The Mindray Nuewa I9 is a cart-based OB/GYN ultrasound system on the ZST+ platform, designed for women's and neonatal healthcare from pre-pregnancy to post-partum. Its tools include Smart Planes CNS for fetal CNS planes, Smart FLC for follicle counts and Smart Hip for DDH screening. Siblings include the Resona I9, positioned for general imaging, and the Nuewa I10, whose iZST+ platform evolved from ZST+.
- Released
- 2021launched by Mindray
- Display
- 23.8-inchplus 15.6-inch touch screen
- Weight
- 105 ± 4 kgstandard config, no probes
Compatible probes
Linear
- L14-3Ws
Convex & microconvex
- C11-3s
- SC6-1s
- SC8-2s
Endocavity
- V11-3Hs
Specialty
- SD8-1s Volume transducer
- DE11-3Ws Volume transducer
- ELC13-4s Biplane
Specifications
Display
- Display
23.8-inch bezel-less main screen; 15.6-inch full-HD touch screen with gesture operation23.8-inch bezel-less main screen; 15.6-inch full-HD touch screen with gesture operation; simultaneous dual-screen displayShow allShow less
Physical
- Weight
- 105 ± 4 kg, standard configuration, without probes
- Dimensions
Length 1020 ± 20 mm; width 550 ± 10 mm; height 1000 ± 20 mm (monitor and panel lowest)Length 1020 ± 20 mm; width 550 ± 10 mm; height 1000 ± 20 mm, with the monitor and control panel in their minimum position. Folds down to a minimum height of 1 m; body width 55 cm.Show allShow less
- Controls
iConsole panel, exam-specific layout, six E-ink keys; floating panel; QWERTY keyboardiConsole control panel with exam-specific adaptive layout and six customizable E-ink keys; full-space floating (adjustable) control panel; 15.6-inch touch screen with gesture operation; QWERTY keyboardShow allShow less
- Probe ports
- Raised ports for probe changes without bending; light indicators for probe activation
- Operating noise
- 26 dB
Power & battery
- Power
- 100–240 V AC, 50/60 Hz; 650 VA rated power consumption
- Battery
Optional; up to 4 hours continuous scanning; no less than 90 minutes normal workingOptional battery assembly: a single 14.4 VDC, 6600 mAh battery. Up to 4 hours of continuous scanning; no less than 90 minutes of normal working. Full charge from empty in less than 6 hours. Residual power shows when the right handle is grasped.Show allShow less
- Auxiliary outlet
- 300 VA maximum output
Connectivity & options
- Connectivity
10/100/1000M network port, HDMI, VGA output, high-speed USB; optional built-in wirelessNetwork port (10/100/1000M), HDMI, VGA output and high-speed USB; optional built-in wireless adapter, 802.11 ac/a/b/g/n, 2.4G/5GShow allShow less
- DICOM
- Optional: DICOM Basic, Worklist, MPPS, Query/Retrieve and OB/GYN SR, among others
- PCM-ES01 probe adapter
- Connects E-type probes (SD8-1E, P7-3TE, SC6-1E, SP5-1E) to the S-type system interface
- PCM-US01 probe adapter
- Connects U-type probes (P7-3TU, SP5-1U) to the S-type system interface
Imaging & software
- Imaging modes (cleared)
B, M, PWD, CWD, Color and Amplitude Doppler, Smart3D, 4D, iScape View, TDI, Color M, …Cleared under K240684 for the Resona I9 family of trade names, Nuewa I9 among them: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, combined modes (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D (real-time 3D), iScape View, TDI, Color M, Strain Elastography, contrast imaging with agents for left ventricular opacification and liver, V Flow, STE and STQ. A clearance-level list, not one unit's installed options.Show allShow less
- ZST+ platform
Channel-data-based processing: Total Recall Imaging, Sound Speed Compensation, …Channel-data-based processing; its named components are Total Recall Imaging, Sound Speed Compensation, Dynamic Pixel Focusing, Advanced Acoustic Acquisition, Enhanced Channel Data Processing and Powerful Processing ArchitectureShow allShow less
- 3D/4D presets
- Preset scenarios including Routine, iLive, Bone, Tissue and Follicle
- Smart Scene 3D
- Scenario-oriented volume scan technique
- iLive with Hyaline
- Volume rendering with multiple simulated light sources of variable intensity
- Smart Planes CNS
Automatic detection of fetal CNS planes (MSP, TCP, TTP, TVP) and measurementsAutomatic detection of fetal CNS planes (MSP, TCP, TTP, TVP) and measurements (BPD, HC, OFD, TCD, CM, LVW)Show allShow less
- Smart ICV
- Automatic fetal brain segmentation and fetal intra-cranial volume measurement
- Smart FLC
- Automatic follicle count and per-follicle volume from a 3D ovarian volume
- Smart-V Trace
Endometrial receptivity analysis, with vascular footprint and blood-flow intensityEndometrial receptivity analysis: detects weak-boundary structures such as the endometrium and assesses vascular footprint and blood-flow intensity in a target areaShow allShow less
- 4D HyCoSy
- 4D hysterosalpingo-contrast sonography for assessing fallopian tube patency
- Smart Pelvic
Standardized pelvic floor evaluation with auto acquisition of multiple parallel planesStandardized pelvic floor evaluation (anterior pelvic compartment or levator hiatus) with auto acquisition of multiple parallel planesShow allShow less
- Smart Hip
DDH screening with auto detection of hip structures and auto α and β measurement (Graf)DDH screening tool with auto detection of hip structures and auto measurement of α and β for Graf classificationShow allShow less
- Processor
- x86, 3.7 GHz (minimum hardware configuration)
- Storage
- 128 GB SSD + 1 TB HDD (minimum hardware configuration)
Environment
- Operating environment
- 0 °C to 40 °C; 20% to 85% relative humidity, no condensation; 700 hPa to 1060 hPa
Compliance
- FDA 510(k)
- K240684 (2024-06-17), K210699 (2021-06-10; Class II, product codes IYN, IYO, ITX)
What to check when buying a used Mindray Nuewa I9
Have a biomed run electrical safety tests
Long use can degrade a system's electrical and mechanical performance, including leakage and wear, and worsen image sensitivity and precision.
How: Ask for protective earth resistance, earth, enclosure and patient leakage, mains on applied part leakage and patient auxiliary readings, all measured with a safety analyzer.
Inspect each probe's head, cable and connector pins
A probe with a damaged or scratched surface or exposed wiring is an electric-shock risk and must not be used.
How: Look for cracks, swelling or peeling on the head, an eroded or deteriorated cable, bent or missing connector pins, and rough or sharp spots on any part that goes inside a patient.
Inspect the power cord, adapter and plug
The cord, adapter and plug carry AC power to the system, so cracks, looseness or a warm plug are electrical faults.
How: Look for wrinkles, cracks or deterioration on the cable, cracks or swelling on the adapter, broken, bent or discolored pins, damaged strain relief, and warmth at the plug in use.
Inspect the enclosure for cracks and spill residue
The system is not waterproof, and liquid sprayed on or into it can cause electric shock or damage.
How: Check the covers for cracks, the enclosure and accessories for fluid residue and loose or missing knobs, dials or terminals, the monitor and control panel for loose screws, and that every label is legible.
Common questions about the Mindray Nuewa I9
Is the Mindray Nuewa I9 FDA-cleared?
Yes. The Nuewa I9 is FDA-cleared as a trade name in 510(k) K210699, a Class II clearance decided June 10, 2021, with product codes IYN, IYO and ITX. It is also among the trade names in K240684, decided June 17, 2024.
What exams is the Mindray Nuewa I9 cleared for?
Under K210699 it is cleared for fetal, abdominal, pediatric and small-organ exams (breast, thyroid, testes), neonatal and adult cephalic, transrectal, transvaginal, musculoskeletal (conventional and superficial), adult and pediatric cardiac, transesophageal cardiac, peripheral vessel, urology and thoracic/pleural exams. The same indications are listed for every system in that clearance, the Nuewa I9 among them.
How is the Mindray Nuewa I9 different from the Resona I9?
The Nuewa I9 is positioned for obstetrics and gynecology, the Resona I9 for general imaging. Both are cleared under the same 510(k), K210699, a submission titled the Resona I9 series with the Resona 7 as main predicate, which also covers the Imagyn I9, Anesus I9, Eagus I9 and their variants.