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GEN blood glucose monitoring system
TECHNICAL INFORMATION
Specifications
Test Sample: Capillary whole blood only
Test Result: Referenced to plasma/serum glucose
Sample Volume: 0.6 μL
Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood
Countdown Time: 5 seconds
Memory: Stores most recent 800 test results
Battery Type: Two 3-volt CR2032 or DL2032 coin cell batteries,
225 mAh capacity
Battery Life: Approximately 1000 tests (1 yr. average use, 3 tests per day)
Meter Operating Temperature Range: 41°F–113°F
Control Testing Temperature Range: 59°F–95°F
Meter Operating Humidity Range: 10% RH–93% RH
Test Strip Storage Conditions: 41°F–86°F, 10%–80% Relative
Humidity (RH)
Dimensions: 78.5 mm (L) x 56 mm (W) x 18 mm (H)
Weight: 53 grams
Meter Use Life: 5 years
Sound Output: 45 dB(A)–85 dB(A) at a distance of 10 cm
Radio Frequency Technology: Bluetooth Low Energy
Radio Frequency Band: 2.4 GHz–2.483 GHz
Maximum Radio Transmitter Power: 1 mW
Modulation: Gaussian Frequency Shift Keying (GFSK)
Electromagnetic Compatibility (EMC): The
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GEN
meter complies with the electromagnetic requirements specified in
IEC 60601-1-2 Edition 4.0. Electromagnetic emissions are low and
unlikely to interfere with other nearby electronic equipment, nor are
emissions from nearby electronic equipment likely to interfere with the
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GEN meter.
Product Labeling Symbols
The following symbols are used throughout the product labeling for
the
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GEN blood glucose monitoring system (meter
packaging and labeling, and test strip and control solution packaging
and labeling).
Symbol
What It Means
Discard
Date:
Control Discard Date
Shake 15 times
The following symbols from the International Organization for
Standardization (ISO) and International Electrotechnical Commission (IEC)
are used throughout the product labeling for the
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GEN
blood glucose monitoring system (meter packaging and labeling, and test
strip and control solution packaging and labeling).
Symbol
Graphic/Title Explanatory Text
Standard
Reference
6-8
Catalog or
model number
Indicates the manufacturer’s
catalog number so that the
medical device can be identified.
ISO 15223-1,
Clause 5.1.6
Use-by date
Indicates the date after which the
medical device is not to be used.
ISO 15223-1,
Clause 5.1.4