7
Safety Information
6
Indications for Use & Statement and Advisory
I. INDICATIONS FOR USE & STATEMENT AND ADVISORY
INDICATIONS FOR USE
The RIGHTEST Continuous Glucose Monitoring System (hereafter referred to as the "RIGHTEST
CGMs") is indicated for detecting glycaemia trends and for the management of diabetes in persons
age 18 to 80. It's an applied part and it is designed to replace blood glucose testing for diabetes
treatment decisions. Interpretation of the RIGHTEST CGMs results shall be based on the glucose
trends and several sequential readings over time. It also aids detecting episodes of hyperglycemia
and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The RIGHTEST CGMs is also intended to autonomously interface with digitally connected devices.
The RIGHTEST CGMs can be used alone or in conjunction with these digitally connected devices for
the purpose of managing diabetes.
STATEMENT AND ADVISORY
This manual is designed to instruct all personnel responsible for the proper use and care of the
RIGHTEST CGMs. All users are urged to carefully read this manual before using the system.
II. SAFETY INFORMATION
The following is a summary of safety information which must be observed before using the
RIGHTEST CGMs. WARNING indicates potential danger to user. PRECAUTION indicates potential
injury to the user or damage to the system. To minimize risks, read the following safety information
before using the system. Improper use and maintenance may damage the system resulting in failure
or user injury. It is important to understand that the safety information is not exhaustive. It is meant to
keep the user safe while using the system.
If you are in the serious incidents caused by the RIGHTEST product, please call local emergency
service for help. Please feel free to report your incident to us and the local competent authority.
WHEN NOT TO USE (CONTRAINDICATIONS) :
No MRI/CT/Diathermy:
The RIGHTEST CGMs (sensor, transmitter, Receiver and/or other
receiving devices) must be removed prior to Magnetic Resonance Imaging (MRI), Computed
Tomography (CT), or high frequency electrical heat (diathermy) treatment.
Summary of Contents for HM312
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