2
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.
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.
1.3 Contraindications
The A7+ TouchCare® System is not recommended for people who are unwilling
or unable to:
Maintain contact with their healthcare provider.
Test their blood glucose levels as recommended by their healthcare
provider.
Maintain sufficient diabetes self-care skills.
Recognize and respond to alerts and alarms. (Sufficient vision and/or
hearing are required.)
1.4 User Safety
1.4.1 Warnings and Precautions
General Statements
Make sure that you have read and are familiar with the User Guide before using
the A7+ TouchCare® System . Failure to follow the instructions may result in pain
or injury and may also affect the system’s performance. If you do not
understand something or have questions, ask your healthcare provider, call
customer support, or contact your local Medtrum distributor.
The A7+ TouchCare® System has many different settings and features. It is best
to talk with your healthcare provider to determine which settings and features
are right for you. Some features require great knowledge of insulin pumping and
advanced self-care skills. Do NOT use the A7+ TouchCare® System until you have
specific information for your treatment plan and have had specific training on
each feature from your healthcare provider or local Medtrum distributor.
B ureau Veritas
Summary of Contents for TouchCare A7+
Page 1: ...B u r e a u V e r i t a s ...
Page 24: ...13 B u r e a u V e r i t a s ...
Page 25: ...14 B u r e a u V e r i t a s ...
Page 29: ...18 B u r e a u V e r i t a s ...
Page 81: ...70 B u r e a u V e r i t a s ...
Page 125: ...114 B u r e a u V e r i t a s ...