Operator’s Manual 2 - 1
2 System Overview
2.1 Intended Use
For FDA region
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System is applicable for adults, pregnant
women, pediatric patients and neonates. It is intended for use in fetal, Laparoscopic, abdominal,
Intra-operative (abdominal, thoracic, and vascular), Pediatric ,small organ (breast, thyroid, testes),
neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal
(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic,
Thoracic/Pleural exams.
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.
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, Contrast imaging (Contrast agent for LVO),TDI,Color M, Smart 3D,Contrast imaging
(Contrast agent for Liver), and iScape View.
For Canada region
TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and
vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-esoph.
(Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology,
peripheral vessel, adult and pediatric cardiac, ophthalmic exams.
2.2 Contraindication
None.
2.3 Safety Classifications
• According to the type of protection against electric shock:
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 probes are rated IPX7
– The foot switch (can be applied in the operating room) is rated IPX8.
– The power adapter is rated IPX1.
• According to the disinfection and sterilization method(s) recommended by manufacturer:
Equipment with disinfection and sterilization method(s) recommended by manufacturer.
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