Table of Contents
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Information
CareSens LINK Blood Glucose Test Strip
CareSens LINK Blood Glucose Meter
Preparation
Testing
Additional Functions
Setting the Time Alarm (alarm 1 ~ 3)
Maintenance
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Table of Contents
Related Manuals for i-SENS CareSens LINK
Summary of Contents for i-SENS CareSens LINK
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Page 1: Table Of Contents
Table of Contents Information Important Information 4 Specifications CareSens LINK Blood Glucose Monitoring System CareSens LINK Blood Glucose Test Strip CareSens LINK Blood Glucose Meter CareSens LINK Blood Glucose Meter Display Preparation Setting up Your System Adjusting the Date, Time and Unit Setting the Sound On/OFF Setting Bluetooth Setting the Test Result Reset Checking the System Control Solution Testing Comparing the Control Solution Test Results Testing Using the Lancing Device Preparing the Lancing Device for Blood Sample Retrieval Preparing the Meter and Test Strip Flagging Post-meal Test Results Applying Blood Sample Discarding Used Lancets Alternative Site Testing Hi and Lo Messages Target Blood Glucose Ranges Additional Functions Meter Memory Viewing Test Results Stored in the Meter’s memory Setting the Alarm Function Setting the Post-meal Alarm (PP2) Setting the Time Alarm (alarm 1 ~ 3) Bluetooth Paring 40 Maintenance Replacing the Batteries Caring for Your System Understanding Error and Other Messages... -
Page 2: Important Information
• A glucose value of less than 70 mg/dL (3.9 mmol/L) may indicate hypoglycemia and a value of more than 240 mg/dL (13.3 mmol/L) Manufacturer Use by may indicate hyperglycemia. Temperature limitations Authorized representative Do not reuse. Batch code If you need assistance, please contact your authorized i-SENS sales Do not discard this product with other household-type representative or visit www.i-sens.com for more information. waste Serial number... -
Page 3: Specifications
Specifications CareSens LINK Blood Glucose Monitoring System Product specifications Reported result range 20 ~ 600 mg/dL (1.1 ~ 33.3 mmol/L) ④ ⑤ Sample size ⑥ Minimum 0.5 ㎕ ⑦ Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma-equivalent ① ⑧ ⑨ Assay method Electrochemical ② ③ 1,000 tests Battery life Power Two 1.5 V alkaline batteries (AAA) - Page 4 • The CareSens LINK blood glucose meter should be used only with The following chart explains the symbols you’ll find in the CareSens the CareSens LINK strip.
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Page 5: Caresens Link Blood Glucose Meter Display
CareSens LINK Blood Glucose Meter CareSens LINK Blood Glucose Meter Display Sound icon appears when test Transmission Port results stored in the appears only when Used to transfer data memory are displayed the sound is set to from the meter to alarm a computer with a appears when the CareSens cable check time alarm has appears when test been set results have not been Display Battery icon saved Shows results, indicates meter Test results messages... -
Page 6: Setting Up Your System
Setting up Your System Press and hold the S button for 3 seconds to switch on the meter. Step 3 Setting the Month After all settings are finished, press and hold the S button for 3 A number indicating the month will be blinking on seconds to turn off the meter. the left corner of the screen. Press or until Press or to reach the accurate value. Press and hold the or the correct month appears. Press the S button to to scroll faster. confirm your selection and enter the date setting mode. Adjusting the Date, Time and Unit Step 1 Entering the SET Mode Press and hold the S button for 3 seconds to switch on the meter. After all the segments flash Step 4 Setting the Date across the screen, the ‘SET’ character icon will be Press or until the screen displays the correct displayed on the screen. -
Page 7: Setting The Sound On/Off
Setting the Sound On/OFF Step 6 Setting the Hour Step 8 Press or until the correct hour appears. After the hour is set, press the S button to enter On pressing or , the screen will display the the minute setting mode. -
Page 8: Setting Bluetooth
Setting the ‘Test Result Reset’ Step 9 Setting the Bluetooth (Deleting all the saved test results) In this mode all the test results stored in the meter can be deleted. Step 10 Please note that if you select YES, all the stored test results will be deleted and can not be restored. In this mode all the test results stored in the meter can be deleted. Please note that if you select YES, all the stored test results will be After the beeper mode is set, press the S button to enter the ‘Test deleted and can not be restored. Result Reset’ mode. The ‘dEL’ character will blink on the screen. Press or to alternate between ‘YES’ or ‘no’. To delete all the After the beeper mode is set, press stored test results press the S button while the screen displays ‘YES’. -
Page 9: Checking The System
Checking the System You may check your meter and test strips using the Step 11 CareSens Control Solution. The CareSens Control Solution contains a known amount of Discard the used test strip by pushing the strip ejection button on glucose and is used to check that the meter and the test strips the right side of the meter as shown in the picture on the right to are working properly. The test strip vials have CareSens a proper disposal container. The meter will turn off automatically Control Solution ranges printed on their labels. Compare in three seconds after the test strip has been removed. the result displayed on the meter to the CareSens Control When the Bluetooth mode is activated, follow the next step (Step Solution range printed on the test strip vial. Before using a new meter or a new vial of test strips, conduct a control solution test following the procedure on page 20. Notes: Step 12 •Use only the CareSens Control Solution. If the Bluetooth mode has been activated, ‘bT’ will appear on the • Check the expiration dates printed on the vial. When you first open a control solution vial, record the discard date (date opened plus display and try to connect with a Bluetooth device when the test three months in the space provided on the label). strip has been removed. Depending on the user’s Bluetooth settings PIN Code input may • M ake sure your meter, test strips, and control solution are at room temperature before testing. Control Solution tests must be done at be necessary in order to register the external Bluetooth device. room temperature (20 ~ 25˚C, 68 ~ 77˚F). -
Page 10: Control Solution Testing
Make sure the confirmation window fills completely. test strip may not work properly. Then, stop using the meter and contact the nearest i-SENS representative. Note • The range printed on the test strip vial is for the CareSens The meter may switch off, if the blood sample is not applied within Control Solution only. -
Page 11: Comparing The Control Solution Test Results
Comparing the Control Solution Test Results You will need a lancing device in order to collect a blood sample. You may use the lancing device contained in the CareSens LINK Repeat the control test if the test result falls outside the range printed Blood Glucose Monitoring System or any other medically approved on label of the test strip vial. -
Page 12: Preparing The Lancing Device For Blood Sample Retrieval
Preparing the Lancing Device for Blood Sample Retrieval Step 1 Step 4 Wash hands and fingertip sample site Select a desired depth of one-to-five (1-5) with soap and warm water. Rinse and dry on lance’s adjustable tip. Rotate ring to thoroughly. align desired number with arrow. A beginning setting of three (3) is recommended. Step 2 Step 5 Unscrew lancing device tip. To cock the lancing device, hold the tip in one hand. Pull the sliding barrel on with the other hand. The lancing device is cocked when you feel a click. Step3 Firmly insert new lancet into carrier. Hold lancet firmly. Gently twist to pull off protective disk. Save disk to recap lancet after use. Replace lancing device tip. Note The skin depth to retrieve samples will vary for various people at different sample sites. The lance’s adjustable tip allows the best depth of skin penetration for an adequate sample size. A beginning setting of three (3) is recommended. -
Page 13: Preparing The Meter And Test Strip
Preparing the Meter and Test Strip Applying Blood Sample Step 6 Step 8 Insert a test strip with the contact bars Obtain a blood sample using the lancing facing upwards into the meter port. Push device. Place the device against the pad of the strip in gently until the meter beeps. Be the finger. The best puncture sites are on careful not to bend the test strip. The the middle or ring fingers. Press the release symbol will appear on the screen. button. Remove the device from the finger. Wait a few seconds for a blood drop to form. A minimum volume of 0.5 microliter is Flagging Post-meal Test Results needed to fill the confirmation window. (actual size of 0.5 ㎕ : ) The CareSens N meter allows you to flag a result of an post-meal Step 9 test with ( ) icon. The post-meal test flag ( ) can be attached just before applying the blood sample. Once you attach the post- After the symbol appears on the meal flag ( ) to the test results, it cannot be deleted. -
Page 14: Discarding Used Lancets
Discarding Used Lancets Step 10 Step 1 The test result will appear after the meter counts down from 5 to 1. The result will be Unscrew general lancing device tip. automatically stored in the meter’s memory. If the test strip is removed after the test result is displayed, the meter will automatically switch off after 3 seconds. Discard used test strips safely in disposable containers. Step 2 Place protective cover on lancet. Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet in a proper biohazard container. Caution The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. -
Page 15: Alternative Site Testing
Alternative Site Testing What is AST(Alternative Site Testing)? Things to know when using AST Usually, when someone tests their glucose, they take the blood Please understand the following things before testing outside of sample from the tip of the finger. However, since there are the fingertip (arms, thighs, calves). many nerve endings distributed there, it is quite painful. When The capillary blood of the fingertip shows the change in glucose doing a glucose test, using different parts of the body such as more rapidly than AST. Therefore, the test results from the the arms, palms, thighs, and calves can reduce the pain during fingertip test and AST may differ. This is because things such as testing. This method of testing with different parts of the body is lifestyle and ingested food have an effect on glucose levels. called Alternative Site Testing. While AST may reduce the pain during testing, it may not be simple for everyone and the following Acceptable situations for AST precautions should be observed during testing. • Fasting period • Before a meal Alternative Site for Testing • Before sleeping Situations requiring fingertip test • W hen the glucose levels are rapidly increasing during the two hours after a meal or exercise • W hen sick or when glucose levels seem quite lower... -
Page 16: Hi And Lo Messages
Note If the sample drop of blood runs or spreads due to contact with Please contact your authorized i-SENS sales representative, hair or with a line in you palm, do not use that sample. if such messages are displayed even though you do not have Try puncturing again in a smoother area. -
Page 17: Target Blood Glucose Ranges
Meter Memory Target Blood Glucose Ranges The CareSens N meter can save up to 250 glucose test results with time and date. If the memory is full, the oldest test result will be deleted and the latest test result will be stored. Reminders The CareSens N meter calculates and displays the averages of total Your target ranges test results, pre-meal test results, and post-meal test ( ) results from from your healthcare expert Time of day the last 14 days. Before breakfast Viewing Test Results Stored in the Meter’s Memory Before lunch or dinner Step 1 1 hour after meals... -
Page 18: Setting The Alarm Function
Setting the Alarm Function Four types of alarms can be set in the CareSens N meter: one post- Step 3 meal alarm (PP2 alarm) and three time set alarms (alarm1 ~ 3). Use the button to scroll through the test results, starting from the The PP2 alarm goes off 2 hours after setting the alarm. most recent and ending with the oldest. Press to return to the The alarms ring for 15 seconds and can be silenced by pressing , result seen previously. or the S button or by inserting a test strip. After checking the stored test result, press the S button to turn off the meter. Setting the post-meal alarm (PP2 alarm) Step 1 Setting the PP2 alarm On Without inserting a test strip, press and hold for 3 seconds to set the post-meal alarm. The ‘PP2’ character, the bell ( ) icon and then the ‘On’ character will be displayed. The screen will then automatically change to the memory check mode. At this... - Page 19 Setting the Time Alarms (alarm1 ~ 3) Step 1 Step 4 Without inserting a test strip, press and On pressing , the number indicating the the S button simultaneously for 3 seconds to minute will start blinking. Press to set the enter the time alarm mode. The ‘alarm1’ will be accurate minute. displayed while the ‘OFF’ character blinks on the screen. Step 2 Step 5 On pressing , the ‘alarm1’ is set and the ‘On’ Press the S button to finish and to enter the character is displayed on the screen. Press ‘alarm 2’ mode. again to cancel the ‘alarm1’. The ‘OFF’ icon will Repeat steps 2 to 5 to set the remaining time blink on the screen . alarms (alarm 2 ~ 3). Step 3 Step 6 Press to adjust the time of the ‘alarm1’. Press the S button for 3 seconds to finish and A number representing the time will blink on turn the meter off.
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Page 20: Bluetooth Paring
Bluetooth Paring Replacing the Batteries When the meter is off, hold the buttons for 2 seconds to pair the The CareSens LINK meter comes with two 1.5 V AAA alkaline batteries. meter and the other Bluetooth device. ‘bT’ will be blinked on the Around 50 tests can still be carried out after the icon appears on the display, and the Bluetooth connection will be available. display for the first time, but the battery should be replaced as soon as Depending on the user’s Bluetooth settings PIN Code input may be possible. necessary in order to register the external Bluetooth device. In this The test results might not be saved if the battery runs out. case, type in ‘0000’ in the input box. Step 1 When the measured glucose value has been transmitted via Bluetooth, the transmitted data in the meter will be automatically Make sure the meter is turned off. Push the deleted and the meter will turn itself off. cover in the direction of the arrow to open the battery compartment. Step 2 Replace the old batteries with new batteries. Remove the old battery by lifting the battery with the index finger and pulling out the battery with your thumb and index fingers as shown in the figure on the right one by one. Insert two new batteries with the + side facing up and make sure the battery is inserted firmly. Step 3 Place the cover on the battery compartment. Push down until you hear the tab click into place. Note Note Blinking ‘bT’ on the display means that the search of the Bluetooth Removing the meter batteries will not affect your stored result. -
Page 21: Caring For Your System
Caring for Your System Understanding Error and Other Messages 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, or acetone, or Message What It Means What To Do household and industrial cleaners that may cause irreparable damage A used test strip Repeat the test with a to the meter. was inserted. new test strip. Store all the meter components in the portable case to prevent loss. Caution: The blood or Repeat the test with control solution a new test strip and • D o not expose the meter to direct sunlight or heat for an extended sample was wait until the icon period of time. applied before appears before applying • P revent the entry of dirt, dust, blood, or water at the meter's test the icon the blood sample. -
Page 22: General Troubleshooting
• Repeat the test after inserting a new test strip. There is a problem Do not use the meter. • C heck the validity period of the test with the meter. Contact your authorized The test result strip. i-SENS sales doesn’t match your • C heck if the strip has passed the representative. expectation. discard date (date of opening the test strip vial plus 6 months). • C heck the meter. Note Note If the error messages persist, contact your authorized i-SENS If the problem is not resolved, please contact your authorized sales representative. i-SENS sales representative. -
Page 23: Performance Characteristics
Performance Characteristics The performance of CareSens N Blood Glucose Monitoring System Precision: Precision studies were performed in a laboratory Strips has been evaluated in laboratory and in clinical tests. using the CareSens LINK BGM System. Accuracy: The accuracy of the CareSens N BGM System (Model GM505LE) was assessed by comparing blood glucose results obtained by patients with those obtained using Within Run Precision a YSI Model 2300 Glucose Analyzer, a laboratory instrument . The Blood average SD = 1.9 mg/dL (0.11 mmol/L) 38.1 mg/dL (2.1 mmol/L) following results were obtained by 110 diabetic patients at clinic CV = 3.7% Blood average 86.1 mg/dL (4.8 mmol/L) centers. Blood average CV = 4.1% 124.5 mg/dL (6.9 mmol/L) Blood average 189.1 mg/dL (10.5 mmol/L) CV = 2.6% Slope 0.961... -
Page 24: Warranty Information
Warranty Information MEMO Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens N Meter shall be free of defects in material and workmanship in normal use for a period of five(5) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering, use, or service of the meter. Any claim must be made within the warranty... - Page 25 FCC Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference. and (2) This device must accept any interference received, including interference that may cause undesired operation. Caution Any changes or modifications (including the antenna) made to this device that are not expressly approved by the manufacturer...