background image

8

7.

 

Blood Drop Symbol  

 

Flashes when it is ready to apply sample to Test Strip.

8.

 

Warning Symbol 

 

Appears when result is out of the range of your setting reference value.

9.  Alarm Function Symbol 

 

Appears when the clock alarm is set.

10. Test Strip Symbol 

  

Appears to tell you when the meter is ready for test.

11.  Day Average Symbol 

 

Shows the average value of test results.

12.  Test Result Area

  

Display test results.

13. Temperature Message 

 

Appears if your meter is out of operating temperature range. 

Содержание Easy Touch

Страница 1: ...Easy Touch Glucose Monitoring System User Manual ...

Страница 2: ...See our other products at www MHCmed com Easy Touch Glucose Monitoring System ...

Страница 3: ... the EasyTouch Meter Display 7 About the EasyTouch Test Strip 9 About the EasyTouch Test Strip Vial 10 Installing Replacing the Battery 11 Setting Up the Meter 12 Setting Up the Date Time 12 Setting Up Alarms 13 Unit Selection 16 Table of Contents Continued on next page ...

Страница 4: ...mple to the EasyTouch Test Strip 24 The Control Solution Test 27 How to Perform a Control Solution Test 28 Comparing Control Solution Results 30 Memory Features 31 Transfer Test Results to a Computer 33 Care and Storage 34 Display Messages 35 Specifications 42 Limitations of the Procedure 44 Service and Warranty 44 Customer Service 46 ...

Страница 5: ... designed to process accurate results utilizing only a small amount of blood for in vitro diagnostics The EasyTouch Glucose Monitoring System is intended for use in the home and in professional settings to monitor whole blood glucose levels obtained from the fingertip palm and forearm This is an over the counter OTC product Please read the entire User s Manual carefully before using this product I...

Страница 6: ...r EasyTouch Glucose Monitoring System contains EasyTouch Meter One Lancing Device Ten Lancets One Carrying Case User Manual Log Book Quick Reference Guide B Your EasyTouch Institutional Meter Only Box contains EasyTouch Meter User Manual Test Strips Control Solution Lancing Device can be purchased individually About the Product ...

Страница 7: ...de in Taiwan Distributed by MHC Medical Products LLC 8695 Seward Road Fairfield OH 45011 Toll 877 358 4342 Blood Glucose Meter AD 041919 8 Rev date 04 2019 Easy Touch S N M14KG020001 In vitro diagnostic medical device Consult instructions for use Meter Label Icons ...

Страница 8: ...utive 7 14 30 day average results and turns the Meter on and off 3 S Button The S select set button is used to select year month day time memory of results and control solution mode 4 Test Port This is where you insert the Test Strip into the Meter 5 Unit Switch Switch for mmol L or mg dL 1 mmol L 18 mg dL 6 Battery Cover 7 Label 8 Reset Button Press this button to re set the system 9 Data Port Co...

Страница 9: ... test and marking the result as a control solution test 4 Memory Symbol Indicates in memory mode 5 Units of Measurement Unit of mmol L or mg dL will appear with the test result 6 Battery Symbol Appears when the battery is low or must be replaced About the EasyTouch Meter Display ...

Страница 10: ...setting reference value 9 Alarm Function Symbol Appears when the clock alarm is set 10 Test Strip Symbol Appears to tell you when the meter is ready for test 11 Day Average Symbol Shows the average value of test results 12 Test Result Area Display test results 13 Temperature Message Appears if your meter is out of operating temperature range ...

Страница 11: ...n be used only once The Test Strip consists of the following parts 1 Target Area This is where blood is drawn into the Test Strip 2 Confirmation Window This is where you can confirm that enough blood has been applied to the target area 3 Contact Bar This end of the Test Strip is inserted into the Test Port to activate the Meter white side face up 3 2 1 ...

Страница 12: ...021 F F WARNING Re cap immediately always close lid tightly Store at 39 86 F 4 30 C Do not refrigerate Always store test strips inside vial Discard Date ______________ Discard 3 months after opening Made in Taiwan Distributed by MHC Medical Products LLC 8695 Seward Rd Fairfield OH 45011 AD DH 042221 2 Rev date 04 2021 For testing of glucose in capillary whole blood For in vitro diagnostic use only...

Страница 13: ...MHC Medical Products LLC 8695 Seward Road Fairfield OH 45011 Toll 877 358 4342 Blood Glucose Meter AD 041919 8 Rev date 04 2019 Easy Touch S N M14KG020001 Fig 1 Fig 3 For In Vitro Diagnostic Use Only Made in Taiwan Distributed by MHC Medical Products LLC 8695 Seward Road Fairfield OH 45011 Toll 877 358 4342 Blood Glucose Meter AD 041919 8 Rev date 04 2019 Easy Touch S N M14KG020001 For In Vitro Di...

Страница 14: ...release S button to choose 24hr military time or 12hr standard Fig 4 Press and release the button to proceed to the next step 2 Setting the Year Press and release the S button until the correct year appears Fig 5 Press and release the button to proceed to the next step 3 Setting the Month and Day Press and release the S button to choose the month Press the button Press and release the S button unt...

Страница 15: ...tton to proceed to the next step 5 You have a choice to set up to 4 alarms To set an alarm press and release the button to indicate YES To skip alarm settings press and release the S button to indicate NO Fig 8 If you select no you will automatically move on to the health management settings step 10 6 If you chose to set alarms press and release the S button to change the hour Press and release th...

Страница 16: ...e to set a third alarm press and release the button to indicate YES If you would not like to set anymore alarms press and release the S button to indicate NO Press and release the button one time then press and release the S button to change the minutes You may move forward to set 1 more alarm Fig 10 9 If you would like to set a fourth alarm press and release the button to indicate YES If you woul...

Страница 17: ...yourself To set the HI alert level press and release the S button to set the HI alarm between 100 400 mg dL After selecting the HI level press and release the button Fig 12 11 The LO alarm setting alerts you with next to the glucose reading when you test below the glucose level you have determined is too low for yourself To set the LO alert level press and release the S button to set the LO alarm ...

Страница 18: ... United States Meters used in the United States must be set to read in mg dL Unit Selection mmol L mg dL For In Vitro Diagnostic Use Only Made in Taiwan Distributed by MHC Medical Products LLC 8695 Seward Road Fairfield OH 45011 Toll 877 358 4342 Blood Glucose Meter AD 041919 8 Rev date 04 2019 Easy Touch S N M14KG020001 ...

Страница 19: ...ble Lancing Device 4 Sterile Lancet Caution To reduce the chances of infection Never share a lancing device and lancet with another person Always use a new and sterile lancet Lancets are for single use only Always use a new Test Strip Test Strips are for single use only Do not get lotion oil dirt or debris in or on the lancet and lancing device ...

Страница 20: ...Insert a Test Strip white side face up with the Contact Bar end first Push all the way into test port until meter automatically turns on 4 A faint beep will sound and the sort line moving clockwise will appear 5 After system checking ok a test strip symbol along with a flashing symbol will appear 6 Now you are ready to obtain a blood sample c K Te a p I h s vitro ...

Страница 21: ...he protective lancet cover to expose the sterile needle tip 4 Recapping and screwing the endcap to the body of the lancing device 5 Pull back on the cocking mechanism until it comes to a stop 6 Place the lancing device firmly against the finger tip and press the release button 7 After sampling remove the endcap containing the used lancet carefully 8 Remove the lancet from the lancing device Discar...

Страница 22: ... Sites Testing Palm and Forearm Alternate Site Testing AST means you can use other parts of the body other than your more sensitive fingertips to check your blood glucose levels The EasyTouch Glucose Monitoring System allows you to test on the palm and the forearm with the equivalent results to fingertip testing Important Information ...

Страница 23: ...fter exercise When there are unknown variables occurring in your day such as illness Whenever you are about to drive CAUTION 1 Physiologic differences in the circulation between the finger and other test sites like the forearm and palm may result in differences in blood glucose measurements from the other test sites and your fingertips Changes in blood glucose may be observed in finger blood sampl...

Страница 24: ...te up to date blood glucose reading test on your fingertip 3 We strongly recommend you do AST ONLY in the following intervals In a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise DO NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia Your AST results do not match the way you feel ...

Страница 25: ...ose result is less than 60 mg dL 3 3 mmol L or higher than 240 mg dL 13 3 mmol L you should contact your healthcare professional and follow his or her treatment advice Any change or administer of medication based on the EasyTouch blood glucose test results without the consent and advice of a physician or healthcare professional is not recommended Severe dehydration and excessive water loss may cau...

Страница 26: ...on as enough blood has filled the Confirmation Window see picture of the Test Strip the Meter will beep and begin counting down from 5 to 1 Your blood glucose result will appear on the LCD display and will be stored into the Meter memory automatically Note To ensure accurate results make sure the Confirmation Window of the Test Strip is completely filled with your blood sample Example Reading ...

Страница 27: ...st result appears if no further tests are performed the Meter will automatically shut off after 3 minutes After finishing the test we recommend using a tissue to remove the used strip from the Meter for proper disposal ...

Страница 28: ...nd test again with a new Test Strip to confirm the result If the same result occurs consult your healthcare professional immediately Fig 13 2 If a LO message appears on the display your Meter has detected that your blood glucose level is lower than 20 mg dL 1 1 mmol L It is suggested that you review your testing procedure and test again with a new Test Strip to confirm the result If the same resul...

Страница 29: ...3 Anytime you question the performance of the system or on a regular basis to ensure accuracy e g once a week 4 When you adjust your diabetic medication plans 5 When your blood glucose test result is lower or higher than your normal level Note There are two Control Solutions at different desired ranges of aqueous glucose Low Level 1 and High Level 3 Both control solutions should be used to perform...

Страница 30: ...eter will automatically turn on Fig 15 3 All segments of the LCD display will appear a beep will sound and moving dotted lines will appear followed by a flashing symbol Fig 16 4 After the symbol appears press the S button for 3 sec to switch control solution mode The ctl symbol indicates that the Meter will mark your current test as a Control Solution test Now you are ready to apply the Control So...

Страница 31: ... touch the drop of Control Solution Control Solution is automatically pulled into the strip through the tip Hold until the meter beeps The meter will now begin counting down from 5 to 1 and the Control Solution test result will appear 7 Repeat these steps with both Low Level 1 and High Level 3 control solutions Caution Please remember that in order to prevent contamination follow the above instruc...

Страница 32: ...rming the test Control solution temperature is lower than 15 C 59 F or higher than 35 C 95 F Expired or contaminated Control Solution Expired or contaminated Test Strips Meter malfunction Note The result will not be incorporated into the average in the Control Solution test ctl mode DO NOT use the system if the problem persists If you are following the appropriate control solution testing steps an...

Страница 33: ... segments of the LCD display will appear The date and time will appear first 2 Press S button the result of control solution will appear on display 3 Press S button the consecutive 7 day average will be shown 4 Press S button the consecutive 14 day average will be shown 5 Press S button the consecutive 30 day average will be shown Note If there are no test results during this stage your meter will...

Страница 34: ...t how to record your results please refer to the log book for further instructions 6 Press S button the most recent test result will appear If it has 14 day average result it will show under the screen at the same time Each time you press the S button the meter will recall the last 300 test results accordingly When the memory is full the oldest result is removed and replaced with the newest result...

Страница 35: ... Get ready to transfer test results Connect the interface cable to a serial port on your computer Then connect the other end of interface cable to the data port located on the side of the meter with the meter turned off PC will appear on the display indicating that the meter is in the communication mode 4 Transfer data Follow the instructions provided in the software to download the results from t...

Страница 36: ...eline NCCLS document M29 A ISBN 1 56238 339 6 1 Handle the Meter with care Dropping or throwing the meter may cause damage to the device 2 Do not expose the Meter Test Strips and Control Solution to extreme conditions such as high humidity heat freezing cold or dust 3 Always wash hands with soap and water and rinse and dry completely before handling the Meter and Test Strips 4 When cleaning the Me...

Страница 37: ...or verifying that all segments of the meter are functioning No action necessary The system is ready to accept a blood sample You may now apply a blood sample The system is ready to accept a Control Solution sample You may now apply a drop of Control Solution sample ...

Страница 38: ...ng to page 19 Indicate the result is LOWER than the LO alarm setting of the health management For your reference or you can change the default setting value 70 mg dL according to page 19 Meter detects blood glucose level is higher than 600 mg dL 33 3 mmol L Indicates high blood glucose level Repeat test If result still occurs consult your physician immediately Example Reading Example Reading ...

Страница 39: ...curs consult your physician immediately Temperature is high during the test procedure Result may be larger variation Move to a cooler environment 10 40 C or 50 104 F and wait 15 minutes before re testing Temperature is low during the test procedure Result may be larger variation Move to a warmer environment 10 40 C or 50 104 F and wait 15 minutes before re testing ...

Страница 40: ...ting 10 40 C or 50 104 F Wait 15 minutes before re testing Temperature is too low to perform the test Repeat the test in a warmer setting 10 40 C or 50 104 F Wait 15 minutes before re testing An error message indicating a problem with the Test Strip Review the instructions and try again with a new Test Strip ...

Страница 41: ...meter again with the test strip If the problem persists contact Customer Service for help Battery power is low Meter will provide approximately 50 more measurements Replace with a new 3 Volt lithium battery CR 2032 Battery power is too low for further usage Replace with a new 3 Volt lithium battery CR 2032 immediately ...

Страница 42: ...d in the memory have been shown An alarm set by the user is ringing as a reminder to perform a blood glucose test Press or S button or wait for 3 minutes to turn off the meter Press or S button to shut off or the alarm will turn off automatically after 30 sec ...

Страница 43: ... pointing down into meter port Replace with a new Test Strip Repeat the test with new Test Strip Meter will automatically turn off Re insert the Test Strip to the test port Contact Customer Service for help Defective Test Strip Insufficient blood sample Test Strip remains in the test port for more than 3 minutes prior to testing LCD display on the Meter is blank when trying to perform a test ...

Страница 44: ...olume 0 5 µl Measuring Unit mg dL or mmol L Measuring Range 20 600 mg dL 1 1 33 3 mmol L Test Time 5 sec Memory Capacity 300 most recent results Average 7 14 30 days average results External Output Standard RS232 PC interface Power supply 3 Volt lithium battery CR 2032 Battery Life Approximately 1000 tests Dimension 92 x58 x19 mm Weight 60 g without battery Specifications ...

Страница 45: ...ut the consent advice of a physician or healthcare professional is not recommended The EasyTouch Test Strips are designed for use with fresh capillary whole blood samples obtained from the fingertip palm and forearm False results may occur when performing the test while severely dehydrated severely hypotensive in shock or in a hyperglycemic hyperosmolar state If you believe you are suffering from ...

Страница 46: ...rips other than those designed for the EasyTouch Glucose Monitoring System The EasyTouch Glucose Monitoring System manufacturer warranty is valid only when used properly within the guidelines of the provided User s Manual and is invalid when the EasyTouch Glucose Monitoring System and EasyTouch Test Strip are used improperly ...

Страница 47: ...at our discretion This warranty does not apply to the performance of a EasyTouch Glucose Monitoring System that has been altered misused tampered with or abused In no event shall our company be liable to the purchaser or any other person for any incidental consequential or punitive damages arising from or in any way connected with the purchase or operation of the EasyTouch Glucose Monitoring Syste...

Страница 48: ...8 4342 Mon Fri 9am 5pm EST E Mail us at info MHCmed com www MHCmed com When you call our Customer Service please have your EasyTouch Meter EasyTouch Test Strip and all other supplies available This will allow us to answer any of your questions with speed and efficiency Made in Taiwan Distributed by MHC Medical Products LLC 8695 Seward Road Fairfield OH 45011 AF004 0011000N 05 Rev date 4 2021 AD DH...

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Страница 52: ...Toll 1 877 358 4342 Web www MHCmed com Email info MHCmed com 8695 Seward Road Fairfield OH 45011 ...

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