Table of Contents
Advertisement
•
•
•
•
•
•
•
Contraindications and Warnings
Contraindications
(1)
Do NOT use the ASUS Ultrasound Imaging System to do following situations then result in the
produce images with inaccurate results:
-
Patients who have had surgery, which may have changed the composition of the examining
tissue, as this could skew or alter the measured density.
-
Patients whose bodies contain foreign artifacts (for example, implants), in the examining
tissue.
-
Intra-operative use (e.g., defined as introducing a System into a surgical incision or burr hole).
-
Ophthalmic use or any use causing the acoustic beam to pass through the eye.
-
At the scene of an emergency outside of a professional healthcare facility.
-
During transportation of a patient to a professional healthcare facility, or between
professional healthcare facilities.
-
Try imaging on an open wound.
The patient's diagnostic environment in circumstances may negatively
impact the system and the exam. For example: (1) Chemicals and gases in
the operating room. (2) Altitudes below -382 m or above 4000 m.
Biological incompatibility may exist between the system materials used
and the biological tissues, cells, and body fluids of the patient/user, taking
account of the intended purpose of this system.
Using this system in the patient environment may be unsafe if the following
conditions exist: (1) Extremes in humidity (RH<15% and RH>90%). (2)
Ambient temperatures that are excessively high (35°C / 95°F) or excessively
low (0°C / 32°F).
Fragile patients, such as children and pregnant/nursing women, may be
more prone to the exposure of acoustic energy when this system is used
for prolonged periods.
Do not use in a patient who would be harmed caused by applying
ultrasound (example: implanted pace-maker)
The patients are not the users (not relevant) only used by related experts.
Users will be trained medical professionals (e.g., doctors, nurses,
technicians) with previous training in ultrasound. Images produced by this
system are transmitted wirelessly to the user's smart device (tablet or
smart phone).
Untrained/unqualified users purchasing and using this system may unable
to measure up quality images.
P17
Advertisement
Table of Contents
