Related Manuals for EPS Bio Technology EasyMax T1
Summary of Contents for EPS Bio Technology EasyMax T1
- Page 1 EasyMax T1 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 2: Intended Use
Dear EasyMax T1 SMBG System Owner, Thank you for using the EasyMax T1 Self-Monitoring Blood Glucose (SMBG) System. We design 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: Important Safety Instructions
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
Standard Accessories Your new EasyMax T1 Blood Glucose meter and accessories work together to measure the amount of glucose in your blood. The system includes: • EasyMax T1 Blood Glucose Meter • User’s Manual • Test Strips (10 ct) • Quick Reference Guide •... -
Page 5: Do You Need Help
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’ve made this SMBG system as simple as possible and help you to use the meter 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 ® EASYMAX T1 blood glucose meter is designed and approved for testing fresh venous blood and capillary whole blood samples from your fingertip, palm or forearm. The meter is for in vitro diagnostic use ONLY (for testing outside the body).
- Page 7 It`s not necessary to require servicing, and maintenance while in use. It`s prohibited to change or modify the glucose device at will. Note: Consult with your healthcare professional before testing on your forearm. Do not touch the strip with a wet hand. ...
- 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
Table of Content Chapter 1: Understanding Your Meter ….......................11 The EasyMax® T1 Blood Glucose Meter …....................11 The EasyMax® T1 Accessories Blood Glucose Test Strip................12 The EasyMax® T1 Accessories Lancing Device and AST Cap..............12 Using EasyMax® T1 Blood Glucose Test Strip..................13 Chapter 2: Control Solution Testing......................14 Why Run A Control Solution Tests ......................14 About The Control Solutions ........................15... - Page 10 Comparing Your Meter Result To A Lab Result …..................32 Chapter 4: Maintenance and Troubleshooting …..................33 Installing Batteries …..........................33 Cleaning and Disinfecting Your Meter and Lancing Device ...............34 Cleaning and Disinfection Frequency ….....................40 Maintenance and Testing ….......................41 Screen Messages And Troubleshooting …....................42 Chapter 5: Technical Information …......................45 Specifications …............................45 Limitation …............................46...
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Page 11: Chapter 1: Understanding Your Meter
Chapter 1: Understanding Your Meter The EasyMax T1 Blood Glucose Meter The Overview of the Display: A. Test Result B. Glucose Unit C. Error D. Apply blood or control solution E. Insert Test Strip F. Batteries Status G. Thermometer... -
Page 12: The Easymax T1 Accessories Blood Glucose Test Strip
The EasyMax T1 Accessories Lancing Device Blood Glucose Test Strip Test Strip Bottle Control Solution Bottle Electrode Sliding barrel Pull on until it clicks and then Sleeve- release to enable Hand Hold Area lancing device. Strip Insert Direction Trigger button-... -
Page 13: Using Easymax® T1 Blood Glucose Test Strip
Using EasyMax® T1 Blood Glucose Test Strip Use only with EasyMax® T1 Blood Glucose Meter. Keep the test strips in their original bottle. After you take a test strip out of the bottle, tightly close the bottle immediately. This keeps the test strips dry. -
Page 14: Chapter 2: Control Solution Testing
Chapter 2: Control Solution Testing Why Run A Control Solution Test We recommend that you run the EASYMAX® T1 Level 2 (Normal) control solution 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 15: About The Control Solutions
About The Control Solution Use only with EasyMax® T1 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 16: Running A Control Solution Test
Running A Control Solution Test You need the meter, a test strip, and control solution. Squeeze the bottle until a tiny drop forms at 2. Place the meter on a flat the tip of the bottle. Touch the drop to the surface, like a table. - Page 17 5. A result appears on the display. Remove the test strip and throw it away Don’t remove 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 18: Understanding Control Test Results
Understanding Control Test Results The label on your test strip bottle shows the acceptable ranges for the Control Solutions – Level 2 and Level 3. 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 19 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 test strip cap close tightly? Or was test uncapped, open a new bottle of test strips.
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Page 20: 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 21: 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 22 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 23: 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 in 4. Place the lancing device against and warm water. the direction of the arrow. the pad of your finger. Rinse and dry thoroughly. - Page 24 Do not apply blood on Apply blood to the edge of the test top of the test strip. strip. Be sure to get Not enough enough blood on strip blood on strip to to make it to the get a test result. confirmation window.
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Page 25: Alternate Site Testing (Ast)
Alternate Site Testing (AST) Understanding Alternate 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. AST that should be used with this device is the forearm only. - Page 26 Fingertip test only: If sick If blood glucose is low After exercising Two hours or less after eating When you have just taken insulin After injecting rapid-acting insulin (two hours or less) AST Results: ...
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Page 27: Running A Blood Glucose Test With Blood From Your Forearm(Optional)
Running A Blood Glucose Test With Blood From Your Forearm (Optional) Please use the clear cap with the lancing device for AST testing Press the trigger button to 1. This graphic shows where Press and hold the device activate the lancing device. the meter cleared for with a clear adjustable tip alternative site testing. -
Page 28: Running A Blood Glucose Test With Blood From Your Palm
Running A Blood Glucose Test With Blood From Your Palm 3. Press the trigger button to activate 1. Massage the puncture area 2. Press and hold the device the lancing device. of palm for a few seconds. with a clear adjustable tip 4. -
Page 29: Discarding Used Lancets
Discarding Used Lancets Pointing the lancing device 1. Unscrew and remove the 2. Without touching the toward a container for sharp or cap. used lancet, stick the biohazard material, slide the lancet tip into its ejection button down to release protective cover the covered lancet into the container. -
Page 30: Understanding Your Test Results
Understanding Your Test Results Expected Values* ® The EASYMAX T1 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 . -
Page 31: 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 (13.33 mmol/L) Below 60 mg/dL (3.33 mmol/L) What It Means:... -
Page 32: Comparing Your Meter Result To A Lab Result
Comparing Your Meter Result to a Lab Result 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 33: Chapter 4: Maintenance And Troubleshooting
Chapter 4: Maintenance and Troubleshooting Installing Batteries The meter uses two CR2032 batteries. Batteries will normally last for over 2000 tests. Other types of CR2032 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 34: Cleaning Your Meter
Cleaning Your Meter Caring for your EASYMAX® Tag 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: ... - Page 35 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.
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Page 36: 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 37: 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 27-28 for information with the test strip. - Page 38 System error Replace the batteries first. There may be a problem with the Refer to pages 15 and 28. If this error meter. message appears again, please contact your local dealer. Test result is higher than 630 Re-check your glucose level. mg/dL (35 mmol/L).
- Page 39 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.
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Page 40: Chapter 5: Technical Information
Chapter 5: Technical Information Specifications EasyMax® T1 Blood Glucose Meter Brand name Range 20~630 mg/dL (1.1~35 mmol/L) Response time 5 seconds Temp. 50°F ~104°F (10°C ~40°C) Operating condition Relative Humidity R.H. ≦ 90% Temp. 2°C ~ 30°C (36°F ~86°F) Storage and transportation condition R.H. - Page 41 Comparison of Measured Values With Laboratory Value Precision Three lots of the EASYMAX® T1 blood glucose test strips have been tested to assess the precision of blood glucose measuring system. This includes a repeat assessment using venous blood and a laboratory precision assessment using the control material.
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Page 42: System Accuracy
System Accuracy The EASYMAX® T1 blood Glucose monitor in comparsion with the YSI. Three lots of EASYMAX® T1 blood glucose test strips have been tested to assess the system accuracy of the EASYMAX® T1 blood glucose measuring system and to compare it with the reference method in which capillary whole blood concentrations of 34.4 to 442.8 mg/dL have been used. - Page 43 whereby 95% of the blood glucose values measured have to fall within the following zones: either ±0.83 mmol/L (±15 mg/dL) of the measured average value when using the reference measuring procedure for blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≧100 mg/dL (≧5.55 mmol/L).
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Page 44: Limitation
Limitation The test strips are used for fresh venous blood and capillary whole blood samples. 1. DO NOT use serum or plasma sample. 2. DO NOT use anticoagulant NaF or potassium oxalate for venous sample preparation. 3. DO NOT use neonate blood sample. 4. - Page 45 4. DO NOT use during xylose absorption testing. Xylose in the blood will interfere Self-Monitoring Blood Glucose System. 5. Interfering Substances depend on the concentration. The below substances up to the test concentration will not affect the test results. Concentrations Glucose 50-100 mg/dL 250-350 mg/dL...
- Page 46 2.2% Sodium Salicylate 40 mg/dL (2.5 mmol/L) 2.3% Tolbutamide 100 mg/dL (3.70 mmol/L) 3.6% Tolazamide 2.5 mg/dL (0.08 mmol/L) 5.6% Triglycerides 800 mg/dL (9.04 mmol/L) 4.0% Uric acid 16.5 mg/dL (0.99 mmol/L) 7.5% Xylose 9.5 mg/dL (0.63 mmol/L)
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Page 47: Device Information
Device Information EasyMax T1 SMBG System EASYMAX® T1 Level 3 (High) Control Solution EasyMax T1 Blood Glucose Test Strips EASYMAX® T1 Level 2 (Normal) Control Solution EASYMAX® T1 Level 1 (Low) Control Solution EasyMax T1 Blood Glucose Meter Manufacturer: EPS BIO TECHNOLOGY CORP. - Page 48 Lancet: Meets the requirements of MDD 93/42/EEC Manufacturer: Shandong Lianfa Medical Plastic Products Co.,Ltd No.1,Sanjian Road,Shuangshan,Zhangqiu,Jinan,City, China Tel: 86-53161329777 Fax: 86-53161329777 E-mail：henry@lianyingchina.com Lancing Device: Meets the requirements of MDD 93/42/EEC Manufacturer: Global Medical Market Corporation Room 1112, Ace Tower 9 Bldg, 130, digital-ro, Geumcheon-gu, Seoul, Korea Tel: +82-2 2104 0470 Fax: +82-2 2104 0472...
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