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Summary of Contents for EPS Bio Technology EasyMax EM44
- Page 1 EM44 Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly Before using your blood glucose meter Dear EM44 SMBG System Owner,...
- Page 2 Thank you for using the EM44 Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be dependable, easy-to-use, compact, lightweight and portable to help you monitor your blood glucose on a regular basis. Please read this manual thoroughly before you begin testing. This manual provides you and your diabetes care team with important information and step-by-step direction to use the EM44 Self-Monitoring Blood Glucose System.
- Page 3 Important Safety Instructions Lancets and meters are for single use only. A new, sterile lancet should be used one time you perform a test. The lancing device, lancets and meter are NOT to be shared between users or other family members. Do NOT use on multiple individuals.
- Page 4 Standard Accessories The EM44 Blood Glucose meter and accessories are working together to measure the amount of glucose in your blood. The system includes: • Carrying Case • CR2032 Lithium Cell 3V Battery (2 pcs) • User’s Manual • Lancing device •...
- Page 5 Why is it so important to test blood glucose regularly? Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day. We have made this SMBG system as simple as possible to help you use it regularly. Your meter is easy to use, and you can adjust the lancing device for your comfort.
- Page 6 Important Information about Your New Meter EM44 blood glucose meter is designed and approved for testing fresh capillary whole blood samples from your fingertip and forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the body).
- Page 7 Note: Consult with your healthcare professional before testing on your 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. ...
- Page 8 Health-Related Information If you are experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than what your blood glucose really is. If you think you are dehydrated, call your doctor right away. If you have followed the steps in the user’s manual, but still have symptoms that don’t seem to match ...
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Page 9: Table Of Contents
The EM44 Blood Glucose Meter …......................11 Setting the Time, Date, Sound Volume and Memory..................13 Using EM44 Blood Glucose Test Strips ................16 Chapter 2: Control Solution Testing......................17 Why Run a Control Solution Test .......................17 About The Control Solutions ........................18 Running a Control Solution Test ........................19 Understanding Control Solution Test Results ....................21 Chapter 3: Testing Your Blood Glucose .......................23 Using the Lancing Device .........................23... - Page 10 Deleting a single Test Result …........................39 Chapter 5: Maintenance and Troubleshooting …..................40 Installing Batteries …..........................40 Cleaning and Disinfecting Your Meter and Lancing Device...……............41 Cleaning and Disinfection Frequency......................47 Maintenance and Testing ...........................48 Screen Messages and Troubleshooting …....................49 Chapter 6: Technical Information …......................52 Specifications …............................52 Limitations…...............................53 Device Information …..........................55...
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Page 11: The Em44 Blood Glucose Meter
Chapter 1: Understanding Your Meter The Overview of the The EM44 Blood Glucose Meter Meaning Display 1 month and date Shows the month and date 2 Meal Before meal, after meal or marked meal. Shows the test result 3 Test result Insert the test strip to start testing blood 4 Insert test strip glucose... - Page 12 Test Strip Slot- Insert test strip here. Up Button- Press to enter memory, Display- adjust setting, and scroll Shows results, through results. messages, and results stored in memory. Apple Button- Press to Down Button- Press to set before meals, after enter memory, adjust meals or marked meals.
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Page 13: Setting The Time, Date, Sound Volume And Memory
Setting the Time, Date, Sound Volume and Memory Setting the current time and date in your meter is important if you use the meter memory. 3. Repeat step 2 to set the date and time. 1. Press up and ON/OFF button for 5 seconds or The flashing field is the one you are insert batteries, the meter beeps and turns on. - Page 14 5. Press up or down button to turn on or turn 4. Press up or down button to set the backlight off the volume and press ON/OFF button to and press ON/OFF button to confirm the confirm the setting. (Defaulted setting: ON) setting.
- Page 15 5. Press up or down button to decide 6. If you decide to delete all memories, whether to delete all memories. press ON/OFF button to confirm the setting. The meter will beep and you can start to insert a test strip.
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Page 16: Using Em44 Blood Glucose Test Strips
Using EM44 Blood Glucose Test Strips Use only with EM44 Blood Glucose Meters. Run a control solution test every time you open a new box of test strips (See Chapter 2 "Control Solution Testing.") Keep the test strips in their original bottle. ... -
Page 17: Chapter 2: Control Solution Testing
Chapter 2: Control Solution Testing Why Run a Control Solution Test We recommend that you run the EM44 control test because it lets you know that your meter and test strips are working properly to give reliable results. You should run the control solution tests when: ... -
Page 18: About The Control Solutions
About The Control Solutions Use with EM44 test strips. Write the date you opened the control solution bottle on the bottle label. The control solutions are good for three months from the date the bottle is opened or until the expiration date on the bottle, whichever comes first. -
Page 19: Running A Control Solution Test
Running a Control Solution Test You need the meter, a test strip, and control solution. Touch the drop to the Blood collection area at the end of the 3. Place the meter on a flat test strip. 1. Press ON/OFF button or put a surface, like a table. - Page 20 7. A result appears on the display. Don’t remove Remove the test strip and throw it away the test strip yet. after you have compared the reading to the Check if the reading falls within the range range printed on the test strip bottle. printed on the test strip bottle.
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Page 21: Understanding Control Solution Test Results
Understanding Control Solution Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions. The result you get should be inside this range. Make sure you compare the result to the correct level of control. When the control solution result is inside the range on the test strip bottle, your test strips and your meter are working properly. - Page 22 Troubleshooting Checks Action Was the test strip exposed to open air for a long If yes, repeat the control test with properly stored period of time? strips. If the cap was not tight, or the bottle was left Does the cap on the bottle keep tightly prevent uncapped, open a new bottle of test strips.
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Page 23: Chapter 3: Testing Your Blood Glucose
Chapter 3: Testing Your Blood Glucose Using the Lancing Device The best depth setting is the lowest number that draws enough blood for a test. Try different settings to find the one that’s right for you. Please do not share your lancing device with anyone. And always use a new, sterile lancet. Lancets are for one time use only. -
Page 24: Inserting A Lancet Into The Lancing Device
Inserting a Lancet into the Lancing Device You must first load the lancet into the lancing device to get it ready for use. 1. Unscrew the Cap. 2. Insert the lancet into the lancing 3. Recap the front cap. device firmly then twist off the protective cover. - Page 25 5. Pull on the sliding barrel of the 6. Set the lancing device aside 4. Select the desired lancing device until it clicks and until later in the test penetration depth. then release. Now the lancing device is ready. Do not prick your finger until your meter and strip are prepared.
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Page 26: Running A Blood Glucose Test With Blood From Your Fingertip
Running a Blood Glucose Test with Blood from Your Fingertip 1. Wash your hands with soap 2. Press ON/OFF button to turn 3. When the test strip flashing and warm water. on the meter. on the display, put a test strip Rinse and dry thoroughly. - Page 27 4. Please wait at least 5 seconds until the intended area is dry and clean 7. Gently squeeze your finger to assist before sampling the blood. the flow of blood. This helps you get a 5. Place the lancing device against the 6.
- Page 28 9. Press apple button to mark the result as before meals 8. The meter will beep when enough blood values ( ), after meals values ( ) or other has entered the strip’s reaction zone. marked values ( The result will appear on the display after 5 seconds.
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Page 29: Alternate Site Testing (Ast)
Alternative Site Testing (AST) Understanding Alternative Site Testing What is AST? What is the advantage of AST? Besides the fingertip, you can test your palm or You have the option of testing other places on forearm. your body besides the fingertip. Consult your health care professional before you begin using the palm or forearm for testing. - Page 30 Fingertip test only: If sick If blood glucose is low After exercising Two hours or less after eating When basal insulin is most active What NOT to do: After injecting rapid-acting insulin (two hours or less) ...
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Page 31: Running A Blood Glucose Test With Blood From Your Palm Or Forearm
1. This graphic shows where the meter cleared for alternative site testing. 2. Massage the puncture area of 3. Press and hold the device with forearm or palm for a few one clear adjustable tip against seconds. the forearm. Note: ... - Page 32 Running a Blood Glucose Test with Blood from Your Palm or Forearm (continued) 4. If you choose the palm, 5. Press the trigger button to 6. Hold the device against repeat step 1-3 to obtain a activate the lancing device. forearm or palm and increase drop of blood sample.
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Page 33: Discarding Used Lancets
Discarding Used Lancets 1. Unscrew and remove the 2. Without touching the used Please discard used cap. lancet, stick the lancet tip disposable lancets according to into its protective cover. the recommendations of your healthcare professional. Or discard the used disposable lancet into an appropriate sharps or biohazard container. -
Page 34: Expected Values
Expected Values* The EM44 Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The American Diabetes Association recommends a post-meal glucose level of less than 180 mg/dl and a pre-meal glucose of 70–130 mg/dL Unusual Test Results If your test result does not match the way you feel, please follow these steps: 1. -
Page 35: Comparing Your Meter Result To Lab Results
Comparing Your Meter Result to a Lab Results A common question is how the blood glucose results on your meter compare to the lab results. Your blood glucose can change quickly, especially after eating, taking medication, or exercising. If you test yourself in the morning, then go to the doctor’s office for a blood glucose test. -
Page 36: Chapter 4: Meter Memory, Setup
Chapter 4: Meter Memory, Setup Memory, Storing Test Results Your meter stores a maximum of 480 test results with the time and date of the test. You can review them at any time. When the memory is full, the oldest result is dropped as the newest is added, so it is very important to have the correct time and date set in the meter. -
Page 37: Viewing Test Results
Viewing Test Results 1. Short press on up or down button to enter the 3. Or press up button to view 7, 14, memory mode. 30 and 90 day averages. 2. Press down button to view test results .The meter shows the number of total recordings first and then shows the result of this storage place. - Page 38 4. The 7, 14, 30 and 90 day average results shows in a order of all values, before meals values, after meals values and other marked values.
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Page 39: Deleting A Single Test Result
Deleting a single Test Result 1. While viewing results, if you would like to 2. The display shows "dEL" 3. The meter beeps and delete any record, take Memory # 26 for on the top of the screen, the display shows “OK”, example, press ON/OFF button, keep it press ON/OFF button to the memory is... -
Page 40: Chapter 5: Maintenance And Troubleshooting
Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses two batteries of CR2032 Lithium Cell 3V. Batteries will normally last for over 2000 tests. Other types of CR2032 Cell 3V batteries are also acceptable, yet the capacity of test times may differ. Install the batteries when you first use the meter or replace with new batteries when the "LP"... -
Page 41: Cleaning And Disinfecting Your Meter And Lancing Device
Cleaning and Disinfecting Your Meter and Lancing Device Choosing the disinfectant The recommended EPA-registered disinfected product is as follow: PDI® Super SANI-CLOTH® Germicidal disposable wipe (EPA Reg. No.:9480-4) Super Sani-Cloth germicidal wipe contains active ingredients: n-Alkyl (60% C , 30%C , 5%C , 5%C dimethyl benzyl ammonium chlorides and n-Alkyl (68%C... - Page 42 Instruction Cleaning All blood and other body fluids must be thoroughly cleaned from surfaces and objects before disinfection by the germicidal wipe. Open, unfold and use first germicidal wipe to remove heavy soil after every use. Disinfection Instruction: Unfold a clean wipe and thoroughly wet all the surface of the meter, including the strip port and other connection port.
- Page 43 1. Meter clearing/disinfection area Code Name Possibility of contact with blood Strip Slot High Front Case High Side Button High Side Case High Front Buttons High Back Case Medium Battery Cover Medium 2. Lancing device clearing/disinfection area Code Name Possibility of contact with blood Lancet holder High...
- Page 44 1-1. Physical Appearance check of the meter after each cleaning or disinfection Check item Accept Result Is it clear to see through the transparency part, like display? Is there NO erosion happened on the strip slot or other parts? Is the labeling on the meter legible? Action: If any of the results is “No”...
- Page 45 1. Insert test strip Is meter powered on? 2. Apply Level 2 control Any reading? solution Is the reading within control range? 3. Remove test strip Is meter powered off? 4. Press and hold on/off Is meter powered on? button for 3 sec. Is meter beep? 5.
- Page 46 2-2. Performance check of the Lancing device Accept Step Check item Result After each cleaning 1. Cap the normal cap to the lancing device. Can the cap be screwed on the lancing device? 2. Pull on the sliding barrel and then release. Can the lancing device click? 3.
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Page 47: Cleaning And Disinfection Frequency
Cleaning and Disinfection Frequency At least 14,600 validated cycles for the meter and lancing device were done and 10,000 cycles of cleaning and 4,600 cycles of disinfections were included. 4 cycles of cleaning per day and 1 cycle of disinfection per week with allow the user to use the device for 4 year. -
Page 48: Maintenance And Testing
Maintenance and Testing Your meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. (See "Screen Messages" and what to do about them.) To make sure the display is working properly, turn off the meter. -
Page 49: Screen Messages And Troubleshooting
Screen Messages and Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Time, Mon-Fri 9:00AM~5:00PM). Low power The test result is higher than 600 The test result is lower than 20 Action: Replace with mg/dL. - Page 50 Humidified / Used strips System fault Less blood detected Action: Replace with a Action: Replace the batteries first. Action: Discard the test strip new strip. If 001 ERROR appears again, and try to apply blood to a please call the Customer Care new test strip again.
- Page 51 The "Ht" and thermometer The "Lt" and thermometer icon icon appears. Temperature is appears. Temperature is too too high, outside the required low, outside the required range range of 50°F-104°F (10°C of 50°F-104°F (10°C-40°C). This -40°C). This alerts users that alerts users that an incorrect an incorrect result may occur result may occur if the test...
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Page 52: Chapter 6: Technical Information
Chapter 6: Technical Information Specifications Brand name EM44 Blood Glucose Meter Range 20~600 mg/dL Response time 5 seconds Memory sets 480 test results Temp. 50°F -104°F (10°C-40°C) Operating condition Relative Humidity R.H. ≦ 90% Temp. 35.6°F -86°F (2°C -30°C) Storage and transportation condition Relative Humidity 40-85 % RH... -
Page 53: Limitations
Limitations The test strips are used for fresh capillary whole blood samples. 1. DO NOT use neonate blood sample. 2. Extreme humidity may affect the results. A relative humidity greater than 90 % may cause incorrect results. 3. The system should be used at temperatures between 50°F and 104°F (10°C and 40°C). Outside this range, the system may get incorrect results. - Page 54 Exogenous Interference data Exogenous highest interference Bias @ blood Note Substances Conc. tested or no glucose Conc. 14.2%@80 mg/dL Acetaminophen 8 mg/dL The highest no interference concentration is 7 mg/dL 14.9%@120 mg/dL Ascorbic Acid 4 mg/dL 31.0%@80 mg/dL The highest no interference concentration is 2.6 Dopamine 5.2 mg/dL 18.2%@120 mg/dL...
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Page 55: Device Information
EM44 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：info@epsbio.com.tw... - Page 56 Lancing Device Meets the requirements of MDD 93/42/EEC Manufacturer: STERILANCE MEDICAL (SUZHOU) INC. No. 32 Xinlian RD. 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 PUB GOT-DONG, IL SAN-GU, GOYANG-CITY, KYUNGGI-DO, KOREA TEL：82-31-923-4330 FAX：82-31-923-4331...
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Page 57: Warranty
Warranty EPS warrants the original purchaser for a period of 4 years from the date of purchase. This means during the warranty period if the Self-Monitoring Blood Glucose System does not work for any reason (other than obvious abuse), EPS will replace it with a new system or an equivalent product free of charge. Please read EM44 User’s Manual before operation.
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