EZ Smart 606 Users Manual
Contents
1. Blood Glucose Monitoring System The Latest Advancement in Biosensor Technology User s Manual For in vitro diagnostic use only 0537 ID B03D106329 Revision 01 g Tys nBia Tyson Bioresearch Inc 5F 22 ke E Road III Science Based Industrial Park Chu Nan 350 Miao Li Country Taiwan About the EZ Smart 606 Meter The FRONT itd 8 5 6 C 0537 7 9 3 1 Display Your test results are displayed here The large easy to read screen guides you 5 Battery Cover 6 Unit Switch Switch for mmol l or mg dL through the test by using numbers and 7 Label symbols 8 Reset Button Press this button to re set 2 M Button the system 3 S Button 9 Glucode Chip Insert the Glucode Chip for 4 Test port This is where you insert the Test coding Strip into the Meter P 3 Installing Replacing the battery The EZ Smart 606 Meter uses one 3 Volt lithium battery CR 2032 When to Replace 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 shown the EZ Smart 606 Meter will provide accurate results for approximately 50 more measurements How to Replace the Battery 1 From the back of the Meter gently slide and remove the battery cover 2 Insert a 3 Volt lithium battery CR 2032 with the side facing up 3 Slide battery cover back into place Setting Up the Meter To tu2. No Action Necessary Code Meter see page 7 This code number should match the code number printed on your EZ Smart 606 Test Strip vial P 15 ACTION Replace with a new 3 Volt lithium battery CR 2032 Replace with a new 3 Volt lithium battery CR 2032 Press S button or wait for 15 sec onds to turn off the meter Check the meter again with the Glucode Chip If the problem persists contact Tyson Bioresearch Inc Customer Ser vice for help P 18 The Lancets are in conformity with the MDD 93 42 EEC Manufacturer Wuxi Xinda Medical Device Co Ltd No 42 Xixin Road Zhangjing Wuxi Jiangsu 214194 PRC 86 510 379 3149 Authorized Representative in the EU EMDAR BV 31 263 653 375 ljsselburecht 3 Postbus 5486 6802 EL Arnhem Netherlands The Lancing Device is being clasified as MDD Class l Manufacturer Wuxi Xinda Medical Device Co Ltd No 42 Xixin Road Zhangjing Wuxi Jiangsu 214194 PRC 86 510 379 3149 Authorized Representative in the EU EMDAR BV 31 263 653 375 Limitations of the Procedure ljsselburecht 3 Postbus 5486 6802 EL Arnhem Netherlands Caution The EZ Smart 606 System is designed for in vitro use only and is not intended to test on newborns The EZ Smart 606 Test Strips are designed for use with fresh capillary whole blood samples False results may occur when performing the test while severely dehydrated severely hypotensive in shock or in a h
3. and sterile lancet Lancets are for single use only Always use a new EZ Smart 606 Test Strip Test Strips are for single use only Do not get lotion oil dirt or debris in or on the lancet and lancing device o ote 7 kS oo 3 Insert the Test Strip white side face up into the test port 2 Pull out an EZ Smart 606 Test Strip from the vial and re cap the vial immediately 1 Wash hands using soap and warm water Rinse and dry thoroughly 4 A beep will sound and the code number will appear followed by a flashing 6 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 mga not match the code number on the Test Strip vial code the Meter by using Glucode Chip accordingly See page 7 Ei Introduction Congratulations on choosing the EZ Smart 606 System the latest advancement in biosensor technology Adopted for its ease of use and quick response time the EZ Smart 606 has the ability to process accurate results utilizing only a small volume of blood for in vitro diagnostics The EZ Smart 606 System s intended use is to provide a convenient and safe monitoring system for diabetic individuals This is an over the counter OTC product Technically blood glucose is oxidized enzymatically when the electrical current generated by glucose ox
4. 6 System manufacturer warranty is valid only when used properly within the guidelines of the provided User s Manual and is invalid when the EZ Smart 606 System and EZ Smart 606 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 original purchase During the stated three year period our company shall repair or replace any EZ Smart 606 Meter found defective with a new EZ Smart 606 Meter This warranty does not apply to the performance of a EZ Smart 606 Meter that has been acciden tally 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 EZ Smart 606 Meter or its parts For manufacturer warranty services purchaser must contact Tyson Bioresearch Inc for help P 22 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 Exiting the Memory Mode 1 Press and release the M button to the end of the memory 000 will show Press the S button again to turn the meter off 2 Meter will shut down automatically after 15 seconds with no further action R
5. 86 266 mg dL 10 test Strips 10 3 14 8 mmol l Code Number Exp Date EZ Smart 606 Control Solution Range Lot Number About the Glucode Chip The Glucode Chip is used to ensure that your EZ Smart 606 Meter provides you with accurate results Before performing the blood glucose test or starting a new strip vial please check your EZ Smart 606 Meter with the Glucode Chip to ensure proper performance further instructions for use of the Glucode Chip is provided on page 7 After checking your Meter the Glucode Chip is also used to code setting mm SSAC d 020 ii Note Always use the Glucode Chip to ensure your EZ Smart 606 Meter is performing properly DO NOT misplace your Glucode Chip CODE Number P 5 The Control Solution Test The Control Solution is used to check and ensure that the EZ Smart 606 Meter and EZ Smart 606 Test Strip are working together properly and that you are performing the test correctly For an accurate reading check the system with the EZ Smart 606 Control Solution on a routine basis approximately once a week NOTE 1 Control Solutions are required but not supplied 2 There are three EZ Smart 606 Control Solutions at different desired range of aqueous glucose Low Normal or High For more information about the EZ Smart 606 Control Solution Please read your EZ Smart 606 Control Solution package insert Two sets of control solution should be used a high level and a low level control solut
6. Applying blood sample to the EZ Smart 606 Test Strip 2 Blood is automatically drawn into the EZ Smart 606 Test Strip 1 After obtaining a blood sample place the drop onto the test well of the EZ Smart 606 Test Strip P 11 3 AS soon as enough blood has Confirmation Window from 8 to 1 4 Your blood glucose result filled the Confirmation Window i tit will appear on the LCD see picture of the Test Strip panel and will be stored into the EZ Smart 606 Meter will l ZZ II the Meter memory beep and begin counting down mg dL automatically Note To ensure accurate results make sure the Confir mation Window of the Test Strip is completely filled with your blood sample 5 The EZ Smart 606 results range between 20 to 600 mg dL 1 1 to 33 3 mmol l If a HI message appears on your display your EZ Smart 606 Meter has detected that your blood glucose level is higher than 600 mg dL 33 3 mmol l It is suggested that you review your testing procedure and test again with a new EZ Smart 606 Test Strip to confirm the result healthcare professional immediately If the same result occurs consult your 6 If a Lo message appears on your display your EZ Smart 606 Meter has de tected 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 EZ E Smart 606 Test Strip to confirm the result If the same res
7. Solution Expired or contaminated EZ Smart 606 Test Strips Improper coding of the EZ Smart 606 Meter EZ Smart 606 Meter malfunction Note The result will not be stored into the memory and will not be incorporated into the average in the ctl mode DO NOT use the system if the problem persists Please call Tyson Bioresearch Inc Customer Services at 886 37 585 998 or website of www tysonbio com P 9 7 7 7 KeS KSA eo 7 KeS Preparing the Test Strip Table of Contents ahd goss ts 2 menn E E E E AE E 2 About the ProdUCt cccream n ree eueeseepereeesy yenusdiesausscedhdnodiaanbnbhboreesnesvanenceadeneacceenss 2 About the EZ Smart 606 Meter cccccccceecceeee cee eeeeceeeeeceeeeeaeeeecaeessaeeeeseeeessaees 3 About the EZ Smart 606 Test Strips ciccccc cccccccceccccccdcenceccnscseecesceedsenenscsersevenscsastanestneenen 4 About the EZ Smart 606 Test Strip Vial ccc ccccceccceseeeeeeeeeeseeeeseeeeeseeeeeeeeeeseeeeeeas 5 About the Glucode iG act awe cieri sninanieencscieseanccinpmipindcdetdlpbeaclsesliunnsinna va deabusbencessandcmnnmead 5 Installing Replacing the DAIET Yi5 wicedsd ster sciveesesanassnteavidein hepedoaeesacnependauesiandeeseseetmmle dened 6 Setting up th IGEN orense aane EE R OENE EKE E aE EE EDE EEEE 6 Coding your EZ Smart 606 MGIC R oc acassccacsaiasasnscnieneecacecekeuliesesandsavcoxeenteixeieseexeinioneexemtacoeors 7 The Control Solution TeSt 0 000c cece cece cece eec
8. esults marked as ctl Control Solution will not be averaged into the nor be stored into the memory Care and Storage 1 Handle the EZ Smart 606 Meter with care Dropping or throwing the Meter may cause dam age to the device 2 Do not expose the Meter Test Strips and Control Solution to extreme conditions such as high humidity heat freezing cold or dust 3 Always wash hands with soap and water and rinse and dry completely before 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 HUMIDITY AND OR DUST It is advised that you store the Meter and its accessories into the provided carrying case P 14 DISPLAY WHAT IT MEANS XO U LON Temperature is too low to Repeat the test in a warmer setting l perform the test 10 40 C or 50 104 F Wait 15 minutes before re testing Temperature is too high to Repeat the test in a cooler setting I perform the test 10 40 C or 50 104 F Wait 15 x 4 minutes before re testing An error message indicating a Review the instructions and try problem with the EZ Smart 606 again with anew EZ Smart 606 Test x Test Strip or Glucode Chip Strip or Glucode Chip mR An error message indicating a Check the meter again with the l problem wit
9. h the EZ Smart 606 Glucode Chip If the problem x CO Meter persists contact Tyson Bioresearch E Inc Customer Service for help P 17 Specifications Meter Operating Conditions Temperature 10 C 40 C 50 F 104 F Relative Humidity 10 90 Hematocrit 35 55 Test Sample Capillary Whole Blood Sample Volume gt 1 5 ul Measuring Range 20 600 mg dL 1 1 33 3 mmol l Test Time 10 sec Memory Capacity 28 most recent results Average Calculates the consecutive results Power supply 3 Volt lithium battery CR 2032 Battery Life Approximately 1000 tests Size 102 x50 x15 mm 4 0 x 1 9 x 0 6 in Weight 55 g The EZ Smart 606 Meter and EZ Smart 606 Test Strips are in conformity with the IVDD 98 79 EC lle aed sj Authorized representative in the EU yson ioresearch Ine Medical Device Safety Service GmbH Industrial Park Chu Nan 350 x g i Miao Li County Taiwan R O C ermany 886 37 585998 49 511 62628630 P 20 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 Unit Our trained specialists will be happy to assist you train you or even reaffirm your results Customer Service Hotline 886 37 585998 our office hours are from 8 30am GMT0030 5 30pm GMT0930 or E Mail us at service tysonbio com When you call our Customer Service Unit please have your EZ Smart 606 Meter EZ Smart 606 Test St
10. idation is measured The advantage of using the System comes from the EZ Smart 606 Test Strips which is specially designed to allow the monitoring of your blood glucose level quickly and easily What makes the EZ Smart 606 Test Strip so special is on how blood samples are drawn Our unique design allows you to use a small amount of blood to produce results in only a short time Please read the entire User s Manual carefully before using this product About the Product Your EZ Smart 606 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 EZ Smart 606 System contains EZ Smart 606 Meter One vial of EZ Smart 606 Test Strips 10 strips One Glucode Chip outside the strip vial One Lancing Device Optional for compact kit Ten Lancets Optional for compact kit One carrying case Note 25 50 test strips vial can be purchased individually P 2 User s Manual Log book Optional for compact kit Quick Reference Guide One vial of Control Solution Optional for compact kit About the EZ Smart 606 Test Strip Vial VIAL LABEL TEST STRIP VIAL EZ Smart 606 votretrigerate Re cap immediately a Blood Glucose Test Strips i E0537 diagnostic use Do not store test strips a ete Lot G4T060705 For the measurement of EXP NOV 2008 glucose in whole blood Use EZ Smart sos onty Control Solution Range 1
11. ion of your choice To perform a Control Solution test 1 Insert a EZ Smart 606 Test Strip code 2 All segments of the LCD dis white side face up Contact Bar s CI CI CI play will appear indicating end first into the test port The l J o that the EZ Smart 606 Meter EZ Smart 606 Meter will auto a is functioning properly Mem mmol l mg dL matically turn on 3 A beep will sound and the code number will appear followed by a flashing 6 symbol Be sure the code number on the display matches the code number on the e EZ Smart 606 Test Strip vial If the code numbers do not match code the EZ rigid Smart 606 Meter by using Glucode Chip accordingly P 8 Obtaining a Blood Sample SAMPLE MAY BE OBTAINED FROM FINGER For further instructions please see the insert provided with lancing device 1 Unscrew and remove the endcap of 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 unscrewing 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 PERFORM THE TEST 7 After sampling remove the endcap containing the used lancet carefully 8 Remove the lancet from the lancing device Discard the used lancet properly in accordance with local state and federal law
12. rawn into the EZ Smart 606 Test Strip 3 Contact Bar This end of the EZ Smart 606 Test Strip is inserted into the Test Port to activate the EZ Smart 606 Meter white side face up P 4 Coding your EZ Smart 606 Meter Each batch of EZ Smart 606 Test Strip is encoded with a number that must match one of the code numbers stored in the EZ Smart 606 Meter In order to ensure an accurate result the code number on the display must also match the code number found on the EZ Smart 606 Test Strip vial 1 Insert the EZ Smart 606 Glucode Chip into the Glucode Chip slot The EZ Smart 606 Meter will automatically be encoded Note Code the EZ Smart 606 Meter whenever you start a new Test Strip vial j code mmm 2 All segments of the LCD display will appear indicating that the EZ m ma Smart 606 Meter is functioning properly Then a beep will sound lz Lel followed by the code number Mem mmol l mg dL ie phe aac es 3 Match the code number on the EZ Smart 606 Meter display with es l J the code number on the EZ Smart 606 Test Strip vial If the code II H matches you may begin to test P 7 Testing your Blood Glucose Level Before testing blood glucose you need the following items 1 EZ Smart 606 Meter 2 EZ Smart 606 Test Strip 3 Adjustable Automatic Lancing Device 4 Sterile Lancet 5 Glucode Chip Caution To reduce the chances of infection Never share a lancing device and lancet with another person gt Always use a new
13. rip and all other system supplies available This will allow us to answer any of your ques tions with speed and efficiency P 23
14. rn the Meter on first pull the plastic tab out from the battery chamber then press the reset button located at the back of the Meter and proceed with the following instructions Code Setting and Unit Selection 1 Select unit mg dL or mmol l on the back mmol l mg dL Kz 2 Plug the Glucode Chip into the Glucode Chip slot for strip coding P 6 4 After the symbol appears press the M button for 3 sec to switch the l i ctl symbol The ctl symbol indicates that the Meter will mark your current test as a Control Solution test Now you are ready to apply the Control Solution 5 Discard the first drop of Control Solution and apply a small drop of Control Solution onto your fingertip Then place this drop of Control Solution onto the target well area 6 As soon as enough solution has been drawn into the Confirmation Window the EZ Smart 606 Meter will beep and begin counting down from 8 to 1 and the Control Solution test result will appear Caution Please remember that in order to prevent contamination follow the above instructions for preforming the Control Solution test Comparing Control Solution Results The EZ Smart 606 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 Expired or contaminated Control
15. seeeee eee eeeeeeaeeseseeeeeeseueseeeeaeseeseueesaeeneeeaeenes 8 Testing your Blood Glucose Levell cccccccceeeeeeeeceeeeeeeeeeeeeeeeeeaeeeeeeecaeeeeeseseaeeeeeesaeaees 10 Preparing th Test Stripe nera erena a eae aaa ea a eaten OEA ae a aE 10 Obtaining a blood Sample dec cceerisccnaacensiaanssacenacdasd neeucentsuacoubeabukedsnencduecuaaedeestoaceunc 11 Applying blood sample to the EZ Smart 606 Test Strip ccceeeeeeeeeeeeseeesseeesteeseeeeees 11 MIGINOFY FP OQGUT OS noc iii sac cc ecundnaicadiecectver a aa ar a a aaa aai 13 Care and SlCr ae e258 c5ccpteeciccdeeccecssnsnetecemah bee rE O EEE AI KENEEN EEEE CERERE EEEE EERE EEEE 14 Display SSS cite ea a eee dws eee 15 Specifications cieee tei ee oreo ico itd a dnce ond adnan E 20 Limitations of the ProceCure ceeeeeeceeeeeeeeseeeeeeeeeeeeeeeeeeaaaeaeneeeeeeeenaeeoaueeeeeeeeeeess 21 Service and gk Le 10 eee nee eee eee EErEE Enr Ennn 22 C stomer ServiCe sismis hc pc ttc te ee aaia ia aieiaiee eee etree 23 About the EZ Smart 606 Test Strip FRONT BACK t The EZ Smart 606 Test Strip is used to perform the blood glucose test in conjunction with the EZ Smart 606 Meter Each strip can be used only once The EZ Smart 606 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 d
16. trol Solution sample trol Solution sample mg dL Ill EZ Smart 606 Meter detects blood Indicates high blood glucose level glucose level is higher than 600 mg Repeat test If result still occurs i tl dL 33 3 mmol l consult your physician immediately i The EZ Smart 606 Meter detects Indicates low blood glucose level i C blood glucose level is lower than 20 Repeat test If result still occurs e a mg dL 1 1 mmol l consult your physician immediately P 16 Other problems that may occur 7X04 U CONI The EZ Smart 606 Test Strip has not been inserted into the Meter properly Review the instructions and re insert the Test Strip correctly white side face up Defective EZ Smart 606 Test Strip Replace with a new EZ Smart 606 Test Strip Repeat the test with new EZ Smart 606 Insufficient blood sample i Test Strip Test Strip remains in the test port for more Meter will automatically turn off than 4 minutes prior to testing Re insert the Test Strip to the test port Contact Tyson Bioresearch Inc Customer Service for help LCD Screen on the Meter is blank when trying to preform a test P 19 Service and Warranty IMPORTANT The EZ Smart 606 Blood Glucose Monitoring System is designed for in vitro diagnostic use only Tyson Bioresearch Inc cannot endorse the performance of the EZ Smart 606 System when used with Test Strips other than those designed for the EZ Smart 606 Meter The EZ Smart 60
17. ult occurs consult your healthcare professional immediately If no further tests are performed the EZ Smart 606 Meter will automatically shut off after 4 minutes P 12 For healthcare professionals using this system on multiple patients 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 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 Display Messages DISPLAY m 3 0 J J J g Ji Q V W code Bo i pij A 0 a g o r a WHAT IT MEANS encoded in use WHATIT MEANS Battery power is too low for fur ther usage Battery power is low Meter will provide approximately 50 more measurements All testing values recorded in the memory have been shown An error message indicating a prob lem with the coding of EZ Smart 606 Meter System check verifying that all seg ments of the Meter are functioning This message appears immedi ately if your Meter has not been This is the current code number ACTION
18. yperglycemic hyperosmolar state If you believe you are suffering from any of the above symptoms consult a healthcare professional immediately P 21 After finishing the test we recommend using a tissue paper to remove EZ Smart 606 Test Strip from the EZ Smart 606 Meter for proper disposal Caution Any change or administer of medication based on the EZ Smart 606 blood glucose test results without the consent advice of a physician or healthcare professional is not recommended Memory Features The with EZ Smart 606 Meter automatically stores the 28 most recent blood glucose results It also provides you an average of your blood glucose test results 1 Press the M button to code 2 All segments of the LCD display turn on the EZ Smart G I CI will appear 606 Meter i ad al aE oD Mem mmol l mg dL 4 The most recent test result 1 st set will 3 The 28 set data aver automatically appear m F age will automati II Press the M button the Meter displays cally appear and lI the data order release the M botton gE _ flash for few seconds Mem mgd Shows its reading accordingly When the mg dL 28 memories are full the oldest result is removed and replaced with the newest result P 13 DISPLAY WHAT IT MEANS ACTION The system is ready to accept a blood You may now apply a blood sample sample e mg dL i l The system is ready to accept a Con You may now apply a drop of Con T jo
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