Tyson Bio EZ Smart-608, User Manual

Page 1: ...Blood Glucose Monitoring System User s Manual For in vitro diagnostic use only...

Page 2: ...User s Manual...

Page 3: ...bout the Glucode Chip 11 Installing Replacing the battery 12 Setting Up the Meter 13 Checking the performance of your EZ Smart 608 Meter 15 Coding your EZ Smart 608 Meter 15 The Control Solution Test...

Page 4: ...Memory Features 25 PC Link Function 26 Care and Storage 28 Display Messages 30 Specifications 36 Limitations of the procedure 38 Service and Warranty 39 Customer Service 41 2...

Page 5: ...stem provides you alternative 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...

Page 6: ...ve symptoms when your blood glucose is low or how you feel doesn t match the results from the alternative site When you have just taken insulin or any time during or after exercise When there are unkn...

Page 7: ...r 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 frequen...

Page 8: ...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 Any change or administer of medicati...

Page 9: ...larger intensive strategy to tightly control blood glucose concentrations Adapted for its ease of use and quick response time the EZ Smart 608 Sys tem has the ability to process accurate results utili...

Page 10: ...r EZ Smart 608 System contains EZ Smart 608 Meter One vial of EZ Smart 608 Test Strips 10 strips One Glucode Chip outside the strip vial One Lancing Device Optional Ten Lancets Optional One carrying c...

Page 11: ...out the EZ Smart 608 Meter 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...

Page 12: ...t Strip consists of the follow ing 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 T...

Page 13: ...8 0 19 3 24 3 Use EZ Smart 608 only 0537 Code VIAL LABEL Lot Number Expiration Date Code Number Control Solution Range TEST STRIP VIAL The Glucode Chip is used to ensure that your EZ Smart 608 Meter...

Page 14: ...w a warning sig nal When this display appears it is time to replace a new battery When the low battery warning signal is shown the EZ smart 608 Meter will provide accurate results for ap proximately 5...

Page 15: ...setting will be the first to appear Press and release the S button until the correct year appears With the correct year on the display press the M button and the month and date setting will appear 3 P...

Page 16: ...ransferring test data see page 22 To finish setting press M button no to turn off the meter Your programmed settings will be shown on the display every time you use the Meter Code Setting and Unit Sel...

Page 17: ...M PM AVG Mem mmol l mg dL Code ctl Checking the Performance of your EZ Smart 608 Meter Coding your EZ Smart 608 Meter Each batch of EZ Smart 608 Test Strip is encoded with a number that must match one...

Page 18: ...vial label If the code matches you may begin to test 4 If the meter code and vial code do not match please ask the store distributor to replace a new vial The Control Solution is used to check and ens...

Page 19: ...lution package insert Two sets of control solution should be used a high level and a low level control solu tion of your choice To perform a Control Solution Test 1 Insert the Test Strip white side fa...

Page 20: ...Control Solution test Now you are ready to apply the Control Solution 5 Discard the first drop of Control Solution and squeeze a small drop of Control Solution on a clean nonabsorbent surface such as...

Page 21: ...outside the specified range may be caused by Error in performing the test The Control Solution temperature is lower than15 C 59 F or higher than 35 C 95 F Expired or contaminated Control Solution Expi...

Page 22: ...Lancet Caution To reduce the chances of infection Never share a lancing device and lancet with another person Always use a new and sterile lancet Lancets are for single use only Always use a new EZ s...

Page 23: ...ound and the code number will appear followed by a flashing symbol Now you are ready to obtain a blood sample Fig 4 Reminder Make sure that the code number on the display matches the code number displ...

Page 24: ...he 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...

Page 25: ...e of the Test Strip the Meter will beep and begin counting down from 8 to 1 Confirmation Window 4 Your blood glucose result will appear on the LCD panel and will be stored into the Meter memory automa...

Page 26: ...thcare professional immediately 6 If a LO message appears on your 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 t...

Page 27: ...o provides you with a consecutive 14 day average of your blood glucose test results DAY AM PM AVG Mem mmol l mg dL Code ctl AM DAY AVG Mem mg dL Memory Features 1 Press the M button to turn on the Met...

Page 28: ...sults please refer to the log book for further in structions 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 act...

Page 29: ...ee page 13 PC will appear on the display 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 the side of the meter 4...

Page 30: ...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...

Page 31: ...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 Laborato...

Page 32: ...tem check verifying that all segments of the Meter are functioning This message appears im mediately if your Meter has not been encoded No Action Necessary Code Meter see page 15 This is the current c...

Page 33: ...ontrol Solution sample The Meter detects blood glucose level is higher than 600 mg dL 33 3 mmol l You may now apply a blood sample You may now apply a drop of Control Solution sample Indicates high bl...

Page 34: ...t test If result still occurs consult your physician immediately Temperature is too low to perform the test Temperature is too high to perform the test Repeat the test in a warm er setting 10 40o C or...

Page 35: ...th a new Test Strip Press the meter reset button and check the meter again with the Glucode Chip If the problem persists contact Tyson Bioresearch Inc Cus tomer Service for help An error message indic...

Page 36: ...en shown Replace with a new 3 Volt lithium battery CR 2032 Press M button or wait for 3 minutes to turn off the meter An error message indicat ing a problem with the cod ing of the Meter Press the met...

Page 37: ...tive Test strip Replace with a new Test Strip Insufficient blood sample Repeat the test with a new Test Strip Test Strip remains in the test port for more than 3 minutes prior to testing Meter will au...

Page 38: ...from Fingertip Palm and Forearm Sample Volume 1 5 l Measuring Range 20 600 mg dL 1 1 33 3 mmol l Test Time 10 sec Memory Capacity 300 most recent results Average 14 days average results Power supply...

Page 39: ...85998 Authorized representative in the EU Medical Device Safety Service GmbH Schiffgraben 41 D 30175 Hannover Germany TEL 49 511 62628630 The Lancets are in conformity with the MDD 93 42 EEC Manufactu...

Page 40: ...608 System is designed for in vitro use only and is not intended to test on newborns The EZ Smart 608 Test Strips are designed for use with fresh capillary whole blood samples obtained from the finger...

Page 41: ...r warranty is valid only when used properly within the guidelines of the provided User s Manual and is invalid when the EZ Smart 608 System and EZ Smart 608 Test Strip are used improperly Manufacturer...

Page 42: ...sed 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...

Page 43: ...ou 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 Custome...

Page 44: ...ID B03E106357 Revision 02 Manufacturer Tyson Bioresearch Inc 5F 22 Ke E Road III Science Based Industrial Park Chu Nan Taiwan Tel 886 37 585998 Fax 886 37 585996 www tysonbio com Made in Taiwan...