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Before Starting

Indications for Use

The 2in1. MICRO Blood Glucose

Monitoring System is intended for the

quantitative measurement of glucose

(sugar) in fresh capillary whole blood

samples drawn from the fingertips,

forearm, upperarm, hand, thigh

or calf as an aid in monitoring the

effectiveness of diabetes management

in the home by patients with diabetes.

The 2in1. MICRO Blood Glucose

Monitoring System is intended to be

used by a single patientand should

not be shared with any other person.

2in1. MICRO System is for self testing

outside the body (in vitro diagnostic

useonly) by people with diabetes

at home as an aid to monitor the

effectiveness of diabetes control. The

2in1. MICRO Blood Glucose Monitoring

System should not be used for the

diagnosis or screening of diabetes or

for newborns.

Alternative site testing should be done

only during steady-state times (when

glucose is not changing rapidly).

Test Principle

The 2in1. MICRO Blood Glucose

Monitoring System is based on

measurement of a small electrical

current produced by the reaction

of glucose in the blood sample

with the reagents on the strip. This

current is changes to the amount

of glucose in the blood sample. The

glucose concentration in the sample

is calculated based on the electrical

current and displayed. The 2in1. MICRO

Blood Glucose Monitoring System is

intended to be used with the Samsung

Galaxy S2, Galaxy S3, Galaxy S4,

Galaxy Note and Galaxy Note 2.

Содержание MICRO

Страница 1: ...ENG User s Guide Blood glucose monitoring system ...

Страница 2: ...Thank you for choosing the 2in1 MICRO System Please read this User s Guide carefully before using to ensure correct use Please keep this User s Guide for your future reference ...

Страница 3: ...linical settings It should not be used for the diagnosis of diabetes or the testing of newborns Features 1 2in1 MICRO system is easy and intuitive with smart phone 2 It is very small size and stylish design allows you to take it everywhere with smart phone 3 It uses the power of a smart phone 2in1 MICRO does not need batteries 4 The meter does not require any settings 5 Smart phone stores all test...

Страница 4: ...ng Results 48 Troubleshooting 50 Caring for System 52 Performance Characteristics 55 Specifications 57 Caution see instructions for use Single use only Expiration date Serial number Lot number In Vitro Diagnostic medical device Manufacturer Authorised representative Symbol for temperature limitation Consult instructions for use Biological risks Contains sufficient for n tests Direct current Separa...

Страница 5: ... home as an aid to monitor the effectiveness of diabetes control The 2in1 MICRO Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for newborns Alternative site testing should be done only during steady state times when glucose is not changing rapidly Test Principle The 2in1 MICRO Blood Glucose Monitoring System is based on measurement of a small elect...

Страница 6: ...ately 2in1 MICRO meter supports the Samsung Galaxy S2 Galaxy S3 Galaxy S4 Galaxy Note and Galaxy Note 2 with Android 4 0 or higher Galaxy is trademark of Samsung Electronics Co Ltd and Android is trademark of Google Inc 2in1 MICRO meter Test Strip Port Insert the end of a 2in1 teststrip here Power Indicator If this is turned on the meter is ready to test Micro USB Plug Insert this into USB jack of...

Страница 7: ...f the meter with the end facing up Clear AST cap is an optional accessory Please contact your local distributor Sample Tip Apply the blood sample to the end of the test strip Adjustable cap Clear AST cap Lancet ejector Sliding barrel Release button Important Lancet and Lancing De vice are subject to change without notice The CE certified Lancet and Lancing Device should be used ...

Страница 8: ...e 2in1 MICRO system for any purpose other than blood glucose testing Before using the 2in1 MICRO system read all instructions in this User s guide and the test strip insert found in the test strip box carefully and practice for accurate and safe testing The 2in1 MICRO meter should only beused with 2in1 Test Strip and 2in1 Control Solution The 2in1 MICRO system contains small parts that may be dang...

Страница 9: ...rips are for single use only Store test strips in their original vial After you take a test strip out of the vial be sure to use it within three minutes Always use test strips within 3 months 90 days after first opening With clean dry hands you may touch the test strip anywhere when removing it from the vial or inserting it into the meter Do not bend cut or alter test strips Cautions for Meter Kee...

Страница 10: ... a free download from the Play Store To download directly on your smartphone tap on the Play Store icon andtouch the Search icon at the top ofthe screen Then type 2in1 MICRO into the search bar at the top The 2in1 MICRO application is a free download from the Play Store The 2in1 MICRO system may only be used with the 2in1 MICRO application Pick out 2in1 MICRO from the list and download as you woul...

Страница 11: ...od into the fingers Dry hands thoroughly until the finger to be pricked is completely dry STEP 3 While holding the lancet carrier insert a new sterile lancet into the bottom of lancet carrier STEP 4 Twist the cap of the lancet off STEP 2 Unscrew the cap of the lancing device by turning it counter clockwise while holding the base firmly ...

Страница 12: ... thin skin 3 for average skin 4 5 for thick or calloused skin STEP 8 Place the lancing device in place Hold the lancing device firmly against the side of the finger with the cap resting on the finger The harder it is pressed the deeper the puncture Press the release button to take a sample STEP 6 Hold the tip firmly in one hand then pull out the sliding barrel with the other hand This will cock th...

Страница 13: ...ce clean CAUTION About Alternate Site Testing The 2in1 MICRO meter lets you obtain a blood sample from your Upper arm Forearm Hand Thigh or Calf Obtaining a drop of blood from these alternate site testing may be less painful than a fingertip sample Following figure shows the areas where you can test with the 2in1 MICRO Avoid moles veins bones and tendons Consult to your healthcare professional bef...

Страница 14: ...acting insulin injection or insulin pump bolus or within two hours after a meal If you are testing for hypoglycemia low blood glucose or if you suffer from hypoglycemia unawareness CAUTION Obtaining a blood sample from alternate sites is different than getting a sample from fingertips After inserting a new sterile lancet into the bottom of lancet carrier put the clear AST cap to the lancing device...

Страница 15: ...se button to take a sample Watch through the clear cap until a sufficient blood sample is taken If there is not enough blood gently massage the area until a sufficient sample has been collected Testing Your Blood Glucose STEP 1 Tap the 2in1 MICRO icon on your smartphone to open the application If the 2in1 MICRO application is not installed install the application See page 19 ...

Страница 16: ...mart phone The white light will turn on showing the meter and Insert Strip message and picture will appear on the display STEP 3 Hold the test strip with electrode end facing up Insert the electrode end of the test strip into the meter as far as it will go using gentle pressure Do not force the test strip into the meter ...

Страница 17: ...Sample will appear letting you know the meter is ready to test To mark the result as a control solution result slide the button at the bottom of the screen STEP 5 Bring tip of the test strip to lightly touch the drop of blood Blood is automatically pulled into the test strip ...

Страница 18: ...he volume of blood sample must beat least 0 5 microliter real size IMPORTANT STEP 6 The application will now show counting progress during 5 seconds STEP 7 Your blood glucose test result is shown on the display screen and automatically stored in your smart phone ...

Страница 19: ... STEP 8 You can add a note to a test result with the way of selecting icon pre meal post meal exercise medication and stress or typing custom comment STEP 9 Remove the used test strip and touch save button to store test result Unexpected results If your test result is below 50 mg dL 2 8 mmol L above 250 mg dL 13 9 mmol L or you see LOW or HIGH on the display repeat the test If you have a second un...

Страница 20: ...national Diabetes Federation 2009 Self Monitoring of Blood Glucose in Non insulin Treated Type 2 Diabetes 2in1 control solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly Control solution is available separately Do a control solution test to practice the test process instead of using blood whenever you open a new vial of test str...

Страница 21: ...art phone to open the application If the 2in1 MICRO application is not installed install the application See page 19 STEP 2 Plug the 2in1 MICRO meter into the USB jack of your smart phone The white light will turn on showing the meter and Insert Strip message and picture will appear on the display ...

Страница 22: ...p Insert the electrode end of the test strip into the meter as far as it will go using gentle pressure Do not force the test strip into the meter STEP 4 Apply Sample will appear letting you know the meter is ready to test Slide the screen and the picture of control solution test will be displayed on the screen ...

Страница 23: ... the cap Gently touch a drop of control solution to the tip of the test strip Hold until the counting progress starts STEP 6 The application will now show counting progress during 5 seconds STEP 7 Your control solution test result is show non the display screen and automatically stored in your smart phone ...

Страница 24: ...tion result call the local distributor Do not use the meter if it is not testing within range Out of range results may be caused by not following the instructions on this USER S GUIDE expired contaminated or watereddown control solution expired or damaged test strip control solution test done outside 20 C to 25 C 68 F to 77 F or a problem with the meter If you continue to get control solution resu...

Страница 25: ...MICRO application to touch the icon of this application in your smart phone the test results are displayed as a list The most recently measured result is displayed at the top of the screen STEP 2 Touching each of these results on a list shows a detailed information of that result Message icon and Mail icon is to transfer the test results by SMS or E mail To secure the private information using cel...

Страница 26: ... does not enter the test mode after inserting 2in1 test strip Probable cause What to do Test strip is inserted upside down wrong end in or incompletely inserted into the meter Insert the test strip with the printed side up and the electrode end of the strip into the test strip port on the meter Blood or foreign objects put into the test strip port Contact your local distributor Test does not start...

Страница 27: ...to strips and control solution Test strips and control solution have expiration dates printed on their vials When you first open a test strip or control solution vial you must record the opening date in the space provided on the label Use all test strips and control solution within 3 months after the first opening Do not use the strips or control solution after the expiration date printed on the v...

Страница 28: ...cap and clear AST cap with mild soap Do not immerse the lancing device in any liquid Clinical accuracy The accuracy of the 2in1 MICRO Blood Glucose Monitoring System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI 2300 Glucose Analyzer System accuracy result for glucose concentrations 75 mg dL 4 2 mmol L System accuracy result for glucose concen...

Страница 29: ...smart phone Size 41 5 mm x 33 6 mm x 9 0 mm Weight 5 9 g 0 21 oz Within run precision 100 venous blood tests per glucose level Total precision 100 control solution tests per glucose level Slope 0 987 Intercept 0 469 mg dL R2 0 989 No of samples 100 Range tested 35 6 422 4 mg dL Mean glucose Standard deviation mg dL Coefficient of variation 41 mg dL 2 3 mmol L 1 2 2 8 99 mg dL 5 5 mmol L 2 7 2 7 13...

Страница 30: ...range and test levels specified in IEC 61000 4 3 The meter has been tested for electromagnetic emissions specified in IEC 61326 Warranty VPD Bled d o o warrants that your 2in1 MICRO meter will be free of defects in materials and workmanship for 5 years valid from the date of purchase The warranty extends only to the original purchaser and is not transferable First and Last name Address Telephone n...

Страница 31: ...ted in Slovenia Edition date and last revision date 2in1 MICRO_ED2016_REV01_EN VPD Bled d o o Pot na Lisice 4 4260 Bled Slovenia EU tel 386 4 574 50 70 fax 386 4 574 50 71 email info vpd si web www 2in1 si ...

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