To Next Page

To Previous Page

Operator’s Manual 2 - 1

System Overview

2.1 Intended Use

For FDA region

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)

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:

EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANESTHETIC

MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS OXIDE

• According to the mode of operation:

Continuous operation

• Does the equipment has any defibrillation-proof applied parts:

Non-defibrillation-proof applied part

• Device signal input and output part:

Mindray TEX20 Operator's Manual

Other manuals for Mindray TEX20