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Summary of Contents for EPS Bio Technology EM50
- Page 1 EM50 Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly Before using your blood glucose meter Dear EM50 SMBG System Owner,...
- Page 2 Thank you for using the EM50 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 EM50 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 each 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 EM50 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 ct) • User’s Manual • Lancing device •...
- Page 5 Note: Although the EM50 SMBG System is easy to use, you may need to consult with your healthcare professional (this may be your doctor, pharmacist or diabetes nurse educator) for instructions on how to use the system. Only the correct use of the system will ensure...
- Page 6 The meter is for in vitro diagnostic use ONLY (for testing outside the body). It should not be used to diagnose or screen for diabetes. EM50 blood glucose meter can only be used with EM50 Blood Glucose Test Strips. Other test strips will give inaccurate results.
- Page 7 Note: Consult with your healthcare professional 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. ...
- 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 EM50 Blood Glucose Meter …......................11 The EM50 Accessories …..........................13 Setting the Time, Date, Sound Volume and Memory..................14 Using EM50 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... - Page 10 Comparing Your Meter Result to Lab Results …..................37 Chapter 4: Meter Memory, Setup ….......................38 Memory, Storing Test Results …........................38 Viewing Test Results ….........................39 Deleting a single Test Result …........................40 Chapter 5: Maintenance and Troubleshooting …..................41 Installing Batteries …..........................41 Cleaning and Disinfecting Your Meter and Lancing Device...……............42 Cleaning and Disinfection Frequency......................48 Maintenance and Testing ...........................49 Screen Messages and Troubleshooting …....................50...
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Page 11: Chapter 1: Understanding Your Meter
Chapter 1: Understanding Your Meter ⑥ ① The EM50 Blood Glucose Meter ⑦ ② ⑧ ③ ⑨ ⑩ ④ ⑤ ⑪ Folder Symbol Meaning Increase or decrease the sound volume Sound Volume When the thermometer icon appears, the temperature Thermometer is too high or too low. - Page 12 Up and Down Button- USB connector- Press to enter memory, adjust setting, Plug the USB connector into the and scroll through results. computer and start to transfer data from the meter to a computer.
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Page 13: The Em50 Accessories
The EM50 Accessories Lancing Device Adjustable tip- Sliding barrel Select the desired penetration depth Pull on until it clicks and then release to enable lancing device. Sleeve- Hand Hold Area Lancing Cap and Trigger button- AST Cap Press the trigger button to... -
Page 14: 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. 1. Press up and ON/OFF button for 5 seconds or insert batteries, the meter turns on. 2. - Page 15 4 Press up or down button to decide whether to delete all memories, then press ON/OFF button to confirm the setting.. (Defaulted setting: OK) 5. Press up or down button to set the display backlight, and then press ON/OFF button to confirm the setting.
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Page 16: Using Em50 Blood Glucose Test Strips
Do not apply blood or control solution to the test strip before you insert it into the meter. Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips. EM50 Self-Monitoring Blood Glucose Test System is a “no code”system and does not require any test strip calibration. -
Page 17: Chapter 2: Control Solution Testing
Why Run a Control Solution Test We recommend that you run the EM50 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
Left over control solution should not be added back into the control bottle. Store control solution at room temperature, between 35.6°F - 86°F (2°C~30°C). Do not freeze. If you would like to purchase EM50 level 2 and level 3 Control Solutions, please contact your local dealer. -
Page 19: Running A Control Solution Test
Running a Control Solution Test You need the meter, a test strip, and control solution. 1. Put a test strip into the meter in the direction of the arrow. The meter will turn on automatically. 2. Press up or down button, the display shows “CtL”... - Page 20 3. Place the meter on a flat surface, like a table. Remove the control solution bottle cap and wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip of the bottle. Touch the drop to the Blood collection area at the end of the test strip.
- Page 21 7. A result appears on the display. Don’t remove the test strip yet. Check if the reading falls within the range printed on the test strip bottle. Remove the test strip and throw the test strip away after you have compared the reading to the range printed on the test strip bottle.
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Page 22: 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 23 Troubleshooting Checks Action Was the test strip exposed to open air for a long Repeat the control test with properly stored strips. period of time? 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 24: 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 25: 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 3. Twist off the protective cover lancing device slot firmly. from the lancet. - Page 26 3. Recap the front cap. 4. Select the desired penetration 5. Pull on the sliding barrel of the depth. lancing device until it clicks and then release. Now the lancet is ready. Do not prick your finger until the test strip is prepared.
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Page 27: 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 and warm water. Please wait at least 5 seconds until the intended area is dry and clean before sampling the blood. 2. Put a test strip into the meter in the direction of the arrow. - Page 28 3. When the blood drop flashes on the display, obtain a drop of blood from your fingertip. 4. Hold the meter firmly against the side of your finger. Press the release button. Then remove the lancing device from your finger. Note: Please make sure to apply blood when the blood drop appears on the display.
- Page 29 5. Gently squeeze your finger to assist the flow of blood. This helps you get a blood drop. 6. Touch the drop to the tip of the transparent window of the test strip. Do not put blood on top of the strip. Be sure to get enough blood on the strip’s reaction zone.
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Page 30: Alternative 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 31: Running A Blood Glucose Test With Blood From Your Forearm
Fingertip test only: If sick If blood glucose is low After exercising Two hours or less after eating After injecting rapid-acting insulin (two hours or less) What NOT to do: If the blood glucose test result from the alternative site test does not match how you feel, do a fingertip test to confirm the result again. - Page 32 2. Press and hold the device with 3. Press the trigger button to one clear adjustable tip against activate the lancing device. the forearm. Hold the device against forearm and increase pressure 1. Massage the puncture area of until the blood sample size is forearm for a few seconds.
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Page 33: Running A Blood Glucose Test With Blood From Your Palm
Running a Blood Glucose Test with Blood from Your Palm 1. Massage the puncture area 2 .Press and hold the device 3. Press the trigger button to of forearm for a few with one clear adjustable tip activate the lancing device. seconds. -
Page 34: Discarding Used Lancets
Discarding Used Lancets 1. Unscrew and remove the 2. Without touching the used Please discard used disposable cap. lancet, stick the lancet tip lancets according to the into its protective cover. recommendations of your healthcare professional. Or discard the used disposable lancet into an appropriate sharps or biohazard container. -
Page 35: Expected Values
Expected Values* The EM50 Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The American Diabetes Association recommends the following values to normal people without diabtetes A post-meal glucose level (After 2 hour) is less than 140 mg/dL A pre-meal glucose (Fasting) is less than100 mg/dL. -
Page 36: Symptoms Of High Or Low Blood Glucose
Symptoms of High or Low Blood Glucose Being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual. Here are the most common symptoms: Greater than 240 mg/dL(13.3 mmol/L) Below 60 mg/dL(3.3 mmol/L) What It Means:... -
Page 37: Comparing Your Meter Result To Lab Results
Keep in mind that the lab could use different technology than your EM50 blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result. -
Page 38: 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 39: Viewing Test Results
Viewing Test Results 1. Press either up or down button to enter the memory. 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. 3. -
Page 40: Deleting A Single Test Result
Deleting a single Test Result 1. While viewing results, if you would like to delete any record, take Memory # 26 for example, press ON/OFF button, keep it pressed and press down button in addition for two seconds. 2. The display shows "dEL" on the top of the screen, press ON/OFF button to confirm the deletion. -
Page 41: Chapter 5: Maintenance And Troubleshooting
Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses two CR2032 Lithium Cell 3V batteries. 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 42: Cleaning And Disinfecting Your Meter And Lancing Device
, 32%C ) dimethyl ethylbenzyl ammonium chlorides and they have been shown to be safe for use with the EM50 meter, but any other disinfectant product with the EPA registration number may be used on this device. Please find the Super Sani-Cloth germicidal wipe in any pharmaceutical store or purchase on the PDI website: http://www.pdipdi.com/healthcare/surface_disinfect.aspx... - Page 43 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 (up to 4 times per day). Instruction: Disinfection Unfold a clean wipe and thoroughly wet all the surface of the meter, including...
- Page 44 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 High Battery Cover High 2. Lancing device clearing/disinfection area Code Name Possibility of contact with blood Lancet holder High...
- Page 45 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 the strip slot and other components free from erosion? Is the labeling on the meter legible? Action: If any of the results is “No”...
- Page 46 After each disinfection 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.
- Page 47 2-2. Performance check of the Lancing device Accept Step Check item Result After each cleaning Can the cap be screwed on the lancing 1. Cap the normal cap to the lancing device. device? 2. Pull on the sliding barrel and then release. Can the lancing device click? 3.
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Page 48: Cleaning And Disinfection Frequency
Cleaning and Disinfection Frequency At least 4 cycles of cleaning per day and 1 cycle of disinfection per week with allow the user to use the device for 4 year. The meter and lancing device can sustain at least 7,300 cycles of cleaning and disinfection. Cleaning Frequency: 4 cycles/day X 365 days/year X 4 year product life = 5840 times of cleaning Disinfection Frequency: 1 cycle/week X 52 weeks/year X 4 year product life = 208 times of disinfection 4 year product life is for properly cleaning and disinfection. -
Page 49: 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 50: 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 Standard Time, Mon-Fri 8:00AM~6:00PM) What it means? What to do? Low Power Replace with new batteries. - Page 51 What it means? What to do? Test again. If the result is still the same, try a control solution test and The test result is higher if the control solution test falls within than 600 mg/dL (33.3 the correct range, please call your mmol/L).
- Page 52 What it means? What to do? Humidified/Used strips Replace with a new strip. Replace the batteries first. If 001 ERROR appears again, please call the Customer Care System fault Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). During non-service hours, please contact your local dealer.
- Page 53 What it means? What it means? The “Ht” and thermometer icon Relocate the meter to a appears. Temperature is too location with temperature high, outside the required range between 50°F-104°F of 50°F-104°F (10°C -40°C). (10°C-40°C). This alerts users that an incorrect result may occur if the test continues.
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Page 54: Chapter 6: Technical Information
Chapter 6: Technical Information Specifications Brand name EM50 Blood Glucose Meter Range 20~600 mg/dL(1.1~33.3 mmol/L) 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% 0.6 μL Blood sample Fresh blood from fingertip, palm, or forearm... -
Page 55: Running With Your Computer
Running with Your Computer 1. Plug the EM50 meter into a USB port on your PC. 2. The display shows ”PC” and the GlucoManager software runs automatically. For more information, please read GlucoManager Data Management Software (GDMS) User’s Manual. 1. Make sure you had exited from GlucoManager software, otherwise DO NOT plug out meter. -
Page 56: Limitations
9. Lipemic samples: Cholesterol level up to 500 mg/dL (12.92mmol/L) and triglycerides up to 3,000 mg/dL(33.6mmol/L) do not affect the results. Grossly lipemic patient samples have not been tested and are not recommended for testing with EM50 Glucose Meter. 10. Critically ill patients should not be tested with EM50 glucose meters. - Page 57 11. The below substances up to the test concentration will not show the interferences (≤ 10% difference). Interfering substance Concentration tested up to (mg/dL) Gentisic Acid Ascorbic Acid Ibuprophen Methyldopa Sodium Salicylate Tetracycline Tolbutamide Galactose Maltose Manose Sucrose Xylitol Glipizide Bilirubin Cholesterol Creatinine...
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Page 58: Device Information
Xylose Uric Acid 15.9 Device Information EM50 SMBG System, EM50 Blood Glucose Test Strips, EM50 Blood Glucose Meter, EM50 Level 2 Control Solution, EM50 Level 3 Control Solution Reference: * American Diabetes Association. Standards of medical care in diabetes. Diabetes care. 2011; Vol. 34, Suppl. - Page 59 Lancing Device Meets the requirements of MDD 93/42/EEC 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 Website：http://www.epsbio.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...
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Page 60: Warranty
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 EM50 User’s Manual 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 Standard Time, Mon-Fri 8:00AM~6:00PM).
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