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You may still have a variation from the result because

blood glucose levels can change significantly over short

periods of time, especially if you have recently eaten,

exercised, taken medication, or experienced stress. In

addition, the blood glucose level from a finger prick can be

up to a 20% variance from blood drawn from a vein (venous

sample) used for a lab test*

2

. 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 (dehydration)

may also cause a meter result to be different from a

laboratory result.

References

*2: Schrot, M.D., Patel, M.D., and Foulis, M.D.; Clinical

Diabetes, 25; 43-49, 2007.

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Содержание SMS-4250

Страница 1: ...SMS 4250 Blood Glucose Monitoring System Version 1 0 June 2009 311 4250200 002 Owner s Manual ...

Страница 2: ...em Please read it thoroughly and carefully and use only with Test Strip The most unique feature of this system is its speaking function which is an acoustic aid for users Another unique feature is its no code function which means no need to calibrate your meter and makes you easily monitor blood glucose at home ...

Страница 3: ... which are not supplied by the 333 manufacturer Do not let the equipment or its flexible cord come into 444 contact with surfaces which are too hot to touch Do not use the equipment where aerosol sprays are 555 being used or where oxygen is being administered Do not use device if it is not working properly or if it 666 has suffered any damage Read all instructions thoroughly and practice the test ...

Страница 4: ...Contents of the System 10 Meter Appearance and Key Functions 12 Meter Display 13 Test Strip 14 BEFORE USE 15 Battery Replacement 15 Setting the Meter and Deleting the Memory 18 BEFORE TESTING BLOOD GLUCOSE 25 PerformanceCheckswithVocalPointControlSolutions 25 Important Control Test Information 26 Performing a Control Test 27 TESTING YOUR BLOOD 31 Test Procedure 32 Expected Test Results 40 ...

Страница 5: ...Y 43 Viewing Results on the Meter 43 Viewing Results on a Personal Computer 48 TAKINGCAREOFYOURMETERANDTESTSTRIPS 50 Cleaning 50 Storage 50 PROBLEM SOLVING GUIDE 53 Special Message 54 Error Message 55 Operational Problem 56 SPECIFICATIONS 58 SUMMARY OF OPERATION 59 ...

Страница 6: ...only capillary whole blood sample to test your blood glucose Using other substances will cause wrong results If you are experiencing symptoms that are inconsistent 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 Reading...

Страница 7: ...eck their blood glucose levels This system provides you to test on the palm the forearm the upper arm the calf or the thigh with the equivalent results to fingertip testing What s the advantage Fingertips feel pain more readily because they are full of nerve endings receptors At other body sites since nerve endings are not so condensed you will not feel as much pain as at the fingertip ABOUT ALTER...

Страница 8: ...take blood sample from your finger only We strongly recommend 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 Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia You are testing for hyperglycemia Your AST results do not match the ...

Страница 9: ... 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 a site that has not been rubbed 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 ...

Страница 10: ...dy state blood glucose conditions described in the section of About Alternative Site Testing AST The system consists of three main products the blood glucose meter test strips and a control solution These products have been designed tested and proven to work together as a system to produce accurate blood glucose test results Use only the same brand name test strips and a control solution with the ...

Страница 11: ...s If your system has been opened prior to use or it does 111 not contain all parts listed above please return your system to the place of purchase Test strips control solutions and lancets are optional 222 They are not included in the standard kit Please contact your local agent or place of purchase for availability PLEASE NOTE ...

Страница 12: ...e meter will turn on automatically after insertion 4 UP BUTTON 5 DOWN BUTTON is used to adjust setting and the speaking volume 6 M BUTTON located in front of the meter with M on it is used to turn on the meter and enter the memory 7 SET BUTTON is used to set up the meter 8 EARPHONE JACK 9 DATA PORT located at the side is for cable connection 10 REPEAT BUTTON is used to replay the previous recordin...

Страница 13: ...e application KETONE WARNING LOW BATTERY SYMBOL Appears when the battery power is low MEMORY SYMBOL Appears when you review the memory Flashes when meter is ready for sample application CTL SYMBOL DAY AVERAGE DATE TIME control test and indicates that the result won t be stored in the memory Indicates that the displayed test result is an average Appears when the test result is equal to or higher th...

Страница 14: ...est strip consists 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 Absorbent Hole Apply a drop of blood here and the blood will be ...

Страница 15: ...two different messages The 111 symbol appears together with other display messages the meter is functional and the result remains accurate but it is time to change the batteries 2 The symbol appears with the E b symbol Error and low the batteries can not provide enough power to do a test You must change the batteries immediately Battery is low please replace Battery is dead please change ...

Страница 16: ...es does not affect the test results stored in memory Batteries might leak chemicals if unused for a long time Remove the batteries if you are not going to use the device for an extended period i e 3 months or more PLEASE NOTE ...

Страница 17: ...remove STEP 2 Remove the old batteries and replace with two 1 5V AAA size alkaline batteries STEP 3 Close the battery cover If the batteries are inserted correctly you will hear a beep As with all small batteries these batteries should be kept away from small children If they are swallowed promptly see a doctor for help WARNING ...

Страница 18: ...o change the time or replace the batteries however you may need to enter the setting mode and reset Please set voice volume year month day hour minute and memory deletion according to the following steps Start with the meter off Then keep pressing the S button for 3 seconds The meter is now in the setting mode You can start setting up the meter You are now in setting mode ...

Страница 19: ...ff will not display on LCD during testing Numbers 1 to 7 indicates speaking volume from low to high At this time will be displayed on LCD during testing Press the S button and then the year segment flashes STEP 2 Set the Year Press the Up or Down button until the desired year appears Press the S button and then the month segment flashes Voice volume is 7 The Year is 2009 ...

Страница 20: ...until the desired month appears Press the S button and then the date segment flashes STEP 4 Set the Date Press the Up or Down button until the desired date appears Press the S button and then the hour segment flashes The month is January The date is 18th ...

Страница 21: ...il the desired hour appears Press the S button and then the minute segment flashes STEP 6 Set the Minutes Press the Up or Down button until the desired hour appears Press the S button and then the minute segment flashes The hour is 10 PM The minutes are 8 ...

Страница 22: ...el and may lead to incorrect treatment WARNING STEP 7 Select mg dL or mmol L Press the Up or Down button to select the unit of measurement you want to use Press the S button and then meter will display dEL and flashing STEP 8 Select F or C Press the Up or Down button to select the unit of measurement you want to use Press the S button and then meter will display dEL and flashing Blood glucose unit...

Страница 23: ... you would like to delete ALL memory press the Up button twice and are displayed on the meter which means that all data stored are deleted The memory of this meter is empty now Delete memory record function Press up key to clear all records Are you sure you want to delete ALL records Press up key again to clear all records All memory records have been deleted Have a nice day ...

Страница 24: ...1 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 days preceding the current date and time settings When the date and time are changed the 7 14 21 28 60 and 90 day averages may change If the meter is in the setting mode and if no button is pressed for 3 minutes the meter will turn off automatic...

Страница 25: ...ocedure using the control solution When you can do three tests in a row that are within the expected range you are ready to test your blood For routinely checking the meter and test strips perform a single test for each level of control solution at least once a week When you first get your meter When you begin using a new vial of test strips Whenever you suspect that the meter or test strips are n...

Страница 26: ... and wipe off the dispenser tip to ensure a pure 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 from 36 to 86 F 2 to 30 C Do not freeze PLEASE NOTE The control solution range printed on the test strip vial is for Vocal...

Страница 27: ...end first into test slot The meter will turn on automatically and displays the followings in sequence CHK and and flashing Thank you for using this product Test strip inserted Today s date is Friday January first 2009 The time is 10 08AM The room temperature is 75 degrees Fahrenheit Please apply blood onto the test strip ...

Страница 28: ...e to do so will cause confusion between the blood glucose test result and the control solution test result in system memory WARNING After the symbol appears on the display press the M button so that 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 M button again and the...

Страница 29: ...her drop and apply the drop to this top of the cap STEP 4 Apply Control Solution Hold the meter up to meet the absorbent hole of the test strip and the drop will be automatically absorbed Once the confirmation window fills completely the meter will begin to count down To avoid contaminating the control solution with the contents of the test strip you have to place a drop of control solution on a c...

Страница 30: ...he solution used Low Normal or High to the proper range Out of range results If test results fall outside the range printed on the test strip vial check the section of Operation Problem in troubleshooting guide and repeat the test If you continue to get out of range results it means that the system may not be working properly Do NOT test your blood Contact the place of purchase for help Now testin...

Страница 31: ...ems needed to test A Blood glucose meter B Test strip C Lancing Device D Sterile lancet E Clear cap Optional item not included To reduce the chance of infection Never share a lancet or the lancing device Always use a new sterile lancet Lancets are for single use only Avoid getting hand lotion oils dirt or debris in or on the lancets and the lancing device WARNING ...

Страница 32: ...mly until it is fully seated Twist the protective disk until it separates from the lancet Replace the lancing device cap Turn the cap until it is snug but not too tight The adjustable tip offers 5 levels of skin penetration Twist the adjustable tip in either direction until the number lines up with the arrow 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin ...

Страница 33: ...he fingertip for AST testing A clear cap 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 control back until it clicks The lancing device is now ready for use Set aside for later use ...

Страница 34: ...t slot The meter will turn on automatically and display the followings in sequence CHK and and flashing Thank you for using this product Test strip inserted Today s date is Friday October first 2009 The time is 12 25 PM The room temperature is 75 degrees Fahrenheit Please apply blood onto the test strip ...

Страница 35: ...ative Site Testing AST for possible punctured sites After penetration discard the first drop of blood with a clean tissue or cotton G e n t l y s q u e e z e t h e punctured area to obtain blood Be careful NOT to smear the blood sample The volume of blood sample m u s t b e a t l e a s t 0 7 microliter in volume actual size Select the puncture site either in finger or in other parts AST Clean the ...

Страница 36: ... your health professional firstly It is recommended that you discard the first drop of blood as it might contain tissue fluid which may affect the test result When is flashing on the screen apply your blood to the absorbent hole of the test strip until the confirmation window is fully covered with blood The meter will then begin to count down automatically Now testing x ...

Страница 37: ... on it against the test strip or try to apply a smeared blood sample on the test strip If you do not apply a blood sample to the test strip within 3 minutes the meter will automatically turn off You must remove and reinsert the test strip to restart the test procedure You can press the M button at anytime to skip the current voice message and go to the next step Your blood glucose is ninety two mi...

Страница 38: ...d the meter will shut off automatically afterward If you want to hear the previous voice message you can press the Repeat button to replay it The blood should completely fill the confirmation window before the meter begins to count down If you find that the confirmation window is not filled with blood when the meter is counting NEVER try to add more blood to the test strip Discard the test strip a...

Страница 39: ... lancet Take the lancet out carefully Place the disk on a hard s u r f a c e a n d p u s h t h e exposed tip into the protective disk The used lancet and the used test strip may be biohazardous Please discard it carefully according to your local regulations WARNING ...

Страница 40: ... and your professional monitor and adjust your treatment plan to gain better control of your diabetes Time of day Plasma glucose r a n g e m g d L for people with diabetes Your target range mg dL Fasting and before meals 1 70 130mg dL 3 9 7 2 mmol L 2 h o u r s a f t e r meals 1 Less than 180mg dL 10 0 mmol L Reference 1 American Diabetes Association 2008 Standards of Medical Care in Diabetes Care...

Страница 41: ...meter with blood that has been collected in a gray top test tube Use fresh capillary blood only Test results from the meter and laboratory are both expressed in plasma equivalent units The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation Meter results can be affected by factors and conditions that do not affect laboratory results in the same...

Страница 42: ...om a finger prick can be up to a 20 variance from blood drawn from a vein venous sample used for a lab test 2 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 dehydration may also cause a meter result to be different from a laboratory result References 2 Schrot M ...

Страница 43: ...the test results through these easy steps 1 Recall the Stored Test Results STEP 1 When the meter is off press and release the M button The screen shows Press the M button again 1 appears first and then the latest glucose result along with date and time will be shown on the screen Thank you for using this product Today s date is Sunday January 10th 2009 The time is 10 08PM Press main key for memory...

Страница 44: ...Have a nice day STEP 2 Press the Up and Down button to recall the test results stored in the meter Keep pressing the M button and the meter will be turned off The result of your blood glucose test will appear after the meter counts down to 0 This reading will automatically be stored in the memory ...

Страница 45: ... button for 2 3 seconds until blinking appears Release the M button and then the 7 day average result will appear on the screen Thank you for using this product Today s date is Saturday January 10th 2009 The time is 10 08PM Press main key for memory recall mode The seven day average is eighty two milligrams per deciliter for sixty six records ...

Страница 46: ...ike the 7 day average the 14 day average and the times of performing test in the past 14 days will be shown on the screen Keep pressing the M button and the meter will be turned off The fourteen day average is eighty three milligrams per deciliter for eighty seven records Have a nice day ...

Страница 47: ...or blood glucose results only Any time you want to exit the memory mode keep pressing the M button for 5 seconds or leave it without any action for 3 minutes The meter will turn off automatically If using the meter for the first time is displayed when you recall the test results or review the average result It means that there is no test result in memory NOTE No memory record available ...

Страница 48: ...or to obtain an Interface Cable separately please contact your local agent or place of purchase for assistance STEP 1 Install Software Install Diabetes Management Software on your Computer by following the instructions provided on Specialty Medical Supplies website www specialtymedicalsupplies com STEP 2 Connect to Personal Computer Connect the interface cable to a serial port of your computer Wit...

Страница 49: ...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 ...

Страница 50: ...ter there is no special cleaning required To clean the meter s exterior wipe with a cloth 111 moistened with tap water or a mild cleaning agent then dry the device with a soft and dry cloth Do not flush with water Do not use organic solvents to clean the meter 222 1 Meter Storage Storage Storage condition 4 F to140 F 20 C to 60 C below 95 relative humidity Always store or transport the meter in it...

Страница 51: ...ackages 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 Handle the test strip with clean and dry hands Use each test strip immediately after removing it from the vial Write the discard date the date opened plus 90 days on the vial label when you first open it Discard remaining test strip...

Страница 52: ...the cap and the test strip may be a choking h a z a r d I f s w a l l o w e d promptly see a doctor for help Storage condition Store the control solution tightly closed at temperatures 36 F to 86 F 2 C to 30 C Do not freeze Record the discard date date opened plus 90 days on the control solution vial Discard on this date ...

Страница 53: ...proper use may cause an inaccurate result without producing an error message In the event of a problem refer to the information under action Never try to disassemble the meter under any circumstances If you encounter any error messages not listed below or if you have followed the actions recommended below but the problem persists please contact your local agent or place of purchase for assistance ...

Страница 54: ...essional Appears when your result is above measurement limit which is higher than 600 mg dL This indicates severe hyperglycemia high blood glucose You should seek immediate medical assistance KETONE appears when your result is equal to or higher than 240 mg dL This indicates there is a possibility of ketone accumulation if you are Type 1 diabetes Please seek immediate medical assistance Special sy...

Страница 55: ...testing Test with a new test strip The room temperature is out of range Thus unable to measure Appears when ambient temperature is below system operation range System operation range is 10 40 C 50 104 F Repeat the test after the meter and test strip have reached the above temperature Appears when ambient temperature is above system operation range Meter malfunction Please contact local distributor...

Страница 56: ...rt the test strip correctly with the contact bar end first and facing up Defective meter Please contact the place of purchase for assistance Insufficient blood sample Repeat the test using a new test strip with larger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after automatic shutdown 3 minutes after last user action Repeat the test with a new ...

Страница 57: ...e test again Expired or contaminated control solution Check the expiration date or the discarded date of the control solution Control solution that is too warm or too cold Place control solution meter and test strips should come to room temperature 68 F to 77 F 20 C to 25 C before testing Test strip deterioration Repeat the test with a new test strip Meter malfunction Contact the local agent of pl...

Страница 58: ... detection Auto sample loading detection Auto reaction time countdown Temperature warning Operating condition 50 F to 104 F 10 C to 40 C below 85 R H non condensing Meter storage transportation condition 4 F to140 F 20 C to 60 C below 95 relative humidity Measurement units mg dL or mmol L Measurement range 20 600mg dL 1 1 33 3mmol L The device has been tested to meet the electrical and safety requ...

Страница 59: ...ore you begin testing STEP 1 Insert the Test Strip dark side up The meter is automatically turned on and displayed the followings in sequence CHK and and flashing Thank you for using this product Test strip Inserted Today s date is October first 2008 The time is 12 25 PM The room temperature is 75 degrees Fahrenheit Please apply blood onto the test strip ...

Страница 60: ...ow is completely filled STEP 3 Obtain accurate results in 7 seconds The meter begins to count down At the time if you find confirmation window does not fill completely do not add blood to the strip Discard the strip and use the new one to retest Now testing x Your blood glucose is ninety two milligrams per deciliter ...

Страница 61: ...STEP 4 Eject the used strip automatically STEP 5 Discard the used strip and the lancet according to your local regulations At all other times you should contact your health care professional for assistance ...

Страница 62: ...62 NOTES ...

Страница 63: ...63 NOTES ...

Страница 64: ...64 NOTES ...

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