i-SENS CareSens N Voice Owner's Booklet

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Page 1 Seocho-gu, Seoul 06646, Korea www.i-sens.com Australian Distributor: NZ Distributor: Pharmaco (Australia) Ltd Pharmaco (NZ) Ltd Gordon, NSW 2072 Auckland Phone: 1800 114 610 Phone: 0800 GLUCOSE (0800 458267) Website: www.caresens.com.au Website: www.caresens.co.nz © 2016 i-SENS, Inc. All Rights Reserved PGJ5E3056 REV1 08/2016...
Page 2 (i.e., outside the body) diagnostic monitoring. The bilingual talking function of CareSens N Voice Meter can be used as an aid for using the meter. The CareSens N Voice Meter is also designed to minimise code related errors in monitoring by using the auto coding function.
Page 3: Table Of Contents
Table of Contents Information Important Information: Read This First! Specifications CareSens N Voice Blood Glucose Monitoring System Inserting or Replacing Batteries Caring for Your System CareSens N Blood Glucose Test Strip CareSens N Voice Blood Glucose Meter CareSens N Voice Blood Glucose Meter Display...
Page 4: Important Information: Read This First
CareSens N Voice • T he CareSens N Voice Blood Glucose Meter should be used Blood Glucose Monitoring System should be used only for only with the CareSens N Test Strips.
Page 5: Specifications
Specifications CareSens N Voice Blood Glucose Monitoring System Product specifications Measurement range 1.1-33.3 mmol/L Sample size Minimum 0.5 μL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma-equivalent Assay method Electrochemical Battery life 1,000 tests Power Two alkaline AAA batteries...
Page 6: Inserting Or Replacing Batteries
Caring for Your System Use a soft cloth or tissue to wipe the meter exterior. The CareSens N Voice Meter uses two AAA alkaline batteries. If necessary, dip the soft cloth or tissue in a small amount of Before using the meter, check the battery compartment and alcohol.
Page 7: Caresens N Blood Glucose Test Strip
CareSens N Blood Glucose Test Strip Warning! The CareSens N Voice Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically • T he CareSens N Test Strips should be used only with fresh absorbs the small blood sample applied to the narrow edge of capillary whole blood samples.
Page 8: Caresens N Voice Blood Glucose Meter Display
CareSens N Voice Blood Glucose Meter CareSens N Voice Blood Glucose Meter Display alarm : appears when the time alarm has been set Data Port mem : appears when test results Used to transfer data stored in the memory are displayed...
Page 9: Setting Up Your System
S button to set the date and to go to the Selection" in the default language next step. (English). To select another language (L2, Spanish), press the ▲ or ▼ button. Press the S button to confirm the language and to go to the next step. 14 www.i-sens.com www.i-sens.com 15...
Page 10 If the talking function is on, the meter will say “Set minute. ” Press the ▲ or ▼ button until the correct minute appears. After setting the minute, press the S button to go to the next step. 16 www.i-sens.com www.i-sens.com 17...
Page 11: Setting The Hypoglycemia Indicator
SET mode. If the talking function is on, the meter will Caution: Ask your healthcare professional to help you announce the set date and time for your confirmation. decide what your hypoglycemia level is before setting your hypoglycemic level. 18 www.i-sens.com www.i-sens.com 19...
Page 12: Checking The System
▲ button for 3 seconds till the "ctl" appears temperature between 8-30˚C. on the display. If the talking function is on, the meter will say “Control solution test. Please apply control solution onto the test strip. ” 20 www.i-sens.com www.i-sens.com 21...
Page 13 Note: The CareSens Control Solution can be purchased "ctl" appears on the display. When the "ctl" is separately. Please contact your authorised i-SENS sales displayed, the result is stored in the meter's representative. memory but is not included in the averages.
Page 14: Comparing The Control Solution Test Results
Note: Repeated puncturing at the same sample site may Do not use your system and contact your authorised i-SENS cause pain or skin calluses (thick hard skin). Choose a sales representative.
Page 15: Preparing The Lancing Device
The lancing device's release button as shown in the diagram. adjustable tip allows the best depth of skin penetration to get an adequate sample size. 26 www.i-sens.com www.i-sens.com 27...
Page 16: Preparing The Meter And Test Strip
Preparing the Meter and Test Strip Flagging Post-meal Test Results Step 7 The CareSens N Voice meter allows you to flag a result of a post-meal test with the symbol. The post-meal test flag ( ) Insert a test strip with the contact bars facing upwards into the can be attached just before applying the blood sample.
Page 17: Applying Blood Sample
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, reinsert, and start from step 2. Good Sample Insufficient Sample 30 www.i-sens.com www.i-sens.com 31...
Page 18: Discarding Used Lancets
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. 32 www.i-sens.com www.i-sens.com 33...
Page 19 • If the sample drop of blood runs or spreads due to contact • W hen hypoglycemia is not well recognised with hair or with lines on your palm, do not use that sample. • W hen insulin has the biggest effect Try puncturing again in a smoother area. • D uring two (2) hours after an insulin injection 34 www.i-sens.com www.i-sens.com 35...
Page 20: Hi And Lo Messages
"Your blood glucose reading is below 1.1 mmol/L." Reference If Lo is displayed again upon retesting, American Diabetes Association. “Standards of Medical Care in please contact your healthcare professional Diabetes -2016. ” Diabetes Care. January 2016; 39(1):S15, S100. immediately. 36 www.i-sens.com www.i-sens.com 37...
Page 21: Transferring Test Results
Transferring Test Results Meter Memory The CareSens N Voice Meter can save up to 500 test results with Test results stored in CareSens N Voice temperature, time and date. If the memory is full, the oldest test meter can be transferred from the meter to result will be deleted and the latest test result will be stored.
Page 22: Viewing Test Results
Use the ▼ button to scroll back through the averages seen previously. To turn off the meter, press the S button. Note: The control solution test results saved with 'ctl' will be displayed with 'ctl' when you review the stored test results. 40 www.i-sens.com www.i-sens.com 41...
Page 23: Setting The Alarm Function
Setting the Alarm Function Setting the Time Alarms (Alarm 1-3) Four alarms can be set in the CareSens N Voice Meter: one post- meal alarm (PP2 alarm) and three time set alarms (alarm 1-3). The Step 1 PP2 alarm goes off 2 hours after setting the alarm. The alarms Without inserting a test strip, press the ▲...
Page 24: Understanding Error Messages
Step 6 volume. Press and hold the S button for 3 seconds to finish and turn the meter off. 44 www.i-sens.com www.i-sens.com 45...
Page 25: Other Important Messages
Repeat the test with Meter error occurred a new test strip. If failure." during the test. the error message persists, contact your authorised i-SENS sales representative. Note: If the error messages persist, contact your authorised i-SENS sales representative. 46 www.i-sens.com www.i-sens.com 47...
Page 26: General Troubleshooting
System has been evaluated in laboratory and in clinical tests. • C heck whether the test strip is Accuracy: The accuracy of the CareSens N Voice BGM System inserted with the contact bars facing (Model GM505UAB) was tested by comparing blood glucose up.
Page 27 Within ± 0.83 mmol/L and Within ± 15 % 599/600 (99.8%) Difference Averages Interferent Interval 1 Interval 2 Precision: Precision studies were performed in a laboratory 2.8~5.5 mmol/L 13.9~19.4 mmol/L using the CareSens N Voice BGM Systems. 1 Acetaminophen -0.1 mmo/L -3.3% Within Run Precision 2 Ascorbic acid 0.4 mmol/L -0.9%...
Page 28: Warranty Information
Warranty Information Manufacturer's Warranty Difference Averages i-SENS, Inc. warrants that the CareSens N Voice Meter shall be Interferent Interval 1 Interval 2 free of defects in material and workmanship in normal use for 2.8~5.5 mmol/L 13.9~19.4 mmol/L a period of 5 years. The meter must have been subjected to normal use.
Page 29 MEMO 54 www.i-sens.com...

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