User's Manual

Table Of Contents
Safety and Regulatory Information
AJ4310 | 2019-08-13 1–25
Intended Use and Essential Performance
Intended Use
TRIMAX 35C is indicated for digital imaging solutions designed for providing general
radiographic diagnosis of the human anatomy. It is intended to replace radiographic
film/screen systems in all general purpose diagnostic procedures. This panel provides
digital X ray imaging for diagnosis of disease, injury, or any applicable health problem.
The image is obtained as the result of an X-ray passing through the human body and
detected by detector.
Carestream would provide hardware and software support for system integration. This
panel is not intended for mammography and extra-oral X-ray applications.
Essential Performance
For TRIMAX 35C, the intended use and the result of risk management, getting imaging
and function of data transmission is defined as essential performance.
Getting qualified dark image proves that essential performance does not influence the
intended use. For the method of getting dark image, see the Installation and Operation
sections.
Application Specification
Patient Population
Age: except for children
Weight: not relevant
Health: not relevant
Nationality: multiple
Patient state: patient is not user
Gender: except for pregnant women
Intended Operator
All procedures should be carried out by an operator who has completed the professional
training offered by the company’s customer service staff.
Life Time
Lifetime: 7 years without frequency limit