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Summary of Contents for EPS EGV1.1
- Page 1 EGV1.1 Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly Before using your blood glucose meter Dear EGV1.1 SMBG System Owner,...
- Page 2 Thank you for using the EGV1.1 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 EGV1.1 Self-Monitoring Blood...
- Page 3 Important Safety Instructions Lancing devices and meters are for single patient 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.
- Page 4 Standard Accessories The EGV1.1 Blood Glucose meter and accessories are working together to measure the amount of glucose in your blood. The system includes: • EGV1.1 Blood Glucose Meter • User’s Manual • Alkaline Battery (2 ct) • Quick Reference Guide •...
- Page 5 Note: Although the EGV1.1 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. EGV1.1 blood glucose meter can only be used with EGV1.1 Blood Glucose Test Strips. Other test strips will give inaccurate results.
- Page 7 Note: Consult with your healthcare professional before testing on your fingertip, palm or 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 an inaccurate glucose result. If you think you have any of these conditions, contact your healthcare provider immediately. 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 EGV1.1 Blood Glucose Meter …......................11 The EGV1.1 Accessories..........................13 Inserting Batteries............................14 Setting The Time and Date - First Time Use....................15 Using EGV1.1 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 Chapter 4: Meter Memory, Setup ….......................35 Memory, Storing Test Results …........................35 Viewing & Deleting Test Results…......................36 Chapter 5: Maintenance and Troubleshooting …..................37 Inserting Batteries …..........................37 Cleaning and Disinfecting Your Meter and Lancing Device..……............38 Cleaning and Disinfection Frequency......................40 Maintenance and Testing ...........................42 Screen Messages and Troubleshooting …....................43 Chapter 6: Technical Information …......................48 Specifications …............................48...
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Page 11: The Egv1.1 Blood Glucose Meter
Chapter 1: Understanding Your Meter The EGV1.1 Blood Glucose Meter Date (on the left side) (Before Noon) Time (on the right side) (After Noon ) Control Solution (Before Meal) Alarm (After Meal) Test Result Error Insert strip Temperature Application of blood... - Page 12 Display- Battery Door- Shows results, Flip open the messages, and results battery door by stored in memory. pushing the tab in the direction of the arrow. Left ( ) Button- Press to enter memory, adjust setting, and Right ( ) Button- scroll through results.
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Page 13: The Egv1.1 Accessories
The EGV1.1 Accessories Test Strip Bottle Blood Glucose Test Strip Lancing Device Control Solution Bottle Sliding barrel Electrode Pull on until it clicks and then release to Sleeve- enable lancing Hand Hold device. Area Strip Insert Direction Trigger button- Press the trigger... -
Page 14: Inserting Batteries
Inserting Batteries 1. Open the battery door on the 2. Insert two batteries. The meter 3. Put the battery door back in back of the meter by pushing the will beep to confirm the place and snap it closed. tab in the direction of the arrow. batteries are inserted correctly. -
Page 15: Setting The Time And Date-First Time Use
Setting The Time and Date—First Time Use Setting the current time and date in your meter is important if you intend to use the meter memory. 1. After inserting batteries, the meter turns on automatically. 2. The last 2-digits of the year flash at 3. -
Page 16: Using Egv1.1 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. EGV1.1 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
You should run the control solution tests when: You use the EGV1.1 Blood Glucose Meter for the first time. You open a new bottle of test strips. -
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 36°F - 86°F (2°C~30°C). Do not freeze. If you would like to purchase EGV1.1 Control Solutions, please contact Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). -
Page 19: Running A Control Solution Test
Running a Control Solution Test You need the meter, a test strip, and control solution. 3. Place the meter on a flat surface, like a table. 4. Remove the control solution bottle cap and wipe the tip of the bottle 1. - Page 20 Remove the test strip and 6. Touch the drop to the Blood 9. The meter starts to count down from 5 dispose of it according to your collection area at the end of seconds and will show the results. A healthcare provider’s the test strip.
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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 the acceptable range for the appropriate control solution level. Make sure you compare the result to the correct level of control. - Page 22 Troubleshooting Check 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 test strip cap close tightly? Or was test 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. 2. Insert the lancet into the lancing 1. Unscrew the Cap. 3. Recap the front cap. device firmly then twist off the protective cover. - Page 25 4. Select the desired penetration 5. Pull on the sliding barrel of the 6. Set the lancing device aside depth. lancing device until it clicks and until later in the test. 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 4. When the blood drop flashes on the soap and warm water. display, swab the blood collection area 2. Insert a test strip into the meter in Rinse and dry thoroughly. - Page 27 Apply blood to the edge Do not apply blood on of the test strip. top of the test strip. 6. Place the lancing device against the tip or side of your finger; press the trigger Be sure to get enough Not enough blood 9.
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Page 28: 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 You have the option of testing other places on your or forearm. body besides the fingertip. Consult your health care professional before you begin using the palm or forearm for testing. - Page 29 Caution: Talk with your healthcare professional before you test palm or forearm. Do NOT ignore symptoms of high or low blood glucose. Fingertip samples are able to show the rapid change of glucose faster than forearm and palm samples.
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Page 30: Running A Blood Glucose Test With Blood From Your Forearm
3. Press the trigger button to activate 1. Massage the puncture area of 2. Press and hold the device with the lancing device. Hold the device forearm for a few seconds. clear adjustable tip against the against forearm and increase forearm. -
Page 31: 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 activate of palm for a few seconds. with a clear adjustable tip the lancing device. against the palm. -
Page 32: Discarding Used Lancets
Discarding Used Lancets 1. Unscrew and remove the 2. Without touching the used cap. lancet, stick the lancet tip 3. Pointing the lancing device into its protective cover. toward a container for sharp or biohazard material, slide the ejection button down to release the covered lancet into the container. -
Page 33: Understanding Your Test Results Expected Values
Understanding Your Test Results Expected Values* The EGV1.1 Pro Blood Glucose test strips are whole-blood referenced and calibrated for easier comparison to lab results. The normal fasting blood glucose range for an adult without diabetes is 70-100 mg/dL*. Two hours after meals, the blood glucose range for an adult without diabetes is less than 140 mg/dL. -
Page 34: Comparing Your Meter Result To Lab Results
Keep in mind that the lab could use different technology than EGV1.1 blood glucose meter, and that blood glucose meters for self testing generally read somewhat lower or higher than the lab result. -
Page 35: 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 36: Viewing & Deleting Test Results
Viewing & Deleting Test Results You can review them at any time without inserting a test strip when the display flashes the icon of Each review requires the user to go back to the main screen (testing mode) by pressing pressing and for 2 seconds. -
Page 37: Chapter 5: Maintenance And Troubleshooting
Chapter 5: Maintenance and Troubleshooting Inserting Batteries 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 may differ. Insert the batteries when you first use the meter or replace with new batteries when the "LP"... -
Page 38: 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 EGV1.1 meter, but any other disinfectant product with the EPA registration number may be used on this device. Please purchase in retail stores like Walmart and Office Depot. You could also purchase on the PDI website:http://www.pdipdi.com/ or online retail sites like amazon.com, medline.com, and Expression medical... - Page 39 patient and not shared. If the meter and lancing device are being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person. Cleaning Instruction All blood and other body fluids must be thoroughly cleaned from surfaces and...
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Page 40: Cleaning And Disinfection Frequency
Physical Appearance check of the Performance check of the meter and meter and lancing device after each lancing device after cleaning and cleaning or disinfection disinfection If you notice any of the following, immediately stop If you notice any of the following, immediately stop using the meter and call the Customer Care Service using the meter and call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time,... -
Page 41: 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 42: Screen Messages And Troubleshooting
Screen Messages and Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, please contact your healthcare professional. Message What it means? What to do? Humidified / Used strips Repeat the test with a new strip. The meter has detected a problem Refer to pages 26-27 for information on with the test strip. - Page 43 Message What it means? What to do? Memory Error Replace the batteries first. If ERROR 005 appears again, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM). System error Replace the batteries first. There may be a problem with the Refer to pages 14 and 38.
- Page 44 Message What it means? What to do? Test result is higher than 600 Re-check your glucose level. mg/dL. If the result is still “HI”, try a control solution test and if the control solution test falls within the correct range, please call the Customer Care Service toll-free at 866-994-3345.
- Page 45 Message What it means? What to do? The “Ht” and thermometer icon Relocate the meter to a location with appears. Temperature is too high, temperature between 10°C - 40°C outside the required range of 10°C (50°F - 104°F). - 40°C (50°F - 104°F). This alerts users that an incorrect result may occur if the test continues.
- Page 46 Message What it means? What to do? Volume detector error Repeat the test with a new strip. If Err appears again, please call The volume of blood or control solution is NOT enough. the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM).
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Page 47: Chapter 6: Technical Information
Chapter 6: Technical Information Specifications Brand name EGV1.1 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 30% - 90% R.H. Temp. 36°F ~86°F (2°C ~30°C) -
Page 48: Limitations
Limitations The test strips are used for fresh capillary whole blood samples. 1. DO NOT use neonate blood sample. 2. Not to be used for diagnosis or screening of diabetes. 3. Alternative site testing with this system can be used only during steady-state blood glucose conditions. 4. - Page 49 10. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results. 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...
- Page 50 Endogenous Interference data Endogenous highest Conc. interference Bias @ blood Note Substances tested or no glucose Conc. Bilirubin- unconjugated 25 mg/dL Cholesterol 500 mg/dL Creatinine 30 mg/dL Triglycerides 1000 mg/dL 14.3%@80 mg/dL The highest no interference concentration is Uric Acid 15.9 mg/dL 17.5%@120 mg/dL 11.9 mg/dL...
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Page 51: Accuracy Study
ACCURACY STUDY The accuracy of the SMBG System was assessed by comparing to laboratory results. The following results were obtained by 153 subjects with diabetes at three independent clinical sites. The regression statistics are derived from a plot of the capillary of fingerstick data versus YSI plasma data. Slope 1.0100 Intercept... - Page 52 Glucose level >75mg/dL within±5% within±10% within±15% within±20% 63/134(47.01%) 99/134(73.88%) 121/134(90.30%) 129/134(96.27%) Hypothenar testing- Slope 1.0896 Intercept -11.7596 mg/dL Number of subject 153 R-square 0.9584 Range tested 53– 517 mg/dL Glucose level ≦75mg/dL within±5mg/dL within±10mg/dL within±15mg/dL 9/19 (47.37%) 16/19 (84.21%) 18/19 (94.74%) Glucose level >75mg/dL within±5% within±10%...
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Page 53: Device Information
Website：http://www.epsbio.com 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. - Page 54 • Outside the USA, call your authorized representative or write to: Customer Service E-mail: info@epsbio.com.tw Lancing Device Meets the requirements of MDD 93/42/EEC Manufacturer: STERILANCE MEDICAL (SUZHOU) INC. 68# LiTangHe RD, XiangCheng, Suzhou, China 215131 Tel: +86 512 65799308 Fax: +86 512 67217663 E-mail：guopings@xinda-medical.com Lancet Meets the requirements of MDD 93/42/EEC...
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