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TECHNICAL INFORMATION
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ONE blood glucose monitoring system
Specifications
Test Sample:
Capillary and venous whole blood
Test Result:
Referenced to plasma/serum glucose
Sample Volume:
0.6 μL
Measuring Range:
0.6 mmol/L–33.3 mmol/L 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:
5°C–45°C
Control Testing Temperature Range:
15°C–35°C
Meter Operating Humidity Range:
10% RH–93% RH
Dimensions:
97 mm (L) x 28 mm (W) x 14.9 mm (H)
Weight:
36 grams
Meter Life:
5 years
Sound Output:
45 dB(A)–85 dB(A) at a distance of 10 cm
Electromagnetic Compatibility (EMC):
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ONE
meter complies with the electromagnetic requirements specified in
ISO 15197: 2013. 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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ONE meter. The C
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ONE meter meets
the requirements of IEC 61000-4-2 for immunity to electrostatic
discharge. Avoid use of electronic devices in very dry environments,
especially if synthetic materials are present. The C
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meter meets the requirements of IEC 61326-1 for radio frequency
interference. To avoid radio frequency interference, do not use the
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ONE meter near electrical or electronic equipment
that are sources of electromagnetic radiation, as these may interfere
with the proper operation of the meter.
Symbols Used
The following symbols are used throughout the product labeling for
the C
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ONE blood glucose monitoring system (meter
packaging and labeling, and reagent and control solution packaging
and labeling).
Symbol
What it Means
Batch Code
Control Discard Date
Consult instructions for use
In Vitro Diagnostic Medical Device
Control Range Low
Control Range Normal
Control Range High
Shake 15 times
Recycle Packaging
Batteries must be disposed of in accordance with laws in
your country. Contact your competent local authority for
information on the relevant laws regarding disposal and
recycling in your area.
The meter should be treated as contaminated and
disposed of according to local safety rules. It should not be
disposed of with waste electronic equipment.
Contact your health care professional or local waste
disposal authority for medical waste disposal guidelines.
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