A06_Specification_40612127.pdf

• Next-generation micro-digital broadband beamformer

• Microfine 2D focusing with dynamic focal tuning

• Dynamic range up to 170 dB (full-time input)

• 65,536 digitally processed channels

• SonoCT real-time beam-steered compound imaging

• XRES adaptive image processing

• AutoSCAN: no-touch continuous intelligent optimization for 2D

• Gray shades: 256 (8 bits) in 2D

• Acquisition frame rate: up to 79 frames per second in high frame rate mode (dependent on field of view, depth and angle)

• Power save mode that automatically senses when you are not actively scanning and reduces frame rate then automatically resumes full rate when you resume scanning

• Tissue Harmonic Imaging

Ultrasound that will have at least these imaging modes in 2D:

• Microfine 2D focusing

• AutoSCAN

• Digital reconstructed zoom up to three times with pan capability with intuitive multi-touch control

• Cineloop image review (up to 10 second loop length)

• 256 (8 bits) discrete gray levels Philips microfine 2D focusing

• Intuitive “Pinch” to zoom and “Touch” to pan image

• Full-screen mode – Available in live-imaging or review

Color Doppler

• Gain 0 to 100 in steps of one

• Cineloop review

• Velocity display

• Touch-controlled color Region of Interest: size and position

• Touch-controlled color steering

• Maps, filters, color sensitivity, scale, line density, smoothing, echo write priority, color persistence, gain and baseline optimized automatically by preset

Pulse Wave Doppler

• Available on all transducers

• Available in all imaging exams

• Measurement tools for quantitative analysis

• iSCAN

M-mode

• Available on all transducers

• Time markers: 0.2 seconds

• Simultaneous live 2D image

The ultrasound will also need to have image optimization using:

SonoCT real-time compound imaging

• High precision beam-steered image compounding acquires additional tissue imaging information compared to orthogonal beams and reduces angle-generated artifacts

SPECIFICATIONS:

Part No. FUS6882 Description: 795005-L12-4, Lumify L12-4 Bundle (Included Components L12-4 Transducer, USB-C cable, Micro USB cable, User Manual, IFU, Carry Bag) QTY: 6 EA

SALIENT CHARACTERISTICS:

We are looking for ultrasound equipment that will support fisheries research. Needs of the ultrasound include:

• Enhanced needle visualization

• Multiple beam-steered lines of sight

• Operates in conjunction with harmonic and XRES imaging Tissue Harmonic Imaging

• System processing of second harmonic frequencies (nonlinear energy) in tissue

• Extends high performance imaging capabilities to most patient body types

• Available in 2D imaging mode

• Image display with reduced artifacts

XRES adaptive imaging processing

• Enhances images without altering the image resolution

• Reduces artifacts, enhances contrast resolution, visibility of tissue texture patterns and border definition

• Available in 2D, zoom, post-freeze and when capturing loops

• Applied to grayscale 2D image data

• Specifically optimized for each clinical application AutoSCAN intelligent optimization

• No-touch continuous intelligent optimization

• In 2D mode, automatically identifies tissue type and continuously adjusts TGC and receiver gain to achieve tissue uniformity and brightness

Full-screen mode

• Available in live-imaging or review

Also the ultrasound needs to allow for B-line detection in lung imaging

• Real-time B-line detection and count during lung imaging

• Automatic maximum B-line count over each cine loop

• Guided scan protocol for comprehensive lung exam (12 regions)

• User edit of B-line count

• Comprehensive lung exam summary page

Touchscreen interface is essential:

• Multi-touch user interface

• Alphanumeric QWERTY soft keyboard with Android voice recognition

• Imaging mode keys: 2D and color Doppler

• 2D image controls: depth, freeze, gain and power

• Depth to 30 cm (exam-specific)

• Measurements: 2D distance calculation; M-mode calculation

• Color Doppler controls: angle, scale (fast/slow flow) gain

• Image acquisition keys: review, save image and save loop

• Annotation controls: text and erase

Home screen must be simplified for quick access to scan, create a ‘patient’ profile with select presets with five clinical application presets including a user friendly main menu that can configure for cardiac image orientation.

The display information will need to have these components:

• On-screen display of all pertinent imaging parameters for complete documentation, including transducer type and frequency range, active clinical options and optimized presets, display depth, grayscale, color map, color scale, frame rate, 2D gain, color gain, color image mode and patient name

• Depth to 30 cm (exam-specific)

• Real-time display of Mechanical Index (MI)

• Real-time display of Thermal Index (TIb, TIc, TIs)

• Annotation text – places, moves, erases, modifies or appends typed text and arrows

• Annotation erased with start of new study

• On-display centerline marker aligned with transducer centerline marker

• End Exam – closes study and returns user to home screen for efficient workflow

• Network connectivity icon to allow immediate feedback about network condition

• Battery status icon and warning to allow immediate feedback about battery condition

(depending on compatible smart device chosen; preferred to be an iOS platform)

Ability for a Cineloop review containing:

• Acquisition, storage in memory, and display in real time of up to 10 seconds of 2D and color images

• Images for retrospective review and image selection

• Slide control of frame-by-frame image selection

• Functions in 2D and color Doppler imaging modes

When using the exam documentation needs are:

• Input and output ports (depending on compatible smart device chosen)

– USB port on smart device; uses include connecting the transducer, supporting data transfer and charging

– Some devices include video output*

– Wi-Fi/cellular; uses include DICOM networking, emailing exams and network shared drive connection for EMR

When using the ultrasound, connectivity will need to include:

• Patient data storage on device

• Configurable barcode reader software utilizing device camera

• DICOM modality worklist (query retrieve)

• Direct digital storage of single-frame color and B/W images to internal hard disk

• Direct digital storage of B/W and color loops to internal hard disk

• Ability to export in PC format (MP4 clips, PNG images) via email or direct connection to PC

• Extensive image management capability, including thumbnail image review

• Exam directory

• DICOM image store

• Export to network share drive

• User may email patient exams

• Option to configure patient data in the DICOM header and images (not DICOM tags), as well as anonymize

PC format images for exported images and loops

• Use Google AnyCast to mirror device screen to secondary display

• Use AnyCast universal Wi-Fi display receiver to mirror device screen to secondary display

• Modality Performed Procedure Step (MPPS)

• VISTA compatible

• Export of DICOM files to storage media.

• IPv6 compatible

• Transducer cable (USB C) included in package

• iOS compatible

Measurements include:

• Multiple distance calipers

• Ellipse tool

• 2-beat M-mode fetal heart rate calculation

• 4-measurement OB fetal growth/age calculation

– Based on Hadlock 1985

• Early fetal age measurement

– Crown-rump length (CRL)

– Gestational mean sac diameter (MSD)

The ultrasound will need to be integrated tele-ultrasound powered by Reacts enables a live ultrasound stream to be shared with another Reacts user on the system, mobile device, or computer for real-time collaboration:

• Face-to-face video sharing

• Live ultrasound streaming

• Two-way audio sharing

• Two-way virtual pointer

• Private encrypted network for HIPAA and PHIPA compliance

The Ultrasound will need to be a linear array, specifically a L12-4 broadband linear array with specifications of:

• Weight: 108 g/3.8 oz (without cable)

• Dimensions: 11.4 cm x 4.5 cm/4.5 in x 1.8 in (L x W)

• Automatically adjusted focal zone based on preset focal zone

• Continuous dynamic receive focusing

• 128 elements

• 4 to 12 MHz extended operating frequency range

• 34.5 mm field of view

• High resolution imaging for lung, musculoskeletal, soft tissue, superficial and vascular applications

• Supports 2D, color Doppler and Tissue Harmonic Imaging

• B-line detection in lung imaging

• Lightweight replaceable USB cable

Must contain electrical safety standards:

• IEC 60601-1, Medical Electrical Equipment:

General requirements for safety, including all applicable collateral and particular standards, as well as all applicable deviations

• IEC 60601-1-2, Collateral Standard, Electromagnetic compatibility – requirements and test

• IEC 60601-2-37, Particular Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

• ANSI/AAMI ES60601-1, Medical Electrical Equipment: General requirements for basic safety and essential performance

With these environmental standards:

• Home Healthcare standard (60601-1-11)

• EMT standard (60601-1-12)

• Military standard for helicopter – RTCA DO-160G

• CE Mark in accordance with the European Medical Device

Directive issued by British Standards Institute (BSI)