i-SENS Inc. GM01CAB Manual Do Utilizador
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INFORMATION: READ THIS FIRST!
To receive safe and optimum system benefits, please read the entire manual
contents before using the system. Please note:
• Do not use the system for the diagnosis of diabetes without the guidance of
a healthcare professional or for testing newborns.
• Use only fresh capillary whole blood samples for testing.
• Wash your hands before each measurement. If water is not available, use
disinfectant wipes with 70 % IPA only, dry your hands carefully.
• Milking of finger may affect result.
contents before using the system. Please note:
• Do not use the system for the diagnosis of diabetes without the guidance of
a healthcare professional or for testing newborns.
• Use only fresh capillary whole blood samples for testing.
• Wash your hands before each measurement. If water is not available, use
disinfectant wipes with 70 % IPA only, dry your hands carefully.
• Milking of finger may affect result.
The following chart explains the symbols you will find in Mendor SMART Blood
Glucose Meter’s user manual, product packaging, and product inserts.
Glucose Meter’s user manual, product packaging, and product inserts.
Warning: For personal use only. Do not share the device with other users.
IMPORTANT INFORMATION
• Mendor SMART Blood Glucose Monitoring System is intended for self-
testing and for outside of the body (in vitro diagnostic) use.
• The glucose in the blood sample mixes with special chemicals on the test
strip that produce a small electrical current through a reaction called glucose
oxidase. The meter detects this electrical current and measures the amount of
glucose in the blood sample.
• Mendor SMART Blood Glucose Meter is designed to minimize code relat-
ed errors in monitoring by using the no-coding function.
• The Mendor SMART Blood Glucose Meter should be used only with the Mendor
Test Strips.
• Severe dehydration and excessive water loss may cause false low results.
Very high (over 60%) or very low (under 20%) hematocrit can lead to inaccurate
test results. If you experience symptoms inconsistent with your test results after
following the instructions in this manual, contact your healthcare professional.
• Follow your local/country laws and regulations for proper disposal of the meter
including the rechargeable battery.
• Make sure to charge Mendor SMART Blood Glucose Meter for at least 3
hours before first use.
• When fully charged, Mendor SMART Blood Glucose Meter will have a stand-
by time of 3 days (8 measurements per day). The battery life-time is approximately
250 measurements. It is recommended that you charge Mendor SMART Blood
Glucose Meter battery at least every 2 days to prevent battery outage.
• If the meter fails to charge, please contact the manufacturer of the blood
glucose meter.
• If this user manual is not complied with the protection provided by the device
may be impaired.
• Mendor SMART Blood Glucose Meter’s Test Strips can be used up until the
expiration date printed on the test strip vial label if the test strips are used and
stored according to the storage and handling conditions presented in this man-
ual. For detailed storage and usage information for test strips, refer also to the
Mendor SMART Blood Glucose Meter’s Test Strip package insert.
• The equipment complies with applicable EMC emission requirements and it
is testes in dynamic electromagnetic fields according to ISO 15197. The equip-
ment is tested for immunity to electrostatic discarge as specified in IEC 61000-
4-2. Emissions of the energy used are low and not likely to cause interference
testing and for outside of the body (in vitro diagnostic) use.
• The glucose in the blood sample mixes with special chemicals on the test
strip that produce a small electrical current through a reaction called glucose
oxidase. The meter detects this electrical current and measures the amount of
glucose in the blood sample.
• Mendor SMART Blood Glucose Meter is designed to minimize code relat-
ed errors in monitoring by using the no-coding function.
• The Mendor SMART Blood Glucose Meter should be used only with the Mendor
Test Strips.
• Severe dehydration and excessive water loss may cause false low results.
Very high (over 60%) or very low (under 20%) hematocrit can lead to inaccurate
test results. If you experience symptoms inconsistent with your test results after
following the instructions in this manual, contact your healthcare professional.
• Follow your local/country laws and regulations for proper disposal of the meter
including the rechargeable battery.
• Make sure to charge Mendor SMART Blood Glucose Meter for at least 3
hours before first use.
• When fully charged, Mendor SMART Blood Glucose Meter will have a stand-
by time of 3 days (8 measurements per day). The battery life-time is approximately
250 measurements. It is recommended that you charge Mendor SMART Blood
Glucose Meter battery at least every 2 days to prevent battery outage.
• If the meter fails to charge, please contact the manufacturer of the blood
glucose meter.
• If this user manual is not complied with the protection provided by the device
may be impaired.
• Mendor SMART Blood Glucose Meter’s Test Strips can be used up until the
expiration date printed on the test strip vial label if the test strips are used and
stored according to the storage and handling conditions presented in this man-
ual. For detailed storage and usage information for test strips, refer also to the
Mendor SMART Blood Glucose Meter’s Test Strip package insert.
• The equipment complies with applicable EMC emission requirements and it
is testes in dynamic electromagnetic fields according to ISO 15197. The equip-
ment is tested for immunity to electrostatic discarge as specified in IEC 61000-
4-2. Emissions of the energy used are low and not likely to cause interference
Consult instructions for use
Caution, consult instructions for use
Temperature limitations
Use by
Do not reuse
Manufacturer
Batch code
In vitro diagnostic medical
device
device
Serial number
Recyclable package
Fragile
Keep away from sunlight
Do not use if package is
damaged
damaged
Sterilised using irradiation
Electric and electronic
waste
waste
Authorized representative
in the European community
in the European community