The Mindray DC-40 is a shared-service primary care ultrasound system for general imaging, OB/GYN and cardiology. The DC-40 with Full HD pairs a 21.5-inch LED monitor with a 13.3-inch touch screen and has four active transducer ports. Mindray launched the DC-40 in 2016, and its FDA clearances share one device name with the DC-35, DC-45, DC-40S and DC-40 Pro.
- Released
- 2016launched by Mindray
- Probe ports
- 4active transducer ports
- Display
- 21.5-inchFull HD LED monitor
Compatible probes
Linear
- 7L4A
- 7L4B
- L7-3
- L13-3
- L14-6NE
Convex & microconvex
- 3C5A
- C6-2
Phased
- P4-2
- P10-4E
Endocavity
- V11-3
- DE11-3E 4D, transvaginal
- CB10-4E Biplane
- 6LB7 Biplane, transrectal
Specialty
- D7-2 4D, body surface
- D7-2E 4D, body surface
Specifications
Display
- Monitor, DC-40 with Full HD
- 21.5-inch Full HD LED monitor, 180° rotation
- Touch screen, DC-40 with Full HD
- 13.3-inch slim Full HD LED touch screen, 30° rotation
- Touch screen quick-access bar
- Most-used applications in a bar on the right side of the touch screen
- Monitor, 2017 specification
- 17-inch LED monitor
- Touch screen, 2016–2017 specification
- 10.4-inch touch screen
Physical
- Control panel
- Rotatable, height-adjustable integrated control panel, designed to be easy to disinfect
- Keyboard
- Retractable QWERTY keyboard
- Transducer ports
- 4 active transducer ports
- Transducer holder and cable management
- Dedicated endocavity transducer holder; transducer cable management structure
- Gel warmer and storage
- Gel warmer; storage plate
Power & battery
- Battery (iPower)
- Built-in battery: more than 80 minutes of scanning without external power
- Power supply
- Power supply class B: runs on urban power as well as hospital (class A) power
Connectivity & options
- iStorage and MedSight
- Transfers clinical images to a PC or smartphone
Imaging & software
- Imaging modes
B, M, PW, CW, Color, Power/Dirpower, THI, 3D/4D, iScape, TDI, Color M, elastographyB-mode, M-mode, PW mode, CW mode, Color mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, biopsy guidance and elastography, with combined modes B+M, PW+B, Color+B, Power+B, PW+Color+B and Power+PW+B; contrast imaging with a contrast agent for the liverShow allShow less
- Image optimization
- iClear speckle reduction, PSH (Phase Shift Harmonic imaging), iBeam spatial compounding
- iTouch
- One-key image optimization in B-mode, color Doppler and spectral Doppler
- One-Touch Switch
- Changes imaging mode with a single keystroke
- Raw Data
- Image adjustment, measurements and other functions on stored data after the exam
- Advanced applications
- Natural Touch Elastography, UWN+ (CEUS), TDI QA, iWorks
- 4D imaging
- iLive 4D imaging (requires the 4D module or Smart 3D) and iPage
- Dual-Volume
- Convex and endocavity volume transducers with application packages for 4D women's care
- Auto measurements
- Auto IMT, Auto LV, Auto PW trace and calculation
- Smart tools
Smart OB, Smart NT, Smart FLC, Smart Face, Smart Bladder, Smart Track, Smart VSmart OB (automatic calculation of BPD, OFD, HC, AC and FL); Smart NT; Smart FLC (automatic count and volume of ovarian follicles from a 3D volume data set); Smart Face (one-touch optimization of the fetal face rendering); Smart Bladder (automatic bladder-volume calculation); Smart Track (one-touch optimization of Color, Power and PW spectrum for vascular imaging by self-tracking); Smart VShow allShow less
- IVF Package
- Documentation of follicle and endometrial measurements
- Urological solution
- Biplane transducers: linear/convex and dual micro-convex
- ComboWave transducers
Composite piezoelectric material to optimize acoustic spectrum and reduce impedanceComposite piezoelectric material to optimize the acoustic spectrum and reduce acoustic impedanceShow allShow less
- iScanHelper
- Built-in educational tool giving scanning guidance
- Applications at the April 2016 launch
Natural Touch Elastography, 4D with iLive and iPage, UWN Contrast Imaging, TDI and TDI QANatural Touch Elastography, 4D imaging with iLive and iPage, UWN Contrast Imaging, TDI and TDI QA, Free Xros M and Free Xros CM, Auto IMTShow allShow less
Compliance
- FDA 510(k)
K162845 (December 15, 2016); K183377 (April 4, 2019)K162845 (decision date December 15, 2016) and K183377 (decision date April 4, 2019; FDA's letter of April 9, 2019 corrects the April 4 letter), both for the DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System; Class II, 21 CFR 892.1550, product codes IYN, IYO and ITXShow allShow less
- EMC certification
- CB test certificate, Ref. No. FI-31332 (DC-40 with Full HD)
- Battery certification
- CB test certificate, Ref. SG PSB-BT-00022
What to check when buying a used Mindray DC-40
Check grounding, leakage current and the power cord
A multi-outlet receptacle can compromise the system's grounding and push leakage current past safety limits, and the system is meant to run on the power cord Mindray supplies with it.
How: Confirm Mindray's power cord comes with the unit, plug it straight into a wall outlet rather than a power strip, check the equipotential terminal on the power supply panel, and have a biomed run an electrical safety inspection before first patient use.
Look for signs of liquid inside the system
The system is not waterproof, and water sprayed on or into it can cause an electric shock.
How: Look around the control panel, keyboard and ports for dried residue, stains or corrosion, and ask how the unit was cleaned and disinfected.
Inspect every probe's lens, cable and connector
A probe damaged by a knock or a drop can give the patient an electric shock.
How: Look for peeling, cracks, protruding parts or a loose acoustic lens on the probe face and cable sheath, and for residue or corrosion on the connector, which is not waterproof and must never be immersed.
Confirm the ECG leads came with the module
ECG leads other than those supplied with the ECG module can cause an electric shock.
How: On units with the ECG module, check that the leads are the ones supplied with it and that an ECG trace displays when they are connected.
Common questions about the Mindray DC-40
Is the Mindray DC-40 FDA-cleared?
Yes. It is cleared under 510(k) K162845, decided December 15, 2016, and K183377, decided April 4, 2019.
Both clearances name the DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System, a Class II device under 21 CFR 892.1550 with product codes IYN, IYO and ITX.
What exams is the Mindray DC-40 cleared for?
Under K162845 it is cleared for fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, transrectal, transvaginal, musculoskeletal (conventional and superficial), adult and pediatric cardiac, and peripheral vessel exams.
K183377 adds urology as a new indication, and its indications also list contrast imaging with a contrast agent for the liver.
Which models share the Mindray DC-40's FDA clearance?
Both clearances name one device covering five models: the DC-40, DC-35, DC-45, DC-40S and DC-40 Pro.
K162845 names the DC-N3 (K140030) as its predicate device, with the same intended uses.