i-SENS CareSens N Plus BT Manual Download Page 1 | Manualshive

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The Bluetooth® word mark and logos are registered trademarks
owned by Bluetooth® SIG, Inc. and any use of such marks by
i-SENS, Inc. is under license. All other trademarks and trade
names are those of their respective owners.

This equipment complies with FCC radiation exposure limits set
forth for an uncontrolled environment.
This equipment should be installed and operated with minimum
distance 8 inches (20 cm) between the radiator and your body.
Any changes or modifications not expressly approved by the
manufacturer could void the user's authority to operate this
equipment.

WARNING:

Turn off the Bluetooth feature in areas where the use of
wireless devices is restricted, such as hospitals, some healthcare
professional offices, and airplanes.

Trademarks

FCC Radiation Exposure Statement:

Note:

The SmartLog mobile app may not be compatible

with all smartphones.

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Summary of Contents for CareSens N Plus BT

Page 1: ...s equipment should be installed and operated with minimum distance 8 inches 20 cm between the radiator and your body Any changes or modifications not expressly approved by the manufacturer could void the user s authority to operate this equipment WARNING Turn off the Bluetooth feature in areas where the use of wireless devices is restricted such as hospitals some healthcare professional offices an...

Page 2: ...Indicator 28 Checking the System 29 Control Solution Testing 30 Comparing the Control Solution Test Results 33 Testing Using the Lancing Device 34 Preparing the Lancing Device 35 Preparing the Meter and Test Strip 37 Applying Blood Sample 37 Discarding Used Lancets 41 HI and Lo Messages 42 Target Blood Glucose Ranges 43 Transferring Test Results 43 Additional Functions Meter Memory 44 Viewing Aver...

Page 3: ...eaning of Symbols Used Cautions for safety and optimum product use Please use this device only for the intended use described in this User s Manual Important Safety Information Limitations of CareSens N Plus BT Blood Glucose Monitoring System An abnormally high or low red blood cell count hematocrit level over 65 or below 15 may produce inaccurate results Inaccurate results may occur in severely h...

Page 4: ...onsult a healthcare professional immediately Critically ill patients should not be tested with blood glucose meters Inaccurate results may occur in patients undergoing oxygen therapy All parts of the kit are considered biohazardous and can potentially transmit infectious diseases even after you have performed cleaning and disinfection If you need assistance please contact Customer Service 1 800 42...

Page 5: ...000 test results Size 108 4 x 55 8 x 15 mm Weight 65 5 g with batteries Bluetooth Frequency range technology 2 4 2 4835 GHz Operating range distance maximum 32 feet 10 meters unobstructed Operating channels 40 channels Security encryption 128 bit AES Advanced encryption standard Operating ranges Temperature 42 8 111 2 F 6 44 C Relative humidity 10 90 Hematocrit 15 65 Storage Transport conditions T...

Page 6: ...the cable for data management software can be ordered separately Please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday The CareSens N Plus BT meter uses two 3 0 V lithium batteries Before using the meter check the battery compartment and insert batteries if empty When the symbol appears on the meter display the batteries should be replaced as soon as possible The test result...

Page 7: ...Push it down until you hear the tab click into place Note Removing the meter batteries will not affect your stored results However you may need to reset your meter settings See page 19 CareSens N Blood Glucose Test Strip The CareSens N Plus BT Blood Glucose Monitoring System measures blood glucose quickly and accurately It automatically absorbs the small blood sample applied to the narrow edge of ...

Page 8: ...ip for testing and use the strip immediately Handle test strips with clean and dry hands Do not bend cut or alter test strips in any way For detailed storage and usage information refer to the CareSens N test strip package insert Caution Keep the meter and testing supplies away from young children Drying agents in the vial cap may be harmful if inhaled or swallowed and may cause skin or eye irrita...

Page 9: ...uld check and update the meter settings such as time and date before using your meter or after changing the meter batteries Press and hold the button for 3 seconds to enter SET mode After all settings are finished press and hold the button for 3 seconds to turn off the meter Press the or button to reach the accurate value Press and hold the or button to scroll faster Step 1 Entering SET Mode Press...

Page 10: ...the PIN number The symbol and PIn will appear if you press the button when the meter screen shows PAIr 2 Launch SmartLog mobile app to start pairing the meter with your smartphone Find the Accessories menu and select the appropriate meter model on SmartLog mobile app 1 The meter will display six digit PIN number Look for CareSens and the last 4 characters of the meter serial number on the SmartLog...

Page 11: ...so scan the QR code on the back cover of this user manual When your meter and smartphone are paired and connected the meter will display SUCCESS and the saved test results will be transferred to your smartphone 6 Adjusting the Date and Time Step 4 Setting the Year Press the or button to adjust until the correct year appears After setting the year press the button to confirm your selection and to g...

Page 12: ... press the button to go to the next step Step 10 On pressing the or button the screen will display On or OFF Press the button to confirm the selection The meter will beep in the following instances if set to On When you press a button to turn on the meter When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is d...

Page 13: ... display EP at the start of October 2021 Caution Ask your healthcare professional to help you decide what your hypoglycemia level is before setting your level Note If the test result is lower than the pre set hypoglycemia level the meter will display the following HYPo warning will blink on the left bottom corner Step 12 This setting allows you to turn the hypoglycemia indicator possible low blood...

Page 14: ...is used to check that the meter and the test strips are working properly The test strip vials have CareSens Control Solution ranges printed on their labels Compare the result displayed on the meter to the CareSens Control Solution range printed on the test strip vial Before using a new meter or a new vial of test strips you may conduct a control solution test following the procedure on pages 30 31...

Page 15: ...d glucose test results and you feel that the meter or test strips are not working properly If you drop or damage the meter Step 4 The display segments will rotate clockwise and a test result will appear after the meter counts down from 5 to 1 When flagged the result is stored in the meter s memory but it is not included in the averages Note The meter may switch off if the control solution sample i...

Page 16: ...t of range results may occur in following situations If results continue to fall outside the range printed on the test strip vial the CareSens N Test Strip and CareSens N Plus BT meter may not be working properly Do not use your system and contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday Situations When the control solution bottle was not shaken well When the meter test strip ...

Page 17: ... single user only and should not be shared with anyone including other family members Use a soft cloth or tissue to wipe the lancing device If necessary a small amount of alcohol on a soft cloth or tissue may be used AdjustableTip Lancet Holder Sliding Barrel Release Button Load Confirmation Window Ejection System Lancet Step 1 Wash hands and sample site with soap and warm water Rinse and dry thor...

Page 18: ...e tip allows the best depth of skin penetration to get an adequate sample size Note 0 least penetration of lancet into the skin 5 most penetration of lancet into the skin Step 8 Obtain a blood sample using the lancing device Place the device against the pad of the finger The best puncture sites are on the middle or ring fingers Press the release button Remove the lancing device from the finger Wai...

Page 19: ...the display segments will rotate clockwise while the blood is going in The test result will appear after the meter counts down from 5 to 1 The result will be 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 If the Bluetooth featu...

Page 20: ...emove the strip after the test result is displayed No flag Pre meal flag Post meal flag Fasting flag Control solution flag Step 1 Unscrew the lancing device tip Step 2 Stick the lancet into the saved protective disk Push the lancet ejector forward with the thumb to dispose of the used lancet in a proper biohazard container Discarding Used Lancets Caution Check for damages before using the lancet I...

Page 21: ...Target Blood Glucose Ranges Reminders Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a m and 4 a m Your target ranges from your healthcare professional Expected Values Normal blood glucose levels for an adult without diabetes are below 100 mg dL before meals and fasting and are less than 140 mg dL two hours after meals Fasting is defined as no ...

Page 22: ...s of total test results Pre meal test results Post meal test results and Fasting test results from the last 1 7 14 30 and 90 days Thenumberoftests withinthecurrentday button button Average 1 7 14 30 90 days Step 3 Viewing Pre meal Averages Press the button to scroll through and view 1 7 14 30 and 90 day averages and the number of pre meals test performed with the symbol for the last test period St...

Page 23: ...followed by the 1 day average and the number of the test results saved within the current day ViewingTest Results Stored in Memory Thenumberoftests withinthecurrentday button button Note The control solution test results saved with the symbol will be displayed with the symbol when you review the stored test results Step 2 Use the button to scroll through the test results starting from the most rec...

Page 24: ... time setting is adjusted to more than two hours before or just past the currently activated PP2 alarm time that the PP2 alarm has been set will be displayed on the screen Step 2 Setting the PP2 alarm OFF To turn off the PP2 alarm press and hold the button for 3 seconds PP2 bell symbol and OFF will appear on the screen Then the screen will change automatically to the memory recall mode without bel...

Page 25: ...eter and lancing device should be disinfected prior to use by the second person Pre cleaning and Disinfection The pre cleaning procedure is needed to clean dirt as well as blood and other body fluids on the exterior of the meter and lancing device before performing the disinfection procedure The disinfection procedure is needed to prevent transmission of blood borne pathogens For the meter and lan...

Page 26: ...ase contact the Clorox company or visit their website as listed above Name Manufacturer EPAregistration number Active ingredients Clorox Healthcare Bleach Germicidal Wipes Clorox Professional Products Company Phone 1 800 537 1415 Website www cloroxprofessional com 67619 12 Sodium Hypochlorite 0 55 Note Pre cleaning procedures should always be performed before the disinfecting procedures Pre cleani...

Page 27: ...ptions on the exterior of the meter or lancing device have been removed When the color of the meter or lancing device has сhanged or faded When cracks or roughness develop on the meter or lancing device When a part of the segment on the meter display does not flash When control solution test results do not fall within the stated range on the test strip vial Caution Do not use other cleaners or dis...

Page 28: ... normally Use of accessories transducers and cables other than those specified or provided by i SENS could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Portable RF Communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any p...

Page 29: ...es persist please contact Customer Service 1 800 429 5001 9 am 9 pm EST Monday Saturday At all other times or in case of emergency contact your healthcare professional or emergency medical response Problem Troubleshooting Check whether the test strip is inserted with the contact bars facing up Check if the strip has been inserted completely into the test strip port Check if the appropriate test st...

Page 30: ...n 15 Within 20 70 0 231 330 96 1 317 330 100 330 330 100 330 330 61 0 25 41 Accuracy results for glucose concentration 75 mg dL Accuracy results for glucose concentration 100 mg dL 97 6 40 41 100 41 41 Within 10mg dL Within 5mg dL Within 15mg dL Within Run Precision Bloodav 43 mg dL SD 1 9 mg dL CV 4 3 Bloodav 71 mg dL SD 2 1 mg dL CV 2 9 Bloodav 135 mg dL SD 3 8 mg dL CV 2 8 Bloodav 203 mg dL SD ...

Page 31: ...by RF fields IEC 61000 4 6 2013 AC Mains 3Vrms 150 kHz to 80 MHz 6Vrms in ISM bands between 0 15 MHz and 80 MHz Power frequency Magnetic Field IEC 61000 4 8 2009 Enclosure 30 A m EMCTable Warranty Information Manufacturer s Warranty i SENS Inc warrants that the CareSens N Plus BT Meter shall be free of defects in material and workmanship in normal use for a period of 5 years The meter must have be...

Page 32: ...64 www i sens com www i sens com 65 MEMO MEMO ...

Page 33: ...66 www i sens com MEMO ...

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