User's Manual

Intended Use and Essential Performance
Intended Use
These devices are indicated for digital imaging solutions designed to provide general
radiographic diagnosis for human anatomy including both adult and pediatric patients.
They are intended to replace lm/screen systems in all general-purpose diagnostic
procedures. This device is not intended for mammography or dental applications.
Essential Performance
For TRIMAX 43C, the intended use and the result of risk management, getting imaging
and function of data transmission is dened as essential performance.
Getting qualied dark image proves that essential performance does not inuence the
intended use. For the method of getting dark image, see the Installation and
Operation sections.
Application Specication
Patient Population
• Adult and pediatric patients
• Weight: not relevant
• Health: not relevant
• Nationality: multiple
• Patient state: patient is not user
• Gender: except for pregnant women
Pediatric Use: Guidance & Considerations
Special care should be exercised when imaging patients outside the typical adult size
range, especially smaller pediatric patients whose size does not overlap the adult size
range (e.g.less than 50 kg (110 lb) in weight and 150 cm (59 in) in height,
measurements which approximately correspond to that of an average 12 year old.
The following ranges of pediatric subpopulations are to be used as a guide for
manufacturers in developing medical devices:
Pediatric Subgroup Approximate Age Range
Newborn (Neonate) From birth to 1 month of age
Infant Greater than 1 month to 2 years of age
Child Greater than 2 to 12 years of age
Adolescent Greater than 12 through 21 years of age
Safety and Regulatory Information
AJ4312 | 2020-02-10 1-25