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IMPORTANT SAFETY INSTRUCTIONS

PLEASE READ THIS BEFORE USING

The following basic safety precautions should always be taken.

1. Close supervision is necessary when the device is used by, on, or near chil-

dren, or handicapped persons.

2. Use the device only for the intended use described in this manual.

3. Do not use strips and control solutions which are not supplied by
the manufacturer.

4. Do not use the device if it is not working properly, or if it has suffered any
damage.

5. Before using any product to test your blood glucose, read all instructions
thoroughly and practice the test. Do all quality control checks as directed and
consult with a diabetes healthcare professional.

KEEP THESE INSTRUCTIONS

IN A SAFE PLACE

Содержание SURETEST

Страница 1: ...Owner s Manual Ver 05 03 2020 311 4227300 XXX Blood Glucose Monitoring System ...

Страница 2: ...nction which means there is no need to calibrate your meter and allows you to easily monitor your blood glucose at home The system is intended for use outside the body in vitro diagnostic use It should be used only for testing glucose sugar and only with fresh capillary whole blood samples The system is intended for use in the home and in clinical settings It should not be used for the diagnosis o...

Страница 3: ...the intended use described in this manual 3 Do not use strips and control solutions which are not supplied by the manufacturer 4 Do not use the device if it is not working properly or if it has suffered any damage 5 Before using any product to test your blood glucose read all instructions thoroughly and practice the test Do all quality control checks as directed and consult with a diabetes healthc...

Страница 4: ...ement 13 Setting the Meter and Deleting the Memory 14 BEFORE TESTING 18 Checking with SureTest Control Solutions 18 Important Control Solution Information 18 Performing a Control Solution Test 19 TESTINGYOUR BLOOD 21 Testing Procedure 22 Expected Test Results 26 COMPARING METER AND LABORATORY RESULTS 26 USING THE METER MEMORY 28 Viewing Results on the Meter 28 Viewing Results on a Personal Compute...

Страница 5: ...elf wicking port Applying other substances to the self wicking port hole will cause inaccurate results If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this owner s manual call your healthcare professional Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate ...

Страница 6: ... you do AST ONLY in the following intervals In a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise Important There are limitations for doing AST Please consult your healthcare professional before you do AST What is AST Alternative site testing AST means that people use parts of the body other than fingertips to c...

Страница 7: ...TE We suggest that you rub the puncture site for about 20 seconds before taking your sample INTRODUCTION OF THE SYSTEM Intended Use The system is intended for use outside the body in vitro diagnostic use It should be used only for testing glucose sugar and only with fresh capillary whole blood samples taken from the finger and the alternative sites including the palm the forearm and the upper arm ...

Страница 8: ... system includes 1 A meter 2 log book 3 Lancing Device with clear cap 4 Sterile lancets 5 Control solution Optional 6 Owner s manual 7 Carrying case 8 Warranty card PLEASE NOTE Check your system to be sure that it is unopened prior to use and that it contains all parts listed above If either of these conditions occurred please return your system to the place of purchase Please note that the contro...

Страница 9: ...ge easy to read display guides you through the test using symbols and simple mes sages SET BUTTON in the back Set the date time and unit located in the battery compartment MAIN BUTTON The main button in front of the meter is used to set up the meter enter the memory mode change the value of date time unit setting memory deletion and turning the meter on and off DATA PORT Located at the side is for...

Страница 10: ...u review the memory Temperature Symbol Appears with ambient temperature after inserting a test strip CTL Symbol Appears when performing a control solution test and indicates that the result will not be stored in the memory Measurement unit Appears with the test result in mmol L Voice Symbol Indicates speaking function is on off Day Average Indicates that the displayed test result is an average Ket...

Страница 11: ...erature is detected The room temperature is number degree Celsius When room temperature is outside operating range Room temperature is out of range thus unable to measure When the meter is ready to test symbol appears on display Please apply blood into the strip When the test is completed The result appears on display Your blood glucose is number Millimole per Liter When the test result is outside...

Страница 12: ...s of the following parts Contact Bars Insert this end of the test strip into the meter Push it in firmly until it will go no further Test Strip Handle Hold this part to insert the test strip into the slot Confirmation Window This is where you confirm if enough blood has been applied to the absorbent hole of the strip Self Wicking Port Apply a drop of blood here The blood will be drawn automaticall...

Страница 13: ... is time to change the batteries 2 The symbol appears with the flashing E b symbol and low the batteries can not provide enough power to do a test You must change the batteries immediately PLEASE NOTE Replacing the batteries does not affect the meter s memory previous test results stored in memory However the time and date settings may need to be updated Batteries might leak chemicals if not used ...

Страница 14: ... 1 2 3 WARNING As with all small batteries the batteries should be kept away from small children who still put things in their mouths If they are swallowed promptly see a doctor for help Setting the Meter and Deleting the Memory Year month date time unit of temperature memory deletion speaking volume and language selection preset However if you replace the batteries you may need to reset the setti...

Страница 15: ...correct month appears To move faster hold the button down With the correct month on the display press the Set button and then the date segment flashes STEP 3 Set the Date Press and release the button until the correct day appears To move faster hold the button down With the cor rect day on the display press the Set but ton and then the hour segment flashes STEP 4 Set the Hour Press and release the...

Страница 16: ...o delete ALL memory and are displayed on the meter The memory of this meter is empty now PLEASE NOTE The above settings can ONLY be changed in the setting mode Therefore when you perform a glucose testing those parameters are not possible to be changed Your meter displays 7 14 21 28 60 and 90 day averages which you can access from the meter memory These averages are calculated from results obtaine...

Страница 17: ...lay on LCD during testing Number 1 to 7 indicates speaking volume from low to high where displays on LCD during testing STEP 8 Select Languages L1 L2 and display on LCD Your monitor can speak in one of two languages Press the button to select Select L1 for English L2 for French The setting model is all completed Press the Set button to turn off the meter OFF is displayed before shut down The setti...

Страница 18: ...at you are performing the test correctly It is very important that you do this simple check routinely to make sure you get accurate results Important Control Solution Information Use only SureTest control solutions Check the expiration date on the control solution vial Do not use if ex pired Control solution meter and test strips should come to room temperature 20 25 C before testing Shake the via...

Страница 19: ...est result will not be stored in the meter memory Failure to do so will confuse the blood glucose test result with the control solution test result in memory WARNING STEP 3 Obtain Control Solution Shake the control solution vial thoroughly before use Squeeze out a drop and wipe it off then squeeze out another drop and place it on the tip of the vial cap STEP 2 Press the button While the symbol app...

Страница 20: ... finger tip first Then touch the test strip to the drop STEP 5 Read and Compare the Result After counting to 0 the test result of control solution is shown on the screen Compare this result with the range printed on the test strip vial It should fall within this range Out of range results If test results fall outside the range printed on the test strip vial check the section of Problem in Operatio...

Страница 21: ...y Avoid getting hand lotion oils dirt or debris in or on the lancets and the lanc ing device TESTING YOUR BLOOD Be sure to read this section and the test strip package insert found in the test strip box carefully before testing Make sure you have all items needed to test 1 Blood Glucose Meter 2 Test Strip 3 Lancing Device 4 Sterile Lancet 1 2 3 4 WARNING ...

Страница 22: ... down firmly until it is fully secured STEP 1 Setting up the SureTest lancing device The SureTest lancing device offers you 6 depths of skin penetration The longer the length of the indicator line the greater the depth of penetration Shallow Deep Average skin Soft or thin skin Thick or calloused skin 1 2 Replace the cap by aligning the arrow on the cap with the release button and then push and tur...

Страница 23: ...ntact bars end first and facing up into the test slot The meter turns on automatically and displays the following in sequence CH and ambient temperature date time and flashing The lancing device is now ready for use Set aside for later use Blood from sites other than the fingertip A clear cap included with the kit makes it easier to get a drop of blood for AST When you want to obtain blood from si...

Страница 24: ...your fingertip Press the release button to prick your finger A click indicates that the puncture is complete Remove the device from the puncture site After penetration remove the first drop of blood with a clean cotton swab Gently squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample Apply the blood to the test strip Sites other than fingertip Please r...

Страница 25: ...hen the meter is counting NEVER try to add more blood to the test strip Discard the test strip and retest with a new one If you have trouble filling the test strip please contact customer service for help STEP 5 Obtain an Accurate Result in 6 Seconds The result of your blood glucose test is shown after the meter counts to 0 This reading is automatically stored in the meter STEP 6 Remove the Lancet...

Страница 26: ...3 Please work with your health care professional to determine a target range that works best for you Time of day Glucose range for people without diabetes Your target range mmol L Fasting and before meal 5 6 mmol L _______ mmol L 2 hours after meals 7 8 mmol L _______ mmol L COMPARING METER AND LABORATORY RESULTS The result you obtain from your meter may differ somewhat from your laboratory result...

Страница 27: ...n or experienced stress 4 In addition if you have eaten recently the blood glucose level from a finger stick can be up to 3 9 mmol L higher than blood drawn from a vein venous sample used for a lab test 5 Therefore it is best to fast for eight hours before doing comparison tests Factors such as the amount of red blood cells in the blood a high or low he matocrit or the loss of body fluid severe de...

Страница 28: ...28 60 and 90 day average will appear in order You can then review the last 450 tests in the memory When using the meter for the first time appears showing that there are no test results in memory The 7 day average is calculated from the blood glucose results obtained during the last 7 days USING THE METER MEMORY It also indicates how many blood glucose tests have been performed within this period ...

Страница 29: ...e Memory Mode Keep pressing the button for 5 seconds to turn off the meter PLEASE NOTE The control solution results are NOT stored in the memory please also go to page 24 WARNING for information The list of past results and the result average are for blood glucose results only When pressing the button to recall the test results the meter will displayed date time and the unit of measurement first I...

Страница 30: ...30 1 888 315 4133 for help call at ...

Страница 31: ...ect the meter by following the disinfecting procedure below Do NOT use organic solvents to clean the meter We recommend for meter cleaning and disinfection you should use the disinfect ing wipe from below which the active ingredients have been tested to be effec tive against Hepatitis BVirus HBV for the meter Canada Clorox Healthcare Professional Disinfecting Bleach Wipes DIN no 02401983 The Unite...

Страница 32: ...he warranty period whichever comes first Stop using the meter if you see any signs of deterioration For example meter cannot be turned on LCD display cracks or becomes cloudy buttons no longer function meter outer casing cracks color or paint printing on housing is abnormal scratches or abrasions on meter are higher than acceptable Please call Customer Care at 1 888 315 4133 for a replacement mete...

Страница 33: ...vial away from children since the cap may be a choking hazard If swallowed promptly see a doctor for help If you do get moisture in the test strip slot wipe it away with a corner of tissue Always dry the meter thoroughly before using it Do not spray the meter directly with cleaning solutions especially those con taining water i e soapy water as this could cause the solution to enter the case insid...

Страница 34: ...r messages not listed below or if you have followed the actions recommended below but the problem re mains unsolved please call the customer service for support Result Indicator Special symbols and messages appear together with your test result MESSAGE WHAT IT MEANS appears when your result is below measurement limit which is less than 1 1 mmol L KETONE appears when your result is equal or higher ...

Страница 35: ...ing blood to the absorbent hole Re test with a new test strip Problem with the meter Review the instructions and re test with a new test strip If the above steps do not work please contact Customer Care at 1 888 315 4133 for help Error Message Problem in Operation 1 If the meter does not display a message after inserting a test strip PROBABLE CAUSE WHAT TO DO Battery exhausted Replace the battery ...

Страница 36: ...p 3 If the control solution test result is out of range PROBABLE CAUSE WHAT TO DO Error in performing the test Read the instructions thoroughly and repeat the test again Did not shake the control solution vial very well Shake the control solution vigorously and repeat the test again Expired or contaminated control solution Check the expiry date or the discard date of the control solution Control s...

Страница 37: ...etection Auto reaction time count down Sleeping Mode Power consumption less than 80uA Auto turn off after 3 minutes without action Temperature Warning Operating Condition 10 C 40 C below 85 R H noncondensing Storage Transportation Condition 4 C 40 C below 85 R H Measurement Unit mmol L Measurement Range 1 1 33 3mmol L Talking Function in both English and French The device has been certified to mee...

Страница 38: ...r or replace any Product found to be defective and return it to you Any replacement product may be new refurbished or a different model This warranty will not apply if the defect or malfunction results from subjecting the Product to any but the speci fied voltage modification alteration or repairs of the Product by persons not authorized by SkyMed misuse abuse damage during transit or lack of reas...

Страница 39: ...eferent In vitro diagnostic medical device Do not reuse Consult instructions for use Humidity Limitations Temperature limitation Use by Manufacturer Batch code Serial number Caution consult accompanying documents ...

Страница 40: ...40 ...

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