What to know before using the System:
•
Review all product information before use.
•
Take standard precautions for transmission of blood borne pathogens
to avoid contamination.
•
Make sure that your devices and Sensor kits are kept in a safe place, and
maintain your devices under your control during use. This is important
to help prevent anyone from accessing or tampering with the System.
Who should not use the System:
•
Do not use the System in people less than 4 years of age.
The System
is not cleared for use in people under 4 years of age.
•
Do not use the System if you are pregnant, on dialysis, or critically
ill.
The System is not cleared for use in these groups and it is not known
how different conditions or medications common to these populations
may affect performance of the System.
•
Performance of the System when used with other implanted medical
devices, such as pacemakers, has not been evaluated.
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