Mindray Eagus TEX21 - System Overview; Intended Use; Contraindication; Safety Classifications

Operator’s Manual 2 - 1
2 System Overview
2.1 Intended Use
For FDA region
This device is a general purpose diagnostic ultrasound system intended for use by qualified and
trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the
human body and fluid, which is intended to be used in a hospital or medical clinic.
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/
TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable
for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic,
fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular), Laparoscopic, pediatric,small
organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-
skeletal(conventional, superficial), Thoracic/Pleural (For detection of fluid and pleural motion/
sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined
mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic
Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast
agent for LVO), and Contrast imaging (Contrast agent for Liver).
NOTE:
The system is not intended for central cardiovascular or central nervous system use.
2.2 Contraindication
None.
2.3 Safety Classifications
• According to the type of protection against electric shock:
External powered class I equipment + internally powered equipment
• According to the degree of protection against electric shock:
Type-BF applied part
• According to the degree of protection against harmful ingress of water:
– The main unit is rated IPX0.
– The i3P and i3PA probes are rated IP68, other probes are rated IPX7.
– The foot switch (971-SWNOM(2-pedal) /971-SWNOM(3-pedal)) is rated IP68.
• According to the disinfection and sterilization method(s) recommended by manufacturer:
Equipment with disinfection and sterilization method(s) recommended by manufacturer.
• According to the degree of safety of application in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE: