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1. Temperature Date Time Test Result Amount Easy Touch HealthPro Glucose Test Strips Test Strip Diagram Target to Apply Blood Sample 5pL V 9 9 Contact Bar Insert this End into Test Strip Port Store the EasyTouch HealthPro Test Strip vials in a cool dry place Keep out of direct sunlight Do not freeze Store test strips in their original vial only Do not mix the test strips in new vials or in any other container Immediately replace the vial cap and close tightly after removing any test strips from the vial Make a note of the discard date which is three months from the date you first open a new vial of strips Throw the EasyTouch HealthPro Test Strips and vial away after the discard date Do not use the test strips after the expiration date printed on the package or vial since it may cause inaccurate results EasyTouch HealthPro test strips are for single use only DO NOT RE USE Do not test at temperatures below 50 F or above 104 F Do not test with humidity below 10 or above 90 Do not bend cut or alter the test strip Avoid getting dirt food and or water on the test strip Avoid getting dirt food and or water on the vial label Refer to additional information in the EasyTouch HealthPro Test Strip package Before You Test Make sure to read this section and the test strip package insert found in the test strip box care
2. built in memory along with the average sugar level for the number of days which you had preset the glucose test meter to calculate IC in l E om MTH RAT MTH DAY iuc t 225 ied te Third Latest Second Latest Latest Press and release button The most recent result appears first Note the time and day of your blood sugar result Press and release the W button and your previous result will appear on the display 7 Day Average from the Test Date 14 Day Average from the Test Date 21 Day Average from the Test Date Press and release the A button and your average result will appear on the display 25 Reviewing Your Results Cont Alternate Site Testing Results Diagram Average Test Result Test Unit Test Result Amount Average Test Result Days Deleting Individual Test Result To delete any individual test result in the memory press A or W button for 3 seconds While the test result is being deleted the DEL message will blink After the second beep sound the deletion will be completed ALL DEL Deleting All Test Results To delete all test results in the memory press p A and V button for 3 seconds While the test e a result is being deleted ALL DEL message will blink LA LL LL After the third beep sound the deletion will be completed CAUTION The deleted test results cannot be recovered Please be careful in deleting the test results 26 AST Diagram Upp
3. or there is too much light Action required The ambient temperature is less than 50 F 10 C The ambient temperature is over 104 F 40 C The test result is lower than 20mg dl Please insert a new glucose test strip and perform your test again Contact MHC Customer Support at 877 358 4342 if the problem persists Place the meter at a temperature between 50 104 F 10 40 C for 10 minutes or more and test again Place the meter at a temperature between 50 104 F 10 40 C for 10 minutes or more and test again If Lo appears on the LCD screen for the Glucose result the measured concentration is below 20mg dl The test should be repeated to ensure that the test procedure was done correctly If you are certain the meter is functioning correctly and that no errors were made during the test procedure and the blood glucose is still consistently measured as Lo the result may indicate severe hypoglycemia low blood glucose You should inform your health care professional immediately 39 Troubleshooting Cont Inconsistent or Unexpected Test Results The test result is If Hl is displayed for the glucose higher than result the measured concentra 600mg dl tion is above 600mg dl The test should be repeated to ensure 3 te accuracy If you are certain the ied ize meter is functioning correctly and that no errors were made during the test procedure and the blood glucose is still co
4. steps for a total of 1 095 times and did not observe any change in performance accuracy or appearance NOTE If any of the following physical and or functional signs of deterioration appear after cleaning and disinfecting the devices stop using and contact MHC Customer Support at 877 358 4342 e Cloudy meter display e Meter displays broken character or icons e Meter will not power on e Meter buttons or strip ejector does not function e Control solution test falls out of range e Lancing device does not function 34 WARNING Do not share lancing device with anyone including other family members Storage of your EasyTouch HealthPro System To avoid the meter and test strips from accumulating dirt dust or other contaminants please wash and dry your hands thoroughly before use Meter Storage e Storage conditions 36 86 F or 2 30 C Temperature Always store or transport the meter in its original carrying case e Avoid dropping and strong impact e Avoid direct sunlight Strip Storage Storage conditions 36 86 F or 2 30 C Temperature Store your test strips in their original vial only Do not transfer to other container Store test strip packages in a cool and dry place Keep away from direct sunlight and heat After removing a test strip from the vial immediately replace the vial cap and close it tightly Record the expiration date 3 months after opening the test strips on the strip label
5. with the Control Solution eee ee eee 17 PerformingYourTest eee eee eee n n 20 Performing a Blood Test with Your Fingertip less 20 Disposing of Your Test Strips and Lancets llle 24 Reviewing your Results eee 25 Reviewing Your Blood Sugar 0 cee eee eee eens 25 Reviewing Your Averages lees 25 Deleting Individual Test Result llle 26 Deleting All Test Results llle 26 Alternate Site Testing 29992929999 2 BPRBRRLCRETCER 27 Lancing and Sampling from an AlternateSite Area 28 Caring for Your EasyTouch HealthPro Meter 32 Cleaning and Disinfecting Procedures 33 Storage ofYourSystem llle 35 Transferring Your Results llle 36 Battery Installation 1 3 o x RUE ied S64 REESE eS SEE REE ES 37 Troubleshooting sssusa oko eo 640904040444 a 38 TUS s eoe ieee So aaa aa a e a a Hie ee ote oh E 42 SDSCITICHEIOFIS eco smod edo qua Tee a CRA EERE ea Gee DoE 43 EasyTouch HealthPro Kit Contents The following items are included 1 EasyTouch HealthPro Meter 6 10 Twist Lancets 2 Carrying Case 7 1 Lancing Device 3 Instruction Manual 4 Logbook 5 Two 3V Coin Batteries CR2032 Your EasyTouch HealthPro Glucose Monitoring System has been sealed to protect the contents If you find your seal has been broken please return it to the pla
6. 33 Lancing Device Lancing Device Cont 1 Wash your hands before performing cleaning and disinfecting procedures 2 Remove a wipe from the container and follow the product label instruction to clean and disinfect 3 Check to make sure used lancet has been removed 4 Wipe the outside of the reusable lancing device carefully To clean the lancing device wipe it with an approved disinfecting towelette To disinfect the lancing device wipe it with another towelette and leave it wet for two minutes CAUTION e To achieve disinfection of the stated efficacy kill claim the lancing device should remain visibly wet for two minutes after the completion of disinfecting 5 Dispose of used wipes 6 Wash your hands thoroughly with soap and warm water after handling the lancing device 7 Whenever the reusable lancing device gets dirty and has blood or liquid on it cleaning and disinfection procedure should be performed It also should be cleaned and disinfected periodically We recommend that you performed the cleaning and disinfection procedures on it once per week Your EasyTouch HealthPro Meter has an expected life of at least 3 years and should withstand the cleaning and the disinfecting recommended in this User Manual We tested the meter and the lancing device with CaviWipes representing daily cleaning and disinfecting two separate steps for three 3 years Once per day 365 days x 3 years x 2 cleaning disinfecting
7. Do not use if expiration date has passed Use the test strip with clean and dry hands Control Solution Storage e Storage conditions Store in a cool dry place between 46 86 F or 8 30 C Temperature e After use close cap tightly e Record the expiration date date opened plus 3 months on the control solution on the bottle e Do not use if expiration date has passed 35 Transferring Your Results Battery Installation You can transfer test results from the EasyTouch HealthPro Meter to a computer You will need to download the software from the following web site http www mhcmed com gt Products gt HealthPro and purchase the computer cable from your local pharmacy or call MHC Customer Support for a retailer near you The cable is sold separately User Meter PC HealthPro Connect Cable to PC 36 The low battery icon will appear in the upper left corner of the LCD display to alert you when the battery power is running low indicating a new battery is needed immediately Your EasyTouch HealthPro Meter uses only two 3V lithium batteries CR2032 which are included When replacing the batteries only CR2032 or equivalent lithium battery should be used Follow up Action 1 Check your meter with the glucose control solution 2 Perform your test again 3 If you are experiencing symptoms that are not consistent with your blood glucose test results call you healthcare professiona
8. Easy Touch HeathPro Glucose Monitoring System BO MHC es Questions or Comments Call 877 358 4342 MHC Medical Products LLC 8695 Seward Road Fairfield Ohio 45240 www EasyTouchProducts com User Manual TE 081313 8 Dear Easy Touch HealthPro Glucose Monitoring System Owner Important Information Thank you for choosing the EasyTouch HealthPro Glucose Monitoring System This manual contains everything you need to know about your new glucose meter and how it works Please take a moment to read the instructions carefully The EasyTouch HealthPro Glucose Monitoring System offers a fast accurate and convenient way to read your glucose levels The meter has been designed to automatically turn on when the test strip is inserted into the meter automatically code the meter to the strip and automatically turn off after the reading Please take a moment to read this manual to learn of more convenient features to help you manage your diabetes After doing so we hope you will agree the EasyTouch HealthPro Glucose Monitoring System is designed to offer a better user experience Always consult with your healthcare professional before making any changes to your diabetes management The EasyTouch HealthPro Glucose Monitoring System is for in vitro diagnostic use only MHC Customer Service is available toll free at 877 358 4342 Monday thru Friday 9am to 5pm EST Intended Use The EasyTouch Hea
9. alteration neglect misuse or maintenance by someone other than MHC Medical Products 2 MHC Medical Products reserves the right to make changes in design without obligation to incorporate such changes into previously manufactured instruments 3 MHC Medical Products reserves the right to replace defective meters with a new meters of a different model For Warranty Service Purchaser must contact MHC Customer Support by calling toll free 877 358 4342 for assistance Service Information MHC Medical Products has trained specialists to help you IMPORTANT Contact an MHC Customer Support at 877 358 4342 before returning your meter for any reason You will be given the information needed to get your problem handled correctly and efficiently Keep your meter test strip and control solution nearby when you call 42 Store 36 86 F or 2 30 Cand no direct Batter Life IGM 0028A Gray LCD Running 5 000 Tests IGM 0028B Back Light LCD Running 1 000 Tests 43
10. ce of purchase Easy Touch HealthPro Meter Easy Touch HealthPro Meter Display Meter Diagram Easy Touch a enr Urp BD C Bm BET Ex Tj i Cuemitpr Erres gi Me gial Promis hi B77 358 4342 CAUTION Test Strip Port Insert the EasyTouch HealthPro Test Strip here Test Strip Ejector For hands free disposal of used test strips Display Screen Displays your test results symbols and messages Power Enter Button Powers the meter on off prompts memory data and acts as an enter button during setup and after tests Up Down Arrow Buttons Scrolls up or down to adjust settings or to retrieve memory Serial Number Battery Cover Do not use the EasyTouch HealthPro Glucose Meter in an environment with humidity below 1096 especially if synthetic materials are present Synthetic clothes carpets etc may cause damaging static discharges in an arid environment Display Layout C A CHK ALL DEL AVG iu rizi vbe E A LEE C Lt LI CODE mmol L mg dl YRMTH DAY AMPM a T ee O A a LO O a ALL DEL AVG IET v CODE mmol L mg dl YRMTH DAY AMPM BB BH Symbol Bank Low Battery Warning Symbol Alarm Symbol Troubleshooting Symbol Delete Results Average Test Result System Before Having a Meal After Having a Meal After Taking Medication After Sport Activity Control Solution Symbol Blood Drop Symbol for Test Strip Code Symbol Test Result Unit Symbol
11. e If you are using the High Level 3 Control Solution according to this particular vial of strips your meter should show a number between 255 and 345 Likewise if you are using the Low Level 1 Control Solution your meter should show a number between 35 and 65 Easy Touch HealthPro Control Solution Us ouch HealthPro Meter amp Strips g RTE High Level 3 255 345 a i A 7 e I Low Level 1 35 65 E zen uz Use wth EasyTouch Hero Meter Sts coii y t Di Note The control values on the test strip vial shown in the picture are not control ranges The control ranges of the control solutions are much greater ATTENTION 1 It is recommended that glucose control solution is stored at room temperature 46 86 F 8 30 C before testing 2 Check the expiration date before performing a glucose control solution test 3 Do not use if expired Once opened the control solution expires after 3 months If your control solution test falls out of range please follow the next steps before contacting MHC Customer Support Checkthe expiration dates on all the products you are using Be sure you are using EasyTouch HealthPro Glucose Control Solution Try another control solution test e If this test falls out of range try another control solution test with a new unopened bottle of strips e If the control test still falls out of range after following the appropriate steps do not perfo
12. ease check the code number on the LCD window with the code number on the test strip 15 Backlight Function Testing with the Control Solution When inserting the glucose test Firmly insert the test strip into the meter test port strip starting measuring Insert down firmly in direction of arrow on test strip process the backlight will turn Do not insert the glucose test strip upside down on for 10 seconds When you insert the glucose test strip into the glucose meter the meter will automatically turn on and identify the strip code After the test results display the backlight will last for 10 seconds If activi li o Oud If activity meal is OFF the icons with the press and release A or V button either the Aor V button until the icon When pressing the power button moving into memory mode the backlight will turn on for until the control i Easy ouch I seconas solution bottle is appears press O 0 blinking press afo Tor When pressing the power button for 3 seconds entering the Check the expiration date before performing a setting mode the backlight will turn on for 10 seconds control solution test Do not use if expired Please note the expiration date on the control solution bottle When inserting the PC cable into the USB port the backlight will turn on for 10 seconds Gently shake the control solution before use Performing a Control Solution Test The con
13. er Arm Forearm Dorsal Hand Fingertips Ventral Palm The EasyTouch HealthPro Glucose Monitoring System gives you the ability to obtain a blood sample for testing your sugar from different areas of your body The figure shown above displays the areas where you can test using your EasyTouch HealthPro Meter You may test you blood sugar from your forearm upper arm palm ventral palm or dorsal hand fingertips thigh or calf It is recommended that alternate site testing be used when sugars are stable before meals and before bedtime However when sugars are changing blood from the fingertip may show these changes sooner than blood from other sites LIMITATION 1 Alternative site testing results should never be used to calibrate continuous glucose monitoring systems 2 Alternative sampling results should never be used in insulin dosing calculations 27 Lancing and Sampling from an Alternate Site Area Lancing and Sampling from an Alternate Site Area Cont Sampling from your upper arm forearm dorsal hand ventral palm thigh or calf allows you to use your fingertips less often You may find that obtaining a blood sample from an alternate site is less painful than using a fingertip Getting a blood sample from your forearm or palm is different than getting a sample from your fingertip Ventral Palm Dorsal Hand Choose a fleshy area on the palm below your thumb or pinky finger Select a spot without any v
14. ets are for single use only 4 Avoiding getting hand lotions oil dirt or debris in and or on the lancets and lancing device 5 Please refer to page 33 for cleaning and disinfecting the EasyTouch HealthPro Glucose Monitoring System FDA Public Health Notification Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Blood born Pathogens Initial Communication Update 11 29 2010 http www fda gov medicaldevices safety alertsandnotices ucm224025 htm CDC Clinical Reminder Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Blood born Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html Table of Contents About your New EasyeTouch HealthPro Glucose Monitoring System About Your New EasyTouch HealthPro Glucose Monitoring System 2 02 e cece reece rccces 7 EasyTouch HealthPro Kit Contents 0 0 00 eee eee eee 7 EasyTouch HealthPro Meter 2 cee eee eee eee eens 8 EasyTouch HealthPro Meter Display llle 9 EasyTouch HealthPro Glucose Test Strip ee eee 10 Before Your Test 6 65 04 446 6 tanne ne 8 ae ewe We oe eee a 11 Comparing your Meter and Lab Results 2008 12 Setting Your Meter 22u c4 ake s Wad Ce Seeds wee ee Sees ewes 13 Auto coding Function 0 0 cee eee tee eee eee 15 Backlight Function iube E49 ERR X EE hehe X eae ESS eR eS 16 Testing
15. fully You will need to have all of the necessary items to begin testing Necessary Items 1 EasyTouch HealthPro Meter 2 EasyTouch HealthPro Test Strip 3 Lancing Device 4 Sterile Lancet If the meter is moved from one temperature to another allow 30 minutes for the meter to adjust to the new temperature before testing Make sure that the EasyTouch HealthPro Meter and Test Strips have adjusted to the temperature of the location from where you are testing Do not operate the EasyTouch HealthPro system in direct sunlight CAUTION To reduce the chance of infection 1 The lancing device and sterile lancets should NOT be shared with others Always use a new sterile lancet and a new glucose test strip Practice using the lancing device and become accustomed with its use Lancets and glucose test strips are for single use only Wash your hands with soap and warm water before testing Avoid getting hand lotion oils dirt or debris on the lancets or on the lancing device 7 Dry your hands completely before testing Qv Ui BW NJ 11 Comparing Your Meter amp Lab Results Setting Your Meter Test results with the EasyTouch HealthPro Glucose Monitoring System are plasma equivalent This method will help you and your healthcare professional compare your meter results with laboratory test results The EasyTouch HealthPro test results and laboratory test results both are expressed in pla
16. g Function AVG Th aa d Days for Avg Alarm On Off Alarm Time After pressing and After pressing and After pressing and releasing either A or V releasing eitherA or V releasing either A or V buttons to set the buttons to turn the buttons to set the alarm number of days alarm on off confirm hour and minute confirm with with 5 confirm with 5 Alarm After programming the number of desired alarms 5 alarms possible confirm with 5 IMPORTANT 1 Your EasyTouch HealthPro Meter is pre set to mg dL as test unit If you find out that the meter is not set to mg dL please contact MHC Customer Support at 877 358 4342 immediately 2 The correct units of the measurement in U S are mg dL 3 Without setting the date properly the average glucose level and the results in memory will not show proper values It is recommended to set the meter before use immediately after new batteries are installed 4 You can t test your blood glucose in the setting mode 5 To turn the meter off during the setup press 5 for at least 5 seconds 1 The EasyTouch HealthPro has an automatic code recognition function 2 The code number on the glucose meter is set automatically and should match the code on your test strip vial CAUTION 1 Do not bend the glucose test strip Bending could cause automatic code recognition failure 2 If the code recognition label is damaged the code recognition may fail Pl
17. isible veins and away from any deep lines This may cause your blood sample to smear Forearm Upper Arm Calf Thigh Choose a fleshy area of the forearm upper arm thigh or calf away from bone visible veins and or hair Sometimes there is less blood flow to these areas than to the fingertip To help you get a large enough drop of blood you may gently message or apply a heating pad to the site to increase blood flow IMPORTANT We recommend that you test on your fingertips if you are testing for hypoglycemia low blood glucose or if you are suffering from hypoglycemia unawareness 28 Accuracy To ensure accurate results when lancing your arm forearm or upper arm leg calf or thigh or palm ventral palm or dorsal hand clean the test site with soap and warm water Make sure there is no cream or lotion on the test site Thoroughly dry your hands and test site WARNING To reduce the chances of getting infection never share a lancet or a lancing device with anyone 29 Lancing Using the Clear Cap for an Lancing Using the Clear Cap for an Alternate Site Area Alternate Site Area Cont REMEMBER 1 Consult with your healthcare professional before using alternate site testing 2 Choose a different puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses 1 Remove the lancing 2 Insert lancet and 3 Rub the test site for a 3 If bruising occurs at an alternate site
18. l NOTE Make sure your date and time are correct after changing your battery 37 Troubleshooting Troubleshooting Cont The following chart may help you identify certain problems but may not solve all problems that can occur Contact your authorized representative or MHC Medical Products customer support if the problem persists r Lr MTH DAY PM ties ide i MTH DAY PM ies cei Z Lo MTH DAY PM ied ide i LL t MTH DAY PM ied ide i um P Dp D h al MTH DAY PM ties ice 38 Hardware is defective Test strip may be contaminated or used Insufficient amount of sample blood is placed on the test strip Inadequate sample of blood or control solution on test strip Blood sample is placed on the test strip before the symbol for blood blinks Reboot the meter by removing and then replacing the batteries while no test strip is inserted Contact MHC Customer Support at 877 358 4342 if the problem persists Please insert a new glucose test strip and perform your test again Please insert a new glucose test strip and apply the blood sample until confirming the window is completely filled Please insert a new glucose test strip and perform your test again Wait for the meter to display the blinking icon before applying your blood sample AN Lv v 023 te Jem LL Vt i023 EA Color bar of the strip is dirty not good
19. lthPro Glucose Monitoring System is intended to be used for the quantitative measurement of glucose sugar in fresh capillary blood samples drawn from the fingertips ventral palm dorsal hand upper arm forearm calf and or thigh The EasyTouch HealthPro Glucose Monitoring System is intended to be used by a single patient and should not be shared The EasyTouch HealthPro Glucose Monitoring System is intended for self testing by people with diabetes at home and on the go and also for healthcare professionals in a clinical setting The EasyTouch HealthPro Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use Alternative site testing should be done only during steady state times when glucose is not changing rapidly The EasyTouch HealthPro Glucose Test Strips are for use with the EasyTouch HealthPro Meter to quantitatively measure glucose sugar in fresh capillary blood samples drawn from the fingertips ventral palm dorsal hand upper arm forearm calf and or thigh The EasyTouch HealthPro Glucose Control Solutions are for use with the EasyTouch HealthPro Meter and Test Strips to check that the meter and test strips are working together properly The test also serves as a quality control to ensure the accuracy of the glucose test results 4 The EasyTouch HealthPro Glucose Monitoring System provides a quick and easy way for patients with diabe
20. n test to make sure the meter is working properly Take your meter with you to the lab While at the Lab Follow all instructions in this owner s booklet for performing a blood sugar test with your meter Conduct your meter test within 15 minutes of lab test Use only fresh capillary blood obtained from the fingertip You may still experience a difference from the laboratory test results because blood sugars can change very rapidly over a short period of time This is due to a variety of reasons such as exercise medication stress or loss of body fluids 12 The EasyTouch HealthPro Meter has a wide variety of functions from which to choose From the setup mode you have the ability to turn activity meal flags set the date time designate three averages and set up to five daily alarms Power On User Activity Option Year Press 5 for at After pressing and After pressing and least 3 seconds releasing either A releasing either A or V or W buttons to turn buttons to set the year the User Activity confirm with 5 Option on off confirm with 5 Date Time Test Unit Temperature Unit After pressing and Your meter is pre set Press and release either releasing either A to mg dL as test units A or V buttons to set C or V buttons to Just confirm it with 5 or F confirm with 5 set the date and The correct units of time confirm the measurement in each with 5 U S are mg dL 13 Setting Your Meter Cont Auto codin
21. nsert a sterile lancet Twist the protective Replace the lancing device cap into the lancing cover off device cap by device Do not discard twisting it on tightly Depth setting Use Pull the end of the To prick your finger 1 2 for soft skin 3 for lancet device back push the center avg skin 4 5 for thick button or calloused skin CAUTION 1 If the blood smears or runs do not use that sample Dry the area and gently squeeze another drop or puncture a new site 2 Do not share reusable lancing device with anyone including other family members 21 Performing Your Test Cont Performing Your Test Cont Step 3 Correct Incorrect The EasyTouch HealthPro Meter only requires 0 5 uL sample volume e Place the edge of the test strip to the drop of blood The blood will automatically be drawn into the test strip channel e When the test strip has collected a large enough blood sample the meter will automatically count down CAUTION 1 If the countdown does not start do not add more blood to the glucose test strip Discard the glucose test strip and start over with a new strip 2 If you do not conduct the test within 5 minutes the glucose test meter will automatically power off to save battery life In this case the test procedure should start again from the beginning 3 You may get an inaccurate result if the blood sample does not completely fill the test strip channel 22 S
22. nsistently measured as HI the result may indicate severe hyperglycemia high blood glucose You should inform your health care professional immediately There are no readings stored in the meter Not enough readings in the memory to display designated averages The glucose test Batteryisdeador Change the battery and if the meter does not there is a problem problem persists contact your power its ON with the meter local representative The glucose test Insufficient amount Please insert a new test strip meter does not of blood and perform your test again start after applied blood sample The results are There may be a Please insert a new test strip inconsistent problem with the and perform your test again glucose test strip If you continue to get unexpected results check your system with the control solution If you experience symptoms that are not consistent with your glucose results review and follow all instruction in this manual Never ignore symptoms or make significant changes to your diabetes control program Inform health care professional of symptoms and or concerns CAUTION 1 Low Glucose Results If your result is lower than 70mg dL it may mean hypoglycemia low blood sugar This may require immediate treatment according to your healthcare professional s recommendations Although this result could be due to a test error it is safer to treat first 2 High Glucose Results If y
23. or you have difficulty getting cap by twisting off replace with the few seconds until you a sample consider sampling from a fingertip instead You may want clear cap feel it getting warm to review the choice of sites with your healthcare professional Applying heat may 4 Do not share lancing device with anyone including other be helpful family members CAUTION Do not test on your upper arm forearm dorsal hand ventral palm thigh or calf when 1 You think you blood glucose is rapidly falling For example within two hours of exercise rapid action insulin injection or an insulin pump bolus 4 Continue to hold the 5 While holding the 6 Lift the lancing device 2 Testing with a fingertip sample may identify hypoglycemia or an insulin lancing device and lancing device on your straight up be careful reaction sooner than testing with a forearm or palm sample gradually increase test site look through not to smear the blood pressure for several the clear cap until on your testing site seconds a round drop of blood appears 7 Place the edge of the test strip to the drop of blood The blood will automatically be drawn up 30 31 Caring for Your EasyTouch HealthPro System Cleaning and Disinfecting Procedures Why should cleaning and disinfecting the meter and the lancing device be performed Blood glucose meters and lancing devices are at the high risk of becoming contaminated with blood born pathogens s
24. our test result is higher than 180 mg dL it may mean hyperglycemia high blood sugar If you are uncertain about your test results consider re testing Your health care professional will help you to decide how to take action If the meter displays HI all the time please re test your blood sugar If it s still higher please contact your healthcare professional immediately Range of Expected Values Self testing of blood glucose levels provide a way to control your diabetes Consults with your physician to determine the best range of your expected blood glucose values Expected blood glucose values for nondiabetic adults are as follows Before eating lt 100 mg dL 5 6 mmol L One to Two hours after meals 140 mg dL 7 8 mmol L Reference American Diabetes Association Clinical Practice Recommendations 2013 Diabetes Care Vol 36 Supplement 1 p S1 S100 41 True Lifetime Warranty Specifications Manufacturer s Warranty MHC Medical Products offers a True Lifetime Warranty to the original purchaser MHC Medical Products will repair or replace the meter if it is found to be defective or fails to perform as designed Proof of purchase may be required Please contact MHC Customer Support at 877 358 4342 Limitations of Warranty This warranty is subject to the following exceptions and limitations 1 MHC Medical Products shall not be required to replace any units which are damaged or malfunction due to abuse accidents
25. performing cleaning and disinfecting procedures Remove a wipe from the container and follow the product label instruction to clean and disinfect Check if the meter is turned off 4 Wipe the outside of the meter carefully 3 horizontal and vertical passes 5 Dispose of used wipes 6 Wash your hands thoroughly with soap and warm water after handling the 7 meter lancing device or test strips Whenever the reusable lancing device gets dirty and has blood or liquid on it cleaning and disinfection procedure should be performed It also should be cleaned and disinfected periodically We recommend that you performed the cleaning and disinfection procedures on it once per week To clean the meter wipe it with an approved disinfecting towelette To disinfect the meter wipe it with another towelette and leave it wet for two minutes NOTE 1 The meter should be cleaned prior to each disinfection Two disinfecting towelettes in total 2 To achieve disinfection of the stated efficacy kill claim the meter and lancing device should remain visibly wet for two minutes after disinfecting 3 Take extreme care not to get liquid in the test strip test strip port control buttons and data port Do not use spray of any sort CAUTION 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 decontaminated prior to use by the second person
26. ready for testing MTH DAY PM ea ice i CAUTION 1 If the code is not displayed automatically pull the glucose test strip out of the port and re start the procedure from the beginning 2 If the code on the LCD display window and on the glucose test strip vial does not match try another new glucose test strip If the mismatch persists please contact MHC Customer Support for help 3 For a more accurate test result avoid testing under direct sunlight 4 If you apply your blood sample before the blood symbol blinks Er5 message will appear on LCD Please refer to Page 38 20 Step 2 Before obtaining a blood sample wash your hands with soap and warm water Dry hands completely before testing WARNING 1 The EasyTouch HealthPro Meter and Lancing Device are for single patient use only Do not share them with anyone including other family members Do not use on multiple patients 2 All parts of the kit are considered bio hazardous and can potentially transmit infectious disease even after you have performed cleaning and disinfection Avoiding getting hand lotion oil dirt or debris in or on the lancets single use only and the lancing device 4 Please refer to page 33 for cleaning and disinfection your EasyTouch HealthPro Glucose Monitoring System 5 Wash your hands thoroughly with soap and warm water after handling the meter lancing device and or test strip UJ Unscrew the lancing I
27. rm a glucose test Please call our toll free MHC Customer Support at 877 358 4342 18 Follow up Actions 1 Check your meter and strip with the glucose control solution 2 Perform your test again CAUTION 1 If your glucose control solution falls out of range do not perform a glucose test and please contact MHC Customer Support at 877 358 4342 2 The glucose control solution range is not the recommended range for your blood glucose level 3 Please discard control solutions according to your local regulations 19 Performing Your Test Performing Your Test Cont Performing a Blood Test with Your Fingertip Step 1 Firmly insert the test strip into the meter test port Insert down firmly in direction of arrow on test strip Please do not insert the glucose test strip upside down When you insert the glucose test strip into the glucose test meter the meter will automatically turn on with the code and temperature Make sure the code number matches the code on the strip bottle e g C21 The meter automatically recognizes the test strip code number and adjusts the meter accordingly If during the setup process you chose to use the activity meal flags amp X amp 4 press and release A or W button to select the activity that will correlate with your results then press and release 0 MTH DAY c3 A blinking test strip will appear at the top of the screen indicating the meter is
28. sma equivalent units However your glucose monitor results may differ from your laboratory results due to normal variation Your glucose monitor results can be affected by factors and conditions that do not affect laboratory results in the same way Your EasyTouch HealthPro monitor value is considered accurate when it is within 20 of the laboratory measurement There are some specific situations that could cause a difference of more than 20 1 You are severely dehydrated 2 You have eaten recently The blood glucose level from blood obtained from a fingertip can be up to 70mg dL higher than blood drawn from a vein venous sample used for a lab test 3 Your hematocrit is above 6096 or below 2096 Sacks D B Carbohydrates Carbohydrates Burits C A and Ashwood E R ed Tietz Textbook of Clinical Chemistry Philadelphia W B Saunders Company 1994 959 If you perform a blood sugar test with the system at a temperature near the low end of the operating range it could result in a false high blood sugar Repeat the test in a warmer environment with a new test strip as soon as possible For additional information on possible limitations for accuracy on precision please refer to your test strip insert In order to make the most accurate comparison to your laboratory results please follow a few basic guidelines Before going to the Lab Do not eat for at least two hours before you test your blood Perform a control solutio
29. tep 4 VEBBHBHEBNMHEBEBBEBSEBESSBESEBEBEBNSISIgj MTH DAY PM gt iuc3 tee CRUE PEEP BERG NU After the beeping sound the test will begin automatically and your results will appear in 5 seconds It should begin counting down from 5 to 1 second on the LCD display window The LCD window will display the result of your blood glucose level temperature and time Record the result value in your logbook When the glucose test strip is removed the glucose test meter turns off automatically CAUTION 1 If the test result is out of the test range the Hi Lo message will be shown on the LCD Please contact your healthcare provider immediately if there is a Hi Lo result 2 Please contact your healthcare provider for instructions on disposing glucose test strips and lancets 23 Performing Your Test Cont Reviewing Your Results Removing and Disposing of Used Test Strip Once the test is complete push the Used test strips may be considered strip forward to remove the test bio hazardous waste in your area strip from the meter Be sure to contact your healthcare provider for instructions on disposing the test strips Disposing of Your Lancet Push the needle into the protective cover Slide the button forward to eject the lancet Be sure to contact your healthcare provider for instructions on disposing the lancets 24 The EasyTouch HealthPro Meter stores up to 365 test results in its
30. tes to measure their blood sugar levels It should only be used with fresh capillary blood samples It is designed for in vitro diagnostics use only and should not be used for any purpose other than monitoring blood sugar levels It should not be used for the diagnosis of diabetes or for the testing of newborns neonates WARNING Do not change your medication based on the EasyTouch HealthPro meter test results without contacting your physician or healthcare professional Important Safety Instructions The Centers for Disease Control and Prevention CDC and the US Food and Drug Administration FDA have become increasingly concerned about the risks for transmitting Hepatitis B virus HBV and other blood born pathogens to persons undergoing finger stick procedures for blood sampling Ex Persons with diabetes who require assistance monitoring their blood glucose levels Reports of HBV infection outbreaks linked to diabetes care have been increasing This notice serves as a reminder that finger stick devices should never be used for more than one person WARNING 1 The EasyTouch HealthPro Meter and Lancing Device are for single patient use only Do not share them with anyone including other family members Do not use on multiple patients 2 All parts of the kit are considered bio hazardous and can potentially transmit infectious diseases even after you have cleaned and disinfected 3 Always use a new sterile lancet Lanc
31. trol solutions contain a known amount of glucose that reacts with the EasyTouch HealthPro Glucose Test Strips By comparing your control solution test results with the expected range printed on the test strip vial it is able to check if the meter and test strips are working properly and that you are performing the test correctly It is very important that you perform the control solutions test routinely to make sure you get accurate results Discard the first drop of control solution this will eliminate any residue Place a drop of control solution on a clean dry surface e g the lid of the test strip vial The glucose control solution should be used Whenever you suspect the glucose test meter or glucose test strip is not functioning properly If your glucose test results are not consistent with your symptoms or if you think they are not accurate If you have dropped the blood glucose test meter For quality control in the point of care usage For teaching or learning the system 16 17 Dip the test strip into the control solution Results will appear in 5 seconds Compare the result to the range printed on the test strip vial the result should fall within that range Testing with the Control Solution Cont CAUTION The Control Solution Range is printed in the lower right of the test strip vial label This will allow you to differentiate between a control solution test and an actual blood test For exampl
32. uch as Hepatitis B Virus HBV Transmission of this virus has been documented due to contaminated blood glucose devices According to the Centers for Disease Control and Prevention cleaning and disinfection of meters and lancing devices can prevent the transmission of this virus through indirect contact The cleaning is to remove soil and dirt on all surfaces of the devices while the disinfecting is to kill the blood born pathogens stated above In addition whenever the meter gets dirty and has blood or liquid on it the cleaning and disinfecting procedure should be performed It also should be cleaned and disinfected periodically We recommend that you perform the cleaning and disinfecting procedures on it once per week Materials Needed Cleaning and disinfecting can be completed by using any commercially available EPA registered disinfectant with the EPA registration number 46781 8 such as CaviWipesXL towelettes Please refer to the disinfectant labeling for additional instructions on the safe use of the disinfectant NOTE 1 Please note any disinfectant product with the EPA registration number of 46781 8 may be used on this device Other cleaning agents have not been validated with the meter and lancing device 2 Please call MHC Customer Support at 877 358 4342 if you have any questions regarding proper cleaning and disinfection procedure and purchasing the materials needed 32 1 2 3 Wash your hands before
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