SkyMed TD-4227, Owner'S Manual

Page 1: ...Owner s Manual Ver 1 12 2013 311 4223500 XXX Blood Glucose Monitoring System ...

Page 2: ...ature is its SureTest function 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 ...

Page 3: ...ly 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 ...

Page 4: ...g Function 13 Appearance of the Test Strip 14 PREPARATION BEFORE USE 15 Battery Replacement 16 Setting the Meter and Deleting the Memory 17 BEFORE TESTING 22 Checking with SureTest Control Solutions 22 Important Control Solution Information 23 Performing a Control Solution Test 24 TESTINGYOUR BLOOD 27 Testing Procedure 28 Expected Test Results 34 COMPARING METER AND LABORATORY RESULTS 35 USING THE...

Page 5: ...CARING FORYOUR METER AND TEST STRIPS 43 Cleaning 43 Storage 43 PROBLEM SOLVING GUIDE 46 Result Indicator 47 Error Message 48 Problem in Operation 49 SPECIFICATIONS 51 WARRANTY CUSTOMER CARE 52 5 ...

Page 6: ...o the absorbent hole Applying other substances to the absorbent 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 low ...

Page 7: ...ST 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 check thei...

Page 8: ...crease the accuracy Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained Blood from the site without rubbing exhibits a measurably different glucose concentration than blood from the finger When the puncture site was rubbed prior to blood extraction the difference was significantly reduced NOTE We suggest that ...

Page 9: ...e upper arm the calf and the thigh The system is intended for home use It should not be used for the diagnosis of diabetes or for the testing of newborns Principle of Measurement The test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip The meter measures the current and displays the corresponding blood glucose level The strength ...

Page 10: ...ter 2 Your first time using guide 3 Test strips sold separately 4 Lancing Device with clear cap 5 10 Sterile lancets 6 Control solution Optional 7 Owner s manual 8 Sporty carrying case 9 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 ...

Page 11: ...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 11 TALKING SYMBOL Indicates that the meter contains speaking function D...

Page 12: ...eview 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 12 Voice Symbol Indicates speaking function is on off Day Average Indicates that the displayed test result is an average Ket...

Page 13: ...3 mmol L Your blood glucose is number Millimole per Liter When the test is completed The result appears on display When the meter is ready to test symbol appears on display Please apply blood into the strip Room temperature is out of range thus unable to measure When room temperature is outside operating range When room temperature is detected The room temperature is number degree Celsius Fahrenhe...

Page 14: ...f 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 Absorbent Hole Apply a drop of blood here The blood will be drawn automatically See ...

Page 15: ... 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 ...

Page 16: ... old batteries and replace with two new 1 5V AAA size alkaline batteries 3 Close the battery cover If the batteries are inserted correctly you will hear a beep WARNING 1 2 3 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 ...

Page 17: ...ith the meter off Then press the Set button located in the battery compartment The meter is now in the setting mode You can start to set up the meter STEP 1 Set the Year The year will appear first with the year segment flashing Press and release the button to advance one year To move faster keep pressing the button until the desired number appears With the correct year on the display press the Set...

Page 18: ...ashes STEP 3 Set the Date Press and release the button until the correct day appears To move faster hold the button down With the correct day on the display press the Set button and then the hour segment flashes STEP 4 Set the Hour Press and release the button to advance one hour To move faster hold the button down With the correct hour on the display press the Set button and then the minute segme...

Page 19: ...the Minutes Press and release the button to advance one minute To move faster hold the button down With the correct minute on the display press the Set button and then the current unit of temperature starts flashing ...

Page 20: ...e 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 obtained during the 7 14 21 28 60 and 90 day preceding the current date and time settings When the date and time are...

Page 21: ...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...

Page 22: ...vironmental conditions See Storage section of this manual When you want to practice running the test If you drop the meter SureTest and SureTest control solutions contain a known amount of glucose that reacts with test strips By comparing your control solution test results with the expected range printed on the test strip vial label it is able to check that the meter and the test strips are workin...

Page 23: ...sure a good sample and an accurate result Use only for 90 days after first opening Record the discard date date opened plus 90 days on the control solution vial Discard after 90 days Store the control solution tightly closed at temperatures below 30 C 86 F Do not refrigerate PLEASE NOTE The control solution range printed on the test strip vial is for SureTest or SureTest control solution only It i...

Page 24: ...uence CH and ambient temperature date time and flashing Contact bars must be inserted all the way into the meter or you may get an inaccurate test result Every time you perform a control solution test you must enter into the CTL test mode so that the test 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 ...

Page 25: ...the vial again to get another drop and place the drop on your fingertip first STEP 2 Press the button While the symbol appears on the display press the button and then CTL will appear on the display With the CTL sign on the display the meter will not store your test result in memory If you decide not to perform a control solution test press the button again and the CTL sign will disappear ...

Page 26: ...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 Operation...

Page 27: ...void getting hand lotion oils dirt or debris in or on the lancets and the lancet device 27 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 ...

Page 28: ... lancet Insert a lancet into the lancet holder and push 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 ...

Page 29: ...the desired depth Pull the cocking control back until it clicks You will see a color change inside the release button when it is ready If it does not click the device may have been cocked when the lancet was inserted Replace the cap by aligning the arrow on the cap with the release button and then push and turn the cap 1 2 3 ...

Page 30: ...ashing 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 sites other than the finger replace the lancing device cap with the clear cap Turn the clear cap until it is snug but not too tight and then Slide the ejection cocking con...

Page 31: ...ingertip use the clear cap Lancing the finger Press the SureTest lancing device s tip firmly against the lower side of 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 ...

Page 32: ...dow is not filled with blood when 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 32 STEP 4 Apply blood into the test strip When is flashing on the screen apply your blood to the absorbent hole of the test strip until the confirmation window is fu...

Page 33: ...y potentially be a biohazard Please discard it carefully according to your local regulations To remove the lancet pull the cap off Place the protective disk on a hard surface and push the exposed tip into the disk Slide the ejector forward to remove the used lancet Dispose of the lancet according to your local regulations ...

Page 34: ...ucose range for people without diabetes Your target range mmol L Fasting and before meal 4 0 7 0 mmol L _______ mmol L 2 hours after meals 5 0 10 0 mmol L 5 0 8 0 mmol L if A1C targets not being met _______ mmol L Source CDA Clinical Practice Guidelines 2008 Treatment goals should be tailored to the individual Glycemic targets for children less than or equal to 12 and pregnant women differ from th...

Page 35: ...e comparison between meter and laboratory results follow the guide lines below Before you go to the lab Perform a control solution test to make sure that the meter is working properly It is best to fast for at least eight hours before doing comparison tests Take your meter with you to the lab While at the lab Make sure that the samples for both tests the meter test and the lab test are taken and t...

Page 36: ...rawn 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 hematocrit or the loss of body fluid severe dehydration may also cause a meter result to be different from a laboratory result References 4 Surwit R S and Feinglos M N Diabetes Forecast 1988 April 49...

Page 37: ...n twice The 7 day average will appear indicating that you are in the memory mode If you continue to press the button the 14 21 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 durin...

Page 38: ...release the button the meter will recall up to your last 450 test results in order When the memory is full the oldest result is dropped as the newest is added The 14 day average is calculated from the blood glucose results obtained during the last 14 days It also indicates how many blood glucose tests have been performed e g 28 28 tests in the last 14 days It is all the same for the 21 28 60 and 9...

Page 39: ...en reaching the last set of result End and will be shown on LCD display and the meter will be turned off automatically STEP 3 Exit the Memory Mode Keep pressing the button for 5 seconds to turn off the meter ...

Page 40: ... the button to recall the test results the meter will displayed date time and the unit of measurement first If you do not press the button within 5 seconds the blinking and will appear In the meantime you can choose to insert a test strip to start testing your blood or press the button again to review the stored test results 40 If no button is pressed for 2 minutes the meter will show OFF and turn...

Page 41: ...o the Data Port of the meter PC will appear on the display indicating that the meter is ready to transmit data Viewing Results on a Personal Computer Results in memory can be transmitted to a personal computer An Interface Cable is required for data transmission but is not included Please ask your local agent or call toll free for help The software is available on the enclosed CD or can be downloa...

Page 42: ...ns provided in the software to transmit data Results transmitted will include date and time Remove the cable and the meter will automatically turn off PLEASE NOTE While the meter is connected to the PC it is unable to perform a blood glucose test ...

Page 43: ...ntrol solution comes in contact with the meter there is no special cleaning required 1 To clean the meter exterior wipe with a cloth moistened with tap water or a mild cleaning agent then dry the device with a soft and dry cloth Do not flush with water 2 Do not use organic solvents to clean the meter Storage Storage condition 20 C 60 C below 95 relative humidity Always store or transport the meter...

Page 44: ...erate Store your test strips in their original vial only Do not transfer to other container Store test strip packages in a cool and dry place Keep away from direct sunlight and heat After removing a test strip from the vial immediately replace the vial cap and close it tightly Touch the test strip with clean and dry hands 2 Strip Storage ...

Page 45: ...ing date 3 Control solution storage Do not bend cut or alter a test strip in any way Keep the strip vial away from children since the cap may be a choking hazard If swallowed promptly see a doctor for help Storage condition Store the control solution tightly closed at temperatures below 30 C 86 F Do not refrigerate Record the discard date date opened plus 90 days on the control solution vial Disca...

Page 46: ...Improper use may cause an inaccurate result without producing an error message or a symbol In the event of a problem refer to the information under action Never try to disassemble the meter in any circumstances If you encounter any error messages not listed below or if you have followed the actions recommended below but the problem remains unsolved please call the customer service for support ...

Page 47: ...s below measurement limit which is less than 1 1 mmol L KETONE appears when your result is equal or higher than 13 3 mmol L This indicates there is a possibility of ketone accumulation if you are Type 1 diabetes Please seek immediate medical assistance appears when your result is above measurement limit which is higher than 33 3 mmol L ...

Page 48: ...t the test after the meter and test strip have reached the above temperature Re test with a new test strip Review the instructions and re test with a new test strip If the above steps do not work please contact your local Customer Care Line at for help Appears when ambient temperature is below system operation range Appears when ambient temperature is above system operation range Remove the strip ...

Page 49: ...rs end first and facing up Defective meter Please call your local Customer Care Line at for help Insufficient blood sample Repeat the test with a new test strip and a larger sample Defective test strip Repeat the test with a new test strip Sample applied after automatic shutoff 3 minutes after last user action Repeat the test with a new test strip apply sample only when appears on the display Defe...

Page 50: ...Expired or contaminated control solution Check the expiry date or the discard date of the control solution PROBABLE CAUSE WHAT TO DO Did not shake the control solu tion vial very well Shake the control solution vigorously and repeat the test again 3 If the control solution test result is out of range Test strip deterioration Repeat the test with a new test strip Meter malfunction Contact your loca...

Page 51: ... 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 meet the electrical and safety requi...

Page 52: ...uct was purchased will repair 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 repairs of the Product by persons not authorized by misuse abuse damage during transit or lack of reason able care with respect to the Product or failure to follow the written instructions encl...

Page 53: ... vitro diagnostic medical device Do not reuse Consult instructions for use Keep away from sunlight Keep dry Temperature limitation Use by Date of manufacture Batch code Serial number Caution consult accompanying documents R ...

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Page 56: ...t was purchased will repair 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 repairs of the Product by persons not authorized by misuse abuse damage during transit or lack of reason able care with respect to the Product or failure to follow the written instructions enclos...

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