I-SENS CareSens N Voice User Manual - page 2
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• Model : GM505VAA
• Test Range : 20-600 mg/dL (1.1-33.3 mmol/L)
• Sample Size : Minimum 0.5 µL
• Test Time : 5 seconds
• Test Sample : Fresh capillary whole blood
• Calibration : Plasma-equivalent
• Assay Method : Electrochemical
• Operating Range
Temperature : 10-40˚C/50-104˚F
Relative Humidity : 10-90%
Hematocrit : 20-60%
Manufacturer’s Warranty
i-SENS, Inc. warrants that the CareSens N Mini
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
tampering, improper handling, use, or service of
the meter. Any claim must be made within the
warranty period.
The i-SENS company will, at its discretion, repair or
replace a defective meter or meter part that is
covered by this warranty. As a matter of warranty
policy, i-SENS will not reimburse the consumer’s
purchase price.
Obtaining Warranty Service
To obtain warranty service you must return the
defective meter or meter part along with proof of
purchase to your authorised i-SENS sales
representative.
10 CareSens N Mini Blood Glucose
Monitoring System Specifications
11 Warranty Information
INTENDED USE AND TEST PRINCIPLE
The CareSens N Test Strips work with the CareSens N
Mini Blood Glucose Meter to quantitatively measure
glucose in capillary whole blood. The CareSens N Mini
Blood Glucose Monitoring Systems are for self-testing
outside the body (in vitro diagnostic use). The
CareSens N Mini Blood Glucose Monitoring Systems
should not be used for the diagnosis of diabetes or for
testing newborns. The glucose in a blood sample
mixes with special test strip chemicals where a small
electrical current is produced. The CareSens N Mini
Blood Glucose Meter detects the electrical current
which reflects the amount of glucose in the blood
sample.
STORAGE AND HANDLING
• Store vial in a cool and dry place between 1-30°C
(34-86°F). Do not freeze.
• Keep the vials of test strips away from direct
sunlight or heat.
• Store unused test strips in their original vials to
Strip information
IMPORTANT
Please read this information and the CareSens N
Mini User Manual before using CareSens N Test
Strips.
The device can be sent back to the manufacturer
for recycling or proper disposal after its useful life.
Alternatively the device should be disposed in
accordance with national laws after its useful life.
METER AND TEST STRIP PERFORMANCE CHECK
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.
• Open a new vial of test strips.
• 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
of the following factors:
CHEMICAL COMPOSITION
• Glucose oxidase : 2.7 units
• Hexaamineruthenium(III) chloride : 45.7 ㎍
• Other ingredients : 1.6 ㎍
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.
Accuracy results for glucose concentration
< 75 mg/dL (4.2 mmol/L)
CareSens N Mini (Model GM505VAA)
Accuracy results for glucose concentration
≥ 75 mg/dL (4.2 mmol/L)
CareSens N Mini (Model GM505VAA)
Within ± 5 mg/dL
(Within ± 0.28 mmol/L)
71/84 (85%)
Within ± 10 mg/dL
(Within ± 0.56 mmol/L)
84/84 (100%)
Within ± 15 mg/dL
(Within ± 0.83 mmol/L)
84/84 (100%)
• Error in performing the test.
• 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.
Within ± 5%
Within ± 10%
Within ± 15%
Within ± 20%
268/516 (52%)
461/516 (89%)
511/516 (99%)
516/516 (100%)
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%
This Study shows that there could be variation of
up to 3.5%.
Reference
1. American Diabetes Association. “Standards of
Medical Care in Diabetes – 2012.” Diabetes Care.
January 2012; 35(1):S11-S63.
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
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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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.
• 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)
avoid damage or contamination.
• Close the vials tight immediately after taking out
a test strip in order to maintain airtightness.
Exposing test strips to humidity for a long period
of time can produce incorrect test results even if
the test strips are new.
• Handle test strips only with clean and dry hands.
• Use the test strip immediately after taking it out of
the vial.
• Do not bend, cut, or alter the test strips in any way.
• Do not force a test strip into the meter. Gently push
it into the meter’s test strip port.
• Apply only fresh capillary whole blood for testing.
• Use all of the test strips within the expiration date
printed on the test strip box and vial label.
• Dispose of test strips past the expiration date
immediately because using test strips past their
expiration date can produce incorrect test results.
• Test strips in new, unopened vials and test strips in
vials that have been opened can be used up until
the expiration date printed on the test strip box and
vial label if the test strips are used according to its
storage and handling methods.
PRECISION
The precision studies were performed in a
laboratory using CareSens N Mini BGM Systems.
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%
• 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.
• Please contact your authorized i-SENS sales
representative if any component is missing or
damaged.
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.
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
The accuracy of the CareSens N Mini BGM System
(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
obtained by diabetic patients at clinic centers.
The results were: