i-SENS, Inc.
Contents
1. Within Run Precision Blood average 41 4 mg dL 2 3 mmol L SD 1 8 mg dL 0 1 mmol L Blood average 79 6 mg dL 4 4 mmol L CV 3 5 Blood average 129 8 mg dL 7 2 mmol L CV 2 6 Blood average 201 9 mg dL 11 2 mmol L CV 3 1 Blood average 349 6 mg dL 19 4 mmol L CV z 2 726 Total Precision Control average 36 2 mg dL 2 0 mmol L SD 1 3 mg dL 0 07 mmol L Control average 117 0 mg dL 6 5 mmol L CV 2 376 Control average 321 8 mg dL 17 9 mmol L CV 2 4 This study shows that there could be variation of up to 2 4 37 pu ee Warranty Information Manufacturer s Warranty i SENS Inc warrants that the Soul Meter shall be free of defects in material and workmanship in normal use for a period of five 5 years The meter must have been subjected to normal use The warranty does not cover improper handling tampering use or Service of the meter Any claim must be made within the warranty period i SENS will at its discretion repair or replace a defective meter or meter part that is covered by this warranty As a matter of warranty policy i SENS will not reimburse the consumer s purchase price Obtaining Warranty Service To obtain warranty service you must return the defective meter or meter part along with proof of purchase to your nearest i SENS Authorized Warranty Station 382. Strip Components CD Soul Blood Glucose Meter Lancing Device Logbook Lancet 10 C Carrying Case Owner s Booklet Soul Blood Glucose Test Strip 10 Quick Reference Guide 9 Battery 2 Check all the components after opening the Soul blood glucose monitoring system package Please contact your authorized i SENS sales representative if any component is missing or damaged The PC care cable for data transmission can be ordered separately Please contact your authorized i SENS sales representative or visit www i sens com The Soul blood glucose monitoring system measures blood glucose quickly and accurately It automatically absorbs the small blood sample applied to the narrow edge of the strip fi Contact bars Gently push the test strip with its contact bars facing up into the test strip port of meter Confirmation window Er Check here to see whether sufficient blood sample has been applied L Edge to apply blood sample Apply blood sample here for testing Soul Blood Glucose Test Strip o Soul Blood Glucose Meter Warning The Soul test strip should be used only with fresh capillary whole blood samples Do not reuse test strips Do not use test strips past the expiration or discard date Check the expiration date printed on the vial When you first open a test strip vial you must record the discard date date opened plus 6 months in t
3. and the latest test result will be stored results dates and times displayed in chronological order The Soul meter calculates and displays the averages of total test After checking the stored test results press the M button to turn off results pre meal test results and post meal test f results from the meter the last 14 days Viewing Test Results Stored in the Meter s Memory Step 1 Press the C button or M button to turn the meter on The current date and time will be displayed on the bottom of the screen for 2 seconds followed by the average value and the number of the test results saved within the last 14 days Step 2 Press C button to view the TT average value and the number m unm of tests performed before eating a meal for the last 14 days l LL j i l LI On pressing C button again the Ta um mg average value and the number m of tests performed post meals The number of The number of pre meal tests post meal tests for the same period will appear on the screen The number of total tests 24 25 o Setting the Alarm Function o Replacing the Batteries The Soul meter has a post meal alarm PP2 alarm The PP2 alarm goes off 2 hours after setting the alarm The alarms ring for 15 seconds and can be silenced by pressing C button or the M button or by inserting a test strip Setting the post meal alarm PP2 alarm Step 1 Setting the PP2 alarm On Without inserting a
4. down from 5 to 1 After your control solution result appears on the display press C button for 3 seconds till the check icon appears on the display When the check icon is displayed the result is not a Te stored in the meter s memory and is not l included in the 14 day averages Step 4 Control Solution Range Compare the result displayed on the meter to Centrol A 100 148mgidL Centrol B 191 1286mg dL the range printed on the test strip vial The result should fall within that range Used strips should be discarded safely in disposable containers Ifthe results you get are not within this range the meter and test strip may not work properly Then stop using the meter and contact the Caution nearest i SENS representative The range printed on the test strip vial is for the Soul Control Solution only It does not have any connection to your blood glucose level 30 Comparing the Control Solution Test Results Repeat the control test if the test result falls outside the range printed on label of the test strip vial Out of range results may occur due to the following factors When the control solution vial was not shaken well When the control solution is past its expiration date or is contaminated When the meter the strip or the control solution were exposed to high or low temperatures When the first few drops of the control solution were not discarded or the tip of the vi
5. set Battery icon indicates meter battery is running T gm mmol L mg dL Test results test results displaying panel Blood insertion icon indicates meter is ready for the application of a drop l 1 low and needs to 7 4 I 1 I I I be replaced 88 88 88 88 Month Day Hour Minute Post meal l test flag appears during post meal testing and when post meal test results are displayed of blood or control solution Decimal point appears when the blood glucose measuring unit is set to mmol L mmol L mg dL unit for measuring blood glucose PEENE EE ENNEN NE ENEE Press and hold the M button for 3 seconds to switch on the meter After all settings are finished press and hold the M button for 3 seconds to turn off the meter Press C button to reach the accurate value Press and hold C button to scroll faster Adjusting the Date Time and Unit Step 1 Entering the SET Mode Press and hold the M button for 3 seconds to switch on the meter After all the segments flash across the screen the SET character icon will be displayed on the screen Press the M button again to enter the year setting mode Step 2 Setting the Year The number that appears on the screen after the meter is turned on indicates the year of manufacture Press and release C button to adjust until the correct year appears Press and hold C button to scroll through the numbers quickly
6. test strip TT ie UP up pgs umm press and hold C button for 3 j seconds to set the post meal c3 FE ST T E CH alarm The PP2 character the alarm icon and then the On character will be displayed The screen will then automatically change to the memory check mode At this time the alarm icon indicating that the PP2 alarm has been set will be displayed on the screen To exit the memory check mode and turn off the meter push the M button Step 2 Setting the PP2 alarm OFF To turn off the PP2 alarm press and hold C button for 3 B5 w P m seconds The PP2 character a the alarm icon and then the Li Li OFF character will appear on E ove the screen Then the screen GEESE Uae mz O85 will change automatically to the icon vanishes memory check mode without the alarm icon being displayed The alarm will not sound if you have turned the sound off 26 The Soul meter comes with two 3 0 V lithium batteries Around 50 tests can still be carried out after the icon appears on the display for the first time but the battery should be replaced as soon as possible The test results will not be saved if the icon appears Step 1 f mn D Make sure the meter is turned off Push E the cover in the direction of the arrow to open the battery compartment Step 2 Pull the plastic tape up and remove the old batteries Insert two new batteries with the side faci
7. 86 F When using the meter for the first time Whenever you open a new vial of test strips If the meter or test strips do not function properly If your symptoms are inconsistent with the blood glucose test results and you feel that the meter or test strips are not working properly f you drop or damage the meter 28 If all the results you get on testing three times continuously are within the range printed on the test strip the meter and test strips are working properly and you may use them for your blood glucose test Control Solution Testing Step 1 Insert a test strip with the contact bars facing upwards into the meter port Push the strip in gently until the meter beeps Be careful not to bend the test strip The 4 symbol will appear on the Screen Step 2 Shake the Soul Control Solution vial before each test Remove the cap and squeeze the vial to discard the first drop Then wipe the tip with P Pw a clean tissue or cloth TIT After the 4 symbol appears on the EI display apply the solution to the narrow edge of the test strip until the meter beeps Make sure the confirmation window fills completely The meter may switch off if the blood sample is not applied within 2 minutes of the 4 icon appearing on the screen If the meter turns off remove the strip reinsert and start from step 1 29 Checking the System Step 3 mm A test result will appear after the meter counts
8. After setting the year press the M button to confirm your selection and enter the month setting mode o Setting up Your System Step 3 Setting the Month A number indicating the month will be blinking on the left corner of the screen Press C button until the correct month appears Press the M button to confirm your selection and enter the date setting mode Step 4 Setting the Date Press C button until the screen displays the correct date Press the M button to confirm the date and enter the time setting mode Step 5 Setting the Time The meter can be set in the AM PM 12 hour or the 24 hour clock format Press C button to select a format The AM PM icon is not displayed in the 24 hour format After selecting the format press the M button to enter the hour setting mode 10 Step 6 Setting the Hour Press C button until the correct hour appears After the hour is set press the M button to enter the minute setting mode Step 7 Setting the Minute Press C button until the correct minute appears After setting the minute press the M button to enter the unit setting mode Step 8 Setting the Measurement Unit The meter is set to mg dL Press C button to change to mmol L or to return to mg dL Press the M button to confirm your selection and to enter the sound setting mode However in some countries the meter may have been set to the unit AR mo dL Tie le B generally used in the coun
9. a When hypoglycemia is not well recognized When insulin has the biggest effect 2 hours after an insulin injection 20 21 o Hi and Lo Messages Target Blood Glucose Ranges Hi Message The meter displays results between Reminders 20 600 mg dL 1 1 33 3 mmol L Your target ranges The Hi icon appears when the blood i i Time of day from your healthcare expert glucose level is more than 600 mg dL D 33 3 mmol L and indicates Before breakfast hyperglycemia mg dL Before lunch or dinner If the Hi icon is displayed again on wia REE hour after meals retesting please contact your healthcare professional immediately 2 hours after meals Between 2 a m and 4 a m Lo Message Source Diagnosis of Diabetes NIH Publication The Lo icon appears when the result No 05 4642 January 2005 is less than 20 mg dL 1 1 mmol L P and indicates hypoglycemia f If the Lo icon is displayed again on retesting please contact your healthcare professional immediately tile de38 Please contact your authorized i SENS sales representative if such messages are displayed even though you do not have hyperglycemia or hypoglycemia 22 23 o Meter Memory The Soul meter can save up to 250 glucose test results with time Step 3 and date If the memory is full the oldest test result will be deleted Each time you press the C button you will see previous test
10. al was not wiped clean When the test strip is past its expiration date When the meter is not functioning properly The Soul Control Solution can be purchased separately Please contact your authorized i SENS sales representative 31 Caring for Your System Understanding Error and Other Messages Use a soft cloth or tissue to wipe the meter exterior If necessary the soft cloth or tissue might be dipped in a small amount of alcohol Do not use organic solvents such as benzene or acetone or household and industrial cleaners that may cause irreparable damage to the meter Store all the meter components in the portable case to prevent loss Caution Do not expose the meter to direct sunlight or heat for an extended period of time Prevent the entry of dirt dust blood or water at the meter s test strip port Do not drop the meter or submit it to strong shocks Do not try to fix or alter the meter in any way Keep the meter away from strong electromagnetic fields such as cell phones and microwave ovens Soul meter should be used only with Soul strips e Store the meter at a temperature between 10 40 C 32 What It Means What To Do A used test strip Repeat the test was inserted with a new test strip EN The blood or Repeat the test control solution with a new test sample was strip and wait until applied before the the 4icon appears 4 icon appeared before a
11. e I sens el i Medical Technology Promedt i SENS Inc Consulting GmbH 465 6 Wolgye4 dong Nowon gu Altenhofstrasse 80 D 66386 Seoul 139 845 Korea St Ingbert Germany WWW i sens com 2010 i SENS Inc All Rights Reserved PGA1E3091 REV2 CCo e I Sens Owner s Booklet Soul Blood Glucose Monitoring System A No Coding System Easy amp Accurate Testing Information Important Information e em emen Specifications Soul Blood Glucose Monitoring System Soul Blood Glucose Test Strip eetere Soul Blood Glucose Meter RR Soul Blood Glucose Meter Display Preparation Setting up Your System Adjusting the Date Time end Unit Setting the Sound On OFF nie Setting the Test Result Reset Testing Using the Lancing Device Preparing the Lancing Device for Blood d Sample R Retrieval eee Preparing the Meter and Test Strip Flagging Post meal Test Results Applying Blood Sample o Discarding Used Lancets sese Alternative Site Testing Hi and Lo Messages e Target Blood Glucose Ranges e walnere daa Additional Functions Meter Memory Viewing Test Results Stored i in nthe Meter s s Memory eene Setting the Alarm Function Setting the post meal alarm PP2 alarm Maintenance Replacing the Batteries Checking the System Caring for Your System Understanding Error and Other Messages General Troubleshooting Performance Characteristics Warranty Infor
12. e test results stored in the meter will be deleted and the screen will be similar to the picture on the right If you do not want to delete the results press the M button while the screen displays no Then the screen will return to step 1 See page 9 At any stage if the M button is pressed for 3 seconds the Time Date and Unit setting mode will finish and the meter will be turned off Press and hold C button to scroll through numbers quickly Using the Lancing Device You will need a lancing device in order to collect a blood sample You may use the lancing device contained in the Soul Blood Glucose Monitoring System or any other medically approved lancing device Ejection System Adjustable Tip Lancet Holder I i Sliding Barrel Release Button To avoid infection when drawing a sample use a lancet only one time and fei Do not use a lancet that has been used by others Always use a new Sterile lancet Keep the lancing device clean Preparing the Lancing Device for Blood Sample Retrieval Step 1 Wash hands and fingertip sample site with soap and warm water Rinse and dry thoroughly Step 2 Unscrew lancing device tip Step 3 Firmly insert new lancet into carrier Hold lancet firmly Gently twist to pull off protective disk Save disk to recap lancet after use Replace lancing device tip o Using the Lancing Device Step 4 Select a desired de
13. easures the amount of glucose in the blood sample e The Soul blood glucose meter is designed to minimize code related errors in monitoring by using the no coding function The Soul blood glucose meter should be used only with the Soul strip The average hematocrit range is between 30 and 50 However people with severe anemia pregnant women and newborns may have higher hematocrit and this can affect the test results Very high 60 or more or very low 20 or less hematocrit can lead to incorrect test results A glucose value of less than 70 mg dL 3 9 mmol L may indicate hypoglycemia and a value of more than 240 mg dL 13 3 mmol L may indicate hyperglycemia If you need assistance please contact your authorized i SENS sales representative or visit www i sens com for more information Product specifications Reported result range 20 600 mg dL 1 1 33 3 mmol L Sample size Minimum 0 510 Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 1 000 tests Two 3 0 V lithium batteries P d disposable type CR2032 Memory 250 test results Size 90 3 X 49 2 X 14 5 mm Weight 50 5 g with battery Operating ranges Temperature 10 40 C 50 104 F Relative humidity 10 90 Hematocrit 20 60 Soul Blood Glucose Monitoring System Soul Blood Glucose Test
14. eat the test after inserting a new test strip Check the validity period of the test strip Check if the strip has passed the discard date date of opening the test strip vial plus 6 months Check the meter NOTE If the problem is not resolved please contact your authorized i SENS sales representative 35 o Performance Characteristics The performance of Soul Blood Glucose Test Strips has been evaluated in laboratory and in clinical tests Accuracy The accuracy of the Soul BGM System GM505k was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer a laboratory instrument The following results were obtained by 122 diabetic patients at clinic centers Slope 1 02 Y intercept 7 39 mg dL Correlation coefficient r 0 992 Number of sample 122 Range tested 40 577 mg dL Accuracy results for glucose concentration lt 75 mg dL 4 2 mmol L Within 5 mg dL Within 10 mg dL Within 15 mg dL Within 0 28 mmol L Within 0 56 mmol L Within 0 83 mmol L 11 11 100 11 11 100 11 11 100 Accuracy results for glucose concentration 75 mg dL 4 2 mmol L Within 5 Within 10 Within 15 Within 20 47 111 42 89 111 80 109 111 98 111 111 100 36 Precision Precision studies were performed in a laboratory using the Soul BGM System
15. he space provided on the label Store test strips in a cool and dry place at a temperature of 8 30 C 46 86 F Keep away test strips from direct sunlight or heat and do not refrigerate or freeze Store test strips only in their original vial Close the vial tightly after removing a test strip for testing and use the strip immediately Handle test strips only with clean and dry hands Do not bend cut or alter test strips in any way For detailed storage and usage information refer to the Soul test strip package insert Keep the meter and testing supplies away from Caution young children Transmission Port Used to transfer data from the meter to a computer with a PC care cable Display Shows results messages rC Button Selects or changes information M Button 7 Turns the meter on off and confirms menu selections I E Test Strip Port Insert test strip here The PC care cable for data transmission to PC can be ordered separately Please contact your authorized i SENS sales representative or visit www i sens com Soul Blood Glucose Meter Display o Setting up Your System mem appears when test results stored in the memory are displayed I I I I alarm 1 appears when r Sound icon appears only when the sound is set to OFF appears when test results have not been saved the time alarm has been
16. mation eee _ o Important Information Read this First To receive safe and optimum system benefits please read the entire manual contents before using the system Please note the following instructions e Do not use the system for the diagnosis of diabetes without the guidance of a healthcare professional or for testing newborns e Use only fresh capillary whole blood samples for testing e Alternative site and fingertip test results may differ significantly due to rapid change in the glucose level post meal insulin injection or exercise The following chart explains the symbols you ll find in the Soul User Manual product packaging and product inserts vD For in vitro diagnostic use C This product fulfills the requirements for Directive 98 79 EC on in vitro diagnostic medical devices Cautions for safety and optimum product use Consult instruction for use Manufacturer Authorized representative Do not reuse z Use by o Batch code Temperature limitations 8 C Do not discard this product with other household type waste Serial number et e f EBS o Important Information o Specifications The Soul blood glucose monitoring system is intended for self testing outside the body in vitro diagnostic use The glucose in the blood sample mixes with special chemicals on the test strip where to produce a small electrical current The Soul meter detects this electrical current and m
17. ng fingers Press the release button Remove the device from the finger Wait a few seconds for a blood drop to form A minimum volume of 0 5 microliter is needed to fill the confirmation window actual size of 0 510 e Step 9 Discarding Used Lancets After the amp symbol appears on the Screen apply the blood sample to the Step 1 narrow end of the test strip till the meter Unscrew general lancing beeps If the confirmation window is not device tip filled before the meter finishes counting down then discard the test strip and insert J a new one N If confirmation window is not filled in time because of abnormal viscosity or i n Step 2 insufficient volume Er4 message will E perm Place protective cover on appsal Sample Sample lancet Pull out the sliding barrel and push the lancet ejector The meter may switch off if the blood sample is not forward it ine HIDE to applied within 2 minutes of the 4 icon appearing on dispose of fhe used lancet ma the screen If the meter turns off remove the strip and proper biohazard container reinsert Step 10 mmm The test result will appear after the meter counts down from 5 to 1 The result will be automatically stored in the meter s memory If the test strip is removed after the test result is displayed the meter will automatically switch off after 3 seconds am Discard used test strips safely in di
18. ng up as shown in the figure Step 3 O Place the cover over the battery mm compartment Push down until you hear the tab click into place Replacing batteries has no effect on the test results previously saved After replacing batteries you may need to reset your meter setting 27 Checking the System You may check your meter and test strips using the Soul Control Solution The Soul Control Solution contains a known amount of glucose and is used to check that the meter and the test strips are working properly The test strip vials have Soul Control Solution ranges printed on their labels Compare the result displayed on the meter to the Soul Control Solution range printed on the test strip vial Before using a new meter or a new vial of test strips conduct a control solution test following the procedure on page 27 Use only the Soul Control Solution Check the expiration dates printed on the vial When you first open a control solution vial record the discard date date opened plus three months in the space provided on the label Make sure your meter test strips and control solution are at room temperature before testing Control Solution tests must be done at room temperature 20 25 C 68 77 F Before using the control solution shake the vial discard the first few drops and wipe the tip clean e Close the control solution vial tightly and store at a temperature of 8 30 C 46
19. pplying the blood sample a The temperature Move to an area during the test was where the above or below the temperature is operating range within the operating range 10 40 C 50 104 F and repeat the test after 30 minutes 33 Understanding Error and Other Messages General Troubleshooting Seo What To Do The blood sample has abnormally high viscosity or insufficient volume Repeat the test after inserting a new test strip MV A test strip was not inserted properly Try to insert a test strip properly There is a problem with the meter Do not use the meter Contact your authorized i SENS sales representative If the error messages persist contact your authorized i SENS sales representative Problem Message What Troubleshooting Means The display is blank even after inserting a test strip Check whether the test strip is inserted with the contact bars facing up Check if the strip has been inserted completely till the end Check whether the batteries are inserted with the side facing up Replace the batteries The test does not start even after applying the blood sample on the strip Check if the confirmation window is filled adequately Repeat the test after inserting a new test strip The test result doesn t match your expectation Rep
20. pth of one to five 1 5 on lance s adjustable tip Rotate ring to align desired number with arrow A beginning setting of three 3 is recommended Step 5 To cock the lancing device hold the tip in one hand Pull the sliding barrel on with the other hand The lancing device is cocked when you feel a click s Preparing the Meter and Test Strip Step 6 Insert a test strip with the contact bars facing upwards into the meter port Push the strip in gently until the meter beeps Be careful not to bend the test strip The 4 symbol will appear on the screen ACT K Flagging Post meal Test Results The Soul meter allows you to flag a result of an post meal test with t icon The post meal test flag t can be attached just before applying the blood sample Once you attach the post meal flag ty to the test results it cannot be deleted 16 Step 7 If you want to attach a post meal flag tt to a test result press and hold C button for 3 seconds after inserting the test strip The post meal flag 11 and the 4 symbol will appear on the screen A The test result will also be displayed with am the post meal flag 1 If you do not want to save the result a post meal test move on to the step 8 after the step 6 Applying Blood Sample Step 8 Obtain a blood sample using the lancing device Place the device against the pad of the finger The best puncture sites are on the middle or ri
21. sposable containers E Caution The lancet is for single use only Never share or reuse P a lancet Always dispose of lancets properly 18 19 T o Alternative Site Testing What is AST Alternative Site Testing Usually when someone tests their glucose they take the blood Please understand the following things before testing outside of the sample from the tip of the finger However since there are many fingertip arms thighs calves nerve endings distributed there it is quite painful When doing a The capillary blood of the fingertip shows the change in glucose glucose test using different parts of the body such as the arms more rapidly than AST Therefore the test results from the fingertip palms thighs and calves can reduce the pain during testing test and AST may differ This is because things such as lifestyle This method of testing with different parts of the body is called and ingested food have an effect on glucose levels Alternative Site Testing While AST may reduce the pain during testing it may not be simple for everyone and the following precautions should be observed during testing Acceptable situations for AST Fasting period Alternative Site for Testing e Before a meal f Before sleeping Situations requiring fingertip test When the glucose levels are rapidly increasing during the two hours after a meal or exercise When sick or when glucose levels seem quite lower than test value
22. try mg dL or mmol L In this case the unit can not be changed and the unit change setting step will be excluded meter so that you will not be able to change the setting The unit setting on the meter may be fixed for your o Setting up Your System Setting the Sound On OFF Step 9 On pressing C Button the screen will display the On or OFF Press the M button to confirm the selection u The meter will beep in the following instances if set to On bEEP When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When it is time for a preset blood glucose test If the sound is set to OFF none of the sound functions will work Only when the sound is set to OFF 1 icon appears on the display 12 Setting the Test Result Reset Deleting all the saved test results Step 10 al L In this mode all the test results stored in the meter can be deleted Please note that if you select YES all the f stored test results will be deleted and cS can not be restored 9 24 12 39 After the beeper mode is set press the M button to enter the Test Result Reset mode The dEL character will blink on the screen Press C button to alternate between YES or no To delete all the stored test results press the M button while the screen displays YES Then all th
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