Blood Glucose Monitoring System
Contents
1. If Lo is displayed again upon retesting please contact the patient s healthcare provider immediately Note If messages for hyperglycemia or hypoglycemia are displayed even if patient does not have those conditions please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday Transferring Test Results Test results stored in LiteTouch CareSens N Voice Multi Blood Glucose Meter can be m transferred from the meter to a computer en a using SmartLog software and cable The I Le i B Pc is displayed when the data cable connects the meter with computer For MU Im single patient use only ea For more information contact Customer Service at 1 800 429 5001 Meter Memory The LiteTouch CareSens N Voice Multi Blood Glucose 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 LiteTouch CareSens N Voice Multi Blood Glucose 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 11 Viewing Past Test Averages Step 1 ww PresstheSor A button to turn on the att meter If the talking function is on the T meter will say Memory recall The 5 mg dL current date and time will be displayed Ar at the bottom of the screen followed EB by t2. and set the date Step 5 Setting the Date The meter will say Set date when the LE talking function is on Press A or W button until blinking number shows the correct date Press the S button to confirm _ ki the date and set the time u o E Step 6 Setting the Time Format The meter can be set in the AM PM 12 i hour or the 24 hour clock format If the I talking function is on the meter will say AM Set time 12 hour 24 hour Press A or BE Se V button to select a format The AM DIH ICh m PM is not displayed in the 24 hour format After selecting the format press the S button to set the hour Step 7 Setting the Hour If the talking function is on the meter will say Set hour Press A or Y button until the correct hour appears After setting the hour press the S button to confirm the hour Ll and set the minute Use ied Step 8 Setting the Minute If the talking function is on the meter will i say Set minute Press A or Y button until the correct minute appears After setting the minute press the S button to set the sound bere a J E p 27 OE it PM r z L Step 9 Turning the Sound On Off A number showing the sound volume will blink and the meter will say Set volume Press A or y 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
3. 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 L After all the segments flash across the all screen SET is displayed on the screen If the talking function is on the meter will say Set meter Press the S button again to select a language Step 2 Selecting a Language N The meter has a bilingual talking function that can be used as a verbal aid for using the meter and hearing test 7 gt results When you enter the 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 Y button Press the S button to gt confirm the language and set the year Step 3 Setting the Year The meter will say Set year if the talking i function is on Press amp or W button 4 until correct year appears Press and hold A or Y to scroll faster After setting the year press the S button to confirm your selection and set the month 7 mdidL 1 Ze D HA mbar LI o 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 BGE eii the S button to confirm your selection
4. See page 19 for how to do a control solution test Note If any of the following deterioration signs appear after pre cleaning or disinfecting please stop using the system and contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday When the inscriptions on the exterior of the meter have been removed When the color of the meter has changed or faded When cracks or roughness develop on the meter When a part of the segment on the meter display does not flash When control solution test results do not fall within the stated range on the test strip vial For more information please refer to the following references FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http www fda gov Medical Devices Safety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html Caution 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 Caution Storage and Handling Do not expose the meter to direct sunlight or heat for extended periods of time Do not let dirt dust
5. by the manufacturer of lancet before using it Step 1 Wash hands and the sample site with soap and warm water Rinse and dry thoroughly Wear appropriate protective gear such as disposable gloves Preparing the Meter and Test Strip Step 2 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 amp symbol appears If the talking function is on the meter will say Blood glucose test Please apply blood onto the test strip Flagging Post Meal Test Results LiteTouch CareSens N Voice Multi Blood Glucose Meter allows you to flag a result of a post meal test with fi 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 3 If you want to attach a post meal flag ff to a test result press and hold the W button sh for 3 seconds after inserting the test strip A The post meal flag ff and the 4 symbol N will appear on the screen Ifthe talking u function is on the meter will say Post meal test Please apply blood onto the test strip The test result will also be displayed with the post meal flag 11 If you do not want to save the result as a post meal test move on to Step 4 after Step 2 If you want to d
6. the number of the test results saved within EG the current day gt e number 0 tests within the current day Step 2 Use the W button to scroll 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 results press the S button to turn off the meter mem mem N rn W button mr l LE ETE mg dL mg dL 3 A button 3 na vr IT a 2020 ZI pr at oO 4 the Setting the Alarm Function Four types of alarms can be set in the LiteTouch CareSens N Voice Multi Blood Glucose 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 Y orS 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 press and hold the A button for 3 seconds to set the post meal alarm PP2 the symbol and On will be displayed If the talking function is on the meter 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 m m Dar TE gt z e m a U PM Step 2 Setting t
7. 001 9 am 9 pm EST Monday Saturday In case of emergency contact your healthcare professional or emergency medical response team 2014 MediCore All Rights Reserved PGA1E3219 REVO 02 2014 Table of Contents Information important Information Read This FINS lu inisaiaia nadando 2 Important Health Related Information cccsccssesssesessssessssesessssssessssessssssesessssesssesseesseessesseesesseeesees 3 o oo o wits 3 LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System sessessssessessesssserssseees 4 Inserting OF Replacing the Batteries airada atan A Litelouch Caresens N Multi Test MID ntc 4 LiteTouch CareSens N Voice Multi Blood Glucose Met f ssseesssessseessseesssessseeesseesssersseeesseessseee 5 CareSens N Voice Multi Blood Glucose Meter Display oococoonoonomnme 5 Preparation SOINI UP TOUR A ee ee 6 Adjusting Language Date Time and SOUNA esmas iaa 6 Setting the Hypoglycemia Indicator e s ssseessseessseessseessseessseesssceosseessserosserssserosserosssrosssrosssrosssessses 7 CHECKNOL A O OS PO II E A 7 Control Solution VSS CNG urinaria did cata 8 Comparing the Control Solution Test ResultS o coconocconononnmme 8 Blood Glucose Testing Blood GIUCOSES Testing aneinander 9 Preparing the Meter and Test Strip ccccssssssscsssssessssssscssssssesssscscssssssssssscsssssscessecscsssseassesseasseeseasess 9 Flagging Post Meal Test Results ninia
8. 8 95 8 48 48 100 48 48 100 27 48 56 3 36 48 75 0 46 48 95 8 48 48 100 i 48 48 100 Warranty Information Manufacturer s Warranty MediCore warrants that the LiteTouch CareSens N Voice Multi Blood Glucose Meter shall be free of defects in material and workmanship in normal use for a period of three 3 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 MediCore 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 MediCore 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 MediCore Authorized Warranty Station 17 18 LiteTouch CareSens N Control Record Chart Example Should see comments section below Meter Serial Number back of the meter I Write Yes if the meter was cleaned and No if it was not Initials N Range is printed on the test strip vial label EE The control solution must be discarded by either the expira tion date printed next to the use by symbol on the bottle or the discard date whichever comes first Count forwa
9. Alternate Care User s Manual touch CareSens Blood Glucose Monitoring System gt W CareSe 9 k Blood Glucose al soge a A Use with CareSens N bran ne pE rah e N Close the vial immediate DO gf Forin vitro dianostic USE on r Store between 34 F 86 For more information see For self testing use only a n Se TM touch CareSens N Voice LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System Thank you for choosing the LiteTouch CareSens N Voice Multi 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 LiteTouch CareSens N Voice Multi Meter can be used as an aid for using the meter The meter is not intended to be used by visually impaired persons The LiteTouch CareSens N Voice Multi 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 Alternate Care Manual contains important information about the LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System Please read it carefully before testing your blood glucose FDA APPROVAL Manufactured for MediCore 2832 Logan Street Suite B Nashville TN 37211 www MediCore com EC REP Contact Customer Service 1 800 429 5
10. Sens N Control Solutions can be purchased separately Contact yourDistributor Blood Glucose Testing CAUTION To reduce the chance of infection Before performing a blood glucose test observe the following safety precautions All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases between patients and healthcare professionals e A new pair of clean gloves should be worn by the user before testing each patient e Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test e Use only an auto disabling single use safety lancet for each patient The meter should be cleaned and disinfected after use on each patient See the cleaning and disinfection section on page 40 For more information please refer to the following guidelines Preparing the Lancing Device 1 Biosafety in Microbiological and Biomedical Laboratories BMBL http www cdc gov biosafety publications bmbl5 2 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition Clinical and Laboratory Standards Institute CLSI M29 A3 You will need a lancet in order to collect a blood sample Only an auto disabling single use safety lancet should be used The auto disabling single use safety lancets can be purchased from your distributor Please read the instructions provided
11. To turn off the sound press the S button when OFF blinks on the display Then the HJ 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 glucose indicator setting mode mee m gure ur 7i N N ZEN FT NAR Lu i T En Da L In r E a pm gt Note 2 symbol is displayed only when the sound is set to OFF 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 Step 10 Turning on the Hypoglycemia Indicator When you enter the hypoglycemia indicator setting mode the N symbol ww and HYPo will blink If the talking function Que is on the meter will say Set hypoglycemia E indicator On pressing A or W thescreen Aj mel will display On or OFF Press button to set HY Po your hypoglycemia level if you choose On The screen will return to step 2 language selection mode if you choose OFF Caution Ask your healthcare professional to help you decide what ne your hypoglycemia level is before setting your hypoglycemic level Step 11 Setting Your Hypoglycemic Level The hypoglycemic level can be set from 60 to 20 mg dL To set your hypoglycemic level press A or y button until the level you want appears Press the S button to confirm Then the screen w
12. abetes control The system is only used with auto disabling single use safety lancets It is not intended for use on neonates and is not for the diagnosis or screening of diabetes The voice feature is not intended for use by visually impaired persons The LiteTouch CareSens N Multi Blood Glucose Test Strips are for use with the LiteTouch CareSens N Voice Multi 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 LiteTouch CareSens N Voice Multi Blood Glucose Meter and LiteTouch CareSens N Multi Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly Important Health Related Information The LiteTouch CareSens N Voice Multi 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 LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System is intended for use by Healthcare Professionals for monitoring blood glucose levels in a multi patient multi user setting After each use healthcare personnel should change gloves The LiteTouch CareSens N Voice Multi Blood Glucose Meter is designed to minimize code related errors while monitoring by using the no coding function The glucose in the blood sample mixe
13. 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 Store all meter components in the carrying case to prevent loss 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 Understanding Error and Other Messages Error 6 Error 7 Error 8 Error 9 Meter failure There isa problem with the meter Do not use the meter Contact Customer Service 1 800 429 5001 What it means What to do Note If the error messages persist contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday The temperature during the test is below the operating range Move to an area where the temperature is within the operating range 50 104 F and repeat the test Message Whatis said What it means What to do Error 1 Used A used test strip Remove the strip im test strip was inserted and insert anew L test strip Error 2 The The blood or Repeat the test P sample has control solution with anew test m E E been applied sample was strip and wait until m before the applied before the 4 symbol blood symbol the 4 symbol appears before appeared appeared applying the blood or control solution sample SA N A The
14. d Glucose Monitoring System has been evaluated in laboratory and clinical tests Accuracy The LiteTouch CareSens N Voice Multi BGM System is calibrated to yield results equivalent to plasma glucose concentrations The accuracy of the LiteTouch CareSens N Voice Multi Blood Glucose Monitor 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 lab 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 lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 14 17 82 17 17 100 17 17 100 16 1 2 50 0 2 2 100 2 2 100 1 2 50 0 2 2 100 2 2 100 2 2 100 1 2 50 0 2 2 100 2 2 100 2 2 100 1 2 50 0 2 2 100 2 2 100 2 2 100 Alternative site test results for glucose concentration gt 75 mg dL Within 5 Within 10 Within 15 Within 20 27 48 56 3 46 48 95 8 48 48 100 48 48 100 19 48 39 6 17 48 35 4 42 48 87 5 47 48 97 9 46 4
15. e for making additional copies Should see comments section below Meter Serial Number back of the meter gt O L q Cc O O Q jo L e oo o 0 a O 0 oO E ro oO T ra As gt Ko n y D oO a O gt 77 xX oO E no y L ra As gt O n y e Mo k pur O O Lh ra As gt O nu D Oo O O O k fy O Control Level Time Test Strips Date Initials Cc x q Cc Ro O lt Per 19 20 Notes
16. elete the post meal flag ff that you have attached press and hold the W button for 3 seconds again before applying the blood sample or when the test result is displayed just after testing Applying the Blood Sample Step 4 Obtain a blood sample using a safety lancet Place the safety lancet against the sampling site in the direction of the arrow The best puncture sites are areas on the middle or ring fingers Remove the safety lancet 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 5 Afterthe 4 symbol appears on the screen apply the blood sample to the narrow end of the test strip until the meter beeps Ifthe blood sample does not fill the confirmation window completely an Er4 message may appear because of abnormal viscosity or OPI insufficient volume If the talking function is on the meter will say Error four The sample was not enough or er amp too thick Good Insufficient Sample Sample Then discard the test strip insert anew one and apply the blood sample again after amp symbol appears on the screen It is recommended that the application of blood sample to the test strip be performed virtually vertical to the sample site as shown in the diagram Note The meter may switch off ifthe blood sample is not applied within 2 minutes of the 4 symbol appearing on the screen Ifthe meter turns off remove t
17. em appears when test results stored in the memory are displayed ctl appears during the control solution testing and when the control solution test results are displayed Test results are displayed here Blood insertion symbol indicates meter is ready for the application of a drop of blood or control solution Temperature symbol appears when the temperature is displayed Post meal test flag appears during 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 11 Battery symbol indicates meter batteries are running low and need to be replaced 412 mg dL mmol L unit for measuring blood glucose 13 Date temperature Time Note The unit of measurement for your LiteTouch CareSens N Voice Multi Blood Glucose Meter is preset and fixed in mg dL Setting Up Your System You should check and update the meter settings such as time and date before using your meter or after changing 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 will appear on the display The meter will also announce each function when the talking function is on Press and hold A or Y to scroll faster Whenever you want to complete the settings and exit from the
18. firmation window is filled adequately e Repeat the test after inserting a new test strip The test result does not match the way you feel e Repeat the test after inserting a new test strip e Check the validity period of the test Strip Perform the control solution test Note If the problem is not resolved please contact Customer Accuracy results for glucose concentration 75 mg dL Within 5 Within 10 Within 15 Within 20 54 93 58 82 93 88 93 93 100 93 93 100 Precision Precision studies were performed in a laboratory using the LiteTouch CareSens N Voice Multi BGMS Within Run Precision 38 mg dL SD 1 9 mg dL 86 mg dL SD 3 2 mg dL 125 mg dL CV 4 1 189 mg dL CV 2 6 Total Precision Control avg 334 mg dL 35 mg dL CV 2 8 SD 1 2 mg dL Control avg 116 mg dL CV 2 4 Control avg 324 mg dL CV 2 3 This study shows that there could be variation of up to 4 1 Alternative Sites Testing Evaluation Comparison of results using various AST sites with the results of YSI measurements Alternative site test results for glucose concentration lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL Service 1 800 429 5001 9 am 9 pm EST Monday Saturday Performance Characteristics The performance of LiteTouch CareSens N Voice Multi Bloo
19. he 1 day average value and the number of the test results saved within The number of the current day tests within the current day Step 2 Viewing Averages Press the A to view the 7 14 30 and 90 day average values and the number of tests performed for the test period A button mem Y a ww Um Average f m al Y Yoo 1d mg dL 90 days mg dL Step 3 Viewing Pre Meal Averages Continue to press the A button to view the 1 7 14 30 and 90 day pre meal average values and the number of tests performed pre meals for the test period The pre meal test averages appear with the Pr symbol mem A button m Pre meal mr w Jt 1 1030 I m KT days BE en En di W button Ls IU Lim Step 4 Viewing Post Meal Averages Continue to repeatedly press the A button the 1 7 14 30 and 90 day post meal average values and the number of tests performed post meals with the ff symbol for the test period will appear on the screen A button mem UY gt N UD Lu pa NIN 1 7 14 30 amy E 90 days ON Ji DAY ITU Se 4 Der Dm AVG D y button at Ma da A we 12 Step 5 Use the W button to scroll back through the averages seen previously To turn off the meter press the S button Viewing Test Results Step 1 nai PresstheS or A button to turn the meter IN on The current date and time will be ic A displayed on the bottom of the screen mg dL followed by the 1 day average value and zie
20. he PP2 Alarm OFF To turn off the PP2 alarm press and hold the A button for 3 seconds PP2 the amp symbol and OFF will appear on the screen If the talking function is on the meter will say Post meal alarm is off Then the screen will change automatically to the memory check mode without A symbol displayed F059 Sr rect gt mi p tht Setting the Time Alarms Alarm 1 3 Step 1 alarm Without inserting a test strip press A and the S button simultaneously for 3 seconds to enter the time alarm mode While OFF blinks on the screen alarm 1 lt ee will be displayed If the talking function PL teus is on the meter will say Set alarm one icon disappears Step 2 alarm On pressing W alarm 1 is set and On is displayed on the screen Press W again to cancel alarm 1 and OFF will blink on the screen 1 Step 3 alarm Press A to adjust the hour of alarm 1 j A number representing the hour will blink on the screen Press W to set the hour Press A to set the minute N I n we Step 4 alarm On pressing A the number indicating the i minute will start blinking Press W to set the minute N u ar Step 5 alarm Press the S button to finish and to enter I the alarm 2 mode Repeat steps 2 to 5 to set the remaining a time alarms alarm 2 and 3 U PY N Z Ltt pm Step 6 Press and hold the S button for 3 seconds to finish and turn the meter off Caring for Your System To minimize
21. he strip reinsert and start from step 2 step 6 ww The test result will appear after the 1 meter counts down from 5 to 1 If T u the talking function is on the result ae maal will be announced The result will be automatically stored in the meter JIH 12 3 memory Step 7 Discard the used test strip safely in a biohazard approved 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 10 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 in the fingertip 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 Testino 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 f
22. ias ii aaa 9 Applying the Blood Salir 9 NA associere PO PS o E A 10 Hrana LO MESS ers uta 11 Transferring Test Beulen dona 11 Additional Functions Meter MENON nennen pais 11 Viewing Past Test AVE ee ee neue 12 viewing Test Rostros 12 Setting the Alarm FUNCION arar aii adas 12 Setting the Post Meal Alarm PP2 Alarim ccscssssssssssssssssssssssscssssssesssssscssssssssssscasssseseseeseasssesees 12 Setting the Time Alarms Alarm 1 3 csssscssssssssssscsssssssssssscsssscssssssesssesscsesseassssacseseescassescsssseaees 13 Maintenance Canna TOR YOU Sy SUTIN roman aaron nao 13 cleaning and Disini e CUO msivninninaricar iaa ida 13 Cleaning and Disinfection PrOCECUIES cssssssssesssseessssssssessssecssseesssesssseeseseeasseeseseesesesseeseseeeseees 14 Ca tion Storage ana Handal unas Oia 15 Understanding Error and Other Me SSagQe ssssscssssssssssssscsssssssssscsssessessseesessssessseeseassseseasseeaeeeeaes 15 General TOU OI STS UNO een eiserne 16 PEPE ON VIN SCPC CONN SI renato ancianas 16 Warranty nta ON aran decanato 17 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 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 d
23. ill return to step 2 language selection mode See page 14 i SE EN DF TE TN ian magia Voit u JE otal I ma rst mic Step 12 Exiting from Set Mode After completing the meter settings 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 Checking the System You should check your meter and test strips using CareSens Control Solution Control N A and B The CareSens Control Solutions contain known amounts of glucose and SareSer are used to check that the meter and the muss test Strips are working properly The test a strip vials have CareSens Control Solution Wt ranges printed on their labels Compare the a result displayed on 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 20 with two different levels of solutions Control A and B Notes e 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 Make sure your meter test strips and control solutions are at room temperature before testing Control solution tests must be done at r
24. ingertip and alternative site sampling Place cocked lancing device against the site Press the release button Massage the site to obtain a round drop at least 0 5 uL of blood Apply test strip tip to blood sample 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 read the following before testing at alternative sites forearms palms thighs and calves The capillary whole blood of the fingertips reflects changes in glucose levels more rapidly than in alternative sites The test results from the fingertip testing and AST may differ due to factors such as lifestyle and ingested food which affect 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 e Two hours after an insulin injection AST Precautions Do not ignore the symptoms of hyperglycemia or hypoglycemia e When the results of the test do not reflect the way patient feels retest using the fingertip If the fingertip result still does not reflect the way patient feels on retesting plea
25. lood Glucose Monitoring System LiteTouch CareSens N Voice Multi BGMS includes the following items LiteTouch CareSens N Voice Multi Blood Glucose Meter User s Manual Quick Reference Guide Batteries 2 LiteTouch CareSens N Voice Multi BGMS may include the following items LiteTouch CareSens N Multi Test Strips 10 _ Lancing Device _ Logbook Carrying Case e Check all the components after opening the LiteTouch CareSens N Voice Multi 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 can be ordered separately Please contact your distributor or call MediCore Caution Only auto disabling single use safety lancets should be used with this system Inserting or Replacing the Batteries 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 the meter is in 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 Then swing the battery cover open Step 2 Remove the used batteries and insert the two new batteries Close the battery cover fi
26. nd Disinfection Procedures Cleaning Wear appropriate protective gear such as disposable gloves 2 Open the cap of the Approved EPA Ey Germicidal Wipes container and pull out 1 towelette and close the cap 4 Dispose of the used towelette in a trash bin The meter should be cleaned prior G2 to each disinfection step l Pa Disinfecting Pull out 1 new towelette and wipe the entire surface of the meter 3 times horizontally and 3 times vertically using the new towelette to remove blood borne pathogens 6 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 J minute gt 14 AA Germicidal ES 2 a Germicidal gt Wipes D 3 Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using one towelette to clean blood and other body fluids A AM Da YA en Ne D Front Back Both sides After disinfection the user s gloves should be removed to be thrown away and hands washed before proceeding to the next patient After the 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
27. ol Solution bottle well before each test Remove the cap and squeeze the bottle to discard the first 1 or 2 drops Then wipe the tip with a clean tissue or cloth While the 4 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 A completely HN Note The meter will switch off if the control solution sample is not applied within 2 minutes of the 4 symbol appearing on the screen If the meter turns off remove the strip reinsert 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 Step 5 Compare the result displayed on the Control Solution Range Control A 101 151 mg dL meter to the range printed on the Control B 184 276 mg dL test strip vial The result should fall EX within that range EXP The ranges depicted on the vials are examples only oe Step 6 Slide the test strip ejector button to discard the used test strip safely in a biohazard approved container Caution The ranges printed on the test st
28. oom temperature 68 77 F 20 25 C 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 tightly and store at a temperature of 46 86 F 8 30 C You should do a control solution test When you want to practice the test procedure using the control solution instead of blood When using the meter for the first time 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 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 en While the blood symbol 4 blinks press and hold the A button for 3 seconds s until the ctl appears on the display If AP the talking function is on the meter To will say Control solution test Please Sap ee ce apply control solution onto the test strip Step 3 Shake the CareSens Contr
29. rd 90 days from the date that you open the bottle of CareSens N Control Solution This is the discard date Write the discard Control Level IL date on the CareSens N Control Solution bottle Range is printed on the test strip vial label AAA The control solution must be discarded by either the expira tion date printed next to the use by symbol on the bottle or the discard date whichever comes first Count forward 90 days from the date that you open the bottle of CareSens N Control Solution This is the discard date Write the discard date on the CareSens N Control Solution bottle The test strip should be discarded by either the expiration date printed next to the use by symbol on the vial or 2 E the discard date whichever comes first Count forward 90 jo O O Q Oo L e oo 0 20 0 0 ro po L ra As 5 oO n y ze nt O oO cl O 0 E C O po Lh ra As gt vo oO n y k O gt O pu per Cc O O Use by Discard date date EEE ESO days from the date that you open a new vial of LiteTouch CareSens N Multi Test Strips This is the discard date Write the discard date on the LiteTouch CareSens N Multi Test Strips vial Time Test Strips Date i oo ee ee H H ae A S S NS A pt pt Cc x Cc O O lt LiteTouch CareSens N Control Record Chart Exampl
30. re test strips in a cool and dry place at a temperature of 34 86 F 1 30 C e Keep test strips away from direct sunlight or heat and do not freeze e Store test strips only in their original vial e Close the vial tightly after taking out 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 LiteTouch CareSens N Multi Test Strip package insert Keep the meter and testing supplies away from young children The test strip vial contains drying agents that are harmful ifinhaled or swallowed and may cause skin or eye irritation LiteTouch CareSens N Voice Multi Blood Glucose Meter Data Port Used to transfer data from the meter to a computer with a cable Speaker Announces each step CareSens IN Voice A Button Selects or Display changes Shows results information and messages V Button ALAA Selects or 4 s V changes S Button information Turns the meter on off confirms menu selections Test Strip Port Insert test strip here Test Strip Ejector Slide down to discard the used strips Note Data management software is only available for single use patients LiteTouch CareSens N Voice Multi Meter Display alarm mem ctl mlali DAN EN AM UN AV UL Pm alarm appears when the time alarm has been set m
31. rip vial are for CareSens Control Solutions only They do not have any connection to your blood glucose level Comparing the Control Solution Test Results The test result of each control solution should be within the range printed on the label of 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 was not shaken well e When the meter test strip or the control solution were exposed to high or low temperatures e When the first drop of the control solution was not discarded or the tip of the vial was not wiped clean e When the meter is not functioning properly Repeat the control solution test by referring to the Notes on page 19 Discard the used control solution and repeat the e When the control solution is past the expiration date printed on the bottle e When the control solution is past its discard date the date the bottle was test using a new opened plus three 3 months bottle of control e When the control solution is contaminated solution If results continue to fall outside the range printed on the test strip vial the LiteTouch CareSens N Voice Multi Meter and LiteTouch CareSens N Multi Test Strip may not be working properly Do not use your system and contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday Note The Care
32. rmly Note Removing the meter batteries will not affect your stored results However you may need to reset your meter settings See page 14 LiteTouch CareSens N Multi Test Strip The LiteTouch CareSens N Voice Multi 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 Y NY VY Contact bars Gently push the test strip with its contact bars facing up into the test strip port of meter 4 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 Safety Instructions for Using Test Strips All components that come into contact with blood samples should be considered biohazards capable of transmitting viral diseases between patients and healthcare professionals The LiteTouch CareSens N Multi Test Strips should be used only with fresh capillary whole blood samples Do not reuse test strips Do not use LiteTouch CareSens N Multi Test Strips beyond the expiration date This may cause inaccurate results 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 as long as the test strips are used and stored according to its storage and handling methods e Sto
33. s with special chemicals on the test strip to produce a small electrical current The LiteTouch CareSens N Voice Multi Blood Glucose Meter converts this electrical current to glucose concentration The LiteTouch CareSens N Voice Multi Blood Glucose Meter should be used only with the LiteTouch CareSens N Multi Test Strips An abnormally high or low red blood cell count hematocrit level over 60 or below 20 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 hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters For questions or concerns contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday At all other times or in case of emergency contact your healthcare professional Specifications 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 2 47 oz with batteries Temperature 50 104 F 10 40 C Relative humidity 10 90 Hematocrit 20 60 LiteTouch CareSens N Voice Multi B
34. se consult the patient s healthcare provider Do not rely on AST results for making treatment decisions The amount of glucose in alternative sites differs from person to person Before using AST please consult the patient s healthcare provider 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 ina smoother area Hi and Lo Messages Hi Message The LiteTouch CareSens N Voice Multi Lf Blood Glucose Meter displays results between 20 600 mg dL Hi appears when the blood glucose level is greater than 600 mg dL and indicates severe mg dL Ln Bor m UM PM hyperglycemia much higher than normal glucose levels If the talking function is on the meter will say Your blood glucose reading is above 600 mg dL If Hi is displayed again upon retesting please contact the patient s healthcare provider immediately Lo Message Lo appears when a test result is less than gt 20 mg dL and indicates severe hypoglycemia very low glucose levels If a Sf the talking function is on the meter will a say Your blood glucose reading is below 20 mg dL
35. the risk of transmission of blood borne pathogens the cleaning and disinfection procedure should be performed as recommended in the instructions below After disinfection users should remove gloves and wash hands before testing the next patient Cleaning and Disinfection The cleaning procedure is needed to clean dirt as well as blood and other body fluids off the exterior of the meter before performing the disinfection procedure The disinfection procedure is needed to prevent transmission of blood borne pathogens For the meter this cleaning and disinfection procedure should be performed after use on each patient Note The life span of a LiteTouch CareSens N Voice Multi Blood Glucose Meter is 3 years We recommend cleaning and disinfecting the meter after the use on each patient We have validated a total of 10 950 cleaning and disinfecting cycles 10 950 cleaning and 10 950 disinfection cycles to represent after each use cleaning and disinfecting over the use life of the LiteTouch CareSens N Voice Multi Blood Glucose Meter 1 cleaning and 1 disinfection cycles per each use 10 uses per day 365 days per year 3 years 10 950 cleaning and 10 950 disinfection cycles 13 For a list of Environmental Protection Agency EPA registered disinfectants effective against HIV Hepatitis C and Hepatitis B virus can be found at the following website http www epa gov oppad001 list_d_ hepatitisbhiv pdf Cleaning a
36. thermometer Retry the test a of meterisnot after about 30 E cr al stabilized yet minutes for the thermometer to be stabilized Error 4 The The blood Repeat the test 7 IM samplewas sample has using a new test l i not enough or abnormally high strip too thick viscosity or insufficient volume SA Error 5 Strip This error Repeat the test a insertion message may with a CareSens N la j al error Please appear when Multi test strip inserta the wrong blood Insert the strip CareSens N glucose test strip with the contact strip properly is used instead bars facing up of the CareSens and pushin N Multi test strip gently until the meter turns on The room temperature is too high The temperature during the test is above the operating range after the meter and test strips have reached a temperature within the Message Whatis said The room temperature is too low operating range 15 General Troubleshooting Problem Troubleshooting The display is blank even after inserting a test strip 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 e Replace the batteries The test does not start even after applying the blood sample on the test Strip e Check if the con
37. ue to rapid changes in the blood glucose level after eating insulin injection or exercise Important Safety Instructions All parts of the LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System should be considered potentially infectious and are capable of transmitting blood borne pathogens between patients and healthcare professionals For more information refer to Guideline for Isolation Precautions Preventing Transmission of Infectious Agents in Healthcare Settings 2007 http www cdc gov hicpac 2007ip 2007isolationprecautions html Only auto disabling single use safety lancets should be used with this system The meter should be cleaned and disinfected after use on each patient This BGMS may only be used for testing multiple patients when standard precautions and the manufacturer s disinfection procedures are followed Intended Use The LiteTouch CareSens N Voice Multi 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 LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System is intended for use outside the body in vitro and is intended for multiple patient use in professional healthcare settings as an aid to monitor the effectiveness of di
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