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Thank you for choosing The ElementTM blood glucose. Element TM meter 2. Owner’s manual 3. using your ElementTM meter. You may test your blood sugar from.
Element™ Meter - Operation Manual Element™ Test Strip. How to use the Element™ blood glucose meter. Downloadable PDF User Manuals: Element™ Meter.
Download 1 Element Blood Glucose Meter PDF manuals. User manuals, Element Blood glucose meter Operating guides and Service manuals.
GL-3F0-1B0-04 Rev. 2008. 11 Dear ElementTM System Owner Thank you for choosing The ElementTM blood glucose monitoring system. This manual contains everything you need to know about your new glucometer and how it works. Please take a moment to read the instructions carefully. Customer Service is available 24 hours a day, 7 days a week, 365 days a year. Please call customer support toll free: 1-888-446-3246 Table of contents About your new Element™ system: Element™ KIT contents Element™ meter Element™ test strip Before you test: Comparing your meter and lab results Setting the meter Performing a control solution test Performing your test: Performing a blood test with your fingertip Disposing of your test strips and lancets Reviewing your results: Reviewing your blood sugar Reviewing your averages Reviewing your results with user ID on Alternate site test: Performing a blood test with an alternate site Caring for your Element™ meter: Cleaning and proper storage Transferring your results Battery installation Troubleshooting Warranty Specifications 6 7 9 11 13 17 20 26 27 28 29 30 38 39 40 41 46 47 Important information The ElementTM system provides a quick and easy way for patients with diabetes to measure their blood sugar levels. It should only be used with fresh capillary whole blood samples. It is designed for in-vitro diagnostics use only and should not be used for any purpose other than monitoring blood sugar levels. It should not be used for the diagnosis of diabetes or for the testing of newborns (neonates). Warning: Do not change your medication based on ElementTM meter test results without contacting your physician or healthcare professional. 4/5 www.infopiausa.com Call toll free : 1-888-446-3246 About Your New ElementTM System About Your New ElementTM System Test Strip Port: Insert the Element TM test strip here Test Strip Ejector Display Screen: Displays your test results, symbols, and messages. Power / Enter Button: Powers the meter on/off, prompts memory data and acts as an enter button during setup and after tests. Up / Down Arrow Buttons: Scroll up or down to adust settings or retrieve memory. Serial Number The following items are included: 1. Element TM meter 2. Owner’s manual 3. Quick reference card 4. Warranty registration card 5. Carrying case 6. Patient logbook 7. Two 3V Li-CR2032 batteries The following items may be included: 1. Lancing device 2. Lancet (5) 3. Control solution 4. Test strip (5) Your Element TM blood glucose monitoring system has been sealed to protect the contents. If you find your seal has been broken, please return it to the place of purchase. Battery Cover 6/7 www.infopiausa.com Call toll free : 1-888-446-3246 Use only ElementTM brand test strips with your ElementTM meter About Your New Element TM System Target to apply blood Confirmation Window Low battery warning Test strip code Contact Bar Ready for blood Alarm clock Before having a meal (full plate) After having a meal (empty plate) After taking medication After exercise Temperature / Date Time Test result unit Control solution Average test result 1. Store the ElementTM test strip vials in a cool, dry place. Keep out of direct sunlight. Do not freeze. 2. Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container. 3. Immediately replace the vial cap and close tightly after removing any test strips from the vial. 4. Make a note of the discard date, which is three months from the date you first open a new vial of strips. Throw ElementTM test strips and vial away after the discard date. 5. Do not use the test strips after the expiration date printed on the package or vial since it may cause inaccurate results. 6. ElementTM test strips are for single use only. DO NOT RE-USE. 7. Do not test at temperatures below 50°F or above 104°F. 8. Do not test with humidity below 10% or above 90%. 9. Do not bend, cut, or alter the test strip. 10. Avoid getting dirt, food, and water on the test strip. Do not handle test strips with wet hands. 11. Avoid getting dirt, food, and water on the color-coding label (backside of test strip). 12. Refer to additional information in the ElementTM test strip package. Call toll free : 1-888-446-3246 8/9 www.infopiausa.com Before Testing Be sure to read this section and the test strip package insert found in the test strip box carefully. You will need to have all of the necessary items to begin testing: Comparing your meter and laboratory results Test results with the ElementTM blood glucose monitor are plasma-equivalent. This method will help you and your healthcare professional compare your meter results with laboratory test results. The ElementTM test result and laboratory test results both are expressed in plasma-equivalent units. However, your glucose monitor result may differ from your laboratory result due to normal variation. Your glucose monitor results can be affected by factors and conditions that do not affect laboratory results in the same way. Your ElementTM monitor value is considered accurate when it is within ± 20% of the laboratory measurement. There are some specific situations that could cause a difference of more than ± 20%. 1. You are severely dehydrated. 2. You have eaten recently. The blood glucose level from blood obtained from a fingertip can be up to 70mg/dL higher than blood drawn from a vein (venous sample) used for a lab test.1 3. Your hematocrit is above 60% or below 20%. 1 1. ElementTM meter 2. ElementTM test strip 3. Lancing device 4. Sterile lancet Always wash and dry your hands prior to testing. If the meter is moved from one temperature to another, allow 30 minutes for the meter to adjust to the new temperature before testing. Make sure that the ElementTM meter and test strips have adjusted to the temperature of the location from where you are testing. 10 / 11 www.infopiausa.com Sacks, D.B.: Carbohydrates.: “ Carbogydrates.” Burits, C.A. and Ashwood, E.R. (ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959 Call toll free : 1-888-446-3246 Comparing your meter and laboratory results You tested at a temperature near the low end of the operating range which could result in a false high blood sugar. Repeat the test in a warmer environment with a new test strip as soon as possible. For additional infomation on possible limitations for accuracy on precision, please refer your test strip insert. In order to make the most accurate comparsion to your laboratory results. Please follow a few basic guidelines: Before going to the lab - Do not eat for at least two hours before you test your blood. - Perform a control solution test to make sure the meter is working properly. - Take your meter with you to the lab. While at the lab - Follow all instructions in this owner's booklet for performing a blood sugar test with your meter. - Conduct your meter test within 15 minutes of lab test. - Use only fresh, capillary blood obtained from the fingertip. You may still experience a difference from the laboratory test results because blood sugars can change very rapidly over a short period of time. This can be for a variety of reasons, such as; exercise, medication, stress or loss of body fluids. 12 / 13 www.infopiausa.com Setting Your Meter The Element TM meter has a wide variety of functions to choose from. From the setup mode you have the ability to turn the activity/meal flags on, set the date/time, designate three unique averages and set up to five daily alarms. Press and hold the power button for approximately 3 seconds to enter the setup mode. The activity/meal flags will appear on the left hand side of your screen. Press and release either the ƞ or Ơ button to turn the flags on or off, then press and release . Call toll free : 1-888-446-3246 Setting Your Meter The year will appear at the bottom of your screen. Press and release the ƞ or Ơ buttons to set the year. By pressing ƞ the number will increase. By pressing Ơ the number will decrease. Then press and release . Setting Your Meter A ‘ ’ will appear on the right hand side of your screen. This stands for the first average you can set. Press and release either the ƞ or Ơ button to set the number of days to be calculated for that average. That number will be blinking next to a ‘ ’ at the bottom. Press and release . You can set up to 3 averages (from 1-99 days). The month, day, and time will appear on your screen with the month blinking. Press and release either the ƞ or Ơ buttons to change the month, then press and release . The day will begin blinking. Press and release either the ƞ or Ơ button to change the day, then press and release . The time will be blinking. Press and release either the ƞ or Ơ button to change the hour and minutes, then press and release . 14 / 15 www.infopiausa.com The Alarm icon will appear at the bottom of your screen. Press and release either the ƞ or Ơ button to turn the alarm ‘On/Off’, then press and release . If the alarm is turned off, the set up mode is now complete. The meter will turn off automatically. Call toll free : 1-888-446-3246 Setting Your Meter Performing a Control Solution Test Note: • ElementTM control solution is sold separately. Please contact your local representative. • It is recommended that control solution is stored at room temperature before testing. • Use only ElementTM control solution with the ElementTM meter. The control solution should be used when there is suspicion that the meter or the strips are not working properly. For example: • If your strips have been exposed to extreme conditions. • If you drop the meter. • Blood sugar results are inconsistent with your symptoms. If the alarm is On, press and release either the ƞ or Ơ button to set the alarm time, then press and release . The second alarm will appear. Press and release either the ƞ or Ơ button to turn additional alarms on/off, then press and release . You have the ability to set up to 5 alarms. Firmly insert the test strip into the meter port with the ‘Blue color’ facing up. Make sure the code number matches the code on the strip bottle. The Element™ automatically adjusts the meter accordingly. If activity/meal is ON If meal activity/meal is OFF OR Caution: Make sure that the day and time are set properly to enable your data to be stored and downloaded properly. Press and release either the ƞ or Ơ button. The control solution bottle will appear at the bottom left hand corner, press . Call toll free : 1-888-446-3246 Scroll through the icons with the ƞ or Ơ buttons until the control solution bottle is blinking, press . 16 / 17 www.infopiausa.com Performing a Control Solution Test Check the expiration date before performing a control solution test. Do not use if expired. Please note the expiration date on the control solution bottle. Performing a Control Solution Test For example only: If you are using the normal control solution, according to this particular vial of strips, your meter should show a number between 80 and 120. Gently shake the control solution before use. Discard the 1st drop of control solution, this will eliminate any residue. Place a drop of control solution on a clean dry surface (ex. the lid of the test strip vial). Dip the test strip into the control solution. Results will appear in 3 seconds. Compare the result to the range printed on the test strip vial, the result should fall within that range. Caution: The control solution bottle is at the very bottom left, not to be confused with the medication bottle. This will allow you to differentiate between a control solution test and an actual blood test. 18 / 19 www.infopiausa.com If your control solution test falls out of range, please follow the next steps before contacting customer support: • Check the expiration dates on all the products you are using. Be sure you are using Element™ control solution. • Try another control solution test. If this test falls out of range, try another control solution test with a new unopened bottle of strips: • After following the appropriate steps and the control test still falls out of range, do not perform a glucose test. Please contact an Infopia USA representative at 888-446-3246. Caution: The control solution range is not the recommended range for your blood sugar level. Call toll free : 1-888-446-3246 Performing Your Test Step 1 Firmly insert the test strip into the meter port with the “Blue Color” facing up. The Infopia logo should be facing towards you. The meter automatically turns on displaying the code, room- temperature, date and time. Performing Your Test A blinking test strip will appear at the top of the screen indicating the meter is ready for testing. Make sure the code number matches the code on the strip bottle. The Element™ automatically recognizes the test strip code number and adjusts the meter accordingly. If during the setup process you chose to use the activity/meal flags ( ), press and release ƞ and Ơbutton to select the activity that will correlate with your result, then press and release the power button. Caution: • Inserting the test strip in the wrong direction will turn the meter on but testing will not be possible. • If the meter does not power on, pull the test strip out of the port and reinsert the test strip. • Be careful not to bend the test strip when inserting it into the port. • For a more accurate test result avoid testing under direct sunlight. 20 / 21 www.infopiausa.com Call toll free : 1-888-446-3246 Performing Your Test Step 2 There are two different lancet device designs available. Unscrew the lancing device cap. First design Pull the end of the lancet device back. Insert a sterile lancet into the lancing device. To prick your finger, push the center button. Twist the protective cover off. Do not discard. OR Second design Click Replace the lancing cap by twisting it back on tightly. To prick your finger, push the trigger button. To adjust the depth setting: Use 1-2 for soft skin, 3 for average skin, 4-5 for thick or calloused skin. 22 / 23 www.infopiausa.com Caution: If the blood smears or runs, do not use that sample. Dry the area and gently squeeze another drop or puncture a new site. Call toll free : 1-888-446-3246 Performing Your Test Step 3 Correct Performing Your Test Step 4 Completely filled Incorrect Insufficient amount of blood • The meter should begin counting down from 3 to 1 on the LCD display. • The LCD window will display the result of your blood sugar level, temperature, and time. • Once the test strip is removed, the meter turns off automatically. Note: If you are not finished testing within 3 minutes, the meter automatically turns off. You will need to start the test procedure from the beginning. Caution: If an error message appears on the screen, please refer to the troubleshooting (p. 41). • Place the edge of the test strip to the drop of blood. • The blood will automatically be “drawn” into the test strip channel. • When there is enough blood, your meter will automatically count down. Warning: You may get an inaccurate result if the blood sample is not completely filled. 24 / 25 www.infopiausa.com Call toll free : 1-888-446-3246 Disposing of Your Test Strips and Lancets Disposing of your test strip Once the test is complete, pull the strip forward to remove the test strip from the meter. Used test strips may be considered bio hazardous waste in your area. Be sure to contact your local representative for proper disposal. Reviewing Your Results The ElementTM meter stores up to 365 test results in its built-in memory. Test results and blood sugar averages can be retrieved any time. Reviewing your blood sugars • Press and release button. The most recent result appears first. Note the time and day of your blood sugar result. Most recent result Disposing of your lancet Push the needle into the protective cover. • Press and release the Ơ button and your previous result will appear on the screen. There are two different lancet device designs available. First design Second design Previous result OR • Press and release the Ơ button again, and the previous one before that will appear. Previous result Call toll free : 1-888-446-3246 Pull the lancet out and discard accordingly. 26 / 27 www.infopiausa.com Pull the end back and press the ejector button forward. Discard accordingly. Reviewing Your Results Reviewing your averages • Press and release button. The most recent blood sugar result will appear first. • Press and release ƞ button and the 1st pre-set average set will appear. Number of tests Average test result Average test result days Reviewing Your Results With User ID On Note : This feature was designed for a clinical setting. You will need to contact an Infopia USA representative to activate the multiple ID feature. • Press and release button once and the multiple patient ID option will appear on the LCD screen. 7day average • Press and release ƞ button and the 2nd pre-set average will appear. • Use the ƞ and Ơ to scroll and choose release button the correct ID number, then press and . 14 day average • Press and release ƞ button and the 3rd preset average will appear. Note: When you have hundreds of results stored in the memory only the latest results will be calculated for the pre-set averages. • After selecting the desired patient ID, you can review those patients’ results exclusively. 21 day average 28 / 29 www.infopiausa.com Call toll free : 1-888-446-3246 Alternate Site Testing Alternate Site Testing Lancing and sampling from an alternate site area. Upper Arm Forearm Dorsal Hand Fingertips Thigh Ventral Palm Sampling from your upperarm, forearm, dorsal hand, ventral palm, thigh, or calf allows you to use your fingertips less often. You may find that obtaining a blood sample from an alternate site is less painful than using a fingertip. Getting a blood sample from your forearm or palm is different than getting a sample from your fingertip. Calf Ventral palm/Dorsal hand Choose a fleshy area on the palm, below your thumb or pinky finger. Select a spot without any visible veins and away from any deep lines. This may cause your blood sample to smear. The ElementTM system gives you the ability to obtain a blood sample for testing your sugar from different areas of your body. The figure shown above displays the areas where you can test using your ElementTM meter. You may test your blood sugar from your forearm, upper arm, palm (ventral palm or dorsal hand), fingertips, thigh, or calf. It is recommended that alternate site testing be used when sugars are stable: before meals and before bedtime. However, when sugars are changing, blood from the fingertip may show these changes sooner than blood from other sites. 30 / 31 www.infopiausa.com Call toll free : 1-888-446-3246 Alternate Site Testing Forearm Upperarm Alternate Site Testing Important : We recommend that you test on your fingertip if you are testing for hypoglycemia (low blood sugar) or if you have a history of reoccurring hypoglycemia. Calf Thigh Choose a fleshy area of the forearm, upperarm, thigh, or calf away from bone, visible veins and/or hair. Sometimes there is less blood flow to these areas than to the fingertips. To help you get a large enough drop of blood, you may gently massage or apply a heating pad to the site to increase blood flow. To ensure accurate results when lancing your arm (forearm or upperarm), leg (calf or thigh), or palm (ventral palm or dorsal hand), clean the test site with soap and water. Make sure there is no cream or lotion on the test site. Thoroughly dry your hands and test site. 32 / 33 www.infopiausa.com Call toll free : 1-888-446-3246 Alternate Site Testing The lancing device clear cap is used for alternate site testing. Lance the test site with the lancing device: 1. Remove the lancing cap by twisting off. Alternate Site Testing 5. Continue to hold the lancing device and gradually increase pressure for several seconds. 2. Insert lancet and replace with the clear cap. 6. While holding the lancing device on your test site, look through the clear cap; until a round drop of blood appears (approximately 0.3 ). 3. To bring fresh blood to the surface of the test site, rub the test site vigorously for a few seconds until you feel it getting warm. Applying heat may be helpful. 4. Adust clear cap to the highest setting (5). Hold the clear cap down against a fleshy area on the alternative site. Press the release button. Do not lift up. 7. Lift the lancing device straight up; be careful not to smear the blood on your testing site. 8. Place the edge of the test strip to the drop of blood. The blood will automatically be drawn up. 34 / 35 www.infopiausa.com Call toll free : 1-888-446-3246 Remember: • Consult with your healthcare professional before using alternate site testing. • Choose a different puncture site each time you test. Repeated punctures in the same spot may cause soreness and calluses. • If bruising occurs at an alternate site or you have difficulty getting a sample, consider sampling from a fingertip instead. You may want to review the choice of sites with your healthcare professional. Information for Healthcare Professional If you are considering recommending AST for your patients, you need to understand that there is a potential for a significant difference between fingertip and AST testing. These physiological effects vary between individuals and can vary within a single individual based upon his or her behavior and relative physical condition. If your patient is used to making treatment decisions based on finger-stick readings, he or she should consider the delay or lag-time affecting the reading obtained from an alternative site. Caution: Do not test on your forearm or palm when: • You think your blood glucose is rapidly falling. For example within two hours of exercise, rapid-acting insulin injection, or an insulin pump bolus. • Testing with a fingertip sample may identify hypoglycemia or an insulin reaction sooner than testing with a forearm or palm sample. 36 / 37 www.infopiausa.com Call toll free : 1-888-446-3246 Caring for Your ElementTM System Cleaning and storing your meter: 1. Your meter does not require special maintenance or cleaning. 2. It is recommended that you store the meter in its carrying case after each use. 3. A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter. Your ElementTM meter is a precision instrument. Please handle it with care. 4. Avoid getting dirt, dust, blood, control solution, or liquids on the meter, the test port, or data port. 5. Do not subject the meter to excessive heat. 6. Do not soak the meter in water or liquid. Transferring your results: You can transfer test results from the ElementTM meter to a computer. You will need to download the software from the following web site (http://www.infopiausa.com) and purchase the computer cable from your local representative.This is sold separately. User Lancet Device: 1. Clean the lancet device and caps with soap and luke warm water. 2. To disinfect the lancet device, prepare a disinfectant solution of one part household bleach to 10 parts water. 3. Dampen a cloth with this solution and wipe the lancet device thoroughly. 4. Soak only the cap for at least 30 minutes in the disinfectant solution. Do not soak the lancet device in liquid. 5. Rinse the lancet device and cap with water and dry thoroughly. Computer Cable 38 / 39 www.infopiausa.com Call toll free : 1-888-446-3246 Battery Installation The low battery icon will appear in the upper left corner of the LCD screen to alert you when the battery power is running low, indicating a new battery is needed. Troubleshooting The following chart may help you identify certain problems, but may not solve all problems that can occur. Contact your authorized representative or Infopia USA customer support if the problem persists. Message Problem Action Requied Problem with the meter Reset the battery and correct the setting. If the problem persists, please contact customer support. Insert a new test strip and try your test again. Refer to performing a blood test (p.20). Insert a new test strip and try your test again. Wet or used strip Your ElementTM meter uses two 3V lithium batteries (CR2032), which are included. When replacing the batteries, only CR2032 or equivalent lithium batteries should be used. After changing the batteries, please be sure to recheck your meter settings. Note: Make sure your date and time are correct after changing your battery. Damaged strip Applied blood before the “ready for blood ” icon. Insert new strip, wait for the “ready for blood” icon and try your test again. Refer to performing a blood test (p.20). Call toll free : 1-888-446-3246 40 / 41 www.infopiausa.com Troubleshooting Message Problem Action Required Troubleshooting Message Problem Action Required Problem with the Auto-coding label Do not test in direct sunlight. Refer to test solution limitation. Insert a new strip and try your test again. The test result is lower than 20mg/dL. Check the accuracy of your test strip by performing a control solution test. If the result is within range try your blood test again. If “Lo” persists, consult your doctor immediately. The ambient temperature is lower than 50°F Place the meter in an area above 50°F for 30 minutes and try your test again. The test result is higher than 600mg/dL. Check the accuracy of your test strip by performing a control solution test. If the result is within range try your blood test again. If “HI” persists, consult your doctor immediately. The ambient temperature is higher than 104°F Place the meter in an area below 104°F for 30 minutes and try your test again. There are no readings stored in the meter. 42 / 43 www.infopiausa.com Call toll free : 1-888-446-3246 Troubleshooting Message Problem Action Required Troubleshooting Caution: Low Glucose Results If your result is lower than 70mg/dL, it may mean hypoglycemia (low blood sugar). This may require immediate treatment according to your health care professional’s recommendations. Although this result could be due to a test error, it is safer to treat first, then do another test. Change the battery. The problem persists, contact your local representative. Not enough readings in the memory to display designated averages. The meter does not power on Battery is dead or there is a problem with the meter. Test does not Insufficient amount of start after applying blood blood. sample Please insert a new test strip and perform your test again. Refer to performing a blood test (p. 20). Caution: High Glucose Results If your test result is higher than 180 mg/dL, it may mean hyperglycemia. If you are uncertain about your test result, consider re-testing. Your doctor can work with you to decide what actions, if any, you should take if your results are higher than 180 mg/dL. If the meter displays HI always re-check your blood sugar. If the reading is still HI, it is important to follow instructions from your doctor or healthcare professional without delay. Inconsistent or Unexpected Test Results If you continue to get unexpected results, check your system with control solution (refer to page 17). If you experience symptoms that are not consistent with your blood sugar results, first be sure you have followed all instructions in this booklet, then contact your doctor. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your doctor. 44 / 45 www.infopiausa.com Call toll free : 1-888-446-3246 Warranty Manufacturer’s Warranty: Infopia USA warrants to the original purchaser that this instrument will be free from defects in workmanship for 3 years from the date of original purchase. Limitations of Warranty: This warranty is subject to the following exceptions and limitations: 1. Infopia USA shall not be required to replace any units which are damaged or malfunction due to abuse, accidents, alteration, neglect, misuse, maintenance by someone other than Infopia USA, or failure to operate in accordance with the instructions. 2. Infopia USA reserves the right to make changes in design without obligation to incorporate such changes into previously manufactured instruments. 3. Infopia USA has no knowledge of the performance of the instrument when the test strip is altered or modified in any manner. For Warranty Service: Purchaser must contact the Customer Service Department of Infopia USA, by calling toll free 888.446.3246, for assistance and/or instructions for obtaining service of this instrument. Service Information: Infopia USA has trained specialists to help you 24 hours a day, 7 days a week, 365 days a year. Important: Speak to an Infopia USA representative before returning your meter for any reason. You will be given the information needed to get your problem handled correctly and efficiently. Have your meter, test strips, and control solution nearby when you call. 46 / 47 www.infopiausa.com Specifications 2 w 3 w .75 in. (55 w 82 w 18mm) 1.7 oz (48g) with batteries Call toll free : 1-888-446-3246
0.3 µl Blood Sample. Not Affected by Presence of Non-Glucose Sugars;. Place Order » Item Numbers. Element meter - INF-ELEMK; Element test strips - INF-ELESTS.
™ Auto-coding Blood Glucose Monitoring System Operation Manual. Once completed, blood symbol. test strips with the Element Auto-coding blood glucose test meter.
The Element glucose meter from Infopia USA. Manual Coding Required: No. Blood. You can use DiabetesMonitor.com's blood glucose meter comparison tool to compare.
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Blood Glucose Meter. If you receive any error messages please refer to the “Troubleshooting”section of this Manual. The finetestTM ( Meter saves up to 200.
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