ALLIANCE i-QARE Скачать руководство пользователя страница 11 | Manualshive

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Applied Standards

This product conforms to the provisions of the FDA 510(K) and
EC directive IVDD (98/79/EC). The following standards apply to
the design and/or manufacturing of the product:

IEC 60601-1

Medical electrical equipment
Part 1: General requirement for safety

IEC60601-1-2

Medical electrical equipment
Part 2: Collateral standard: Electromagnetic
compatibility-requirements and test

IEC 61010-1

Safety requirements for electrical equipment for measurement,
control and laboratory use
Part 1: General requirement

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Содержание i-QARE

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Страница 2: ...ng System It also provides you with services tools and information helping you to manage your monitoring system and blood sugar To start testing quickly you can also refer to the Quick Start Guide If you have any questions please contact Alliance International Co Ltd Customer Service Center toll free at 1 866 400 3336 or visit www alliance intl com tw Assistance is available 24 hours a day 7 days ...

Страница 3: ...r local distributor The i QARE DS A Blood Glucose Monitoring System is used with the i QARE DS A Draw In Blood Glucose Test Strips and 2 level Controls for the measurement of glucose in whole blood Testing is done outside the body in vitro diagnostic use It is indicated for use at home over the counter OTC by person with diabetes or in clinical setting by health care professionals as an aid to mon...

Страница 4: ...warranty expiration or 90 days after the shipment of a replacement meter whichever period is longer This warranty applies only to the original purchaser of the meter This warranty does not apply to the performance of a Glucose Meter that has been damaged by accident or has been altered misused tampered with or abused in any way Alliance International Co Ltd will handle meters that show damage or a...

Страница 5: ...i QARE Blood Glucose Meter under the above Warranty or Non Warranty Service Policy must be made to the Customer Service Center by calling 1 866 400 3336 Alliance International Co Ltd or local distributor Customer experiencing difficulties of operating meter should review troubleshooting or Error Message of this manual For more information or inquiries please contact Alliance International Co Ltd o...

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Страница 7: ...standing Your New System 13 Introduction of i QARE Draw In Test Strip 15 Symbols Introduction of the LCD Screen 16 Connecting or changing the Battery 17 Setting Year Time and Date 18 Coding the Meter 19 Chapter 2 Control Testing 20 Control Solution 20 Verifying Strip Accuracy Using Control Solution 21 Notes 22 Chapter 3 Testing Your Blood Glucose 23 Running a Blood Glucose Test 25 Expected Blood G...

Страница 8: ... Maintenance 32 Blood Glucose Meter 32 Lancing device 32 Battery 33 Meter Operational Status Checking 33 Suggestions 34 Chapter 6 Safety and Disposal 35 Chapter 7 Screen Message and Troubleshooting 36 Message Description and Proceeding Solution 36 Troubleshooting 40 ...

Страница 9: ...Wallet x 1 8 User s Manual x 1 9 Quick Reference Guide x 1 10 Diary for Self Monitoring x 1 11 Control Solution Normal x 1 Supplies and Accessories Need to be purchased separately 1 Draw In Glucose Test Strip 50 pcs 25 2vials 2 Lancing device 3 Lancets 4 Battery CR2032 3V 5 Control Solution 2 levels Normal and High 2x2ml Note The above supplies and accessories are available in Alliance Internation...

Страница 10: ... Memory 360 results with time and date 7 Automatic power on Electrode inserting detection 8 Sample size 1μL 9 Measuring time 6 seconds 10 Sleep Mode Power consumption less than 20uA 11 Automatic power off After 1 minute without action 12 Temperature warning function 13 Operation Condition 14 40 57 2 104 14 Storage Transportation Condition 4 32 39 3 89 6 95 R H 15 Altitude Limit under 2610 meters 8...

Страница 11: ...r manufacturing of the product IEC 60601 1 Medical electrical equipment Part 1 General requirement for safety IEC60601 1 2 Medical electrical equipment Part 2 Collateral standard Electromagnetic compatibility requirements and test IEC 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirement ...

Страница 12: ...ials box 9 Storage Transportation Condition 4 32 39 3 89 6 95 R H DO NOT REFRIGERATE Caution 1 Do not use any expired strips 2 The strips are only used with i QARE glucose meter 3 Do not use any blood that has been preserved e g by fluoride 4 It is not recommended to test the blood level to newborn baby 5 Taking high dose of vitamin C or having high level of uric acid may influence the blood gluco...

Страница 13: ...nal or local regulations Avoid other people touching the used lancets or test strips which may cause cross infection 8 Keep the test strip vial away from children the cap is a choking hazard In addition the cap may contain drying agents which can harm the body if swallowed or inhaled It may cause skin or eye irritation ...

Страница 14: ...s stored in memory Test Strip Slot Insert test strip here Function Button Press this button to enter to the Set Mode move between fields such as time date etc Power Button Press this button to enter or exit the Memory mode or change values in the Set mode Front View Data Slot Transfer date from the meter to a computer Side View ...

Страница 15: ...y Cover Slide out cover to change battery Back View Lanyard Hole Test Strip Vial Code Card Cap with Comfort Dial Depth Selection Plunger Release Button Ejector Test Strip Reaction Zone Lancet Cover Protective ...

Страница 16: ... the reaction zone it will be rapidly drawn in 3 Introduction Zone On the test strip black bars are located in the bottom area and it must be inserted into the strip slot of the meter with the black bars facing up Caution 1 Blood sample should not be applied to the Introduction Zone black bars 2 Avoid touching the reaction and application zones for long periods as moisture may affect the reaction ...

Страница 17: ... to determine whether the test strip and display function are ready or not To check that all the display symbols are working press the power button or insert the test strip electrodes into the meter When a test strip or CODE CARD is inserted the display will turn on automatically Each time the meter is on all the symbols should appear briefly ...

Страница 18: ...attery is low and should be changed soon 3 Place a new battery in a 45 degree to the tray with the side facing up 4 Push the top of the battery until it is firmly positioned 1 Use your thumb to slide the battery cover out of the meter 2 Slightly pull back the buckle to loosen the battery ...

Страница 19: ...e the month until the desired month is displayed 5 Repeat step 3 and 4 to change day hour minute and unit 1 With meter off press Set button the year will flash 2 Press power button to change the year until the desired year is displayed 6 Press to finish set up and the meter will turn off automatically 3 Press again the month will flash ...

Страница 20: ...omatically and show the strip code number Please make sure the code number on the meter screen matches the code on the test strip vial 3 Throw away the old code card Caution 1 Each box of test strip contains one CODE CARD designed specially with one code number REMEMBER to change the CODE CARD every time you open a new box of test strip 2 DO NOT insert different brands or models of CODE CARD or st...

Страница 21: ...he code number printed on each test strip vial label Use of controls for two levels is also recommended in the following conditions For practice purpose to the first time users when using a new glucose meter or a new vial of test strips 1 All levels of control solution should be run with each new lot of test strips 2 Whenever the test strips are exposed to the temperatures above 40 104 or below 14...

Страница 22: ... from the vial and close the vial lid immediately 2 Insert the test strip into the meter strip slot and open the Control Solution 3 Squeeze a drop of control solution on a clean plastic surface and close the control solution vial 4 Apply the drop to the application zone of the test strip The solution is automatically drawn in and an audible signal is heard for confirming that the test strip took i...

Страница 23: ... strip vial an accurate blood glucose reading is ensured If the test result falls outside the range the following may apply A The control solution is no longer fresh or the test strip is not sufficiently filled B Ensure the glucose meter is used under 14 40 57 2 104 and the test strips and the control solution are stored under 4 32 39 3 89 6 95 R H C Ensure the blood sample fully fills the reactio...

Страница 24: ...paring lancing device to get blood sample 1 Twist and pull off the cap 1 Twist and pull off the cap 2 Insert a lancet firmly into the holder 3 Twist off the lancet s protective cover 4 Snap the cap back on and twist the cap back to the device ...

Страница 25: ...Caution 1 To reduce the risk of infection NEVER share your lancet with anyone 2 When checking the blood glucose level from different users remember to disinfect the lancet cap and the entire surface that has stained with blood after testing It is NOT appropriate to disinfect and reuse the lancet Please dispose the used strip and lancet safely and properly 1 Plunger ...

Страница 26: ...warm water to wash your hands and dry them Then massage your fingertips gently It will be easier to get blood sample with less pain 3 Insert a test strip make sure the code on the meter matches the code on the test strip vial 2 Take one test strip from the vial and close the vial cap rapidly and tightly ...

Страница 27: ... screen will display E t message 3 If the code number on the display does not match the code on the test strip vial please contact Alliance International Co Ltd or your local distributor 6 This helps you get a blood drop Touch the drop to the tip of the yellow application zone of the test strip Do not apply blood on top surface of test strip When you hear a beep sound you have enough blood in the ...

Страница 28: ... has enough blood in the test strip Ensure the blood application zone is fully filled and then remove your fingertip from the test strip Incorrect Blood Application The strip has insufficient blood in the strip which may result in an error message or inaccurate result Please discard the strip and insert a new test strip to measure again 1 Note ...

Страница 29: ...e quality control If your blood glucose is under 50mg dL contact your healthcare provider immediately 2 If your blood result appears doubtful repeat the test procedure by using new test strips and running the quality control to ensure that the strip and meter are working properly If the control results are within the ranges on the vials retest your glucose level 3 If you open a new vial of test st...

Страница 30: ...iting dystopia somnolence belly ache please consult with your physician immediately Low Blood Glucose Value If the Blood Glucose Value is too low or you have the symptoms such as night sweat cold to shake palpitating headache dystopia dizzy tachycardia tinnitus paralysis of fingertip please consult with your physician immediately Unusual Test Results If your blood sugar result doesn t match the wa...

Страница 31: ...e Setting Year Time and Date that information is also stored and displayed with your test results Moreover the Healthy Life Meter can also check the average value of blood glucose results for the past 7 14 21 and 28 days The i QARE meter will first display 7 14 21 and 28 days average values as follows 1 With the meter off press to turn on the meter Example 2 Press to display the 7 day average ...

Страница 32: ...ing Date and Time Repeat this step to check the following test results 5 To quit the memory recall keep pressing to turn off the glucose meter Notes 1 Once the memory is full 360 sets the latest result will cover the oldest one Example 3 Press again to display the 14 day average By repeating this step you can check the average values of 21 and 28 days ...

Страница 33: ...ment between 14 40 57 2 104 4 DO NOT expose the Blood Glucose Meter and Test Trip to extreme hot temperature high humidity Kitchen or bathroom or direct sunlight 5 DO NOT use abrasive cleaners and never submerge the body of the blood Glucose Meter in water or other liquids For proper cleaning use a soft dry lint free cloth to clean the body of the Meter and lancing device Cleaning Your Lancing Dev...

Страница 34: ...attery 4 Changing the battery will not affect the test results in the memory 5 After changing the battery you will have to reset time and date Please refer to Setting Year Time and Date Meter Operational Status Checking 1 Insert CODE CARD firmly into the test strip slot the code number will display on the screen 2 After removing the CODE CARD the upper left side of display will show the symbol Thi...

Страница 35: ...iry date and should be stored in the normal room temperature Please DO NOT refrigerate it 6 If the fresh blood sample has very high density of reducing substrate Vitamins C Uric Acid etc it will affect the value of test result 7 The hematocrit of the blood sample is higher than 55 it will cause the value of the test result to be lower than the normal test result value 8 During the blood glucose te...

Страница 36: ...seases 2 It is important to treat the used materials as infectious or biologically hazardous wastes 3 Do not dispose as household waste Dispose according to local regulations Battery 1 Before using please ensure that the battery cover is closed 2 Use only approved battery type non approved battery may cause damage 3 Do not dispose as household waste Dispose according to local regulations 4 Do not ...

Страница 37: ...tions please contact your local Distributor Message Description Proceeding Solution Every time after starting your glucose meter please ensure all the symbols show on the display briefly Please compare it with Symbols Introduction of the LCD Screen If there are any symbols that do not display properly it could cause incorrect test result Please contact local distributor After inserting the CODE CA...

Страница 38: ...into the test strip the 6 second countdown shall start After the countdown is finished the rest result will display on the screen NONE Your blood glucose may be extremely low If it is lower than 20mg dL Ensure the test strip has drawn in sufficient blood sample to the blood application zone and test again with new strip If it is still displaying the LO symbol please consult with your physician You...

Страница 39: ...Result for the past 7 14 21 and 28 days After entering the memory mode press key to see the average value of blood glucose result for the past 7 14 21 and 28days sequentially If the temperature is extremely high or low during the operation of the glucose meter Move to an area between 14 C 40 C 57 2 104 wait 5 minutes and repeat the test The test strip is used or damaged Please DO NOT reuse the tes...

Страница 40: ...cose meter does not insert the CODE CARD for coding Please refer to Coding the Meter and the use of correct CODE CARD The battery is out of power Please change the battery to avoid incorrect test results or else the glucose meter cannot be operated ...

Страница 41: ...acing upward The test strip is inserted in wrong direction or is not inserted completely Ensure to insert the introduction zone of the test strip firmly into the strip slot which is located on the top of the meter Then insert the test strip to the end of strip slot The glucose meter or the test strip is not working The battery is weak or no battery is installed After inserting the test strip and t...

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