TECHNICAL,
SER
VICE & CARE
71
www.bayerdiabetes.com/us
Need Help? Call toll free: 1.800.348.8100 (available 24 hours a day, 7 days a week)
TECHNICAL,
SER
VICE & CARE
70
WARNING (Part 15.21)
Changes or modifications not expressly
approved by the party responsible for
compliance could void the user’s authority to
operate the equipment.
T
echnical Information
Federal Communications Commission (FCC) Certified Device
Technical Information
Federal Communications Commission
(FCC) Certified Device
This equipment has been tested and found to meet the
limits for a Class B digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in
a residential installation. This equipment generates,
uses and can radiate radio frequency energy and,
if not installed and used in accordance with the
instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation.
If this equipment does cause harmful interference to
radio or television reception, which can be determined
by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment
and receiver.
This portable transmitter with its antenna complies
with FCC/IC RF exposure limits for general population/
uncontrolled exposure.
If you have questions, please contact Bayer Diabetes
Care Customer Service at 1-800-348-8100 (available
24 hours a day, 7 days a week).
Within
± 5 mg/dL
Within
± 10 mg/dL
Within
± 15 mg/dL
Acceptance criteria in ISO 15197: 2003 are that 95% of
all differences in glucose values (i.e., between reference
method and meter) should be within 15 mg/dL for
glucose values less than 75 mg/dL, and within 20%
for glucose values greater than or equal to 75 mg/dL.
Accuracy
The C
ONTOUR
®
N
EXT
LINK blood glucose monitoring
system was tested by 110 lay users using capillary
blood samples and three C
ONTOUR
®
N
EXT
test strip
lots. The results were compared to the YSI
®
Glucose
Analyzer laboratory reference method, traceable to the
CDC hexokinase method. The tables below show how
well the two methods compare.
Table 1
— System accuracy results in lay users for
C
ONTOUR
N
EXT
LINK meter using C
ONTOUR
N
EXT
test strips at glucose concentration < 75 mg/dL
8 of 8
(100%)
8 of 8
(100%)
8 of 8
(100%)
Table 2
— System accuracy results in lay users for
C
ONTOUR
N
EXT
LINK meter using C
ONTOUR
N
EXT
test strips at glucose concentration ≥ 75 mg/dL
Within
± 5%
Within
± 10%
Within
± 15%
Within
± 20%
82 of 102
(80.4%)
101 of 102
(99.0%)
101 of 102
(99.0%)
102 of 102
(100%)
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