i-SENS CareSens II Plus Owner's Booklet

Blood glucose monitoring system

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i-SENS, Inc.

43, Banpo-daero 28-gil, Seocho-gu,

Seoul 06646, Korea

www.i-sens.com

Medical Technology Promedt

Consulting GmbH,

Altenhofstrasse 80, D-66386

St. Ingbert, Germany

• Rapid Test Result with Very

Small Size of Sample

• Efficient Diabetes

Management with

Tagging Symbols

• Hypoglycemia Indicator

• Stores 1,000 Test Results

in Memory

HYPO

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Page 1 • Hypoglycemia Indicator • Stores 1,000 Test Results in Memory HYPO i-SENS, Inc. Medical Technology Promedt 43, Banpo-daero 28-gil, Seocho-gu, Consulting GmbH, Seoul 06646, Korea Altenhofstrasse 80, D-66386 www.i-sens.com St. Ingbert, Germany © 2017 i-SENS, Inc. All Rights Reserved. PGA1E3513 REV0 05/2017...
Page 2 Welcome to the CareSens II Plus Blood Glucose Monitoring System Thank you for choosing the CareSens II Plus Blood Glucose Monitoring System. The system provides you with rapid and convenient blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 5 seconds with a small (0.5 µL) blood...
Page 3 CareSens II Plus Blood Glucose Monitoring System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -...
Page 4 Intended use: • The CareSens II Plus blood glucose meter should be used only with CareSens II Plus Blood Glucose Monitoring System is used for the the CareSens Test Strips. quantitative measurement of the glucose level in capillary whole blood as an aid in monitoring diabetes management effectively •...
Page 5: Specifications
Size 91.5 x 45 x 15.9 (mm) Weight 49.7 g (with batteries) Operating ranges • Check all the components after opening the CareSens II Plus Blood Temperature 5-45˚C (41-113˚F) Glucose Monitoring System package. The exact contents are listed Relative humidity 10–90%...
Page 6: Inserting Or Replacing The Batteries
Inserting or Replacing the Batteries Caring for Your System The CareSens II Plus meter uses two 3.0 V lithium batteries. Before Use a soft cloth or tissue to wipe the meter exterior. If necessary, dip using the meter, check the battery compartment and insert batteries if the soft cloth or tissue in a small amount of alcohol.
Page 7 CareSens Blood Glucose Test Strip Warning! The CareSens II Plus Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically absorbs the small • The CareSens Test Strips should be used only with fresh capillary blood sample applied to the narrow edge of the strip.
Page 8 CareSens II Plus Blood Glucose Meter CareSens II Plus Blood Glucose Meter Display Data Port Display Test results : test results displaying panel Used to transfer data Shows results, Memory recall mode : appears when test from the meter to...
Page 9: Setting Up Your System
S button to confirm your selection and to go to the Press the ▶ button to select a format. The AM•PM next step. symbol is not displayed in the 24-hour format. After selecting the format, press the S button to go to the next step. 14 www.i-sens.com www.i-sens.com 15...
Page 10 If the sound is set to OFF, none of the sound functions will work. After setting the sound, press the S button to progress to the next step. Note: symbol is displayed only when the sound is set to OFF. 16 www.i-sens.com www.i-sens.com 17...
Page 11 If the expiration date is set to Caution: October of 2019, the meter Ask your healthcare professional to help you decide what your will display EP at the start of hypoglycemia level is before setting your level. November, 2019. 18 www.i-sens.com www.i-sens.com 19...
Page 12 Step 1 Entering the Expiration Date Setting For accurate results, the code number on the CareSens II Plus Meter and CareSens Test Strips must match. You must code your meter Press and hold the S and ▶ buttons at the same time for 3 seconds to before using it for the first time and each time you open a new vial of enter the expiration date settings.
Page 13: Checking The System
• Before using the control solution, shake the bottle, discard the first few drops and wipe the tip clean. • Close the control solution bottle tightly and store at a temperature between 8–30˚C (46–86°F). Caution: If the meter is not correctly coded, you will get inaccurate results. 22 www.i-sens.com www.i-sens.com 23...
Page 14 Step 2 You can flag the control solution test result by pressing the ▶ button for 3 seconds. To undo the control solution flag, press the ▶ button for 3 seconds again. 24 www.i-sens.com www.i-sens.com 25...
Page 15 If results continue to fall outside the range printed on the test strip The CareSens Control Solution can be purchased separately. Please vial, the CareSens Test Strip and CareSens II Plus meter may not be contact your authorised i-SENS sales representative.
Page 16 Preparing the Lancing Device You will need a lancing device in order to collect a blood sample. You may use the lancing device that is included in the CareSens II Plus Step 1 Blood Glucose Monitoring System or any other medically approved Wash hands and sample site with soap and lancing device.
Page 17 The skin depth to get blood samples will vary for various people at to fill the confirmation window. (Actual size of 0.5 μL: ) different sample sites. The lancing device's adjustable tip allows the best depth of skin penetration to get an adequate sample size. 30 www.i-sens.com www.i-sens.com 31...
Page 18 The meter may switch off if the blood sample is not applied within 2 minutes of the symbol appearing on the screen. If the meter turns off, remove the strip and reinsert it, and start from Step 2. 32 www.i-sens.com www.i-sens.com 33...
Page 19 No flag Pre-meal flag Post-meal flag Caution: Fasting flag Control solution flag The lancet is for single use only. Never share or reuse a lancet. Always dispose of lancets properly. 34 www.i-sens.com www.i-sens.com 35...
Page 20 Then press the release button while continuing to apply pressure. Keep holding the lancing device against your skin until sufficient (at least 0.5 μL, actual size: ) blood is drawn. Carefully lift the lancing device away from your skin. 36 www.i-sens.com www.i-sens.com 37...
Page 21: Hi And Lo Messages
Try puncturing again in a smoother area. Note: Please contact your authorised i-SENS sales representative if such messages are displayed even though you do not have hyperglycemia or hypoglycemia.
Page 22: Meter Memory
Target Blood Glucose Ranges Meter Memory The CareSens II Plus meter can save up to 1,000 glucose test results Reminders Your target ranges with time and date. If the memory is full, the oldest test result will be from your healthcare professional Time of day deleted and the latest test result will be stored.
Page 23 Press the S button to view 1, S button 7, 14, 30 and 90-day average Fasting values and the number of average tests performed during fasting (1, 7, 14, 30, with the symbol for the last 90 days) test period. ▶button 42 www.i-sens.com www.i-sens.com 43...
Page 24 PP2 alarm time. Note: The control solution test results saved with symbol will be displayed with symbol when you review the stored test results. 44 www.i-sens.com www.i-sens.com 45...
Page 25: Understanding Error Messages
(5-45˚C) and repeat the test after the meter and test strips have reached a temperature within the operating range. The blood sample has abnormally high viscosity or insufficient volume. > Repeat the test after inserting a new test strip. 46 www.i-sens.com www.i-sens.com 47...
Page 26: General Troubleshooting
• Check the expiration date of the test way you feel. strip. • Perform control solution test. Note: Note: If the error messages persist, contact your authorised i-SENS sales If the problem is not resolved, please contact your authorised i-SENS representative. sales representative. 48 www.i-sens.com www.i-sens.com 49...
Page 27: Performance Characteristics
29.5 mg/dL (1.6 mmol/L) and 455 mg/dL(25.3 mmol/L) has been evaluated in laboratory and in clinical tests. Accuracy: The accuracy of the CareSens II Plus BGM System (Model 29.5 mg/dL (1.6 mmol/L) and 455 mg/dL(25.3 mmol/L) GM01JAA, GM01JAB) was assessed by comparing blood glucose results 598/600 (99.7%)
Page 28 0.4 mg/dL (0.02 mmol/L) 1.9% and 100% within ±15% of the medical laboratory values at glucose Ibuprofen -1.5 mg/dL (-0.1 mmol/L) 2.8% concentrations at or above 100 mg/dL (5.55 mmol/L). Icodextrin -2.7 mg/dL (-0.2 mmol/L) -0.5% 52 www.i-sens.com www.i-sens.com 53...
Page 29: Warranty Information
Warranty Information Manufacturer’s Warranty i-SENS, Inc. warrants that the CareSens II Plus 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.

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