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Samsung HM70 EVO

Samsung Healthcare · HM series

PortableObstetrics & GynecologyCardiologyVascular

Samsung HM70 EVO portable ultrasound system

The Samsung HM70 EVO is a portable general-imaging ultrasound system with a 15-inch display, weighing about 6.0 kg with its battery. It is FDA-cleared for obstetrics, gynecology, abdominal, cardiac, peripheral vessel, lung and dermatology exams, with FAST presets for emergency medicine. An update to the HM70 line after the HM70A, it has a new battery design, CrystalLive processing and a magnesium case.

Released
2021first FDA clearance
Probe ports
2 on consoleup to 3 with optional cart
Display
15-inch LCD1024x768, LED backlight
Weight
approx. 6.0 kg13.2 lb, with battery

Compatible probes

Linear

  • LA2-9S Added in 510(k) K220269
  • LA3-16AD S-Vue Transducer
  • LN5-12
  • LS6-15 Added in 510(k) K220269

Convex & microconvex

  • C2-8
  • CA1-7AD S-Vue Transducer
  • CA2-8AD S-Vue Transducer
  • CA4-10M Added in 510(k) K210713

Phased

  • PA1-5A Added in 510(k) K220269
  • PA3-9B Added in 510(k) K220269
  • PN2-4
  • SP3-8 S-Vue Transducer

Endocavity

  • EVN4-9

Specialty

  • EV2-10A Volume (3D/4D)
  • VN4-8 Volume (3D/4D)
  • DP2B CW transducer

Specifications

Display
Display
15-inch LCD, LED backlight; 1024x768 (4:3); 16.7M colors; adjustable brightness
Physical
Weight
Approx. 6.0 kg (13.2 lb) including battery
Dimensions
Height 67.2 mm, width 383.5 mm, depth 355 mm
Construction
Magnesium case; wave-pattern exterior, honeycomb interior structureShow all
Controls
Backlit alphanumeric keyboard, trackball, dynamic software menu, user-programmable keys
Handle
Front handle on the console
Optional cart
Approx. 25 kg (55.1 lb); gas-lift height 823.0 to 1003.0 mm; 4 swivel wheelsShow all
Power & battery
Battery
Lithium-ion, 14.4 VDC, 6,900 mAh; approx. 75 min (60 to 90 min by use environment)
Power
Input 100-240 VAC, 3.5 A, 50-60 Hz; output 19 VDC, 10.5 A, 200 VA
Extended Power Pack (optional)
19 VDC, 10.5 A, 27.6 Ah; 216 x 368 x 100 mm (W x L x H); approx. 7.7 kg
Minimal Extended Power Pack (MEPP)
Additional portable power supply
Connectivity & options
Probe ports
2 on console (260-pin mini-DLP; pencil, optional); 3 extension ports on optional cartShow all
Ports
1 LAN (10/100/1000 BASE-T), 1 HDMI out, 4 USB; analog RGB or composite via VIDEO OUTShow all
DICOM
DICOM 3.0: Storage, Print, Worklist, PPS, SC, SR structured reports; optional
Storage
Integrated SSD, min. 256 GB, encrypted; 150,000 images (RAW); external USB 2.0/3.0 HDD
Export
JPEG, BMP, TIFF, DICOM, AVI, MPEG; to CD/DVD+R/-R/RW or USB flash; QuickSave to USBShow all
Security
SSD encryption, user accounts, audit trail, password control; secure EMR/DICOM transferShow all
ECG
USB ECG (AHA/IEC), optional; type CF
Peripherals
DVD-Multi drive; color and B/W video printers; laser and inkjet printers; USB foot switchShow all
Accessories
KeySkin cover, carrying case with shockproof cushion, CP-Skin, carrier bag, gel warmerShow all
System options
4D, 3D XI, XI STIC, Stress Echo, Strain+, Auto IMT+, ElastoScan, E-Strain, 2D NT and moreShow all
Imaging & software
Revision and software
Published software versions v1.01 and v1.02.00a
Computer platform
i3-8145UE processor or similar; 8 GB memory; Windows 10 64-bit
Boot time
Full boot max. 150 s, from sleep max. 60 s; approx. 85 s and 25 s on v1.02.00a
Imaging modes
2D, Color, Power, M, PW, CW, TDI, TDW, ElastoScan, S-Flow, 3D/4D, Dual/Quad and moreShow all
Frequency range
1 to 18 MHz
Imaging depth
2 to 38 cm, probe dependent
Image processing
Hybrid full digital beam-forming; Full Spectrum Imaging (max. 3 bands); 256 gray shadesShow all
Frame rate
Max. 2,000 fps; color max. 400 fps
Transmit focusing
Max. eight points, four selectable at once
Doppler velocity range
PW 0.1 cm/s to 8.8 m/s; CW 1 cm/s to 19.3 m/s
Cine and loop memory
Cine max. 45,000 frames; loop max. 14,000 lines
Imaging engine
CrystalLive: 2D image processing, 3D rendering and color signal processing
Image enhancement
ClearVision, S-Harmonic, MultiVision (option), HQ-Vision, Quick ScanShow all
S-Flow
Directional power Doppler showing blood flow intensity and direction
Elastography
ElastoScan mode; E-Strain strain ratio, optional; E-Strain+ optional on v1.02.00a
3D/4D tools
CrystalVue, RealisticVue, 3D XI, XI STIC, VOCAL, XI VOCAL, OVIX, MagiCut and moreShow all
Panoramic+
Extended-field panoramic view, optional
Measurement tools
StressEcho, Strain+ wall motion measurement, AutoIMT+ IMT measurement; all optional
OB/GYN tools
BiometryAssist; 2D Follicle; optional 2D NT, LaborAssist and 5D FollicleShow all
Needle visualization
NeedleMate+, optional
AI software
NerveTrack and UterineAssist, AI-based software functions
Presets
Over 30 user-programmable; Lung and FAST presets for emergency medicine
Workflow tools
EzExam+, EzAssist, EzCompare, QuickExam, QuickPreset, Full Screen Mode, Mobile ExportShow all
Environment
Operating
10 to 35 °C; humidity 30 to 75%; pressure 700 to 1060 hPa
Storage and shipping
-25 to 60 °C; humidity 20 to 90%; pressure 700 to 1060 hPa
Compliance
FDA 510(k)
K210713 (2021-07-09), K220269 (2022-05-06), K233112 (2023-12-21)Show all
Electrical safety
Class I (AC adapter, cart); internally powered (battery, EPP); BF probe, CF ECGShow all
Water ingress
IPX0 main unit; IPX7 probes; IPX8 footswitch
Languages
User interface
English, German, French, Italian, Spanish, Russian, Chinese, Portuguese

What to check when buying a used Samsung HM70 EVO

  1. Have electrical safety tested before you buy

    It is Class I equipment on its AC adapter and cart, and its probes and ECG module are applied parts that touch the patient, so a grounding or leakage fault puts patients at risk.

    How: Have a biomed run an electrical safety test on the adapter, the cart, every probe and any ECG module, and ask for the unit's maintenance records, since Japan classes it as a medical device that requires specified maintenance control.

  2. Look for liquid on the case and connectors

    The main unit has no protection against water, and a unit or connector that liquid has reached must not be used as it is.

    How: Look for dried liquid, staining or corrosion on the case, the keyboard and every probe connector, and treat any sign of liquid inside as a fault.

  3. Power it on and watch it start

    A unit that does not start up normally, or that makes an abnormal noise or gives off an abnormal odor, has a fault the buyer would inherit.

    How: Press the power button, confirm the system starts up and operates normally, and listen and smell for any abnormal noise or odor while it runs.

  4. Inspect the case for impact damage

    Tilting, vibration and shock, in use or in transport, can damage the system, so scratches or deformation on the magnesium case show how it was handled.

    How: Look over the case, its corners and the front handle for scratches, cracks, dents or deformation, and ask how the unit was packed for shipping.

Common questions about the Samsung HM70 EVO

Is the Samsung HM70 EVO FDA-cleared?

Yes. The HM70 EVO Diagnostic Ultrasound System is FDA-cleared under three 510(k)s: K210713, decided July 9, 2021; K220269, decided May 6, 2022; and K233112, decided December 21, 2023.

It is a Class II device, product code IYN, under regulation 892.1550.

What is the Samsung HM70 EVO FDA-cleared to scan?

Under its third clearance, K233112, it is cleared for fetal and obstetric, abdominal, gynecology, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), urology, adult and pediatric cardiac, trans-esophageal cardiac, peripheral vessel, lung and dermatology use.

Lung came with the first clearance, K210713, and dermatology with K233112.

What are the US model numbers of the Samsung HM70 EVO?

The US versions are USS-M7ENFC0/US and USS-M7ENL10/US, cleared under K210713; USS-M7ENFCB/US, under K220269; and USS-M7ENLCC/US, under K233112.

Does the Samsung HM70 EVO show the ElastoScan+ strain value in the US?

No. The ElastoScan+ strain value does not apply in the United States or Canada.

ElastoScan elastography is one of the system's cleared modes, and E-Strain strain-ratio calculation is an option.

Does the Samsung HM70 EVO have a DHA Authority to Operate?

Yes. The US Defense Health Agency's Authority to Operate (ATO) designation for the HM70 EVO was announced on April 12, 2023, together with the HS60 and V8.