Table of Contents - Orange Juice Communications
Contents
1. Between 2 a m and 4 a m Expected Values The range of a normal fasting blood glucose level for non diabetic adults is between 3 9 5 5 mmol L Two 2 hours after a meal the range of a normal blood glucose level for non diabetic adults is between 5 6 7 7 mmol L Fasting is defined as no caloric intake for at least eight 8 hours Reference American Diabetes Association Standards of Medical Care in Diabetes 2012 Diabetes Care January 2012 35 1 S11 S63 34 www i sens com Test results stored in CareSens N Voice meter can be transferred from the meter to a The Pc is displayed when the data cable 7 computer using PC care software and cable me D connects the meter with computer For more information contact the Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk www Spirit healthcare co uk 35 Meter Memory The CareSens N Voice Meter can save up to 500 test results with temperature time and date If the memory is full the oldest test result will be deleted and the latest test result will be stored The CareSens N Voice Meter calculates and displays the averages of total test results pre meal test Pr results and post meal test ff results from the last 1 7 14 30 and 90 days Viewing Averages Step 1 Press the S or A button to turn on mem the meter If the talking function a m is on the meter will say Memory recall The2. However since there are many nerve endings distributed there it is quite painful When doing a glucose test using different parts of the body such as the forearms palms thighs and calves can reduce the pain during testing This method of testing with different parts of the body is called 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 Alternative Sites for Testing Alternative Site Blood Sampling forearm palm thigh calf Select a clean soft and fleshy sample site area free of visible veins and hair and away from bones Gently massage the Sample site to help blood circulation to minimize result differences between fingertip and alternative site sampling Firmly press and hold the lancing device against site Wait until the skin surface under the lancing device changes color Then press the release button while continuing to apply pressure Keep holding the lancing device against your skin until sufficient at least 0 5 uL actual size e blood is drawn Carefully lift the lancing device away from your skin 30 www i sens com Things to know when using AST Please understand the following things before testing at alternative site forearms palms thighs and calves The capillary whole blood of the fingertips shows changes in glucose levels more rapidly than in alternative s
3. 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 The i SENS Inc 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 Spirit Healthcare www spirit healthcare co uk 49
4. your authorized i SENS sales representative Note If the error messages persist contact the Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk 44 www i sens com www spirit healthcare co uk 45 General Troubleshooting Performance Characteristics Problem Troubleshooting 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 into the test Strip port Check if the appropriate test strip was used Check if the batteries are inserted correctly Replace the batteries The test does not start even after applying the blood sample on the strip The test result doesn t match the way you feel Check if the confirmation window is filled completely Repeat the test after inserting a new test strip Repeat the test after inserting a new test strip Check the expiration date of the test strip Check the meter Note If the problem is not resolved please contact the Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk 46 www i sens com The performance of CareSens N Voice Blood Glucose Monitoring System has been evaluated in laboratory and in clinical tests Accuracy The accuracy of the CareSens N Voice System Model GM505UVAA was tested by comparing
5. Two alkaline AAA batteries Memory 500 test results Size 100 x 56 x 19 mm Weight 70 g with batteries e Operating ranges Temperature 10 40 C 50 104 F Relative humidity 10 90 Hematocrit 20 60 6 www i sens com CareSens N Voice BGM System includes the following items CareSens N Voice Blood Glucose Meter Owner s Booklet Quick Reference Guide Carrying Case Batteries CareSens N Voice BGM System may include the following items CareSens N Blood Glucose Test Strips Lancets Lancing Device Logbook e Check all the components after opening the CareSens N Voice Blood Glucose Monitoring System package e The cable for data management software can be ordered separately Please contact Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk www spirit healthcare co uk 7 Inserting or Replacing Batteries CareSens N Blood Glucose Test Strip The CareSens N Voice Meter uses two AAA alkaline batteries Before using the meter check the battery compartment and insert batteries if empty When the symbol appears on the display while use the batteries should be replaced as soon as possible The test results may not be saved if the batteries run out completely Step 1 Make sure the meter is turned off Press firmly on the battery cover and slide in the direction of the arrow And then swing it open Step 2 Remove the
6. arrow The initial setting of three 3 is recommended Note 1 least penetration of lancet into the skin 5 most penetration of lancet into the skin 24 www i sens com Step 5 To cock the lancing device hold the tip in one hand Pull the sliding barrel with Pa the other hand The lancing device is lt cocked when you feel a click E Ke S EA Note The skin depth to retrieve samples will vary for various people at different sample sites The lancing device s adjustable tip allows the best depth of skin penetration for an adequate sample size The initial setting of three 3 is recommended Preparing the Meter and Test Strip Step 6 Insert a test strip with the contact bars facing upwards into the meter s test strip port Push the strip in gently until the meter automatically turns on and the amp symbol appears Be careful not to bend the test strip The amp symbol will appear on the screen If the talking function is on the meter will say Blood glucose test Please apply blood onto the test strip www spirit healthcare co uk 25 Marking Post meal Test Results The CareSens N Voice meter allows you to mark a result of a post meal test with ff symbol The post meal test mark ff can be attached just before applying the blood sample Once you attach the post meal mark ff to the test results it cannot be deleted Step 7 If you want to attach a post meal flag ff to a test result press and h
7. blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer a lab instrument The results below were obtained by diabetic patients at clinic centers Slope 0 998 Y intercept 0 002 mmol L Correlation coefficient r 0 993 Number of Sample 600 Range tested 1 7 mmol L 23 9 mmol L Accuracy results for glucose concentration lt 4 2 mmol L Within 0 56 mmol L Within 0 56 mmol L Within 0 83 mmol L 62 78 79 5 76 78 97 4 78 78 100 Accuracy results for glucose concentration 4 2 mmol L Within 5 Within 10 Within 15 Within 20 238 522 45 6 421 522 80 7 506 522 96 9 521 522 99 8 www spirit healthcare co uk 47 Warranty Information Precision Precision studies were performed in a laboratory using the CareSens N Voice BGMS Within Run Precision Bloodavg 2 3 mmol L SD 0 1 mmo L Bloodavg 4 9 mmol L SD 0 2 mmo L Bloodavg 7 3 mmol L CV 2 9 Bloodavg 10 8 mmol L CV 3 0 Bloodavg 17 3 mmol L CV 2 8 Total Precision Controlavg 40 mg dL 2 2 mmol L SD 0 1 mmol L Controlavg 131 mg dL 7 3 mmol L CV 3 4 Controlavg 348 mg dL 19 3 mmol L CV 3 7 This study shows that there could be variation of up to 3 7 48 www i sens com Manufacturer s Warranty i SENS Inc warrants that the CareSens N Voice Meter shall be free of defects in material and workmanship in normal use for a period of 5 years
8. current date and time T E will be displayed at the bottom of te the screen followed by the 1 day The number ae 00 Sry average value and the number of ae of tests the test results saved within the current day Step 2 Viewing Averages Press the A to view the 7 14 30 and 90 day average d md A button TY values and the number of a Average tests performed for that ri in 7 14 30 90 test period mmol L das mmol L Hi eae or eS Si ave btm Sie 7 Y button 36 www i sens com Step 3 Viewing Pre meal Averages Repeatedly press the A mem A button mem button to view the 1 zZ Paget re 7 14 30 and 90 day average pre meal average value A l 7 14 30 90 A A and the number of tests E mmol L ays mmol L lt __ _ performed pre meals TTI ey gree arr with the Pr symbol for Y button that test period Step 4 Viewing Post meal Averages On pressing the A ai A button mem again 1 7 14 30 and mw mz 90 day average value m l and the number of tests At i 7450 00 it A performed post meals AD days for the last test period aa omnes D rys aa will appear on the oo V button screen Step 5 Use the W button to scroll back through the averages seen previously To turn off the meter press the S button www spirit healthcare co uk 37 Setting the Alarm Function Viewing Test Results Step 1 Press the S or A button to turn the mem meter on The current date and time Z m will be displayed on the bot
9. lt a a stored in the memory are displayed m m Ny 3 ctl appears during the control solution testing and when the 5e control solution test results are 8 KOK O VA displayed m A 4 Test results test results displaying O4 one panel Dir misma s 5 Blood insertion symbol indicates OO 60 we OG Pu meter is ready for the application of 4 a drop of blood or control solution 6 Temperature symbol displays recorded temperature when blood glucose levels are tested 7 Post meal test flag appears when post meal testing and when post meal test results are displayed Hypoglycemia symbol appears when the test result is below the hypoglycemic level 9 Post meal alarm symbol appears when the post meal alarm has been set Mute symbol appears only when the sound is set to OFF Battery symbol indicates meter batteries are running low and needs to be placed 42 mg dL mmol L unit for measuring blood glucose 3 Date temperature 44 Time Note The unit of measurement is fixed in mmol L and it cannot be changed to mg dL by the user 12 www i sens com You should check and update the meter settings such as time and date before using your meter or when you change the meter batteries Press and hold the S button for 3 seconds to enter the SET mode While you are setting the meter current settings appear on the display The meter will also announce each function when the talking function is on Press and ho
10. the sample drop of blood runs or spreads due to contact with hair or with lines on your palm do not use that sample Try puncturing again in a smoother area 32 www i sens com HI Message The CareSens N Voice Meter displays results between 1 1 33 3 mmol L HI appears when i the blood glucose level is greater than 33 3 mg dL and indicates severe hyperglycemia much f higher than normal glucose levels If the talking function is on the meter will say Your blood ung Ban glucose reading is above 33 3 mmol L If HI is displayed again on retesting please contact your healthcare professional immediately Lo Message Lo appears when a test result is less than 1 1 mmol L and indicates severe hypoglycemia very low glucose levels If the talking function is on the meter will say Your blood glucose reading is L E below 1 1 mmol L If Lo is displayed again on retesting please ID an contact your healthcare professional x immediately Note Please contact the Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk if such messages are displayed even if you do not have hyperglycemia or hypoglycemia www Spirit healthcare co uk 33 Target Blood Glucose Ranges Transferring Test Results Reminders Your target ranges Time of day from your healthcare professional Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals
11. time 12 hour 24 hour Press A or W button to select a format The AM PM is not displayed in the 24 hour format After selecting the format press the S button to enter the hour setting mode 14 www i sens com iJ tLe mmol L WE Ltt em iJ te pe Ma hth pm Step 6 Setting the Hour After selecting the format press the S button to enter the hour setting mode If the talking function is on the meter will say Set hour Press A or W button until the correct hour appears After the hour is set press the S button to enter the minute setting mode Step 7 Setting the Minute If the talking function is on the meter will say Set minute Press A or W button until the correct minute appears After setting the minute press the S button to enter sound setting mode J Le mmol L mei erm wit Iha hath t pm 715 www Spirit healthcare co uk 15 Step 8 Setting or Turning off the Sound A number showing the sound volume will blink and the meter will say Set volume Press A or W button to adjust the volume from 1 lowest to 3 highest or to turn the sound off or the beep sound on When you select On the meter will beep instead of announcing messages To turn off the sound press the S button when OFF blinks on the display Then the Aj symbol will appear on the display and the meter will be muted Press the S button to save the setting and move to the hypoglycemia low blood gl
12. used batteries and insert the two new batteries Close the battery cover firmly ald Note Removing the meter batteries will not affect your stored results However you may need to reset your meter settings See page 13 17 8 www i sens com The CareSens N Voice 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 Contact bars Gently push the test strip with its contact bars facing up into the test strip port of meter Insert Confirmation window Check here to see whether sufficient blood sample has been applied _ Edge to apply blood sample Apply blood sample here for testing www spirit healthcare co uk 9 CareSens N Voice Blood Glucose Meter Warning e The CareSens N Test Strip should be used only with fresh capillary whole blood samples e Do not reuse test strips Donotuse test strips past the expiration date e Test strips in new unopened vials and test strips in vials that have been opened can be used up until the expiration date printed on the test strip box and vial label if the test strips are used and stored according to its storage and handling methods e Store test strips in a cool and dry place at a temperature of 1 30 C 34 86 F e Keep test strips away from direct sunlight or heat and do not freeze Store test strips only in their original
13. 2 drops and wipe the tip clean e Close the control solution bottle tightly and store ata temperature of 8 30 C 46 86 F You may do a control solution test e When you want to practice the test procedure using the control solution instead of blood e When using the meter for the first time 18 www i sens com e 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 If you drop or damage the meter Control Solution Testing Step 1 Insert a test strip into the meter s test strip port with the contact bars facing upwards Gently push the test strip into the port The amp symbol will blink on the screen If the talking function is on the meter will say Blood glucose test Please apply blood onto the test strip Step 2 While the blinks press and hold the A ott button for 3 seconds till the ctl symbol appears on the display If the talking function ae is on the meter will say Control solution test Please apply control solution onto the test R strip www Spirit healthcare co uk 19 Step 3 Step 5 Shake CareSens Control Solution Compare the result displayed on the bottle well before each test meter to the range printed on the test ara Remove the cap and squeeze the Strip vial The
14. 3 seconds to finish and turn the meter off www spirit healthcare co uk 41 Caring for Your System Understanding Error 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 Caution Do not expose the meter to direct sunlight or heat for an extended period of time Do not let dirt dust blood or water enter into 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 The CareSens N Voice meter should be used only with CareSens N Strips Keep the meter in a cool and well ventilated place Store all the meter components in the carrying case to prevent loss 42 www i sens com Message What is said What it means What to do Error 1 Used test Strip A used test Strip was inserted Remove the strip and reinsert a new test strip Error 2 The Sample has been applied before the blood symbol appeared The blood or control solution sample was applied before the symbol appeared Repeat the test with a new test strip and wait until the amp symbol appears before a
15. Table of Contents Information Important Information Read this First Specifications CareSens N Voice Blood Glucose Monitoring System Inserting or Replacing Batteries CareSens N Blood Glucose Test Strip CareSens N Voice Blood Glucose Meter CareSens N Voice Blood Glucose Meter Display Preparation Setting up Your System Adjusting Date Time and Sound Setting the Hypoglycemia Indicator Checking the System Control Solution Testing Comparing the Control Solution Test Results Blood Glucose Testing Using the Lancing Device Preparing the Lancing Device Preparing the Meter and Test Strip Marking Post meal Test Results Applying Blood Sample Discarding Used Lancets Alternative Site Testing HI and Lo Messages Target Blood Glucose Ranges Transferring Test Results Additional Functions Meter Memory Viewing Averages Viewing Test Results Setting the Alarm Function Setting the Post meal Alarm PP2 Alarm Setting the Time Alarms Alarm 1 3 Maintenance Caring for Your System Understanding Error Messages Other Important Message General Troubleshooting Performance Characteristics Warranty Information Important Information Read this First Important Information To receive safe and optimum system benefits please read the entire manual contents before using the system Please note the following i
16. al current The CareSens N Voice Meter detects this electrical current and measures the amount of glucose in the blood sample e The CareSens N Voice Blood Glucose Meter is designed to minimize code related errors in monitoring by using the auto coding function e The CareSens N Voice Blood Glucose Meter should be used only with the CareSens N Strip e An abnormally high or low red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results e If your test result is below 3 3 mmol L or above 13 3 mmol L consult a healthcare professional immediately e Inaccurate results may occur in severely hypotensive having low blood pressure individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic high blood sugar or hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters If you need assistance please contact Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk for more information www spirit healthcare co uk 5 Specifications CareSens N Voice Blood Glucose Monitoring System e Product specifications Reported result range 1 1 33 3 mmol L Sample size Minimum 0 5 uL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 1 000 tests Power
17. er setting press and hold the S button for 3 seconds to confirm all your selections and exit from SET mode If the talking function is on the meter will announce the set date and time for your confirmation www spirit healthcare co uk 17 Checking the System i CareSe lucose Control S LOT Date Inufacturer i SENS Inc pS Wolgye4 dong Nowon gu Seo Notes You may check your meter and test strips using the CareSens Control Solution control A and or B The CareSens 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 CareSens Control Solution ranges printed on their labels Compare the result displayed on the meter to the CareSens Control Solution range printed on the test strip vial Before using a new meter or a new vial of test strips you may conduct a control solution test following the procedure on pages 19 21 e Use only the CareSens Control Solution e Check the expiration dates printed on the bottle When you first open a control solution bottle record the discard date date opened plus three 3 months in the space provided on the label e 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 e Before using the control solution shake the bottle discard the first 1 or
18. ites Therefore the test results from the fingertip test and AST may differ This is because things such as lifestyle and ingested food have an effect on glucose levels Acceptable situations for AST When your blood glucose levels are stable e Fasting period Before a meal e Before sleeping Situations requiring fingertip test When your blood glucose levels are unstable e During the two 2 hours after a meal or exercise e When sick or when glucose levels seem lower than test value e When hypoglycemia is not well recognized e When insulin has the biggest effect e Two 2 hours after an insulin injection www spirit healthcare co uk 31 HI and Lo Messages AST Precautions e Do not ignore the symptoms of hyperglycemia or hypoglycemia e When the results of the test do not reflect your opinion retest using the fingertip test If the fingertip result still does not reflect the way you feel please consult your healthcare professional e Do not rely on the AST results for changing your treatment method e The amount of glucose in alternative sites differs from person to person e Before using AST please consult your healthcare professional Note Results from alternative site and fingertip samples may differ from each other as there is a time lag for the glucose levels to reach the same value Use a fingertip sample if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms Note If
19. ld A or to scroll faster Whenever you want to complete the setting and exit from the SET mode press and hold the S button for 3 seconds again Adjusting Date Time and Sound Step 1 Entering the SET Mode Press and hold S button for 3 seconds After all the segments flash across the screen the SET is displayed on the screen If the talking function is on the meter will say Set meter Press the S button again to enter the year setting mode Step 2 Setting the Year If the talking function is on the meter will say Set year Press A or W button until correct year appears After setting the year press the 19 S button to confirm your selection and enter OM the month setting mode aha www spirit healthcare co uk 13 Step 3 Setting the Month A number indicating the month will blink on the bottom left corner of the screen If the talking function is on the meter will say Set month Press A or W button until the correct month appears Press the S button to confirm your selection and enter the date setting mode Step 4 Setting the Date The meter will say Set date when the talking function is on Press A or W button until blinking number shows the correct date Press the S button to set the date and enter time setting mode Step 5 Setting the Time Format The meter can be set in an AM PM 12 hour or 24 hour clock format If the talking function is on the meter will say Set
20. n order to collect a blood Sample You may use the lancing device contained in the CareSens N Voice Blood Glucose Monitoring System or any other medically approved lancing device Adjustable Tip Lancet Holder Ejection System aaj 1 Lancet Release Button Sliding Barrel e The lancing device may not be used by more than one individual Ensure the lancing device is not shared among different users e Use a soft cloth or tissue to wipe the lancing device If necessary a small amount of alcohol on a soft cloth or tissue may be used Caution To avoid infection when drawing a sample use a lancet only one time and e Donot use a lancet that has been used by others e Always use a new sterile lancet e Keep the lancing device clean Note Repeated puncturing at the same sample site may cause pain or skin calluses thick hard skin Choose a different site each time you test www spirit healthcare co uk 23 Preparing the Lancing Device Step 1 Wash hands and the sample site with soap and warm water Rinse and dry thoroughly Step 2 Unscrew and remove the lancing device tip Step 3 Firmly insert a new lancet into the lancet holder Hold the lancet firmly Gently twist to pull off protective disk Save disk to recap lancet after use Replace lancing device tip Step 4 Select a desired depth of one to five 1 5 on lancing device s adjustable tip Rotate ring to align desired number with
21. new one and apply the blood sample again after amp symbol appears on the screen Good Sample Insufficient Sample www spirit healthcare co uk 27 Note The meter will switch off if the blood sample is not Discarding Used Lancets applied within 2 minutes of the amp symbol appearing on the Step 1 screen If the meter turns off press S button or A button and apply the blood sample after the amp symbol appears on the Unscrew lancing device tip screen Step 10 The test result will appear after the meter counts down from 5 to 1 If the talking function is on x Step 2 the result will be announced The result will be Place the protective cover on the automatically stored in the meter memory al lancet Push the lancet ejector forward with the thumb and simultaneously mmol L o hg EIT pull out the sliding barrel to dispose of the used lancet in a proper biohazard container Step 11 If the test strip is removed after the test result is displayed the meter will automatically turn off after 3 seconds Discard the used test strip safely in an appropriate container Caution The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly 28 www i sens com www spirit healthcare co uk 29 Alternative Site Testing What is AST Alternative Site Testing Usually when someone tests their glucose they take the blood sample from the tip of the finger
22. nstructions Intended use CareSens N Voice Blood Glucose Monitoring System is used for the quantitative measurement of the glucose level in capillary whole blood as an aid in managing diabetes effectively at home or in clinical settings CareSens N Voice Blood Glucose Monitoring System should be used only for self testing outside the body in vitro diagnostic use only CareSens N Voice Blood Glucose Monitoring System should not be used for the diagnosis of diabetes or for testing newborns Testing sites include the traditional fingertip testing along with alternate sites testing on forearm palm thigh and calf The following chart explains the symbols you ll find in the CareSens N Voice owner s booklet product packaging and product inserts wo For in vitro diagnostic use CE This product fulfills the requirements for Directive 98 79 EC on in vitro diagnostic medical devices Cautions for safety and optimum product use Use by unopened or opened test strip vial Do not discard this product with other household type waste Authorized representative Batch code Consult instruction for use gf Manufacturer Do not reuse xO fh Temperature limitations Serial number 4 www i sens com e The CareSens N Voice Blood Glucose Monitoring System is intended for self testing outside the body in vitro diagnostic use e The glucose in the blood sample mixes with special chemicals on the test strip to produce a small electric
23. old the W Button for 3 seconds after inserting the test strip The post meal flag ff and the amp symbol will appear on the screen If the talking 7 IN function is on the meter will say Post meal t test Please apply blood onto the test strip The test result will also be displayed with the post meal flag ff If you do not want to save the result as a post meal test move on to Step 8 after Step 6 If you want to delete the post meal flag ff that you attached press and hold the button for 3 seconds again before applying the blood sample or when the test result is displayed just after testing 26 www i sens com 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 ring fingers Press the release button Remove the lancing 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 5 uL e Step 9 After the amp symbol appears on the screen apply the blood sample to the narrow end of the test strip If the blood sample does not fill the confirmation window completely an Er4 message may appear because of abnormal viscosity or insufficient volume If the talking function is on the meter will say Error four The sample was not enough or too thick Then discard the test strip insert a
24. pplying the blood or control solution sample N A Error 4 The Sample was not enough or too thick The thermometer of meter is not Stabilized yet The blood sample has abnormally high viscosity or insufficient volume Retry the test after about 30 minutes for the thermometer to be stabilized Repeat the test using anew test strip www spirit healthcare co uk 43 Other Important Messages Message Whatis said What it means What to do Theroom The temperature temperature is too low during testing was below the operating Message Whatis said What it means What to do Error 5 This error Repeat the test im Z m Strip message may with a CareSens N L al insertion appearwhen test strip error Please the wrong insert a blood glucose CareSensN test strip is strip used properly instead of CareSens N blood glucose test strip range Move to an area where the temperature is within the operating range 10 40 C 50 104 F The room The and repeat the test temperature temperature after the meter is too high during testing and test strips was above have reached a the operating temperature within range the operating range Message rf e7 c a co Lit fr to Lew bb What is said What it means What to do Error 6 Error 7 There isa problem Do not use the Error 8 Error 9 with the meter meter Contact Meter failure
25. result should fall within that Control A 5 6 84 mmol L vial to discard the first 1 or 2 drops range ase aaa Then wipe the tip with a clean ay tissue or cloth While the amp symbol blinks apply the control solution to the narrow edge of the test strip until the meter beeps Make sure the confirmation window of Step 6 test strip fills completely Slide the test strip ejector button to discard the used test strip safely in Note The meter will switch off if the countrol solution sample appropriate containers is not applied within 2 minutes of the amp symbol blinking on the screen If the meter turns off remove the test strip and the screen If the meter turns off press S button or A button and start from step 2 Step 4 A test result will appear after the meter counts down from 5 to 1 If the talking function is on the test result will be announced If you missed step 2 you can mark the test result as a control solution test result by pressing and holding the A button for 3 seconds until the ctl symbol appears on the display When the ctl symbol is displayed the result is stored in the meter s On memory but is not included in the averages Caution The range printed on the test strip vial is for the CareSens Control Solution only It does not have any connection to your blood glucose level D e Note The CareSens Control Solution can be obtained free s C from Spirit Healthcare on 0800 881 5423 20
26. rm OFF To turn off the PP2 alarm press mem and hold the A button for 3 mrn Z m seconds PP2 the symbol o an o and then OFF will appear on the L mid screen If the talking function is on the meter will say Post meal parece alarm is off Then the screen will change automatically to the A symbol vanishes memory check mode without symbol being displayed g t oe 207 a m t LIP www Spirit healthcare co uk 39 Setting the Time Alarms Alarm 1 3 Step 1 Without inserting a test strip press A and the S button simultaneously for 3 seconds to enter the time alarm mode alarm 1 will be displayed while OFF blinks on the screen If the talking function is on the meter will say Set alarm one Step 2 On pressing WV alarm 1 is set and On is displayed on the screen Press W again to cancel alarm 1 OFF will blink on the screen Step 3 Press A to adjust the time of alarm 1 A number representing the time will blink on the screen Press W to set the time Press A to end 40 www i sens com alarm alarm alarm m 1 8 Pr gt aa E Ez l Step 4 On pressing A the number indicating the minute will start blinking Press W to set the minute Step 5 Press the S button to finish and to enter the alarm 2 mode Repeat steps 2 to 5 to set the remaining time alarms alarm 2 and 3 Step 6 alarm Press and hold the S button for
27. tom of the screen for 2 seconds followed T E by the 1 day average value and the number of the test results saved The number nm ED So within the current day oftests Step 2 Use the W button to scroll EE aaa through the stored test Sy gt 7 results starting from the m Y button a a most recent and ending TE E AD i with the oldest Press the BPE A button to return tothe 55 aw MOM A button REPU result seen previously The a e CS test date and the recorded temperature will display alternately After checking the stored test result press the S button to turn off the meter 38 www i sens com Four alarms can be set in the CareSens N Voice Meter one post meal alarm PP2 alarm and three time set alarms alarm 1 3 The PP2 alarm goes off 2 hours after setting the alarm The alarms ring for 15 seconds and can be silenced by pressing A W or S button or by inserting a test strip Setting the Post meal Alarm PP2 Alarm Step 1 Setting the PP2 alarm On Without inserting a test strip mem press and hold the A button for mr a m 3 seconds to set the post meal alarm PP2 the symbol and a gt E then On will be displayed If the talking function is on the meter Se D m puan ea will say Post meal alarm is on The screen will then automatically change to the memory check mode At this time the symbol indicating that the PP2 alarm has been set will be displayed on the screen Step 2 Setting the PP2 ala
28. ucose indicator setting mode Fh oo ae ce f a 4 ee its TER Th Kalieni AMI Cue ie ee er a mr mo Note Only when the sound is set to OFF 4 symbol appears on the display Setting the Hypoglycemia Indicator You can set the meter to let you know when your test result indicates a possible low blood glucose hypoglycemia You can also select the hypoglycemia level 16 www i sens com Step 9 Turning on the Hypoglycemia Indicator When you enter the hypoglycemia indicator setting mode the amp symbol and HYPo will blink If the talking function is on the meter will say Set hypoglycemia lt indicator On pressing A or W the ree M screen will display On or OFF Press S button to set your hypoglycemia Eg J E level if you choose On The screen SAT YL loi Voit T Lvs a Da he et Dy he will return to step 2 year setting mode if you choose OFF Caution Ask your healthcare professional to help you decide what your hypoglycemia level is before setting your hypoglycemic level Step 10 Setting Your Hypoglycemic Level The hypoglycemic level can be set q cael from 3 3 to 1 1 mmol L To set your m m hypoglycemic level press A or V button until the level you want to al a appear Press the S button to confirm A no dmon Then the screen will return to step 2 HH Po HH Po year setting mode See page 13 Step 11 Exiting from Set Mode After completing met
29. vial e Close the vial tightly after taking out a test strip for testing and use the strip immediately e Handle test strips only with clean and dry hands Do not bend cut or alter test strips in any way e For detailed storage and usage information refer to the CareSens N Test Strip package insert Caution Keep the meter and testing supplies away from young children The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation 10 www i sens com Data Port Used to transfer data O from the meter to a Speaker computer with a cable Announces each step CareSens N Voice alarm mem ctl Display ml Tf Shows results A Button E n pu T and messages Turns the meter on selects T Y Button or changes CACHES oe N cr leceo information changes 4 _ WO v information S Button Turns the meter on off confirms menu selections S Test Strip Port Insert test strip here Test Strip Ejector Slide down to discard the used strips Note The cable for data management software can be ordered separately Please contact Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk www spirit healthcare co uk 11 CareSens N Voice Blood Glucose Meter Display Setting up Your System 1 alarm appears when the time Q alarm has been set alarm mem ctl mem appears when test results
30. www i sens com www Spirit healthcare co uk 21 Using the Lancing Device Comparing the Control Solution Test Results The test result of each control solution should be within the range printed on the label of the test strip vial Repeat the control solution test if the test result falls outside of this range Out of range results may occur due to the following factors e When the control solution bottle Repeat the was not shaken well control solution When the meter test strip or the test by referring control solution were exposed to to the Notes high or low temperatures on page 18 e When the first drop of the control solution was not discarded or the tip of the bottle was not wiped clean e When the meter is not functioning properly When the control solution is past the Discard the used expiration date printed on the bottle control solution When the control solution is past its and repeat the discard date the date the bottle was test using anew opened plus three 3 months bottle of control e When the control solution is solution contaminated If results continue to fall outside the range printed on the test Strip vial the test strip and meter may not be working properly Do not use your system Please contact the Spirit Healthcare 24 7 Freephone Support Line for a free replacement of your meter at 0800 881 5423 or go to www spirit healthcare co uk 22 www i sens com You will need a lancing device i
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