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Device Information 

EME SMBG System,   
EME Blood Glucose Test Strips, 
EME Blood Glucose Meter, 
EME Level 2 Control Solution, 
EME Level 3 Control Solution 
 

Reference:  

* American Diabetes Association. Standards of medical care in diabetes-Table 10 Diabetes care. 2011; Vol. 
34, Suppl. 1, S21. 
 

Manufacturer: 

EPS BIO TECHNOLOGY CORP. 

No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077 
TEL

：

+886-3-6686868  

 

FAX

：

+886-3-6686866 

E-mail

：

[email protected]

   

Website

：

http://www.epsbio.com.tw   

 

Содержание Self-Monitoring Blood Glucose Meter

Страница 1: ...EME Self Monitoring Blood Glucose System User s Manual Please read this User s Manual thoroughly Before using your blood glucose meter...

Страница 2: ...tem Thanks again for choosing the EME SMBG Intended Use The EME Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples...

Страница 3: ...may transmit infection even if you have performed cleaning and disinfection Wash hands thoroughly with soap and water before and after handling the meter or lancing device For further information plea...

Страница 4: ...tion is included with the system 2 EME Level 3 Control Solution is available For purchase please call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM Blood Gluco...

Страница 5: ...istance please call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service hours please contact your healthcare provider Please complete your warrant...

Страница 6: ...the meter as this may cause damage to the components resulting in incorrect readings Disassembling the meter will also void the warranty Always keep the meter clean and store it in a safe place Prote...

Страница 7: ...nal before testing on your palm and forearm Do not touch the strips with wet hands Do not use expired strips the expiration date is shown on the bottle Do not bend cut or twist the strips Up to the al...

Страница 8: ...away If you have followed the steps in the user s manual but still have symptoms that don t seem to match your test results contact your Healthcare Professional or physician immediately If you have qu...

Страница 9: ...Solution Test 17 About The Control Solutions 18 Running a Control Solution Test 19 Understanding Control Solution Test Results 22 Chapter 3 Testing Your Blood Glucose 24 Using the Lancing Device 24 In...

Страница 10: ...wing Test Results 38 Chapter 5 Maintenance and Troubleshooting 39 Installing Batteries 39 Cleaning and Disinfecting Your Meter and Lancing Device 40 Cleaning and Disinfection Frequency 44 Maintenance...

Страница 11: ...move the strip Display Shows results messages and results stored in memory Left Buttons Press to enter memory adjust setting and scroll through results Battery Door Flip open the battery door by pushi...

Страница 12: ...before noon PM Indicate after noon Batteries status When the battery symbol appears prepare new batteries for installation AC ante cibos Indicate before meal PC post cibos Indicate after meal Insert...

Страница 13: ...p Select the desired penetration depth Hub Unscrew or Recap the Cap Sleeve Hand Hold Area AST Lancing Device Cap Use this transparency cap for AST testing Sliding barrel Pull on until it clicks and th...

Страница 14: ...ery door on the back of the meter by pushing the tab in the direction of the arrow and pulling the door up 3 Put the battery door back in place and snap it closed The meter turns on automatically 2 In...

Страница 15: ...mory 3 Repeat step 2 to set the date and time The flashing field is the one you are currently setting A AM P PM 1 Press right button to turn the meter on 2 The display shows the last 2 digit of the ye...

Страница 16: ...it Record the date you open the test strip bottle Be sure to check the expiration date on the test strip bottle The test strip is good for three months from the date the bottle is opened or until the...

Страница 17: ...s are working properly to give reliable results You should run the control solution tests when You use the EME Blood Glucose Meter for the first time You open a new bottle of test strips You think the...

Страница 18: ...st Do not use a control solution that is past the expiration date Control solutions can stain clothing If you spill the solution wash your clothes with soap and water Close the bottle tightly after ev...

Страница 19: ...trip and control solution 1 Put a test trip into the meter as the direction of the arrow on the test strip The meter turns on automatically 3 The icons and show themselves 2 Press left button to set A...

Страница 20: ...e with a tissue 6 Squeeze the bottle until a tiny drop forms at the tip of the bottle 7 Touch the drop at the tip of the test strip 8 The meter starts to count down from 5 seconds and then shows the t...

Страница 21: ...21 10 Push the Strip Ejector to Remove the test strip 11 Throw the test strip away after you have compared the reading to the range printed on the test strip bottle...

Страница 22: ...on result is inside the range on the test strip bottle your test strips and your meter are working properly If your control solution result is not inside the acceptable range printed on your test stri...

Страница 23: ...tle of test strips Do not reuse the strips from the affected bottle 9 Is the control solution expired or contaminated Replace with new control solution to check the performance of SMBG system 9 Were t...

Страница 24: ...ice are being operated by a second person who is providing testing assistance to the user the meter and lancing device should be disinfected prior to use by the second person For the disinfection inst...

Страница 25: ...to the lancing device to get it ready for use 1 Unscrew the Cap 2 Insert the lancet into the lancing device firmly then twist off the protective cover 3 Recap the front cap Note Lancets are for single...

Страница 26: ...g lancing devices and lancets may transmit blood borne pathogens such as viral hepatitis 6 Set the lancing device aside until later in the test 5 Pull on the sliding barrel of the lancing device until...

Страница 27: ...rtip 1 Wash your hands with soap and warm water Rinse and dry thoroughly 2 Put a test strip into the meter in the direction of the arrow The meter turns on automatically 3 Press left button to set AC...

Страница 28: ...ly squeeze and or massage your fingertip until a round drop of blood on your fingertip 7 Wipe away the first drop with a tissue and use the second drop Note please make sure to apply blood when the bl...

Страница 29: ...get enough blood in the strip s confirmation window Otherwise an inaccurate reading may yield 9 The meter starts to count down from 5 seconds and then shows the test result 10 Push the Strip Ejector t...

Страница 30: ...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 un...

Страница 31: ...er than forearm samples Measurements from alternative site testing should never be used to calibrate a continuous glucose monitor CGM or entered into insulin dose calculators for insulin dosing recomm...

Страница 32: ...ze is sufficient 4 Wipe away the first drop with a tissue and use the second drop 1 Massage the puncture area of forearm for a few seconds Running a Blood Glucose Test with Blood from Your Palm or For...

Страница 33: ...emove the adjustable cap 2 Pull on the sliding barrel of the lancing device and slide the ejection control at the same time The used lancet will be pushed out 3 Discard used disposable lancets into an...

Страница 34: ...or for the appropriate blood glucose range Unusual Test Results If your test result does not match the way you feel please follow these steps 1 Run a control test Chapter 2 Control Solution Testing 2...

Страница 35: ...it just means that time has elapsed and your blood glucose has changed If you want to compare your meter result to the lab result you must be fasting Bring your meter to the doctor s office and test y...

Страница 36: ...est is added so it is very important to have the correct time and date set in the meter Note 1 Do not change your therapy based on one individual result in memory 2 The memory is not lost when you rep...

Страница 37: ...ys averaging to help track your blood glucose result soundlessly 1 Press until turning the meter on 2 Press to view the latest test result 3 All results are shown in turn from records of M480 to M001...

Страница 38: ...battery symbol The meter uses two alkaline 1 5V AAA batteries Batteries will normally last for more than 2000 tests Other types of 1 5V AAA batteries are also acceptable but the capacity of test times...

Страница 39: ...e http www pdipdi com healthcare surface_disinfect aspx Cleaning and Disinfection Instruction Please keep the meter and lancing device free of dirt dust bloodstain and water stains EME blood glucose m...

Страница 40: ...ated area must remain visibly wet for a full 2 minutes Let the devices air dry for 0 5 minute Do disinfection once per week Do Not Get any moisture in the test strip slot Spray any cleaning solution d...

Страница 41: ...ble Yes Action If any of the results is No the user should call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM for assistance Performance check of the meter Ste...

Страница 42: ...Press and release right button Can the result be clearly read Yes Action If any of the results is No stop using the device Please call the Customer Care Service toll free at 866 994 3345 Eastern Time...

Страница 43: ...ancet be fixed on the lancet holder Yes 2 Cap the AST cap to the lancing device Can the AST cap be screwed on the lancing device Yes Can the cap be screwed on the lancing device Yes 3 Remove the AST c...

Страница 44: ...es of cleaning and disinfection Cleaning Frequency 9 cycles day X 365 days year X 4 year product life 13 140 cycles of cleaning Disinfection Frequency 1 cycle week X 52 weeks year X 4 year product lif...

Страница 45: ...Screen Messages and what to do about them To make sure the display is working properly turn off the meter Press and hold to see the complete display All the indicators should be clear and look exactly...

Страница 46: ...994 3345 Eastern Time Mon Fri 9 00AM 5 00PM Low power Action Replace with new batteries System fault Action Replace the batteries first If ERROR 001 appears again please call the Customer Care Servic...

Страница 47: ...Action Replace the batteries first If Err appears again please call the Customer Care Service toll free at 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service hours please contact your...

Страница 48: ...mperature between 10 C 40 C 50 F 104 F The Lt and thermometer icon appears Temperature is too low outside the required range of 10 C 40 C 50 F 104 F This alerts users that an incorrect result may occu...

Страница 49: ...ive Humidity R H 90 Temp 35 6 F 86 F 2 C 30 C Storage and transportation condition Relative Humidity 40 85 RH 0 6 L Blood sample Fresh capillary blood from fingertip palm or forearm Hematocrit Hct 20...

Страница 50: ...uld be used at a temperatures between 50 F and 104 F 10 C and 40 C Outside this range the system may get incorrect results 7 DO NOT reuse the test strips The test strips are for single use only 8 Hema...

Страница 51: ...Bilirubin 25 Cholesterol 500 Creatinine 30 Triglycerides 1000 Fructose 30 11 Interference was observed with the substances below at the concentrations listed Interfering substance Interference observe...

Страница 52: ...3 Control Solution Reference American Diabetes Association Standards of medical care in diabetes Table 10 Diabetes care 2011 Vol 34 Suppl 1 S21 Manufacturer EPS BIO TECHNOLOGY CORP No 8 R D RD III Hsi...

Страница 53: ...Pingjiang Suzhou P R China 215031 TEL 0086 512 67217661 FAX 0086 512 67217663 E mail guopings xinda medical com Lancet Meets the requirements of MDD 93 42 EEC Manufacturer SAE HAN MEDICAL CORP 700 113...

Страница 54: ...anual before operation If you have any questions and or need assistance please contact us as follows Within the USA call toll free 866 994 3345 Eastern Time Mon Fri 9 00AM 5 00PM During non service ho...

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