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English
Introduction
The Guardian 4 sensor is part of the
Continuous Glucose Monitoring (CGM)
system. The sensor converts small
amounts of glucose from the interstitial
fluid under the skin into an electronic
signal. The system then uses these
signals to provide sensor glucose
values.
Sensor assembly
Indications for use
The Guardian 4 sensor (MMT-7040) is intended to monitor glucose
levels for the management of diabetes for persons ages seven
years and older. It is indicated for use as an adjunctive device to
complement, not replace, information obtained from the standard
blood glucose monitoring devices. The sensor is intended for
single use and requires a prescription. The Guardian 4 sensor is
indicated for up to seven days of continuous use. Refer to the
system user guide for treatment decisions.
Contraindications
Refer to the system guide for contraindications associated with
Guardian 4 sensor use.
User safety
Warnings
Read this entire user guide before attempting to insert the
Guardian 4 sensor. The one-press serter (MMT-7512) is the only
serter approved for use with the sensor. Failure to follow directions,
or the use of a different insertion device, may result in improper
insertion, pain, or injury.
Do not attempt to connect a transmitter or recorder that is not
compatible with the sensor. The sensor is designed to work with
approved transmitters only. Connecting the sensor to a transmitter
or recorder that is not approved for use with the sensor may
damage the components. Refer to the system user guide for a list
of compatible products.
Do not use continuous glucose monitoring if hydroxyurea, also
known as hydroxycarbamide, is taken. Hydroxyurea is used to
treat certain diseases, such as cancer and sickle cell anemia.
Hydroxyurea use results in higher sensor glucose readings
compared to blood glucose readings. Taking hydroxyurea while
using continuous glucose monitoring can result in substantially
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