Safety
4-8
LOGIQ E9
–
User Guide
Direction 5454884-100 English
Rev. 1
Diagnostic information
The images and calculations provided by the system are
intended for use by competent users, as a diagnostic tool. They
are explicitly not to be regarded as the sole, irrefutable basis for
clinical diagnosis. Users are encouraged to study the literature
and reach their own professional conclusions regarding the
clinical utility of the system.
The user should be aware of the product specifications and of
the system accuracy and stability limitations. These limitations
must be considered before making any decision based on
quantitative values. If in doubt, the nearest GE Ultrasound
Service Office should be consulted.
Equipment malfunction or incorrect settings can result in
measurement errors or failure to detect details within the image.
The equipment user must become thoroughly familiar with the
equipment operation in order to optimize its performance and
recognize possible malfunctions. Applications training is
available through the local GE representative. Added
confidence in the equipment operation can be gained by
establishing a quality assurance program.
The system provides calculations (e.g estimated fetal weight)
and charts based on published scientific literature. The
selection of the appropriate chart and clinical interpretation of
calculations and charts is the sole responsibility of the user.
The user should consider contraindications for the use of a
calculation or chart as described in the scientific literature. The
diagnosis, decision for further examination, and medical
treatment must be performed by qualified personnel following
good clinical practice.
Be certain to ensure privacy data of patient information.
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