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Envision
Recorder
The recorder is used as a component of the Envision
System. The Envision
from the sensor, then sends it to the Envision
(app) through a Bluetooth
One-Press Serter
The One-press serter is used as a component of the Envision
Pro CGM System. The serter is used as an aid for inserting the Envision
indicated for single-patient use and is not intended for multiple-patient use.
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CareLink
for Professional CGM Systems
™
CareLink
for Professional CGM Systems is used as a component of the Envision
CGM System. CareLink
healthcare professionals, for the purpose of analyzing and displaying uploaded data. This
information is intended to supplement, not replace, blood glucose information obtained
using standard home glucose monitoring devices. The information may allow
identification of patterns of glucose-level excursions above and below a desired range,
facilitating therapy adjustments, which may minimize these excursions.
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Envision
Pro Mobile App
The app is used as a component of the Envision
serve as an interface to collect behavioral information such as meals and exercise. The
app will then collect information from the Envision
CareLink software.
Contraindications
None known.
Warnings
• Always refer to the Envision
guides for all contraindications, warnings, precautions, and instructions relating to the
sensor. Not referring to the user guide can result in serious injury to the patient or
damage to the component.
• No modification of the system components is allowed.
• This product contains small parts and may pose a choking hazard for young children.
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recorder connects to and receives data
™*
wireless connection.
™
for Professional CGM Systems is intended for use by
™
sensor, One-press serter, and Envision
™
Pro CGM
™
Pro application
™
™
Pro CGM system. It is intended to
™
recorder and send the data to the
-2-
Sensor
Recorder
™
sensor. It is
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Pro
™
recorder user