Medtronic iPro2 User's Guide Page 6

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4 CGMS
®
iPro
TM
Continuous Glucose Recorder User Guide
Solutions
®
Software for CGMS
®
iPro
TM
Continuous Glucose Recorder (MMT-7319)
Optional components
The following optional components allow you to connect up to four serial devices to
your PC at once. For example, you can connect a meter and a COMLINK iPro to your PC
at the same time.
Manual serial data switch box (Part number: 1112058-003)
Serial interface cable for the manual serial data switch box (MMT-7324)
Indications for use
The CGMS iPro Digital Recorder is intended to continuously record interstitial glucose
levels in persons with diabetes mellitus. This information is intended to supplement,
not replace, blood glucose information obtained using standard home glucose-
monitoring devices. The information collected by the digital recorder may be
downloaded and displayed on a computer and reviewed by healthcare professionals.
This information may allow identification of patterns of glucose-level excursions above
or below the desired range, facilitating therapy adjustments which may minimize these
excursions.
The CGMS iPro Digital Recorder:
Is intended for prescription use only.
Will not allow readings to be made available directly to patients in real time.
Provides readings that will be available for review by physicians after the recording
interval (72 hours).
Is currently intended for occasional rather than everyday use.
Is to be used only as a supplement to, and not a replacement for, standard invasive
measurement.
Is not intended to change patient management based on the numbers generated, but
to guide future management of the patient based on response to trends noticed.
That is, these trends or patterns may be used to suggest when to take fingerstick
glucose measurements to better manage the patient.
The glucose sensor, tester, charger, and CGMS iPro Wand are intended for use with the
CGMS iPro Digital Recorder. The Sen-serter
®
device is indicated only for insertion of the
Medtronic MiniMed glucose sensor.
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