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Stat Medical Devices EASYMAX N User Manual

Self-monitoring
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EasyMax N
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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  • Page 1 EasyMax N 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

    Dear EasyMax N SMBG System Owner, Thank you for using the EasyMax N Self-Monitoring Blood Glucose (SMBG) System. We designed this system to be dependable, easy-to-use, compact, and lightweight and portable to help you monitor your blood glucose on a regular basis.
  • Page 3 Standard Accessories Your new EasyMax N Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. The system includes: • Wallet • Check Strip • User’s Manual • Quick Reference Guide • Self-Test Log Book •...
  • Page 4 Note: Although the EasyMax N SMBG System is easy to use, you may need to consult 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 accurate results.
  • Page 5 EasyMax N blood glucose meter is designed and approved for testing fresh capillary blood from fingertip. The meter is for outside the body (in vitro) use. It should not be used to diagnose diabetes. EasyMax N blood glucose meter only use with EasyMax N Blood Glucose Test Strips. Other test strips will give inaccurate results.
  • Page 6 Remove batteries if the meter will not be used for one month or more. 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.
  • Page 7 Health-Related Information If you are very dehydrated, urinating frequently, low blood pressure, shock or hyperosmolar hyperglycemic nonketotic coma (HHNK), 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 your test results, or if you have questions, please talk to your doctor.

  • Page 8: Table Of Contents

    Checking Your System …...........................12 Coding Your Meter .............................13 Setting The Time And Date ........................14 Using EasyMax N Blood Glucose Test Strips ...............16 Chapter 2: Control Solution Test ........................17 Why Run A Control Solution Tests ......................17 About The Control Solutions ........................18 Running A Control Solution Test ........................19...
  • Page 9 Symptoms of High or Low Blood Glucose..............36 Comparing Your Meter Result To A Lab Result …..................37 Chapter 4: Meter Memory, Setup ….......................38 Memory, Storing Test Result …........................38 Viewing & Deleting Test Results …......................39 Meter Setup …............................40 Setting Thermometer …..........................41 Setting The Alarm …...........................42 Setting The Beeper For The Alarm …......................44 Setting The Clock …...........................45 Chapter 5: Maintenance And Troubleshooting …..................46...

  • Page 10: Chapter 1: Understanding Your Meter

    Chapter 1: Understanding Your Meter The EasyMax N Blood Glucose Meter M Button To turn on the meter or read records. S Button To turn on the meter or go into Setting Mode. Note: When you use software with the meter, the symbol of “Type” will show you to start operation.
  • Page 11 Strip Slot USB Port To insert test strip or check strip. To transfer data to a Computer. A. Blood collection area B. Reaction area Expiration C. Hand hold area Date D. Strip insert direction E. Electrode Test Strip Bottle...

  • Page 12: Checking Your System

    Checking Your System A new check strip is included with your meter. 1. Make sure your check strip is 2. The display shows "OK". 3. Remove the check strip and inserted. The meter will turn the meter will turn off on automatically.

  • Page 13: Coding Your Meter

    Coding Your Meter Your meter had coded by 888 code. You don’t need to code your meter again. Put a test strip into the meter in the direction of the arrow. The meter turns on. The display shows the code number (888) briefly. Make sure the code number on the display matches the code number on the test strip bottle.

  • Page 14: Setting The Time And Date

    Setting The Time and Date—First Time Use Setting the current time and date in your meter is important if you use the meter memory or if you want to download your results to a computer. 1. Press and hold the "S" button 2.
  • Page 15 4. Press and release "S" button 5. Repeat step 3 and 4 to set 6. Press the "S" button to to set the year. the date, hour, and minute. confirm the setting. The month will then flash. The flashing field is the one The display will show "SCL"...

  • Page 16: Using Easymax N Blood Glucose Test Strips

    Using EasyMax N Blood Glucose Test Strip Use only with EasyMax N Blood Glucose Meter. Run a control 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 Test

    Why Run A Control Solution Test We recommend that you run the EasyMax N Normal and High Control Solutions test lets you know that your meter and test strips are working properly to give reliable results. You should run the control solution tests when: You use the EasyMax N Blood Glucose Meter for the first time.

  • Page 18: About The Control Solutions

    About The Control Solution Use only with EasyMax N test strips. Write the date you opened the bottle on the bottle 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 1. Put a test strip into the meter in the direction of 2. If you miss seeing the code number, take the the arrow. The meter turns on. test strip out and reinsert it into the meter.
  • Page 20 3. Place the meter on a flat surface, like a table. Squeeze the bottle until a tiny drop forms at the tip of the bottle. Remove the control solution bottle cap and Touch the drop to the Blood collection area at wipe the tip of the bottle with a tissue.
  • Page 21 6. 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.

  • Page 22: Understanding Control Test Results

    Understanding Control 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 result is inside the range on the test strip bottle, your test strips and your meter is working properly.
  • Page 23 Troubleshooting Checks Action Repeat the control test with properly stored strips. Was the test strip exposing to open air for a long period of time? Was the test strip bottle capped tightly? This will humidify strips inside. Replace the test strips.

  • 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 lancing device firmly then twist off the protective cover.
  • Page 26 4. Select the desired penetration depth. 3. Recap the front cap. Note: Select 1-3 for soft or thin skin. 4-5 for average. 6-8 for thick or calloused skin.
  • Page 27 5. Pull on the sliding barrel of the lancing device until it clicks and then release. Now the lancing device is ready. Do not prick your finger until your meter and strip are prepared. 6. Set the lancing device aside until later in the test.

  • Page 28: 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. Put a test strip into the meter 3. If you miss seeing the code and warm water. in the direction of the arrow. number, take the test strip Rinse and dry thoroughly.
  • Page 29 4. When the blood drop flashes on the display, 6. Place the lancing device against the pad of obtain a drop of blood from your fingertip. your finger. Press the trigger button to activate the 5. Swab the blood collection area on your finger lancing device.
  • Page 30 7. Gently squeeze your finger to assist the flow 8. The meter will beep when enough blood has of blood. This helps you get a blood drop. entered the strip’s reaction zone. Touch the drop to the tip of the transparent The result will appear on the display after 5 window of the test strip.

  • Page 31: Alternative Site Testing

    Alternative Site Testing (AST) Understanding Alternative Site Testing What is AST? What is the advantage of AST? Besides the fingertip, you can test the forearm. You have the option of testing other places on your body besides the fingertip. Consult your health care professional before you begin using the forearm for testing. Blood glucose test results obtained from your forearm may differ significantly from fingertip samples.
  • Page 32 Fingertip test only: If sick If blood glucose is low After exercising Two hours or less after eating When basal insulin is most active After injecting rapid-acting insulin (two hours or less) What NOT to do: If the blood glucose test result does not match how you feel, do a fingertip test to confirm the result again.

  • Page 33: Running A Blood Glucose Test With Blood From Your Forearm

    Running A Blood Glucose Test With Blood From Your Forearm 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 activate the lancing device. Hold seconds.

  • Page 34: Discarding Used Lancets

    Discarding Used Lancets 1. Unscrew and remove the adjustable cap. 2. Discard the used disposable lancet into an Without touching the used lancet, stick the appropriate sharps or biohazard container. lancet tip into its protective cover. Grip the lancet carrier firmly and pull the lancet safely out.

  • Page 35: Understanding Your Test Results

    Understanding Your Test Results The EasyMax N Blood Glucose test strips are plasma referenced and calibrated for easier comparison to lab results. The normal fasting blood glucose range for an adult without diabetes is 70~110 mg/dL. Two hours after meals, the blood glucose range for an adult without diabetes is less than 120 mg/dL. For people with diabetes: please consult your doctor for the blood glucose range appropriate for you.

  • 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 Below 60 mg/dL What It Means:...

  • Page 37: Comparing Your Meter Result To A Lab Result

    Keep in mind that the lab could use different technology than EasyMax N 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 & Deleting Test Results

    Viewing & Deleting Test Results Press and hold the "S" button To delete a test result, Press 6. Press "M" and release to until turning the meter on. and hold "M" for more than 3 review the average results seconds. for the last seven days 2.

  • Page 40: Meter Setup

    Meter Setup Using The Set Mode By using the set mode, you can personalize your meter to suit your needs. Here are the features you can customize — Time and Date — to set the time and date (see Chapter 1). Thermometer —...

  • Page 41: Setting Thermometer

    Setting The Thermometer 3. Press the "S" and the meter will change the Press the "S" to turn the meter on. temperature reading to Fahrenheit. 2. Press the "M" and "S" buttons at the same time Press the "S" again and the meter will and hold for more than 3 seconds.

  • Page 42: Setting The Alarm

    Setting The Alarm 3. Press the "S" when the 1. Press the "M" to turn the 2. Press the "S" when the display shows "On", the alarm On or OFF. display shows "OFF" to first 2-digits of time "On” or "OFF" indicators change the meter alarm mode (hour field) will flash.
  • Page 43 If the time shows 12:00 AM, 6. And then can establish other 7. If you don’t want the alarm on you must press the "M" 12 alarms fitting in with your at all, please confirm every times to set at "PM". demand.

  • Page 44: Setting The Beeper For The Alarm

    Setting The Beeper For The Alarm You will see the Beep Setting Mode after the Press the "S" to confirm. Alarm Setting was confirmed. Press the "M" to switch the "On" "OFF" at the center of the display.

  • Page 45: Setting The Clock

    Setting The Clock After confirming the beep setting, the meter will go to the Clock Mode You will see seconds being counted in the The meter alarm will sound when clock time center of the display, 2-digits (month field) and matches the time set in the alarm mode.

  • Page 46: Chapter 5: Maintenance And Troubleshooting

    Chapter 5: Maintenance and Troubleshooting Installing Batteries The meter uses two alkaline 1.5V (AAA) batteries. Batteries will normally last for over 2000 tests. Other types of 1.5V (AAA) 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 47: Cleaning Your Meter

    Cleaning Your Meter Caring for your EasyMax N SMBG system does not require special cleaning. Please keep the meter free of dirt, dust, bloodstain, and water stains. Follow these guidelines carefully to help you get the best performance possible: Do Not: Make sure the meter is turned off.

  • 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 contact your local dealers. Humidified/Used strips Low power Action: Replace with a new Action: Replace with new strip. batteries.
  • Page 50 System fault System fault Replace the batteries first. If 001 ERROR Replace the batteries first. If Err appears Action: Action: appears again, please call Customer Service again, please call Customer Service toll-free toll-free 1-866-203-2761. 1-866-203-2761.
  • Page 51 The "Ht" and thermometer icon appears. The "Lt" and thermometer icon appears. Temperature is too high, outside the required Temperature is too low, outside the required range of 50°F ~104°F (10°C ~40°C). This alerts range of 50°F ~104°F (10°C ~40°C). This users that an incorrect result may occur if the alerts users that an incorrect result may test continues.
  • Page 52 Test result is higher than The test result is lower than 600 mg/dL. 20 mg/dL. Test again. If the result Test again. If the result is Action: Action: is still the same, please still the same, please contact contact your healthcare your healthcare professional.

  • Page 53: Chapter 6: Technical Information

    Chapter 6: Technical Information Specifications Brand name EasyMax N 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% 0.6 μL Blood sample...
  • Page 54 ♦ A state of hypoglycemic-hyperosmolar state (with or without ketosis) 9. Lipemic samples: Cholesterol level up to 500 mg/dL and triglycerides up to 3,000 mg/dL do not affect the results. Grossly lipemic patient samples have not been tested and are not recommended for testing with EasyMax N Glucose Meter.
  • Page 55 10. Critically ill patients should not be tested with home-use blood glucose meters. 11. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results. Test Interfering , Bias at 50±5 % Bias at 250±5 % Bias at 500±5 Concentration...

  • Page 56: Device Information

    Device Information EasyMax N SMBG System, EasyMax N Blood Glucose Test Strips, EasyMax N Blood Glucose Meter, EasyMax N Normal Control Solution, EasyMax N High Control Solution. Reference: ＊ American Diabetes Associations: Standards of Medical Care for Patients with Diabetes Mellitus, Diabetes Care, 25(2002), p.S37...

  • Page 57: Warranty

    1835 N.E. 146th Street, North Miami, FL33181, USA TEL：(001) 305-945-0011 FAX：(001) 305-949-7370 E-mail：stat@statdevices.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 E-mail：saehan@saehanmed.com Warranty EPS warrants the original purchaser for a period of 5 years from the date of purchase. This means during the warranty period if your 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.

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