Contour TS User Manual

34
CONTOUR
®
TS meter CONTOUR
®
TS test strips
Technical,
Service & Care
Technical Information
Technical Information
The CONTOUR
®
TS blood glucose monitoring system
was tested in 100 capillary blood samples using 600
CONTOUR
®
TS test strips. Two replicates were tested with
each of 3 lots of
CONTOUR TS test strips for a total of 600
readings. Results were compared to the YSI
®
glucose analyzer,
which is traceable to the CDC hexokinase method. The tables
below compare the performance of the 2 methods.
Table 1 – System accuracy results for glucose
concentration < 5.55 mmol/L
Difference range
in values between
YSI laboratory
reference method and
CONTOUR TS meter
Within ±
0.28 mmol/L
Within ±
0.56 mmol/L
Within ±
0.83 mmol/L
Number (and percent)
of samples within
specifi ed range
77 of 180
(42.8%)
145 of 180
(80.6%)
170 of 180
(94.4%)
Table 2 – System accuracy results for glucose
concentration ≥ 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
CONTOUR TS meter
Within ±
5%
Within ±
10%
Within ±
15%
Number (and percent) of
samples within specifi ed
range
297 of 420
(70.7%)
399 of 420
(95.0%)
416 of 420
(99.0%)
Accuracy
5718657_CntrTS_Karajishi_UG_EN_FpBp_v0.indd 34 3/24/17 4:13 AM
35
Technical,
Service & Care
Technical Information
Table 3 – System accuracy results for glucose
concentrations between 2.0 and 24.6 mmol/L
Within ±0.83 mmol/L or ±15% 586 of 600 (97.7%)
Acceptance criteria in ISO 15197: 2013 are that
95% of the measured glucose values shall fall within
either ±0.83mmol/L of the average measured values
of the reference measurement procedure at glucose
concentrations <5.55 mmol/L or within ±15% at
glucose concentrations ≥5.55mmol/L.
User Accuracy
A study evaluating glucose values from fingertip capillary
blood samples obtained by 132 lay persons showed
the following results: 100% within ±0.83mmol/L of the
medical laboratory values at glucose concentrations below
5.55mmol/L and 95.6% within ±15% of the medical
laboratory glucose concentrations at or above 5.55 mmol/L.
Precision
A repeatability study was conducted with the CONTOUR
®
TS
blood glucose monitoring system using 5 venous
whole blood specimens with glucose levels from 2.2 to
18.3mmol/L. Multiple replicates (n=300) were tested using
multiple CONTOUR TS blood glucose meters and 3lots
of CONTOUR
®
TS blood glucose test strips. The following
precision results were obtained.
5718657_CntrTS_Karajishi_UG_EN_FpBp_v1.indd 35 4/3/17 9:17 AM
35
Technical,
Service & Care
Technical Information
Table 3 – System accuracy results for glucose
concentrations between 2.0 and 24.6 mmol/L
Within ±0.83 mmol/L or ±15% 586 of 600 (97.7%)
Acceptance criteria in ISO 15197: 2013 are that
95% of the measured glucose values shall fall within
either ±0.83mmol/L of the average measured values
of the reference measurement procedure at glucose
concentrations <5.55 mmol/L or within ±15% at
glucose concentrations ≥5.55mmol/L.
User Accuracy
A study evaluating glucose values from fingertip capillary
blood samples obtained by 132 lay persons showed
the following results: 100% within ±0.83mmol/L of the
medical laboratory values at glucose concentrations below
5.55mmol/L and 95.6% within ±15% of the medical
laboratory glucose concentrations at or above 5.55 mmol/L.
Precision
A repeatability study was conducted with the CONTOUR
®
TS
blood glucose monitoring system using 5 venous
whole blood specimens with glucose levels from 2.2 to
18.3mmol/L. Multiple replicates (n=300) were tested using
multiple CONTOUR TS blood glucose meters and 3lots
of CONTOUR
®
TS blood glucose test strips. The following
precision results were obtained.
5718657_CntrTS_Karajishi_UG_EN_FpBp_v1.indd 35 4/3/17 9:17 AM
34
CONTOUR
®
TS meter CONTOUR
®
TS test strips
Technical,
Service & Care
Technical Information
Technical Information
The CONTOUR
®
TS blood glucose monitoring system
was tested in 100 capillary blood samples using 600
CONTOUR
®
TS test strips. Two replicates were tested with
each of 3 lots of
CONTOUR TS test strips for a total of 600
readings. Results were compared to the YSI
®
glucose analyzer,
which is traceable to the CDC hexokinase method. The tables
below compare the performance of the 2 methods.
Table 1 – System accuracy results for glucose
concentration < 5.55 mmol/L
Difference range
in values between
YSI laboratory
reference method and
CONTOUR TS meter
Within ±
0.28 mmol/L
Within ±
0.56 mmol/L
Within ±
0.83 mmol/L
Number (and percent)
of samples within
specifi ed range
77 of 180
(42.8%)
145 of 180
(80.6%)
170 of 180
(94.4%)
Table 2 – System accuracy results for glucose
concentration ≥ 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
CONTOUR TS meter
Within ±
5%
Within ±
10%
Within ±
15%
Number (and percent) of
samples within specifi ed
range
297 of 420
(70.7%)
399 of 420
(95.0%)
416 of 420
(99.0%)
Accuracy
5718657_CntrTS_Karajishi_UG_EN_FpBp_v0.indd 34 3/24/17 4:13 AM
85718657_CntrTS_Karajishi_UG_EN_FpBp_v4_placed.pdf:36

Contour TS Specifications

General

Sample Size	0.6 μL
Test Time	5 seconds
Coding	No coding required
Memory	250 test results
Battery Life	Approximately 1000 tests
Measuring Range	0.6 to 33.3 mmol/L
Battery	1 CR2032 battery
Operating Temperature	5°C - 45°C (41°F - 113°F)
Weight	56.7 g (2 oz)