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Summary of Contents for EPS Bio Technology EastMax LTC
- Page 1 Long Term Care (LTC) Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using this blood glucose meter.
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Page 2: Intended Use
Introduction Welcome to the EasyMax LTC Self-Monitoring Blood Glucose (SMBG) System. This system is dependable easy-to-use, utilizing a compact, lightweight and portable meter that will aide you in monitoring your patients’ blood glucose levels. Please read this manual thoroughly before you begin testing. It provides you and your diabetes care team important information and step-by-step directions for use of the EasyMax LTC Self-Monitoring Blood Glucose System. -
Page 3: Important Safety Instructions
Important Safety Instructions In Long Term Care settings, use only single-use safety lancets, and a new safety lancet should be used for each test. All parts of the kit are considered biohazardous and may transmit infection, even if you have performed cleaning and disinfection. - 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 Why is it so important to test blood glucose regularly? Testing blood glucose regularly can make a big difference in how you or your patient manages their day to day diabetic care. We’ve made EasyMax LTC Self-Monitoring Blood Glucose System as simple as possible to help you use it regularly.
- Page 6 Important Information about your new EasyMax LTC Meter The EasyMax LTC Blood Glucose Meter is designed and approved for testing fresh capillary whole blood samples from the fingertip, palm and forearm. The meter is for in vitro use ONLY (for testing outside the body).
- 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 your patient still has symptoms that don’t seem to match their test results,...
- Page 9 Explanation of Meter Symbols Date Medical Record No. (on the left side) (patient number) Time Apply Control Solution (on the right side) Apply blood Unit Result / Message Battery Insert a strip Temperature...
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Page 10: Table Of Contents
Table of Contents Chapter 1: Understanding Your Meter …......................12 EasyMax LTC Blood Glucose Meter …......................12 The EasyMax LTC Accessories........................13 Inserting Batteries............................14 Setting the Time, Date and Medical record....................15 Using EasyMax 15 Blood Glucose Test Strips …...…………………............17 Chapter 2: Control Solution Test ........................18 When to Run a Control Solution Test ......................18 About Control Solution ..........................19 Running a Control Solution Test .........................20... - Page 11 Chapter 4: Meter Memory, Setup …........................30 Memory, Storing Test Result …........................30 Viewing and Deleting Test Results…......................31 Using With Your Computer…........................32 Chapter 5: Maintenance and Troubleshooting …..................33 Battery Information............................33 Cleaning and Disinfecting the EasyMax LTC Meter in LTC Settings............34 Cleaning And Disinfection Frequency......................38 Maintenance and Testing ...........................39 Screen Messages and Troubleshooting …....................40 Chapter 6: Technical Information ….......................44...
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Page 12: Chapter 1: Understanding Your Meter
Chapter 1: Understanding Your Meter EasyMax LTC Blood Glucose Meter Test Strip Slot- Strip Ejector- Insert a test strip here. Push the strip ejector up to remove the strip. Display- Shows results, patient numbers, Battery Door- and messages. Flip open the battery door by pushing the tab in the direction of Power Button-... -
Page 13: The Easymax Ltc Accessories
The EasyMax LTC 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, Date And Medical Record
Setting the Time, Date and Medical record — First Time Use Setting the current time and date your meter is important if you use the meter memory. 1. Press (Power Button) 2. Press (Right button) for 2 3. The screen display flashes the and hold the button until seconds to get into the setting last 2-digits of the year. - Page 16 4. Repeat step 3 to set the date and time. 5. Press (Left button) or (Right button) to turn on/off the The flashing field is the one you are function of medical record number and press (Power currently setting. Button) to confirm the setting. Note: When the function of is on, it allows you to keep testing records of multiple users separate...
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Page 17: Using Easymax 15 Blood Glucose Test Strips
Using EasyMax 15 Blood Glucose Test Strips Use only with EasyMax LTC or EasyMax NG Blood Glucose Meters. EasyMax LTC Self-Monitoring Blood Glucose System is a no code system and does not require test strip calibration. EasyMax LTC Self-Monitoring Blood Glucose System utilizes glucose dehydrogenase chemistry to avoid incorrect readings on patients receiving Oxygen therapy. -
Page 18: Chapter 2: Control Solution Test
Chapter 2: Control Solution Testing When to Run a Control Solution Test Running the 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 LTC Blood Glucose Meter. When you open a new vial of EasyMax 15 test strips. -
Page 19: About Control Solution
About Control Solution Use only with EasyMax 15 test strips and EasyMax LTC or EasyMax NG 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. Do not use a control solution that is past the expiration date. -
Page 20: 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 1. Put a test strip into the meter in of the bottle with a tissue. - Page 21 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.
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Page 22: 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 23: Troubleshooting Checks
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 it wasn’t, the strips could be humidified. Replace Was the test strip vial capped tightly? the test strips. -
Page 24: Chapter 3: Testing Blood Glucose
Chapter 3: Testing Blood Glucose Instructions for Using Single-Use Pressure Activated Safety Lancets Clean test site prior to use. Your patient should wash their hands with 2. Remove the protective cap from the safety lancet. soap and warm water. Rinse and dry thoroughly. - Page 25 3. Place the raised platform end of 5. Without touching the used Please discard used disposable safety lancet on the test site. lancet, stick the lancet tip into lancets according to your facility’s protective cover. guidelines. Or discard the used 4.
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Page 26: Running A Blood Glucose Test With Blood From Fingertip
Running a Blood Glucose Test with Blood from Fingertip 1. Wash your hands with soap and 2. Put a test strip into the meter in 4. Please wait at least 5 seconds warm water. Rinse and dry the direction of the arrow. The until the intended area is dry meter turns on and the icon and clean before using the... - Page 27 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. 7. Gently squeeze and/or massage 8. Touch the blood drop at the tip of the the fingertip until a round drop of transparent window of the test strip.
- Page 28 9. The meter starts to count down from 5 Push the Strip Ejector to eject the test strip. seconds and then displays the test Properly dispose of both strip and lancet. result. 11. After discarding, wash hands thoroughly with soap and water. Rinse and dry thoroughly. 12.
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Page 29: Understanding Test Results
Understanding 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 30: 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 31: Viewing And Deleting Test Results
Viewing and Deleting Test Results 3. To delete a test result, press (Left button) for more than 2 seconds and display shows “dEL”, press to confirm deletion. 2. The test results of control 1. Press (Left button) or (Right 4. Press (Left button) or solution will show without button) to view the test results of... -
Page 32: 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 33: 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 34: Cleaning And Disinfecting The Easymax Ltc Meter In Ltc Settings
Cleaning and Disinfecting the EasyMax LTC 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 35 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, &...
- Page 36 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 37 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.
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Page 38: 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 39: 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 40: 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 41 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 33. 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 42 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 26-28 for information on enough. sample application. Re-check your glucose level.
- Page 43 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 outside the required range of 50°F - (10°C - 40°C). 104°F (10°C - 40°C). This alerts users that an incorrect result may occur if the test continues.
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Page 44: Chapter 6: Technical Information
Chapter 6: Technical Information Specifications Brand name EasyMax LTC 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) Storage and transportation condition Relative Humidity... -
Page 45: Limitations
Limitations The test strips are used for fresh capillary whole blood samples. 1. DO NOT use neonate blood sample. 2. Extreme humidity may affect the results. A relative humidity greater than 90% may cause incorrect results. 3. The system should be used at temperatures between 50°F and 104°F (10°C and 40°C). Outside this range, the system may get incorrect results. - Page 46 Based on this chart, many of these substances do not have an effect on EasyMax LTC 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 Gentisic Acid...
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Page 47: Device Information
Control Solution EasyMax 15 Blood Glucose Test Strip Manufacturer: EPS BIO TECHNOLOGY CORP. No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077 Oak Tree Health warranty During the warranty period, if your EasyMax LTC 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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