Mindray Resona R9 - System Overview; Intended Use; Contraindication; Safety Classifications

Operator’s Manual 2 - 1
2 System Overview
2.1 Intended Use
NOTE:
The system is not intended for central cardiovascular or central nervous system use.
Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates. It is intended for use in fetal, abdominal, Intra-operative, pediatric, small organ (breast,
thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal
(conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel,
urology 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, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast
imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver)
2.2 Contraindication
The diagnostic ultrasound system is not intended for ophthalmic use.
2.3 Safety Classifications
• According to the type of protection against electric shock:
Externally powered CLASS I 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 or particulate matter:
– The main unit is classified as IPX0
– The probe is classified as IPX7
– The footswitch (can be used in the operating room) is classified as IPX8
• According to the disinfection and sterilization method(s) recommended by manufacturer:
The devices recommended by the 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.