Owner's Booklet Blood Glucose Monitoring System Accurate, complete blood glucose monitoring through advanced biosensor technology i-SENS, Inc. 465-6 Wolgye4-dong, Nowon-gu Seoul 139-845, Korea www.i-sens.com Medical Technology Promedt Consulting GmbH, Altenhofstrasse 80, D-66386 St. Ingbert, Germany © 2012 i-SENS, Inc. All Rights Reserved.
Welcome to the CareSens II Blood Glucose Monitoring System Thank you for purchasing the CareSens II Blood Glucose Monitoring System. The system provides you with fast, safe, and convenient blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You will receive an accurate results in only five seconds with a small 0.5 ㎕ blood sample.
Table of Contents Welcome to the CareSens II Blood Glucose Monitoring System Table of Contents Important Information: Read This First! CareSens II Blood Glucose Monitoring System CareSens II Blood Glucose Meter Meter Display Setting the Meter Setting the Month and Date Setting the Time Setting the Year and Measurement Unit Storing Test Results in Meter Memory Deleting Stored Test Results from Meter Memory Checking the Meter with the CareSens II Check Strip CareSens II Blood Glucose Te
Important Information: Read This First! Table of Contents Target Blood Glucose Ranges Hi and Lo Messages Caring for Your System Replacing the Batteries Specifications Performance Characteristics Understanding Error and Other Messages General Troubleshooting Warranty Information 37 38 39 40 41 42 44 46 47 To receive safe and optimum system benefits, please read the entire manual contents before using the system. Please note: • Do not use the system for the diagnosis of diabetes or for testing newborns.
CareSens II Blood Glucose Monitoring System For in vitro diagnostic use This product fulfills the requirements for Directive 98/79/EC on in vitro diagnostic medical devices. Verify that all the following components are included in the system box.
CareSens II Blood Glucose Meter Meter Display [1] Meter Display Test result, symbol and simple message display. [2] М Button On-off power button. Also used to call memory or setting modes. [3] C Button Power button to review previous test results or change code, date, time, year or measurement units. [4] Test Strip Port Insert test strip here.
Setting the Meter Setting the Month and Date When you turn on your CareSens II Meter the first time, its display will show the following setting: [1] Setting the Month • • • 10 Display format for the date: MM-DD (Month-Date) Display format for the time: 12 h (AM/PM) Year: year of manufacture Press and hold the M Button for three (3) seconds. A blinking number indicating the month will appear on the lower left display corner. Press and release the C Button until correct month appears.
Setting the Time Setting the Year and Measurement Unit [3] Setting the Time [6] Setting the Year The meter can be set in an AM/PM 12-hour or 24-hour format. Press the C Button to select format. [4] Setting the Hour Press the M Button to move to hour setting mode. Press the C Button until correct hour appears. After hour is set, press the M Button to enter minute setting mode. Press the C Button until correct year appears. After setting the year, press the M Button to move to unit setting mode.
Storing Test Results in Meter Memory The CareSens II Meter provides storage for up to 250 blood glucose test results. It also stores the 14-day average and number of tests performed. The following procedure lets you store your test results. [1] Press the M Button to turn on meter. The current date and time will appear at the bottom of the screen for two (2) seconds, followed by the 14-day average and number of tests performed. [2] Press the C Button.
Checking the Meter with the CareSens II Check Strip The CareSens II Check Strip is used to determine if the meter is functioning properly. To perform the test, start with the meter turned off.
Coding Meter to Match Test Strips Warning! • • • • • • • • • • • The CareSens test strip should be used only with fresh capillary whole blood samples. Do not reuse test strips. Do not use test strips past the expiration date. Test strips in new, unopened containers and test strips in containers that have been opened can be used up until the expiration date printed on the test strip box and container label if the test strips are used and stored according to its storage and handling methods.
Checking the System [3] Press the M or the C Button to select the correct code number. Each time you press the M button, the number will increase by one, and each time you press the C Button, the number will decrease by one. Press and hold the C Button to scroll code numbers down. [4] After selecting correct code number, wait for three (3) seconds until the symbol appears on display. CareSens Control Solution: You may check your meter and test strips using the CareSens Control Solution.
If all the results you get on testing three times continuously are within the range printed on the test strip, the meter and test strips are working properly and you may use them for your blood glucose test. CareSens Gloucose Control Solution Storage and Handling Discard the CareSens Control Solution after its expiration date on the bottle or discard date, whichever comes first. Add three (3) months to the date you open the bottle and write it on the bottle label. This is the discard date.
Comparing the Control Solution Test Results [3] Test results appear after the meter counts down from five-to-one (5-to-1). To mark test result, press and hold the C Button for three (3) seconds. Check will appear on the display. Marked test results will not be shown in your averages. Repeat the control test if the test result falls outside the range printed on label of the test strip vial.
Using the Lancing Device You will need a lancing device in order to collect a blood sample. You may use the lancing device contained in the CareSens II Blood Glucose Monitoring System or any other medically approved lancing device. Adjustable Tip Lancet Holder • • [1] Wash hands and fingertip sample site with soap and warm water. Rinse and dry thoroughly. Ejection System Release Button • Preparing the Lancing Device for Blood Sample Retrieval Sliding Barrel [2] Unscrew lancing device tip.
Using the Lancing Device at Fingertip Sample Site [4] Select a desired depth of one-to-five (1-5) on lancing device’s adjustable tip. Rotate ring to align desired number with the arrow. A beginning setting of three (3) is recommended. [5] To cock the lancing device, hold the tip in one hand. Pull the sliding barrel with the other hand. The lancing device is cocked when you feel a click. [1] Place cocked lancing device against fingertip side.
Testing Your Blood Glucose Levels [1] Insert test strip with contact bars facing up into a port. Push strip gently until meter beeps. A code number will appear for three (3) seconds. The symbol will appear. Display code number should match the one on the test strip bottle. If not, see Coding Meter to Match Test Strips on pages 19-20. [2] Use lancing device to get blood sample. Sample must be at least 0.5 ㎕ (actual size: ) to fill the test strip reaction cell.
Alternative Site Testing The meter will automatically turn off if a sample is not applied within two (2) minutes. If this happens, remove the test strip from the port. Reinsert the test strip to restart the meter. Alternative site and fingertip results may differ significantly due to rapid changes in the glucose level after meals or exercise, hypoglycemic symptoms, dehydration or effects of drugs such as insulin. Rubbing the site before drawing the sample reduces these differences.
Things to know when using AST AST Precautions Please understand the following things before testing outside of the fingertip (arms, thighs, calves). The capillary blood of the fingertip shows the change in glucose more rapidly than AST. Therefore, the test results from the fingertip test and AST may differ. This is because things such as lifestyle and ingested food have an effect on glucose levels.
Discarding Used Lancets Proper discarding of used lancets protects you and others from infection and injury. The following shows the correct process. [1] Unscrew general lancing device tip. Target Blood Glucose Ranges Reminders Time of day Your target ranges from your healthcare expert Before breakfast Before lunch or dinner 1 hour after meals [1] Place protective cover on lancet.
Hi and Lo Messages Caring for Your System The CareSens II Meter displays test results between 20 to 600 mg/dL (1.1-33.3 mmol/L). Please refer to the instructions below if you receive a Hi or Lo message. Use a soft cloth or tissue to wipe the meter exterior. If necessary, the soft cloth or tissue might be dipped in a small amount of alcohol. Do not use organic solvents such as benzene, acetone, or household and industrial cleaners that may cause irreparable damage to the meter.
Replacing the Batteries Specifications When the icon appears on the display for the first time, the battery should be replaced as soon as possible. Use only non-rechargeable, replaceable, type CR2032 lithium battery with 3 V nominal voltage, 220 mAh nominal capacity, and a 0.2 mA nominal standard discharge. • • • • • • • • • • • • • • [1] Turn the meter over and at the top you see the recess for openning the battery compartment cover. Slide the cover out of the meter. [2] Remove the battery.
Performance Characteristics The performance of CareSens II Blood Glucose Monitoring System Strips has been evaluated in laboratory and in clinical tests. Accuracy: CareSens II BGM Systems are calibrated to yield results equivalent to plasma glucose concentrations. The accuracy of the CareSens II System was evaluated by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument.
Understanding Error and Other Messages Message 44 What It Means What To Do Test strip has been used. Use a new strip. Blood sample applied before symbol the appeared. Repeat test with a new strip. Wait until the symbol appears before applying sample. Temperature recommended system range during test. Take system where temperature is within operating range (10-40˚C/ 50-104˚F ) and repeat test after 30 minutes.
General Troubleshooting The display is blank even after inserting a test strip. • Check whether the test strip is inserted with the contact bars facing up. Check if the strip has been inserted completely till the end. • Check whether the batteries are inserted with the '+’ side facing up. • Replace the batteries. The test does not start even after applying the blood sample on the strip. • Check test strip confirmation window for adequate blood sample. • Repeat test with a new test strip.
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