Manual del Usuario User's Manual - i-SENS
Contents
1. paniasay siut IV DU SNIS LOZ o elnuabiawe 9p PDIPSW uoi e1sa1uo e o ODIPDSW ns uod 032e1UO2 Ud s uod ep 10484 ernusDJeuo op sosed ue o soueJou so1uaJsJIp UJ opeqes seun LSJ S44 00 LC amp 00 60 LO0OS 6CT 008 1 91U8l Je OIDIAIAS WOD SU S MMM 2910 S78 6EL N S NB UOMON OJ UNBUeMY 9 Z7 DU SN3S 22UD2qD3 SeJbues ue esoonj6 ns JeqoJd ep so1ue opepin uoo Pd OAC JOd 2210A N sSU9S9J0 VP LSND ap o3Jo1luO W ep amp UJ93SIS 34005 Jueyodw uo euuojJur ej euanuoo enueuJ 9189 71 0 ep aibues op eusenuj euenbad eun uo sopunbes ODUID Ud OSI23Jd opej3 nsaJ un eJiqi29J pN UOIDeDIJIPOD o0jne op uomuny e op osn o 91ueipoauu 03J01IUOUIJ Ja Us OHIPOD 9 UOD sopeuorbej a1 S 1011 SO JEZIWIUILU eJed opeuesip ejso DIO N sSU9S3J ep 10pIp W uarquue Jopipoeuu Jap osn j eyed epn e eun owo Jezi nn epend as 9210A N SU9S9Je ap JOPIPAW ep seuuoipi sop ue zoa ep uomuny e ouJa1xe osn ap JI29p S on UI eJbues ue esoon b ap o nsoubeip oa101IuoUJ UN Pf e d 3 eujaisis 3 9210A N sSUeSaJe eJbueg Ud PSOIN H ep 03J01IUOW ep LW JSIS e JIHaja Jod senep 92310A N SU9SS9Je eso2n 5 ep 03J03IUuO N 9p eUi9jSIS e OpiusA ueig Table of Contents Information Important Information Read This First Important Health Related Information Specifications CareSens N Voice Blood Glucose Monitoring System Inserting or Replaci2. Keep the lancets in a cool and dry place Caution The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly www i sens com 29 Alternative Site Testing What is AST Alternative Site Testing When someone tests their glucose they usually take the blood sample from the tip of the finger However since there are many nerve endings distributed there it can be 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 Testina 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 blood is drawn Carefu
3. If you want to attach a post meal flag 11 to a test result press and hold the W button for 3 seconds after inserting the test strip The post meal flag ff and the 4 symbol will PU appear on the screen If the talking function is I a on the meter will say Post meal test Please DR2u En 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 1f 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 the 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 Step 9 After the 4 symbol appears on the screen apply the blood sample to the narrow end of the test strip until the meter beeps 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 T
4. What to do Message What is said What it means The room temperature is too low The temperature during the test is below the operating range The room temperature is The temperature during the test is above the operating range Move to an area where the temperature is within the operating range 50 104 F and repeat the test after the meter and test strips have reached a temperature within the operating range Error 6 Error 7 Error 8 Error 9 Meter failure There is a problem with the meter Do not use the meter Contact Customer Service 1 800 429 5001 Note If the error messages persist contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday 48 www i sens com www i sens com 49 General Troubleshooting Performance Characteristics Troubleshooting e 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 e Check if the appropriate test strip was used e Check if the batteries are inserted correctly Replace the batteries The display is blank even after inserting a test strip The test does not start even after applying the blood sample on the test strip e Check if the confirmation window is filled adequately Repeat the test after inserting a new test strip Repeat the test after inserting a new The test result do
5. Step 1 Setting the PP2 alarm On Without inserting a test strip mem press and hold the A button n jur 3i for 3 seconds to set the post meal alarm PP2 the symbol l j Ll and On will be displayed If the mess talking function is on the meter Dic D eine 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 alarm OFF To turn off the PP2 alarm press and hold the A button for 3 mo J EE seconds PP2 the symbol ay mg dL alarm is off Then the screen IZ tem avo Z and OFF will appear on the screen If the talking function is will change automatically to the icon vanishes memory check mode without amp symbol being displayed on the meter will say Post meal 38 www i sens com Setting the Time Alarms alarm 1 3 Step 1 Without inserting a test strip press A and the S alarm button simultaneously for 3 seconds to enter the time alarm mode While OFF blinks on the screen alarm 1 will be displayed If the talking function is on the meter will say Set alarm one Z X Vt za J E3 Step 2 On pressing V alarm 1 is set and On is displayed alarm 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 represen
6. 48 100 48 48 100 www i sens com 53 Warranty Information 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 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 your nearest i SENS Authorized Warranty Station 54 www i sens com
7. Blood avg 38 mg dL SD 1 9 mg dL Blood avg 86 mg dL SD 3 2 mg dL Blood avg 125 mg dL CV 4 1 Blood avg Blood avg Total Precision Control avg 189 mg dL 334 mg dL 35 mg dL CV 2 6 CV 2 8 SD 1 2 mg dL Control avg Control avg 116 mg dL 324 mg dL CV 2 4 CV 2 3 This study shows that there could be variation of up to 4 1 Alternative Sites Testing Evaluation gt Comparison of results using various AST sites with the results of YSI measurements Alternative site test results for glucose concentration 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL Fingertip 1 2 50 0 2 2 100 2 2 100 Forearm 1 2 50 0 2 2 100 2 2 100 Palm 2 2 100 2 2 100 2 2 100 1 2 50 0 1 2 50 0 52 www i sens com 2 2 100 2 2 100 2 2 100 2 2 100 Alternative site test results for glucose concentration 2 75 mg dL Within 5 Within 10 Within 15 Within 20 Fingertip 27 48 56 3 46 48 95 8 48 48 100 48 48 100 Forearm Palm Calf 19 48 39 6 28 48 58 3 27 48 56 3 42 48 87 5 47 48 97 9 48 48 100 38 48 79 2 46 48 95 8 48 48 100 Thigh 17 48 35 4 36 48 75 0 46 48 95 8 48 48 100 46 48 95 8 48
8. hypoglycemia low blood glucose indicator setting mode Nal Gos niz M LEN N N Note Only when the sound is set to OFF the A 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 from 60 to 20 mg dL 16 www i sens com Step 10 Turning on the Hypoglycemia Indicator When you enter the hypoglycemia indicator setting mode the N symbol and HYPo will blink If the talking function is on the meter will say Set hypoglycemia indicator On pressing A or V the gt ay 2 Une screen will display On or OFF Press iL m e S button to set your hypoglycemia f Fg y J A level if you choose On The screen 7A meld A podi will return to step 2 language HU Pa mu p selection 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 11 Setting Your Hypoglycemic Level The hypoglycemic level can be set v 102 from 60 to 20 mg dL To set your ur um hypoglycemic level press A or V D LI j LI button until the level you want to appear Press the S button to confirm Then the screen will return to step 2 ix language selection mode See page 13 Fi Cu Djs 9d mg d Step 12 Exiting from Set Mode After completing meter se
9. mame ere Lt het ULL ht pm iJ a rw a le UL Lt ew Step 6 Setting the Time Format The meter can be set in the AM PM 12 hour or the 24 hour clock format If the talking function is on the meter will say Set time 12 hour 24 hour Press A or W button to select a format TN The AM PM is not displayed in the 24 hour nod format After selecting the format press the S DOoq DH button to set the hour I gt Step 7 Setting the Hour If the talking function is on the meter will say Set hour Press A or W button until the correct j hour appears Press the S button to confirm the hour and set the minute iL mg dL V ut n LICUIT Duc da PM Step 8 Setting the Minute If the talking function is on the meter will say Set minute Press A or W button until the correct j ww minute appears After setting the minute press ee the S button to set the sound TN mg dL www i sens com 15 Step 9 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 the beep 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 2j symbol will appear on the display and the meter will be muted Press the S button to save the setting and move to the
10. symbol indicates ele fci UN riri m meter is ready for the application of a Q4 drop of blood or control solution 09 Temperature symbol appears when the temperature is displayed 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 Post meal alarm symbol appears when the post meal alarm has been set Mute symbol appears only when the sound is set to OFF 1 Battery symbol indicates meter batteries are running low and need to be replaced 62 mg dL mmol L unit for measuring blood glucose a3 Date temperature Time Note The unit of measurement for your CareSens N Voice Meter is preset and fixed in mg dL 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 hold 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 Language Date Time and Sound Step 1 Entering the SET Mode Press and hold the S button for 3 seconds After all the segments flash across the screen SET is display
11. tip with a clean 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 test strip fills completely Note The meter will switch off if the control solution sample is not applied within 2 minutes of the amp symbol appearing on 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 appears on the display When the ctl is displayed the result is stored in the meter s memory but is not included in the averages 20 www i sens com ctl a WP UD AY VAN mg dL Step 5 Compare the result displayed on the meter to the range printed on the test strip vial The result should fall within that range Control Solution Range Control A 101 151 mg dL Control B 184 276 mg dL LOT EXP Step 6 Slide the test strip ejector button to discard the used test strip safely in disposable container Caution The ranges printed on the test strip vial are for CareSens Control Solutions only They do not have any connection to your blood glucose level www i sens com 2
12. 1 Using the Lancing Device Comparing the Control Solution Test Results You will need a lancing device in order to collect a blood The test result of each control solution should be within the sample You may use the lancing device contained in the range printed on the label of test strip vial Repeat the control CareSens N Voice Blood Glucose Monitoring System or any solution test if the test result falls outside of this range Out of other medically approved lancing device range results may occur due to the following factors Adjustable Tip Lancet Holder Ejection System e When the control solution bottle was not Repeat the shaken well control solution e When the meter test strip or the control test by referring Slidina Barrel solution were exposed to high or low to the Notes on Lancet Release Button ere temperatures page 18 e When the first drop of the control solution e The lancing device is for use by a single user only and should was not discarded or the tip of the vial was not be shared with anyone including other family members not wiped clean e When the meter is not functioning properly CAUTION To reduce the chance of infection e When the control solution is past the Discard the used All components that come into contact with blood expiration date printed on the bottle control solution samples should be considered to be biohazards capable of When the control solution is past its and repeat the transmit
13. best depth of skin penetration for an adequate sample size A beginning setting of three 3 is recommended Step 2 Unscrew and remove the adjustable tip Preparing the Meter and Test Strip Step 6 Insert a test strip with the contact bars facing up into the meter s test strip port Push the strip gently into the strip port until the meter automatically turns on and the 4 symbol appears If the talking function is on the meter will say Blood glucose test Please apply blood onto the test strip Step 3 Insert a new disposable lancet firmly into the lancet holder Twist off the protective cover of the lancet and set it aside then replace the adjustable tip Keep the protective cover to replace on top of the used lancet after testing Step 4 The lancing device has five puncture depth settings numbered 1 through 5 The smaller numbers are for a shallower puncture and the larger numbers are for a deeper puncture Choose a depth of penetration by rotating the top portion of the adjustable tip until the setting number matches the arrow 24 www i sens com www i sens com 25 Flagging Post meal Test Results CareSens N Voice Meter allows you to flag a result of a post meal test with ff symbol The post meal flag ff can be attached and deleted just before applying the blood sample or when the test result is displayed just after testing Once the test result is saved with the post meal flag ff it cannot be deleted Step 7
14. d displays the averages of total test results pre meal test Pr results and post meal test 11 results from the last 1 7 14 30 and 90 days Viewing Past Test Averages Step 1 Press the S or A button to turn on PS the meter If the talking function is on T the meter will say Memory recall Ji j The current date and time will be ic i al displayed at the bottom of the screen ngal for 2 seconds followed by the 1 day M in average value and the number ofthe The ULL test results saved within the current of tests day Step 2 Viewing Averages Press the A to view the 7 m button TOT 14 30 and 90 day average Im A button a values and the number of Average ew tests performed for the P 1 f 90 al al test period mg dL mg dL HOE em Ao Sav i Ln W button DEO Rn 34 www i sens com www i sens com 35 Step 3 Viewing Pre meal Averages Continue to press the mem Abutton mem A button to view the e J icm m m 1 7 14 30 and 90 day average e D pre meal average values A 1 7 14 30 90 al a and the number of tests LT days mg dL performed pre meals Ceo C PAA for the test period The V button pre meal test averages appear with the Pr symbol Step 4 Viewing Post meal Averages Continue to repeatedly ars A button mem press the A button the Ja S equ m 1 7 14 30 and 90 day average post meal average values m A 1 7 14 30 90 j eL and the number of tests mg dL days G
15. disinfecting please stop using the system and contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday e When the inscriptions on the exterior of the meter or lancing device have been removed e When the color of the meter or lancing device has changed or faded e When cracks or roughness develop on the meter or lancing device e When a part of the segment on the meter display does not flash e When control solution test results do not fall within the stated range on the test strip vial Caution e Do Not use other cleaners or disinfectants because other chemicals have not been validated and may damage the meter e Do Not get fluids inside the meter through the test strip port data transmission port or battery compartment Never immerse the meter or hold it under running water because this will damage the meter www i sens com 45 Understanding Error and Other Messages Caution Storage and Handling Whatis said What it means Error 1 Used A used test strip Remove the strip test strip was inserted and insert a new test strip Error2 The The blood or Repeat the test sample has control solution with a new test been applied sample was strip and wait until before the applied before the 4 symbol blood symbol the 4 symbol appears before appeared appeared applying the blood or control solution sample Do not expose the meter to direct sunlight or heat for extended periods
16. ed on the screen If the talking function is on the meter will say Set meter Press the S button again to select a language l J Step 2 Selecting a Language The meter has a bilingual talking l N V SN Y function that can be used as a verbal J aid for using the meter and hearing B test results When you enter the t L D language selection mode for the first time L1 will be blinking and the meter will announce Language Selection in the default language English To select another language L2 Spanish press A or V button Press the S button to confirm the language and set the year www i sens com 13 Step 3 Setting the Year The meter will say Set year if the talking function is on Press A or W button until correct year appears Press and hold A or V to scroll faster After setting the year press the S button to confirm your selection and set the month Step 4 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 set the date Step 5 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 confirm the date and set the time 14 www i sens com 13 AL 7 mg dL
17. ek Note The life span of a CareSens N Voice Meter is 5 years We recommend disinfecting both the meter and lancing device at least once per week We have validated a total of 260 cleaning and disinfecting cycle 260 pre cleaning and 260 disinfection Cycles to represent weekly cleaning and disinfecting over the use life of your meter and lancing device 1 pre cleaning and 1 disinfection cycles per week 52 weeks per year 5 years 260 pre cleaning and 260 disinfection cycles www i sens com 41 e We have validated Clorox Germicidal Wipes with 0 55 sodium hypochlorite as the active ingredient for disinfecting the CareSens N Voice Meter and lancing device It has been shown to be safe for use with the meter and lancing device This disinfectant is available commercially in towelette form In addition to CareSens N Voice BGMS instruction please read the instructions provided by the manufacturer of Clorox Germicidal Wipes before using it Name Clorox Germicidal Wipes Manufacturer Clorox Professional Products Company Phone 1 800 537 1415 Website www cloroxprofessional com EPA registration number Active ingredients Sodium Hypochlorite 0 55 67619 12 Note The disinfectant products can be purchased online retailers e g Amazon or by telephone at the manufacturer To find out where to purchase the disinfectant product please contact the manufacturer or visit their website as listed above 42 www i sen
18. es test strip not match the way Check the validity period of the test you feel strip e Check the meter Note If the problem is not resolved please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday 50 www i sens com The performance of CareSens N Voice Blood Glucose Monitoring System has been evaluated in laboratory and clinical tests Accuracy The CareSens N Voice BGM System is calibrated to yield results equivalent to plasma glucose concentrations The accuracy of the CareSens N Voice System Model GM505UAA was tested by comparing 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 Obtained by healthcare Obtained by professionals lay users Slope 1 023 1 032 Y intercept 1 86 mg dL 3 63 mg dL Correlation coefficient r 0 995 0 985 Number of sample 110 105 Range tested 30 485 mg dL 67 413 mg dL Accuracy results for glucose concentration 75 mg dL Within 5mg dL Within 10mg dL Within 15 mg dL 14 17 8296 17 17 100 17 17 100 Accuracy results for glucose concentration 2 75 mg dL Within 5 Within 10 Within 15 Within 20 54 93 58 82 93 88 93 93 100 93 93 100 www i sens com 51 Precision Precision studies were performed in a laboratory using the CareSens N Voice BGMS Within Run Precision
19. for hyperglycemia or hypoglycemia are displayed even if you do not have those conditions please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday www i sens com 33 Target Blood Glucose Ranges Meter Memory 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 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 70 99 mg dL Two 2 hours after a meal the range of a normal blood glucose level for non diabetic adults is between 100 139 mg dL 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 Transferring Test Results Test results stored in CareSens N Voice Meter can be transferred from the meter to a ce computer using PC care software and cable Ly a The Pc is displayed when the data cable J im connects the meter with computer For more information contact Customer nn Service at 1 800 429 5001 The CareSens N Voice Meter can save up to 500 test results with time date and temperature 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 an
20. he following instructions e Do not use the system for diagnosis or screening of diabetes e Use only fresh capillary whole blood samples for testing Alternative site and fingertip test results may differ significantly due to rapid changes in the blood glucose level after eating insulin injection or exercise Intended Use The CareSens N Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm palm thigh and calf Alternative site testing should be used only during steady state blood glucose conditions The CareSens N Voice Blood Glucose Monitoring System is intended for self testing outside the body in vitro by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The system is intended to be used by a single person and should not be shared It is not intended for use on neonates and is not for the diagnosis or screening of diabetes The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Voice Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites The CareSens Control Solutions are for use with the CareSens N Voice Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the
21. he sample was not enough or too Good Insufficient thick Sample Sample Then discard the test strip insert a new one and apply the blood sample again after 4 symbol appears on the screen Approximate size B www i sens com 27 Note The meter will switch off if the blood sample is not applied within 2 minutes of the amp symbol appearing on the screen If the meter turns off press S button or A button and apply the blood sample after the amp symbol appears on the screen Step 10 The test result will appear after the meter counts down from 5 to 1 If the talking function is on the result will be announced The result will be automatically stored in the meter memory CareSens N Voice Step 11 Discard the used test strip safely in disposable container by pushing up the test strip ejector If the test strip is removed after the test result is displayed the meter will automatically turn off after 3 seconds 28 www i sens com Discarding Used Lancets Step 1 Unscrew the lancing device tip ae ca amp Step 2 Place the protective cover on the lancet Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet in a proper biohazard container Caution Check for damages before using the lancet If they have been damaged please discard it and use other lancet e The lancet is very sharp Please keep away from children
22. lly lift the lancing device away from your skin 30 www i sens com Caution AST results should never be used to calibrate Continuous Glucose Monitoring Systems nor entered into an insulin dosing calculator or pump for dosing recommendations Things to know when using AST Please understand the following before testing at sites other than the fingertip forearms palms thighs and calves The capillary whole blood of the fingertips shows changes in glucose levels more rapidly than in alternative sites Therefore the test results from the fingertip testing and AST may differ This is because things such as lifestyle and ingested food having an effect on glucose levels Acceptable situations for AST Fasting period Before a meal Situations requiring fingertip test When the glucose levels are rapidly increasing such as during the two hours after a meal or exercise When sick or when glucose levels seem quite lower than test value When hypoglycemia is not well recognized e When insulin has the biggest effect Two hours after an insulin injection www i sens com 31 HI and Lo Messages AST Precautions Do not ignore the symptoms of hyperglycemia or hypoglycemia e When the results of the test do not reflect the way you feel retest using the fingertip If the fingertip result still does not reflect the way you feel on retesting please consult your healthcare professional Do not rel
23. ly and store at a temperature of 46 86 F 8 30 C TH p E 82 2 You should 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 e When using the meter for blood glucose test after any disinfection procedure 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 until the meter automatically turns on and the 4 symbol appears If the talking function is on the meter will say Blood glucose test Please apply blood onto the test strip Step 2 While the blood symbol amp blinks press and Ce hold the A button for 3 seconds till the ctl appears on the display If the talking function is on the meter will say Control solution test s d Please apply control solution onto the test strip T www i sens com 19 Step 3 Shake the CareSens Control Solution bottle well before each test Remove the cap and squeeze the bottle to discard the first 1 or 2 drops Then wipe the
24. mg dL performed post meals a lt Qn inna with the ff symbol forthe 77 wbuton 72m e test period will appear on the screen Step 5 Use the W button to scroll back through the averages seen previously To turn off the meter press the S button 36 www i sens com Viewing Test Results Step 1 Press the S or A button to turn the mem meter on The current date and time 3n will be displayed on the bottom of the screen for 2 seconds followed by the m Ll 1 day average value and the number geL of the test results saved within the The number 8 50059 current day of tests Step 2 Use the W button to scroll mem mem through the stored test results starting from the most recent and ending with the oldest Press the A button to return to the result seen previously The test date and the recorded temperature will display alternately After checking the stored test result press the S button to turn off the meter n P oos m UL ULL dL dL me poem E Zi PAY Z Tp AM n LE LL Dum Ma ay pe E www i sens com 37 Setting the Alarm Function Four types of 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
25. ng the Batteries CareSens N Single Blood Glucose Test Strip CareSens N Voice Blood Glucose Meter CareSens N Voice Blood Glucose Meter Display Preparation NOONAN 4 od Setting up Your System Adjusting Language 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 Flagging Post meal Test Results Applying the Blood Sample Discarding Used Lancets Alternative Site Testing HI and Lo Messages Target Blood Glucose Ranges Transferring Test Results Additional Functions Meter Memory Viewing Past Test 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 Pre cleaning and Disinfection Pre cleaning and Disinfection Procedures Caution Storage and Handling Understanding Error and Other Messages General Troubleshooting Performance Characteristics Warranty Information www i sens com 3 Important Information Read This First Important Health Related Information To receive safe and optimum system benefits please read the entire manual contents before using the system Please note t
26. of time Do not let dirt dust blood or water enter into the meter s test strip port Do not drop the meter or subject it to strong shocks Do not try to fix or alter the meter in any way Keep the meter in a cool and airy place Keep the meter away from strong electromagnetic field sources such as cell phones and microwave ovens The CareSens N Voice Meter should be used only with CareSens N Single Test strips Store all meter components in the carrying case to prevent loss The thermometer Retry the test of meter is not after about 30 stabilized yet minutes for the thermometer to be stabilized Note You can get additional information or technical assistance by calling our Customer Service Center 1 800 429 5001 9 am 9 pm EST Monday Saturday Error 4 The The blood Repeat the test sample was sample has using a new test not enough or abnormally high strip too thick viscosity or insufficient volume 46 www i sens com www i sens com 47 Message Error 5 Strip insertion error Please inserta CareSens N What is said strip properly This error message may appear when the wrong blood glucose test strip is used instead of the CareSens N Single test Strip What it means What is said What it means What to do Repeat the test with a CareSens N Single test strip Insert the strip with the contact bars facing up and push in gently until the meter turns on
27. ojos 1e6ou ja ue osn ouensn ojos UN eJeg im 2 v nae a oJbueg ue eSOIN D ep OdIONUOW 9p euJeisig Suo9Sgo1e onensn jap jenuew yadxq 10su soig au suos I e I Sens The Biosensor Expert User s Manual CareSens Blood Glucose Monitoring System A E areSens 4 ig For single user home use only Welcome to the CareSens N Voice Blood Glucose Monitoring System Thank you for choosing the CareSens N Voice Blood Glucose Monitoring System The system provides you with safe fast and convenient blood glucose in vitro i e outside the body monitoring The bilingual talking function of CareSens N Voice Meter can be used as an aid for using the meter The CareSens N Voice Meter is also designed to minimize code related errors in monitoring by using the auto coding function You ll receive an accurate result in five seconds with a small 0 5 uL blood sample This booklet contains important information about the CareSens N Voice Glucose Monitoring System Please read it carefully before testing your blood glucose Manufacturer i SENS Inc 27 36 Gwangun ro Nowon gu Seoul 139 845 Korea www i sens com Contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday At all other times or in case of emergency please contact your healthcare professional or emergency medical response gl O 2013 i SENS Inc All Rights Reserved
28. ort of meter Confirmation window Check here to see whether sufficient blood sample has been applied Edge to apply blood sample Apply blood sample here for testing Important Safety Instruction All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases even after disinfection Do not share the meter or lancing device with another person The CareSens N Single Test Strip should be used only with fresh capillary whole blood samples www i sens com 9 CareSens N Voice Blood Glucose Meter e Do not reuse test strips Data Port Do not use CareSens N Single Test Strips beyond the Used to transfer data from the expiration date This may cause inaccurate results Bind to a computer with a o e Test strips in new unopened vial and test strips in vial that nume Speaker have been opened can be used up until the expiration date Announces each step printed on the test strip box and vial label if the test strips are used and stored according to its storage and handling e methods A Button Store test strips in a cool and dry place at a temperature of Selects or Dj 2 E isplay 34 86 F 1 30 C changes Sh l l inf B OWs results Keep test strips away from direct sunlight or heat and do not LOU and messages freeze e Store test strips only in their original vial l i 4 l Ww Button e Close
29. r data management software can be ordered separately Please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday Caution The meter and lancing device are only intended for a single user Do not share them with anyone including other family members Never use on multiple users www i sens com 7 Inserting or Replacing the Batteries CareSens N Single 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 used batteries and insert the two new batteries Close the battery cover firmly Note Removing the meter batteries will not affect your stored results However you may need to reset your meter settings See page 13 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 v ev wv Contact bars Gently push the test strip with its contact bars facing up into the test strip p
30. r questions or concerns contact Customer Service 1 800 429 5001 9 am 9 pm EST Mon Sat At all other times or in case of emergency please contact your healthcare professional or emergency medical response www i sens com 5 Specifications CareSens N Voice Blood Glucose Monitoring System Measurement Range 20 600 mg dL 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 Two alkaline AAA batteries Memory 500 test results Size 3 90 x 2 21 x 0 75 in Weight Temperature 2 47 oz with batteries 50 104 F 10 40 C Relative humidity 10 90 Hematocrit 6 www i sens com 20 60 CareSens N Voice System includes the following items CareSens N Voice Blood Glucose Meter User s Manual Quick Reference Guide Batteries 2 CareSens N Voice System may include the following items CareSens N Single Blood Glucose Test Strips 10 Lancing Device Lancets 10 Logbook Carrying Case Check all the components after opening the CareSens N Voice Blood Glucose Monitoring System package The exact contents are listed on the main box The CareSens Control Solutions Control A amp B are necessary but not included The CareSens Control Solutions and the cable fo
31. s com Pre cleaning and Disinfection Procedures D Open the cap of the Clorox Germicidal Wipes container and B Clorox Germicidal pull out 1 towelette Wipes and close the cap Sn KO Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using one towelette to pre clean blood and other body fluids P n LU Og lt q pP Front Back Both sides Dispose of the used towelette in a trash bin 4 Pull out 1 new towelette and wipe the entire surface A 3 of the meter 3 times horizontally and 3 times em vertically using the ane new towelette to remove blood borne pathogens www i sens com 43 5 Dispose of the used towelette in a trash bin Allow exteriors to remain wet for 1 minute then wipe the meter using a dry cloth dry cloth minute eel 7 Repeat the same procedure for the lancing device step to step X After the pre cleaning and disinfection procedure the control solution should be tested to confirm that the meter works properly before using the meter Control solution tests should be performed with two different levels of solutions Control A amp B Verify that the test results are within the range printed on the test strip vial See page 19 for how to do a control solution test 44 www i sens com Note If any of the following deterioration signs appears after pre cleaning or
32. test is performing correctly 4 www i sens com The CareSens N Voice Blood Glucose Monitoring System is intended for in vitro outside the body diagnostic use only and for the quantitative measurement of glucose in capillary whole blood The CareSens N Voice Blood Glucose Monitoring System is intended for use by a single user only Do not share the meter and lancing device with another person The CareSens N Voice Blood Glucose Meter is designed to minimize code related errors in monitoring by using the no coding function The glucose in the blood sample mixes with special chemicals on the test strip to produce a small electrical current The CareSens N Voice Meter converts this electrical current to glucose concentration The CareSens N Voice Blood Glucose Meter should be used only with the CareSens N Single Test Strip An abnormally high or low red blood cell count hematocrit level over 6096 or below 2096 may produce inaccurate results 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 All parts of the kit are considered biohazardous and can potentially transmit infectious diseases even after you have performed pre cleaning and disinfection Fo
33. the vial tightly after taking out a test strip for testing A N A Selects or s lal S gt and use the strip immediately 5 V changes e Handle test strips only with clean and dry hands S Button information Do not bend cut or alter test strips in any way Turns the meter on off confirms e For detailed storage and usage information refer to the meni eeo CareSens N Single Test Strip package insert Keep the meter and testing supplies away from young Test Strip Port children Insert test strip here Test Strip Ejector Note You can get more safety information at FDA Public Slide down to discard Health Notification http www fda gov MedicalDevices the used strips Safety AlertsandNotices ucm224025 htm or at CDC Clinical Reminder http www cdc gov injectionsafety Fingerstick Note The cable for data management software d ae DevicesBGM html ordered separately Please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday 10 www i sens com www i sens com 11 CareSens N Voice Meter Display Setting up Your System alarm appears when the time alarm has been set alarm mem ctl 02 mem appears when test results lt WB O stored in the memory are displayed m m In 03 ctl appears during the control solution testing and when the control solution test results are displayed ooi QA 4 Test results test results are ATA Qjmg dL _ displayed here mmol L2 Blood insertion
34. ting the time will blink on the screen Press W to set the time Press A to set the minute alarm d dr 4 www i sens com 39 Caring for Your System Step 4 On pressing A the number indicating the alarm minute will start blinking Press W to set the minute V1 Lei Lu t Sk Step 5 Press the S button to finish and to enter the alarm alarm 2 mode Repeat steps 2 to 5 to set the remaining time m alarms alarm 2 and 3 L 4 Lt ZI N VE te Step 6 Press and hold the S button for 3 seconds to finish and turn the meter off 40 www i sens com To minimize the risk of transmission of blood borne pathogens the pre cleaning and disinfection procedure should be performed as recommended in the instructions below e Wash your hands thoroughly with soap and water after handling the meter lancing device or test strips e If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be disinfected prior to use by the second person Pre cleaning and Disinfection Pre cleaning procedure is needed to clean dirt as well as blood and other body fluids on the exterior of the meter and lancing device before performing the disinfection procedure The disinfection procedure is needed to prevent transmission of blood borne pathogens For the meter and lancing device this pre cleaning and disinfection procedure should be performed once per we
35. ting viral diseases even after disinfection discard date the date the bottle was test using a new Do not use a lancet that has been used by another person opened plus three 3 months bottle of control and never share your meter and lancing device with anyone e When the control solution is contaminated solution e Wash your hands thoroughly with soap and water after handling your meter lancing device or test strips Keep your meter and lancing device clean See the pre cleaning and disinfection section on page 41 If results continue to fall outside the range printed on the test strip vial the CareSens N Voice Meter and CareSens N Single Test Strip may not be working properly Do not use your system and contact Customer Service 1 800 429 5001 9 am 9 pm uS Sea cause pain or skin calluses thick hard skin Choose a different Note The CareSens Control Solutions can be purchased site each time you test separately Contact Customer Service 1 800 429 5001 22 www i sens com www i sens com 23 Preparing the Lancing Device Step 5 Step 1 Wash hands and the sample site with soap and warm water Rinse and dry thoroughly Cock the lancing device by holding the body in one hand and pulling on the sleeve with the other hand until the device clicks Note The skin depth to retrieve samples will vary for various people at different sample sites The lancing device s adjustable tip allows the
36. tting 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 i sens com 17 Checking the System You should check your meter and test strips using f CareSens Control Solution Control A and B The m CareSens Control Solutions contain known amounts of glucose and are used to check that the meter and a the test strips are working properly The teat strip wis Vials have CareSens Control Solution ranges printed on their labels Compare the result displayed on E n the meter to the control solution range printed on the test strip vial Before using a new meter or a new vial of test strips you should conduct a control solution test following the procedure on page 19 with two different levels of solutions Control A and B Notes Use CareSens Control Solutions only 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 solutions are at room temperature before testing Control solution tests must be done at room temperature 68 77 F 20 25 C e Before using the control solution shake the bottle discard the first 1 or 2 drops and wipe the tip clean e Close the control solution bottle tight
37. y on the AST results for changing your treatment method The amount glucose in alternative sites differs from person to person 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 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 20 600 mg dL HI appears when the i blood glucose level is greater than 600 mg dL leg and indicates severe hyperglycemia much higher than normal glucose levels If the talking mg dL function is on the meter will say Your blood glucose reading is above 600 mg dL If HI is displayed again on retesting please contact your healthcare professional immediately Lo Message Lo appears when a test result is less than 20 mg dL and indicates severe hypoglycemia D very low glucose levels If the talking function B is on the meter will say Your blood glucose L J i reading is below 20 mg dL mg dL If Lo is displayed again on retesting please Taea ean contact your healthcare professional immediately Note If messages
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