Table of Contents
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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
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.
FCC Radiation Exposure Statement:
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.
Note:
The SmartLog mobile app may not be compatible
with all smartphones.
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Table of Contents
Related Manuals for i-SENS CareSens N Plus BT
Summary of Contents for i-SENS CareSens N Plus BT
- Page 1 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. FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
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Page 2: Table Of Contents
Table of Contents Information Important Information Specifications CareSens N Plus BT Blood Glucose Monitoring System Inserting or Replacing the Batteries CareSens N Blood Glucose Test Strip CareSens N Plus BT Blood Glucose Meter CareSens N Plus BT Blood Glucose Meter Display... -
Page 3: Important Information
• Dehydration (excessive water loss) may cause false low CareSens N Plus BT Blood Glucose Meter and CareSens N Blood results. If you believe you are suffering from dehydration, Glucose Test Strips to check that the meter and the test strips consult your healthcare professional immediately. - Page 4 The CareSens N Plus BT meter is designed to minimize code related errors in monitoring by using the no-coding function. • The CareSens N Plus BT meter should be used only with CareSens N test strips. • The meter and lancing device are for single patient use.
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Page 5: Specifications
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) 10 www.i-sens.com www.i-sens.com 11... -
Page 6: Caresens N Plus Bt Blood Glucose Monitoring System
Inserting or Replacing the Batteries CareSens N Plus BT System includes the following items: The CareSens N Plus BT meter uses two 3.0 V lithium batteries. Before using the meter, check the battery compartment and *CareSens N Plus BT Blood Glucose Meter insert batteries if empty. -
Page 7: Caresens N Blood Glucose Test Strip
CareSens N Blood Glucose Test Strip The CareSens N Plus BT Blood Glucose Monitoring System Step 3 measures blood glucose quickly and accurately. It automatically Place the cover on the battery absorbs the small blood sample applied to the narrow edge of compartment. -
Page 8: Caresens N Plus Bt Blood Glucose Meter
CareSens N Plus BT Blood Glucose Meter Warning! Data Port Used to transfer data • The CareSens N Blood Glucose Test Strip should be used only from the meter to with fresh capillary whole blood samples. a computer with a •... -
Page 9: Caresens N Plus Bt Blood Glucose Meter Display
CareSens N Plus BT Blood Glucose Meter Display Setting Up Your System Test results You should check and update the meter-settings such as time and date before using your meter or after changing the meter Memory recall mode batteries. Post-Meal Alarm Press and hold the ●... -
Page 10: Setting Up Bluetooth
SmartLog For in vitro diagnostic use. For self-testing use only. Use with CareSens N Blood Glucose Test Strip. Model: GM01BAD mobile app screen to correctly i-SENS, Inc. Manufacturer: 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea www.i-sens.com... -
Page 11: Adjusting The Date And Time
Some smartphones, especially those that are not tested or displays the correct date. Press the ● button approved by i-SENS, may be incompatible with your meter. to confirm the date and to go to the next Visit www.i-sens.com/smartlog for more information about step. -
Page 12: Setting The Sound On/Off
After setting the sound, press the ● button to go to the next step. correct minute appears. After the minute is set, press the ● button to go to the next step. Note: symbol is displayed only when the sound is set to OFF. 24 www.i-sens.com www.i-sens.com 25... -
Page 13: Turning On The Strip Expiration Date Indicator
October of 2021, the meter will display 'EP' at the start Caution: Ask your healthcare professional to help you decide of October, 2021. what your hypoglycemia level is before setting your level. 26 www.i-sens.com www.i-sens.com 27... -
Page 14: Setting The Strip Expiration Date Indicator
Compare the result displayed on the meter to the CareSens Control trol Solution Range Written on Str ard Date : ufacturer : i-SENS, Inc. anpo-daero 28-gil, Seocho-gu, Seoul, 06646 Solution range printed on the test strip vial. PGA2E0580 REV... -
Page 15: Control Solution Testing
5 to 1. seconds. To undo the control solution flag, press When flagged, the result is stored and hold the ▼ button for 3 seconds again. in the meter's memory but it is not included in the averages. 30 www.i-sens.com www.i-sens.com 31... -
Page 16: Comparing The Control Solution Test Results
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–... -
Page 17: Using The Lancing Device
Note: Repeated puncturing at the same sample site may and release button as shown in the cause pain or skin calluses (thick hard skin). Choose a different diagram. site each time you test. 34 www.i-sens.com www.i-sens.com 35... -
Page 18: Preparing The Meter And Test Strip
The lancing device's A minimum volume of 0.5 microliter is adjustable tip allows the best depth of skin penetration to needed to fill the confirmation window get an adequate sample size. (actual size of 0.5 μL: ) 36 www.i-sens.com www.i-sens.com 37... - Page 19 • The SmartLog mobile app must be launched. The meter will transmit data in the following cases, • When the strip is ejected after measuring, • When the meter is turned on (only when untransmitted data exists). 38 www.i-sens.com www.i-sens.com 39...
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Page 20: Discarding Used Lancets
• The lancet is very sharp. Please keep away from children. • Keep the lancets in a cool and dry place. Fasting flag Control solution flag Caution: The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. 40 www.i-sens.com www.i-sens.com 41... -
Page 21: Hi And Lo Messages
If you continue to get HI or Lo results and think the meter may not be functioning properly, contact Customer Test results stored in the CareSens N Plus BT Service: 1-800-429-5001 (9 am–9 pm EST, Monday–Saturday). meter can be transferred from the meter to a At all other times or in case of emergency, contact your computer using SmartLog software and cable. -
Page 22: Meter Memory
Meter Memory The CareSens N Plus BT meter can save up to 1,000 glucose test Step 3 Viewing Pre-meal Averages results with time and date. If the memory is full, the oldest test Press the ▲ button to button ▲... -
Page 23: Viewing Test Results Stored In Memory
After checking the stored test results, press the ● button to turn off the meter. Note: The control solution test results saved with the symbol will be displayed with the symbol when you review the stored test results. 46 www.i-sens.com www.i-sens.com 47... -
Page 24: Setting The Alarm Function
Setting the Alarm Function Setting the Time Alarms (alarm 1–3) Four types of alarms can be set in the CareSens N Plus BT meter: one post-meal alarm (PP2 alarm) and three time set alarms Step 1 (alarm1–3). The PP2 alarm goes off 2 hours after setting the alarm. -
Page 25: Caring For Your System
• For the meter and lancing device, this pre-cleaning and disinfection procedure should be performed once a week. Note: The life span of a CareSens N Plus BT meter is 5 years. We Step 6 recommend disinfecting both the meter and lancing device at Press and hold the ●... - Page 26 Wipes container, pull commercially in towelette form. out one towelette and In addition to the CareSens N Plus BT Blood Glucose Monitoring close the cap. System instructions, please read the instructions provided Wipe the entire surface of the meter three times horizontally ②...
- Page 27 Storage and Handling Caution: • Do not expose the meter to direct sunlight or heat for an extended period of time. • Do not let dirt, dust, blood, or water enter into the meter’s test strip port. 54 www.i-sens.com www.i-sens.com 55...
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Page 28: Understanding Error Messages
• Keep the meter away from strong electromagnetic field sources such as cell phones and microwave ovens. • The CareSens N Plus BT meter should be used only with CareSens N test strips. The blood or control solution sample was •... -
Page 29: General Troubleshooting
Service: 1-800-429-5001 (9 am–9 pm EST, Monday–Saturday). At all other times or in case of emergency, contact your At all other times or in case of emergency, contact your healthcare professional or emergency medical response. healthcare professional or emergency medical response. 58 www.i-sens.com www.i-sens.com 59... -
Page 30: Performance Characteristics
Monitoring System has been evaluated in laboratory and clinical tests. Within ± 15 mg/dL and Within ± 20% Accuracy: The accuracy of the CareSens N Plus BT BGM System 371/371 (100%) (Model: GM01BAD) was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Precision: The precision studies were performed in a laboratory Model 2300 Glucose Analyzer, a laboratory instrument. -
Page 31: Emc Table
The following tables contain the Manufacturer’s declaration and Manufacturer's Warranty additional information required by IEC 60601-1-2:2014 (Fourth i-SENS, Inc. warrants that the CareSens N Plus BT Meter shall Edition). be free of defects in material and workmanship in normal use for a period of 5 years. - Page 32 MEMO MEMO 64 www.i-sens.com www.i-sens.com 65...
- Page 33 MEMO 66 www.i-sens.com...