Safety Guidelines and Precautions

The following are guidelines and precautions for the safe use and maintenance of your system.

• Application Specification

Overview of the intended use of the device, indications and contraindications for use, target populations, intended users and environments for use, and how it is used

• Safety Precautions

In the event of changes in the performance of the device

• Packaging and Disposal

Guidelines for retaining packaging, and disposal of hardware and batteries

• HIPAA and Privacy

Overview of HIPAA compliance

• Privacy Policy

Notice of privacy practices

• Disclaimer