EPS Bio Technology EasyMax NG User Manual
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EPS Bio Technology EasyMax NG User Manual

Next generation (ng) self-monitoring blood glucose system
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Next Generation
(NG) Self-Monitoring Blood Glucose System
User's Manual
Please read this User's Manual thoroughly
before using your blood glucose meter.

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Summary of Contents for EPS Bio Technology EasyMax NG

  • Page 1 Next Generation (NG) Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using your blood glucose meter.

  • Page 2: Intended Use

    Testing is done outside the body (In Vitro diagnostic use). The EasyMax NG Blood Glucose System can be used by a single patient or for multiple-patient use in professional healthcare settings, as an aid to monitor the effectiveness of diabetes control.

  • Page 3: Important Safety Instructions

    Standard Precautions when using the meter and obtaining a sample. A new pair of gloves should be worn by the user before testing each patient. The meter should be disinfected after each use. The EasyMax NG Self Monitoring Blood Glucose Test System may be used for testing multiple patients when Standard Precautions and the disinfection procedures included in this manual are followed.
  • Page 4 For further information, please see: "Biosafety in Microbiological and Biomedical Laboatories (BMBL)" http://www.cdc.gov/biosafety/publications/bmbl5/ "Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline--Third Edition " Clinical and Laboratory Standards Institute (CLSI) M29-A3. “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007”, http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
  • Page 5 Testing blood glucose regularly can make a big difference in how you manage you or your patients’ day to day diabetes care. We’ve made EasyMax NG Self-Monitoring Blood Glucose System as simple as possible to help you use it regularly.
  • Page 6 Remove batteries if the meter will not be used for one month or more. The EasyMax NG Blood Glucose Meter can only be used with EasyMax 15 Blood Glucose Test Strips. Other test strips will give inaccurate results. EasyMax 15 Blood Glucose Test Strips feature a unique and accurate glucose dehydrogenase chemistry system.
  • Page 7 Warning for potential biohazard: Healthcare professionals using this system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral disease. Note: Do not touch the strips with wet hands.
  • Page 8 Health-Related Information If the patient is experiencing dehydration, frequent urination, low blood pressure, shock or hyperosmolar hyperglycemic nonketotic coma (HHNKC), you may get a test result that is lower than the actual blood glucose level. We recommend confirming the result on such patients via a clinical laboratory. If you have followed the steps in the user’s manual, but still have symptoms that don’t seem to match your test results, or if you have questions, please call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM).
  • Page 9 Explanation of Meter Symbols Date Memory (on the left side) Record/Average Time (on the right side) display Result Apply Blood Apply Control Temperature Solution Application of blood or control Unit solution Insert a strip Battery...

  • Page 10: Table Of Contents

    Table of Contents Chapter 1: Understanding Your Meter …......................12 EasyMax NG Blood Glucose Meter …......................12 The EasyMax NG Accessories........................13 Inserting Batteries............................14 Setting the Time and Date...........................15 Using EasyMax 15 Blood Glucose Test Strips …...…………………............16 Chapter 2: Control Solution Test ........................17 When to Run a Control Solution Test ......................17...
  • Page 11 Using With Your Computer…........................31 Chapter 5: Maintenance and Troubleshooting …..................32 Battery Information............................32 Cleaning and Disinfecting the EasyMax NG Meter in LTC Settings............33 Cleaning And Disinfection Frequency......................37 Maintenance and Testing ...........................38 Screen Messages and Troubleshooting …....................39 Chapter 6: Technical Information ….......................43 Specifications …............................44...

  • Page 12: Chapter 1: Understanding Your Meter

    Chapter 1: Understanding Your Meter EasyMax NG Blood Glucose Meter Strip Ejector- Test Strip Slot- Push the Strip Ejector to remove Insert test strip here. the strip. Battery Door- Flip open the Display- battery door by Shows results, pushing the tab in...

  • Page 13: The Easymax Ng Accessories

    The EasyMax NG Accessories EasyMax 15 Blood Glucose Test Strip Test Strip Bottle & Control Solution Bottle Electrode Strip Insert Direction Hand Hold Area Reaction area Blood collection Expiration Date area...

  • Page 14: Inserting Batteries

    Inserting Batteries 1. Open the battery door on the back of the meter by pushing the tab in the direction of the arrow and pulling the door up. 2. Insert two AAA batteries. The meter will beep to confirm the batteries are inserted correctly. 3.

  • Page 15: Setting The Time And Date

    Setting the Time and Date Setting the current time and date your meter is important if you use the meter memory. 1. Press (Power Button) The last 2-digits of the year flashes Repeat step 3 to set the date and hold the button until at the top of the display.

  • Page 16: Using Easymax 15 Blood Glucose Test Strips

    Use only with EasyMax NG or EasyMax LTC Blood Glucose Meters. EasyMax NG Self-Monitoring Blood Glucose System is a no code system and does not require test strip calibration. EasyMax NG Self-Monitoring Blood Glucose System utilizes glucose dehydrogenase chemistry to avoid incorrect readings on patients receiving Oxygen therapy.

  • Page 17: Chapter 2: Control Solution Test

    Running a EasyMax 15 Control Solution Test will let you know that your meter and test strips are working properly. You should run control solution tests: If you are using a new EasyMax NG Blood Glucose Meter. When you open a new vial of EasyMax 15 test strips.

  • Page 18: About Control Solution

    About Control Solution Use only with EasyMax 15 test strips and EasyMax NG or EasyMax LTC meters. Write the date you first open the Control Solution bottle on the label. The control solution is 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. 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. 1.
  • Page 20 6. Touch the drop to the blood 7. Do not remove the test strip until you 8. Push the strip ejector to collection area at the tip of the confirm that the reading falls within eject the test strip into a test strip.

  • Page 21: Understanding Control Solution Test Results

    Understanding Control Solution Results The label on your test strip vial shows the acceptable ranges for the different control solution levels. 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 Checks

    (Chapter 2) Replace with new EasyMax 15 control solution to Is the control solution expired or contaminated? check the performance of your EasyMax NG meter. Were test strips and control solutions stored in Repeat the control test with properly stored strips cool, dry places? and/or control solutions.

  • Page 23: Chapter 3: Testing Your Blood Glucose

    Chapter 3: Testing Your Blood Glucose Instructions for using single-use lancets with a 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.
  • Page 24 4. Select the desired penetration 5. Pull on the sliding barrel of the 6. Set the lancing device depth. lancing device until it clicks and aside 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.

  • Page 25: 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 2. Put a test strip into the meter in the 4. Please wait at least 5 seconds warm water. Rinse and dry direction of the arrow. The meter until the intended area is dry thoroughly.
  • Page 26 Apply blood to the edge of the test strip. Do not apply blood on top of the test strip. Be sure to get enough blood on strip to make it to the confirmation window. 6. Gently squeeze and/or massage 7. Touch the blood drop at the tip of the your fingertip until a round drop of transparent window of the test strip.
  • Page 27 9. Push the Strip Ejector to eject the test strip. Dispose of both strip and lancet properly. 10. After discarding, wash hands thoroughly with soap and water. Rinse and dry thoroughly. 11. Clean and disinfect the meter following the instruction in Chapter 5. 8.

  • Page 28: Understanding Your Test Results

    Understanding Your Test Results Expected Values* The EasyMax 15 Blood Glucose test strips are plasma referenced and calibrated for easier comparison to lab results. The American Diabetes Association recommends a post-meal glucose level of less than 140 mg/dL and a pre-meal glucose of less than 100 mg/dL*. American Diabetes Association: Diagnosis and Classification of Diabetes Mellitus (Position Statement).

  • Page 29: 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 30: Viewing And Deleting Test Results

    Viewing and Deleting Test Results Each review requires the user to go back to the main screen (testing mode) by pressing the power button. 3. To delete a test result, press (Left button) for more than 2 seconds and display 1.

  • Page 31: Using With Your Computer

    Using With Your Computer To Transfer data, the meter can be turned on or turned off. The USB mini port can be found on the bottom of your meter below the power, left and right buttons. 2. The meter starts to transfer When all data is uploaded from 1.

  • Page 32: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Battery Information 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. Install the batteries when you first use the meter or replace with new batteries when the "LP"...

  • Page 33: Cleaning And Disinfecting The Easymax Ng Meter In Ltc Settings

    Cleaning and Disinfecting the EasyMax NG Meter in LTC Settings Choosing a disinfectant According to Guideline for Disinfection and Sterilization in Healthcare Facilities in 2008, you should clean your glucose meter after every use to prevent any possibility of cross infection. Wipes used should be EPA-registered as a disinfectant.
  • Page 34 Step 1: Cleaning Instruction: Clean first to remove any heavy soil left on the surface of the meter. All blood and bodily fluids must be thoroughly cleaned from surfaces and objects before disinfection with a germicidal wipe. Open, unfold and use the first germicidal wipe to remove heavy soil. Step 2: Disinfection Instruction: After cleaning, and before using the meter again, unfold a new wipe and thoroughly wet all meter surfaces, including the strip port and the connection port.
  • Page 35 Performance check of the meter Accept Steps Check item Result After each cleaning 1. Press and hold power Does the meter turn on? button for 3 sec. Does the meter beep? 2. Press and release left or Does the meter have stored results? right button.
  • Page 36 Physical Appearance check of the meter after each cleaning or disinfection Check item Accept Result Is the display clear to read? Is the screen clear? Is the strip slot and other parts free of corrosion? Action: If any of the results are “No” the user should call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM) for assistance.

  • Page 37: Cleaning And Disinfection Frequency

    Cleaning And Disinfection Frequency At least 9 cycles of cleaning per day and 1 cycle of disinfection per week will allow the user to use the device for 4 years. The meter can sustain 20,000 cycles of cleaning and disinfection and the lancing device can sustain 14,600 cycles of cleaning and disinfection.

  • Page 38: 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 39: Screen Messages And Troubleshooting

    Screen Messages And Troubleshooting Never make treatment decisions based on an error message. If you have any concerns, call the Customer Care Service toll-free at 866-994-3345 (Eastern Standard Time, Mon-Fri 8:00AM-6:00PM). Message What it means? What to do? Humidified / Used strips Repeat the test with a new strip and The meter has detected a problem with puncture site.
  • Page 40 Message What it means? What to do? System error Replace the batteries first. There may be a problem with the meter. Refer to pages 14 and 32. If this error message appears again, please contact Customer Service. Memory Error Replace the batteries first. If ERROR 005 appears again, please contact Customer Service.
  • Page 41 Message What it means? What to do? Repeat the test with a new strip, Insufficient Volume error puncture site, enough The volume of blood or blood/control solution. control solution is NOT Refer to pages 25-27 for information on enough. sample application. Re-check your glucose level.
  • Page 42 Message What it means? What to do? The “HF” and thermometer icon Relocate the meter to a location with appears. Temperature is too high, temperature between 50°F - 104°F (10°C outside the required range of 50°F - - 40°C). 104°F (10°C - 40°C). This alerts users that an incorrect result may occur if the test continues.

  • Page 43: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications Brand name EasyMax NG 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. -4F - 122°F (-20°C - 50°C)

  • Page 44: Limitations

    4. DO NOT use during xylose absorption testing. Xylose in the blood will interfere with the Self-Monitoring Blood Glucose System. 5. Interfering Substances depend on the concentration. EPS (EasyMax NG mfg) has tested above the therapeutic levels and at or above the suggested testing levels of the EPA for many common substances.
  • Page 45 Based on this chart, many of these substances do not have an effect on EasyMax NG blood glucose results. Blood Concentration, mg/dL Suggestion tested Result Exogenous Interferent Therapeutic Conc. conc. by EPA (+/-) tested conc. Acetaminophen 0.5-3 Ascorbic Acid 0.8~1.2 Dopamine 0.09...

  • Page 46: Device Information

    Oak Tree Health warranty During the warranty period, if your EasyMax NG Self-Monitoring Blood Glucose System does not work for any reason (other than obvious abuse), Oak Tree Health will replace it with a new system or an equivalent product free of charge.

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