The Samsung HERA I10 is a women's health ultrasound system in Samsung's HERA family, with a built-in examination chair. It shares the HERA W10's platform, with an ergonomic redesign as a chair-type system. Its FDA clearance includes obstetrics, gynecology and urology, plus abdominal, pediatric and cardiac applications.
- Released
- 2019launched by Samsung
- Display
- LCD monitorLED backlight
Compatible probes
Linear
- L3-12A
- LA2-9A
- LA2-14A
Convex & microconvex
- CA1-7A
- CA2-9A
- CA3-10A
- CF4-9
Phased
- PA3-8B
- PA4-12B
- PM1-6A
Endocavity
- EA2-11AR
- EA2-11AV
Specialty
- CV1-8A Volume transducer
- EV3-10B Volume transducer
- EV2-10A Volume transducer
Specifications
Display
- Monitor
- LCD with LED backlight, 256 gray shades
- Touch screen
- Touch Gesture: rotate, zoom and move 3D images
Physical
- Dimensions
- Maximum 7.5 × 6 × 5.7 ft (230 × 183 × 175 cm), L × W × H, with built-in chair
- Built-in chair
Powered, adjustable WMH152 (iChair); independent, designed to be compatible with HERA I10Powered, adjustable built-in chair, model WMH152, marketed as iChair; an independent product designed to be compatible with the HERA I10Show allShow less
- Chair height
- 18.9 in (start position) to 38.6 in (maximum); wheelchair-accessible seat height
- Chair load rating
- Designed to withstand up to 440 lb (a chair rating, not system weight)
- Chair positions
Four programmable positions; named positions initial, abdominal, flat and lithotomyFour programmable positions; named positions initial, abdominal, flat and lithotomy (with foot stirrups); fully automatic chair movementShow allShow less
- Controls
Floating control panel, touch screen, hand remote, optional foot controllerFloating console; touch screen with Touch Gesture; Contextual Button (functions assignable to control panel buttons); QuickPreset (one-touch transducer and preset selection); hand remote control; foot controller (optional)Show allShow less
- Console features
- WideScreen, AmbientLight
- Transducer cable management
Transducer station and cable support arm; paper roll hangerTransducer station; cable support arm carrying most of the transducer cable's weight, with the cable coming from a higher position; paper roll hangerShow allShow less
- Example room layouts
- 11.8 × 11.8 ft and 11.8 × 10.2 ft
Power & battery
- Power
- 100–240 VAC, 1100 VA, 50/60 Hz
Connectivity & options
- Wireless
- WLAN adapter (accessory)
- Image sharing
SonoSync™ and HelloMom™ (both optional)SonoSync™ (optional): real-time image sharing to PC and smartphone with voice chat, text chat, real-time marking and MultiVue; an image sharing solution, not a diagnostic solution. HelloMom™ (optional): QR-code sharing of selected fetal imagesShow allShow less
- Accessories
- Digital Storage/Transfer Station, Foot Switch, ECG, Gel Warmer, WLAN Adapter
- Cybersecurity
Antivirus and firewall, secured OS, account management, audit trail, data encryptionSecurity tools (anti-virus and firewall), secured operating system, account management, enhanced audit trail, data encryption, transmission securityShow allShow less
Imaging & software
- Imaging modes
B, M, Color M; PW, CW, color, power and tissue Doppler; harmonics; 3D/4D; Elastoscan+B-mode, M-mode, PW Doppler, CW Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode, and combinations of these modesShow allShow less
- Imaging architecture
Crystal Architecture™: CrystalBeam™ beamforming, CrystalLive™ processingCrystal Architecture™: CrystalBeam™ (beamforming: Arbitrary Waveform Transmission, Massive Parallel Beamforming, Synthetic Aperture) and CrystalLive™ (2D image processing, 3D rendering, color signal processing), based on S-Vue Transducer™Show allShow less
- Beamformer
- 192
- Processing vs Samsung WS80A
- 3× GPU memory, 11× processing power, 10× data transfer rate
- 2D image processing
- ShadowHDR™, ClearVision, HQ-Vision™
- 3D/4D rendering
- CrystalVue™ (optional), RealisticVue™ (optional), HDVI™
- Flow imaging
- LumiFlow™ (optional), MV-Flow™ (optional), S-Flow™ directional power Doppler
- Measurement and analysis tools
- BiometryAssist™, Uterine Contour
- Optional measurement and analysis tools
- HeartAssist™, ViewAssist™, Slice A, 5D CNS+™, 5D Limb Vol.™, MPI+
- Functions in the US clearance
Q Scan, MultiVision, Needle Mate, Auto IMT+, S-Detect, CEUS+, E-Cervix and moreQ Scan, ClearVision, MultiVision, Panoramic, Needle Mate, Auto IMT+, Strain+, Elastoscan, E-Thyroid, E-Breast, E-Strain, S-Detect for Breast, S-Detect for Thyroid, ADVR, 3D Imaging (Volume Data Acquisition), 3D Imaging presentation, 3D Cine/4D Cine, 3D Rendering MPR, 3D XI MSV/Oblique View, Volume CT, 3D MagiCut, Volume Calculation (VOCAL, XI VOCAL), XI STIC, HDVI, Realistic Vue, CEUS+, HQ Vision, MV-Flow, Crystal Vue, CrystalVue Flow, 5D CNS+, 5D Follicle, 5D Heart Color, 5D Limb Vol, 5D LB, 5D NT, 2D NT, IOTA-ADNEX, BiometryAssit [sic], E-Cervix, Lumi-Flow, ShadowHDR, MPI+Show allShow less
Compliance
- FDA 510(k)
K190444, substantially equivalent May 22, 2019K190444, HERA I10 Diagnostic Ultrasound System: received February 25, 2019; substantially equivalent May 22, 2019; Class II, product codes IYN, IYO and ITX; predicate HERA W10 Diagnostic Ultrasound System (K182595)Show allShow less
- Electrical safety
- Evaluated to IEC 60601-1:2005+AMD1:2012
- US device model (GUDID)
- USS-HRI1F40/US
What to check when buying a used Samsung HERA I10
Run an electrical safety test at acceptance
The HERA I10 was evaluated for electrical safety to IEC 60601-1, and a used unit has to be tested again to show it still meets that standard.
How: Have a biomedical technician run the electrical safety test when the unit arrives and record the results, and reject a unit that fails any part of it.
Run the chair through every position and height
The powered chair moves the patient automatically between its programmable positions and through its height range, so a fault in its movement puts the patient at risk.
How: Send the chair to each stored position, including lithotomy, and from its lowest to its highest setting, and reject it if it strains, stalls, jerks or stops short.
Confirm MI and TI display in every mode
The HERA I10 displays the mechanical index and thermal index automatically in real time, and they are the operator's on-screen reading of acoustic output.
How: Scan in each imaging mode and confirm both indices appear on screen, treating a mode that shows only one or neither as a fault.
Check the ECG leads and trace, if equipped
ECG is an accessory on the HERA I10, and the system was evaluated with a defibrillation-proof ECG electrode.
How: If the unit has ECG, connect the leads and confirm a trace displays, and look for cracked insulation, exposed wire or damaged connectors on the cables.
Common questions about the Samsung HERA I10
Is the Samsung HERA I10 FDA-cleared?
Yes. The HERA I10 Diagnostic Ultrasound System is cleared under FDA 510(k) K190444, found substantially equivalent on May 22, 2019, as a Class II device with product codes IYN, IYO and ITX. Its predicate is the HERA W10 Diagnostic Ultrasound System (K182595).
The clearance lists fetal and obstetric, abdominal, gynecologic, pediatric, small organ, neonatal and adult cephalic, transrectal, transvaginal, musculoskeletal (conventional and superficial), urology, adult and pediatric cardiac, and peripheral vessel applications.
When was the Samsung HERA I10 released?
The HERA I10 was cleared by the FDA on May 22, 2019, and Samsung announced its US commercial availability on September 26, 2019; it was unveiled at SDMS 2019. Samsung had shown it as a chair-type prototype at the ISUOG World Congress in Singapore in October 2018.
How is the Samsung HERA I10 related to the HERA W10?
The HERA I10 shares the HERA W10's platform, redesigned as a chair-type system that combines the ultrasound system with a built-in examination chair. The HERA W10 is the predicate device in the HERA I10's 510(k), and the two use the same fundamental scientific technology.
In October 2020 the HERA series comprised the HERA W10, HERA I10 and HERA W9.
Which transducers are in the Samsung HERA I10's FDA clearance?
Its 510(k), K190444, names these transducers for use with the HERA I10: CA1-7A, CA2-9A, CA3-10A, CF4-9, CV1-8A, E3-12A, EA2-11B, EV3-10B, L3-12A, LA2-9A, LA4-18B, PA3-8B, PA4-12B, PM1-6A and VR5-9.
The HERA I10's features, options and transducers are not sold in every country, so a unit's transducers are worth checking against that list before a US purchase.
Is the Samsung HERA I10's chair a separate product?
Yes. The built-in chair shown with the HERA I10 is an independent product designed to be compatible with it, model WMH152, also marketed as iChair, so a HERA I10 can be offered with or without it. The chair is powered and adjustable, with four programmable positions and fully automatic movement.