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GEN blood glucose monitoring system
LIMITATIONS
• Serious Illness: The system should not be used to test critically
ill patients and should not be used by persons with reduced
peripheral blood flow. Inaccurate results may occur in severely
hypotensive individuals, those dehydrated or patients in shock.
Inaccurate low results may occur for individuals experiencing a
hypoxia state, or a hyperglycemic-hyperosmolar state, with or
without ketosis.
3,4
• Meter Operating Temperature Range: 41°F–113°F
• Meter Storage Temperature Range: -4°F–149°F
• Meter Operating Humidity Range: 10% RH–93% RH
• Control Testing Temperature Range: 59°F–95°F
• Test Strip Storage Conditions: 41°F–86°F, 10%–80% Relative
Humidity (RH)
• Second-Chance
®
sampling conditions: Temperature Range
59°F–95°F, Hematocrit 20%–55%
• Sample Volume: 0.6 μL
• Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood
• Altitude: This system has not been tested at altitudes higher than
20,674 feet (6301 meters).
• Hematocrit:
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test strip results are not significantly
affected by hematocrit levels in the range of 20% to 55%.
• Xylose: Do not use during or soon after xylose absorption
testing. Xylose in the blood will cause an interference.
• Neonatal Use: The
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GEN meter is not
indicated for neonatal use.
• Keep batteries away from children. Many types of batteries are
poisonous. If swallowed, immediately contact your poison control
center.
• This device is not intended for use in healthcare or assisted-
use settings such as hospitals, physician offices, or long-term
care facilities because it has not been cleared by FDA for use in
these settings, including for routine assisted testing or as part of
glycemic control procedures.
• Use of this device on multiple patients may lead to
transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.
PRECAUTIONS
•
Read your
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GEN user guide, the lancing
device package insert, if provided, and all instructional
materials provided in your meter kit before testing. Follow
all instructions for use and care exactly as described to help
avoid inaccurate results.
• Examine the product for missing, damaged, or broken parts. If
the test strip bottle is open inside a new box of strips, do not use
those strips.
For replacement parts, contact Customer Service. See the
back cover for contact information.
• Your
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GEN meter works ONLY with
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test strips and
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control solution.
• Always keep the
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test strips in their original bottle.
Tightly close the bottle immediately after removing a test strip.
The bottle is designed to keep the test strips dry. Do not place
or store other items or medications in the test strip bottle. Avoid
exposing meter and test strips to excessive humidity, heat, cold,
dust, or dirt. Exposure to room humidity by leaving the bottle
open or not storing the strips in their original bottle can damage
your test strips. This could lead to inaccurate results. Do not use
a test strip that appears damaged or has been used.
