For people with diabetes more frequent test ing is a good thing Just remember any time you want to be sure of an ac curate up to date blood glucose reading test on your fingertip 3 We strongly recommend you do AST ONLY in the following intervals e In a pre meal or fasting state more than 2 hours since the last meal e Two hours or more after taking insulin e Two hours or more after exercise DO NOT use AST if e You think your blood glucose is low e You are unaware of hypoglycemia e Your AST results do not match the way you feel e You are testing for hyperglycemia e Your routine glucose results are often fluctuating e If you are pregnant e Low or high blood glucose readings can indicate a potentially serious med ical condition If your blood glucose reading is unusually low or high or if you do not feel the way your reading indica
25. ructions for use
26. tes repeat the test with a new test strip If your reading is not consistent with your symptoms or if your blood glucose result is less than 60 mg dL 3 3 mmol L or higher than 240 mg dL 13 3 mmol L you should contact your healthcare professional and follow his or her treatment advice e Any change or administer of medication based on the TysonBio EVOLVE blood glucose test results without the consent and advice of a physician or healthcare professional is not recommended e Severe dehydration and excessive water loss may cause false low results If you believe you are suffering from severe dehydration consult your phy sician immediately Introduction Thank you for choosing the TysonBio EVOLVE Blood Glucose Monitoring System the latest advancement in biosensor technology As you already know self monitoring of blood glucose SMBG is a necessary part of the treatment plan of people with diabetes mellitus The Diabetes Control and Complications Trial DCCT has confirmed the significant benefits from SMBG when practiced as part of a larger intensive strategy to tightly control blood glucose concentrations Adapted for its ease of use and quick response time the TysonBio EVOLVE System has the ability to process accurate results utilizing only a small vol ume of blood for in vitro diagnostics The TysonBio EVOLVE Blood Glucose Monitoring System is intended for use in the home and in professional set tings to monitor whole blood glucos
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