i-SENS CareSens N User Manual page 2

• Certain components may not be included
depending on the place of purchase.
• Check all the components after opening the
CareSens N Mini Blood Glucose Monitoring
System package. The exact contents are listed on
the main box.
Strip information
• Please contact your authorized i-SENS sales
representative if any component is missing or
damaged.
IMPORTANT
Please read this information and the CareSens N
The device can be sent back to the manufacturer Mini User Manual before using CareSens N Test
for recycling or proper disposal after its useful life.
Strips.
Alternatively the device should be disposed in
INTENDED USE AND TEST PRINCIPLE
accordance with national laws after its useful life.
The CareSens N Test Strips work with the CareSens N
Mini Blood Glucose Meter to quantitatively measure
10 CareSens N Mini Blood Glucose
glucose in capillary whole blood. The CareSens N Mini
Blood Glucose Monitoring Systems are for self-testing
Monitoring System Specifications
outside the body (in vitro diagnostic use). The
• Model : GM505VAA
CareSens N Mini Blood Glucose Monitoring Systems
• Test Range : 20-600 mg/dL (1.1-33.3 mmol/L) should not be used for the diagnosis of diabetes or for
• Sample Size : Minimum 0.5 µL testing newborns. The glucose in a blood sample
• Test Time : 5 seconds mixes with special test strip chemicals where a small
electrical current is produced. The CareSens N Mini
• Test Sample : Fresh capillary whole blood
• Calibration : Plasma-equivalent Blood Glucose Meter detects the electrical current
which reflects the amount of glucose in the blood
• Assay Method : Electrochemical
sample.
• Operating Range
Temperature : 10-40˚C/50-104˚F
STORAGE AND HANDLING
Relative Humidity : 10-90%
• Store vial in a cool and dry place between 1-30°C
Hematocrit : 20-60%
(34-86°F). Do not freeze.
• Keep the vials of test strips away from direct
sunlight or heat.
13 • Store unused test strips in their original vials to
avoid damage or contamination.
11 Warranty Information
• Close the vials tight immediately after taking out
a test strip in order to maintain airtightness.
Manufacturer's Warranty
Exposing test strips to humidity for a long period
i-SENS, Inc. warrants that the CareSens N Mini
of time can produce incorrect test results even if
Meter shall be free of defects in material and
the test strips are new.
workmanship in normal use for a period of five (5)
• Handle test strips only with clean and dry hands.
years. The meter must have been subjected to
• Use the test strip immediately after taking it out of
normal use. The warranty does not cover
the vial.
tampering, improper handling, use, or service of
• Do not bend, cut, or alter the test strips in any way.
the meter. Any claim must be made within the
• Do not force a test strip into the meter. Gently push
warranty period.
it into the meter's test strip port.
The i-SENS company will, at its discretion, repair or
• Apply only fresh capillary whole blood for testing.
replace a defective meter or meter part that is
• Use all of the test strips within the expiration date
covered by this warranty. As a matter of warranty
printed on the test strip box and vial label.
policy, i-SENS will not reimburse the consumer's
• Dispose of test strips past the expiration date
purchase price. immediately because using test strips past their
expiration date can produce incorrect test results.
Obtaining Warranty Service
• Test strips in new, unopened vials and test strips in
To obtain warranty service you must return the
vials that have been opened can be used up until
defective meter or meter part along with proof of
the expiration date printed on the test strip box and
purchase to your authorised i-SENS sales
vial label if the test strips are used according to its
representative.
storage and handling methods.
WARNINGS AND PRECAUTIONS
• Keep test strips and test strip vial away from
children. The test strips and vial cap may be
choking hazards. Drying agents in the vial cap
may be harmful if inhaled or swallowed or may
cause skin or eye irritation.
• Test strips are for single use only. Do not reuse.
• If the test strip does not absorb the blood sample
properly, please contact your authorized i-SENS
sales representative.
14
Please note that:
• An abnormally high or low red blood cell count
(hematocrit level over 60% or below 20%) may
produce inaccurate results.
• Severe dehydration (excessive water loss) may cause
false low results. If you believe you are suffering
from severe dehydration, consult your physician
immediately.
• There is no effect from altitude up to 3,000 m
(10,000 ft) above sea level.
Accuracy results for glucose concentration
METER AND TEST STRIP PERFORMANCE CHECK < 75 mg/dL (4.2 mmol/L)
CareSens N Mini (Model GM505VAA)
The CareSens Control Solution contains a known
amount of glucose that reacts with the CareSens N
Test Strip in combination with the CareSens N Mini
Meter to make sure they are working properly
together and the correct testing procedure is being
followed.
You may run a check with the control solution when you:
• Want to practice the test procedure using the
control solution instead of blood.
• Use the meter for the first time.
Accuracy results for glucose concentration
≥ 75 mg/dL (4.2 mmol/L)
• Open a new vial of test strips.
CareSens N Mini (Model GM505VAA)
• Have symptoms that are inconsistent with your
blood glucose test results.
• Believe your test results are not accurate.
• Suspect your meter and test strips are not properly
performing.
If your control solution test results do not fall within
the range printed on the test strip vial, repeat the
test. Out of range results may be due to one or more
1 of the following factors: 3
PRECISION
• Error in performing the test.
The precision studies were performed in a
laboratory using CareSens N Mini BGM Systems.
• Expired or contaminated control solution.
• Expired or damaged test strip.
• Failure to shake control solution bottle.
• Failure to discard first drop of control solution and
wipe bottle tip clean.
If results continue to fall outside the range printed on
the test strip vial, the CareSens N Test Strip and Meter
may not be working properly. If so, do not use your
system and contact your authorized i-SENS sales
representative.
CHEMICAL COMPOSITION
• Glucose oxidase : 2.7 units
• Hexaamineruthenium(III) chloride : 45.7 ㎍
• Other ingredients : 1.6 ㎍
PERFORMANCE CHARACTERISTICS
The performance of CareSens N Mini BGM System
has been tested in laboratory and clinical studies.
The testing range of the CareSens N Mini BGM
System is 20-600 mg/dL (1.1-33.3 mmol/L).
ACCURACY
This Study shows that there could be variation of
The accuracy of the CareSens N Mini BGM System
up to 3.5%.
(Model GM505VAA) was assessed by comparing blood
glucose results obtained by patients with those
obtained using a YSI Model 2300 Glucose Analyzer, a
laboratory instrument . The following results were
Reference
obtained by diabetic patients at clinic centers.
1. American Diabetes Association. "Standards of
The results were:
Medical Care in Diabetes – 2012. " Diabetes Care.
2 4 January 2012; 35(1):S11-S63.
• Slope 1.0132
• Y-intercept 1.0053 mg/dL
(0.0559 mmol/L)
• Correlation coefficient(r) 0.9864
• Number of Sample 600
• Range tested 33-455 mg/dL
(1.8333–25.278 mmol/L)
Within ± 5 mg/dL
71/84 (85%)
(Within ± 0.28 mmol/L)
Within ± 10 mg/dL
84/84 (100%)
(Within ± 0.56 mmol/L)
Within ± 15 mg/dL
84/84 (100%)
(Within ± 0.83 mmol/L)
Within ± 5% 268/516 (52%)
Within ± 10% 461/516 (89%)
Within ± 15% 511/516 (99%)
Within ± 20% 516/516 (100%)
5
Within Run Precision
• Blood avg. 35 mg/dL (1.9 mmol/L)
SD = 1.9 mg/dL (0.1 mmo/L)
• Blood avg. 83 mg/dL (4.6 mmol/L)
SD = 2.3 mg/dL (0.1 mmo/L)
• Blood avg. 128 mg/dL (7.1 mmol/L)
CV = 3.5%
• Blood avg. 288 mg/dL (16.0 mmol/L)
CV = 3.3%
• Blood avg. 347 mg/dL (19.3 mmol/L)
CV = 2.7%
Total Precision
• Control avg. 37 mg/dL (2.1 mmol/L)
SD = 1.7 mg/dL (0.1 mmol/L)
• Control avg. 122 mg/dL (6.8 mmol/L)
CV = 2.8%
• Control avg. 394 mg/dL (21.9 mmol/L)
CV = 3.1%
6
For in vitro diagnostic use
Consult instruction for use
Manufacturer
Do not reuse
Temperature limitations
Use by (unopened or opened test strip
vials)
Batch code
Authorized representative
CE Mark reg. IVDD 98/79/EC
Serial number
Do not discard this product with other
household-type waste
7
i-SENS, Inc.
465-6 Wolgye4-dong, Nowon-gu
Seoul 139-845, Korea
www.i-sens.com
Medical Technology Promedt
Consulting GmbH,
Altenhofstrasse 80, D-66386
St. Ingbert, Germany
2012 i-SENS, Inc. All Rights Reserved.
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