MEDTRUM TECHNOLOGIES Inc. FM008 User Manual
Not all devices or accessories are available in all countries where the A7
TouchCare® System is approved. To order supplies, contact your local
representatives.
TouchCare® System is approved. To order supplies, contact your local
representatives.
1.2 Indications
The A7 TouchCare® System is indicated for use in people (ages 2 and older)
with diabetes. The system is intended for single patient use and should be
used under the guidance of a healthcare provider.
with diabetes. The system is intended for single patient use and should be
used under the guidance of a healthcare provider.
The Patch Pump is indicated for the continuous subcutaneous delivery of
insulin, at set and variable rates, for the management of diabetes mellitus in
persons requiring insulin.
insulin, at set and variable rates, for the management of diabetes mellitus in
persons requiring insulin.
The CGM System is indicated for continuous monitoring of interstitial fluid
glucose levels, and detecting possible low and high glucose episodes.
Interpretation of the CGM System results should be based on the glucose
trends and several sequential readings.
glucose levels, and detecting possible low and high glucose episodes.
Interpretation of the CGM System results should be based on the glucose
trends and several sequential readings.
1.3 Contraindications
The A7 TouchCare® System is not recommended for people who are unwilling
or unable to:
or unable to:
Maintain contact with their healthcare provider.
Test their blood glucose levels as recommended by their healthcare
provider.
provider.
Maintain sufficient diabetes self-care skills.
Recognize and respond to alerts and alarms. (Sufficient vision and/or
hearing are required.)
hearing are required.)