Summary of Contents for FortisCare EMMU
- Page 1 EMMU Self-Monitoring Blood Glucose System User’s Manual Please read this User’s Manual thoroughly before using your blood glucose meter.
- Page 2 ® lancets, and FortisCare EMMU Safety Lancets are a part of the system. A new safety lancet should be used every time you perform a test. The system is not to be used on neonates, nor for the diagnosis of, or screening for, diabetes mellitus.
- Page 3 ® The meter should be disinfected after each use. The FortisCare EMMU 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 ® The FortisCare EMMU 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). It should not be used to diagnose diabetes.
- Page 6 Testing blood glucose regularly can make a big difference in how you manage your patients’ day ® to day diabetic care. We’ve made the FortisCare EMMU Self-Monitoring Blood Glucose System as simple as possible to help you use it regularly.
- Page 7 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.
- Page 8 Explanation of Meter Symbols Date Medical Record No. (on the left side) (patient number) Time Apply Control (on the right side) Solution Apply blood (Before Noon) Unit (After Noon ) Result / Message Battery Insert a strip Temperature...
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Page 9: Table Of Contents
Table of Contents Chapter 1: Understanding Your Meter ….................11 ® The FortisCare EMMU Blood Glucose Meter …..............11 ® The FortisCare EMMU Accessories...................12 Inserting Batteries.........................13 Setting the Time, Date and Medical record................14 ® Using FortisCare Blood Glucose Test Strips ……………………........16 Chapter 2: Control Solution Test .....................17 When to Run a Control Solution Test ...................17... - Page 10 Viewing and Deleting Test Results…..................29 Running With Your Computer…....................30 Chapter 5: Maintenance and Troubleshooting …..............31 Inserting Battery ….......................31 ® Cleaning and Disinfecting the FortisCare Blood Glucose Meter........32 Cleaning And Disinfection Frequency...................36 Maintenance and Testing .....................37 Screen Messages and Troubleshooting …................38 Chapter 6: Technical Information …..................42...
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Page 11: Chapter 1: Understanding Your Meter
Chapter 1: Understanding Your Meter ® FortisCare EMMU Blood Glucose Meter Test Strip Slot- Strip Ejector- Insert a test strip here. Push the Strip Ejector to remove the strip. Display- Shows results, patient numbers, Battery Door- and messages. Flip open the... -
Page 12: The Fortiscare ® Emmu Accessories
® The FortisCare EMMU Accessories Safety Lancet Blood Glucose Test Strip Test Strip Bottle Control Solution Bottle Electrode Strip Insert Lancet Direction Protector Hand Hold Area Lancet Holder Reaction area Expiration Date Note: The used lancet Blood collection cannot be reloaded. -
Page 13: 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 batteries. The meter will beep to confirm the batteries are inserted correctly. 3. -
Page 14: Setting The Time, Date And Medical Record
Setting the Time, Date and Medical record — First Time Use Setting the current time and date in your meter is important if you use the meter memory. 1. Press (Power Button) 2. Press (Right button) 3. The large display shows the last to turn the meter on. - Page 15 4. Repeat step 2 to set the date 5. Press (Left button) or (Right button) to turn on/off and time. The flashing field is the function of medical record number and press the one you are currently (Power Button) to confirm the setting. setting.
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Page 16: Using Fortiscare ® Blood Glucose Test Strips
® Use only with FortisCare Blood Glucose Meters. ® FortisCare EMMU Self-Monitoring Blood Glucose System is a “no code” system and does not require test strip calibration. ® FortisCare EMMU 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
® If you are using a new FortisCare EMMU Blood Glucose Meter. ® When you open a new vial of FortisCare test strips. If you think the meter or test strips may be working incorrectly. If the meter is dropped. -
Page 18: About Control Solutions
About Control Solution ® Use only with FortisCare test strips. Write the date you initially opened 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. 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 with a tissue. - Page 20 6. Touch the drop to the Blood 7. Do not remove the test strip 8. Push the Strip Ejector to collection area at the tip of until you confirm that the eject the test strip. the test strip. Do not put reading falls within the range 9.
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Page 21: Understanding Control Solution Test Results
Understanding Control Solution Test Results The label on your test strip vial shows the acceptable ranges for the Control Solutions – normal, high, and low. 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. When the control result is inside the range on the test strip vial, your test strips and your meter are working properly. - Page 22 (Chapter 2) Replace with new control solution to check Is the control solution expired or ® the performance of FortisCare contaminated? Self-Monitoring Blood Glucose System. Were test strips and control solutions Repeat the control test with properly stored stored in cool, dry places? strips and/or control solutions.
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Page 23: Chapter 3: Testing Your Blood Glucose
Chapter 3: Testing For Blood Glucose ® Instructions for Using the FortisCare Safety Lancets Clean test site prior to use. Only single-use safety lancets should be used with this system. 1. Twist off the protective 2. Position the lancet and 3. -
Page 24: Running A Blood Glucose Test With Blood From Your Fingertip
Running a Blood Glucose Test with Blood from Your Fingertip 2. Insert a test strip into the 4. Swab the blood collection area on 1. Wash your hands with meter in the direction of the a patient’s finger with an alcohol soap and warm water. - Page 25 Apply blood to the edge of Do not apply blood on top of the test strip. the test strip. Be sure to get enough Not enough blood on strip to blood on strip to make it to get a test result. the confirmation window.
- Page 26 10. Push the Strip Ejector to eject the test 9. The meter starts to count down from 5 strip & dispose of both strip & lancet seconds and then displays the test properly. result. 11. After discarding, wash hands thoroughly with soap and water.
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Page 27: Understanding Your Test Results
Understanding Your Test Results Expected Values* ® The FortisCare 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 28: 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 29: 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. 1. Press (Left button) or 2. The test results of control 4. Press (Left button) or (Right button) to view the solution shows without... -
Page 30: Running With Your Computer
Running With Your Computer To Transfer data, the meter has to be at the status of hibernation. 2. The meter starts to 3. When all data are 1. Use the USB cable to transfer data to the uploaded from the meter connect to the meter and “... -
Page 31: Chapter 5: Maintenance And Troubleshooting
Chapter 5: Maintenance and Troubleshooting Inserting Battery 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 32: Cleaning And Disinfecting The Fortiscare ® Blood Glucose Meter
® Cleaning and Disinfecting the FortisCare Blood Glucose Meter Choosing the 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. - Page 33 Step 1: Cleaning Instruction: Clean first to remove any heavy soil left on the surface of the meter. All blood and body 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.
- Page 34 Performance check of the meter Accept Steps Check item Result After each cleaning 1. Press and hold power Is meter powered on? button for 3 sec. Does meter make beep sound? 2. Press and release left or Does data indicate as stored in the memory? right button.
- Page 35 Physical Appearance check of the meter after each cleaning or disinfection Check item Accept Result Is the display clear to read? Is the transparency clear? Are the strip slot & other parts free of corrosion? Action: If any of the results are “No” the user should call the Customer Care Service toll-free at 866-922-6033 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM) for assistance.
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Page 36: Cleaning And Disinfection Frequency
Cleaning And Disinfection Frequency At least 9 cycles of cleaning per day and 1 cycle of disinfection per week with 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 37: 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 38: 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 866-922-6033 (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. - Page 39 Message What it means? What to do? System error Repeat the test with a new test strip. There may be a problem with the meter. Refer to pages 24-26. If this error message appears again, please contact your local dealer. Memory Error Replace the batteries first.
- Page 40 Message What it means? What to do? Volume detector error Replace the batteries first. The volume of blood or If Err appears again, please control solution is NOT contact your local dealer. enough. Test result is higher than Re-check your glucose 600 mg/dL (33.3 mmol/L).
- Page 41 Message What it means? What to do? The “Ht” and thermometer icon Relocate the meter to a location appears. Temperature is too with temperature between 50°F - high, outside the required range 104°F (10°C - 40°C). of 50°F - 104°F (10°C - 40°C). This alerts users that an incorrect result may occur if the test continues.
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Page 42: Chapter 6: Technical Information
Chapter 6: Technical Information Specifications ® Brand name FortisCare EMMU 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 43: Limitation
2. 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 FortisCare EMMU Blood Glucose Meter. 3. Critically ill patients should not be tested with home-use blood glucose meters. - Page 44 5. 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 Conc. interference Bias @ blood Note Substances tested or no glucose Conc. 14.2%@80 mg/dL The highest no interference Acetaminophen 8 mg/dL...
- Page 45 Endogenous Interference data Endogenous highest Conc. interference Bias @ blood Note Substances tested or no glucose Conc. Xylitol 200 mg/dL Glipizide 8 mg/dL 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 Uric Acid 15.9 mg/dL 17.5%@120 mg/dL...
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Page 46: Device Information
No.8, R&D RD. III, Hsinchu Science Park, Hsinchu, Taiwan 30077 Oak Tree Health warrants ® This means during the warranty period if your FortisCare EMMU 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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