Digital Colour Doppler IAEA Specification

Shared Service Ultrasound

System with Elastography Dated 2021-11-10

SPECIFICATION

Digital Colour Doppler Shared Service Ultrasound System with Elastography

for several countries (Type 2)

1. Scope
This specification describes the requirements for Digital Colour Doppler shared
service ultrasound machine systems including 1) Convex Probe with biopsy and 2)
Linear Probe with biopsy and 3) endocavitary probe designed to serve a wide range
of clinical applications with imaging for radiology, cardiac and vascular applications
(hereinafter referred as the “System”). The Sysrem will be used for general imaging
with elastography/ tissue contrast enhancement technology features for cardiac,
abdomen, prostate, OB-GYN, Muskulosleletal, thyroid and breast imaging
capabilities.
The System will be installed at the end-user facility (hereinafter referred as the “End-
User”) in:
• Al-Bashir Hospital, Jordan;
• Central Public Health Laboratory, Ministry of Health, Palestine.

2. Applicable Documents
The following documents shall be applicable for this Specification to the extent
specified hereinafter:
System designed and built to perform shared service ultrasound machine system.
for general imaging with elastography/ tissue contrast enhancement technology
features for cardiac, abdomen, prostate, OB-GYN, Muskulosleletal, thyroid and
breast imaging capabilities.
“In the event of conflict between the documents listed above and the content of this
Specification, the content of this Specification shall take precedence to the extent
of the conflict.”

3. Definitions, Acronyms, and Abbreviations

The following definitions, acronyms, and abbreviations shall apply throughout this
Specification unless defined otherwise hereinafter:
B-mode ultrasound - Brightness-mode
dB - Decibels
OB/GYN- Obstetrics/ Gyencological
PW - Pulsed wave
M-mode- motion mode
US - Ultrasound
2D- Two dimensional

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Digital Colour Doppler IAEA Specification
Shared Service Ultrasound
System with Elastography Dated 2021-11-10

4D- Four dimensional

4. Requirements
4.1. Functional and Performance Requirements
The System shall meet the following functional and performance requirements:
4.1.1. Provide adequate image quality support for several applications;

4.1.2. Provide adequate 2D & Doppler image quality;

4.1.3. Perform cardiology as well as women’s health and radiology
applications/exams including:
4.1.3.1. Abdominal;
4.1.3.2. Women's Health Care (gynecology and & breast);
4.1.3.3. Obstetrics;
4.1.3.4. Small Parts (Breast, Thyroid, Testi);
4.1.3.5. Muskuloskeletal/Anesthesiology;
4.1.3.6. Pediatrics
4.1.3.7. Urology (Renal, Prostate);
4.1.3.8. Interventional Cardiology
4.1.3.9. Surgery;
4.1.3.10. Contrast Imaging _ General Imaging (Low MI);
4.1.3.11. Contrast Imaging _ Cardiac (High or Low MI);
4.1.3.12. Bowel Imaging; and
4.1.3.13. Strain Elastography.

4.1.4. Capable of 4D imaging for OB/GYN applications;

4.1.5. Provide excellent ergonomics and workflow;
4.1.6. Capable of providing the following imaging modes or equivalent:
4.1.6.1. 2D, M mode;
4.1.6.2. M-color Flow Mode;
4.1.6.3. Anatomical M-mode;
4.1.6.4. Trapezoidal Mode;
4.1.6.5. Color, Power Angio, Pulse Wave Doppler;
4.1.6.6. Bi-directional Power (=HD FLOW);
4.1.6.7. SCW Doppler;
4.1.6.8. Tissue Doppler(Velocity) Imaging;
4.1.6.9. Freehand 3D;
4.1.6.10. Live 3/4D OB/GYN;
4.1.6.11. Spatio-Temporal Image Correlation;
4.1.6.12. Stress Echo;
4.1.6.13. Strain and Strain Rate (Cardiac);
4.1.6.14. Panoramic Imaging;
4.1.6.15. Contrast Imaging – Cardiac;
4.1.6.16. Contrast Imaging - General Imaging; and
4.1.6.17. Strain-based Elastography.

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Digital Colour Doppler IAEA Specification
Shared Service Ultrasound
System with Elastography Dated 2021-11-10

4.2. Technical Requirements

The System shall meet the following technical requirements:
4.2.1. Monitor up to 21.5” with image resolution of minimum full HD resolution
1024x768 pixels with touch screen and tilt/rotate capabilities;
4.2.2. 4 active transducer ports, (1) DICOM (1) Ethernet port (1) HDMI port (1)
USB port;
4.2.3. Minimum of three probes to provide support for general imaging,
including Adult abdomen, renal, obstetrics, and gynecology:1) Convex
Probe with biopsy, 2) Linear Probe with biopsy and 3) endocavitary probe
each configuration ranging from 2 – 18 MHz; Additional probe types can be
provided as options;
4.2.4. Quantification set and related software for processing images from depth
of 1 cm to 30 cm;
4.2.5. Distributed multi-core processing architecture;
4.2.6. Up to 280 dB digital broadband acoustic beamforming;
4.2.7. Up to 4,718,592 total digital channels;
4.2.8. Exam Pre-sets: Shall be able to store at least user specific Image pre-
sets;
4.2.9. PC – based operating principles. With up to 512 GB storage
capacity;
4.2.10. DVD+RW drive;
4.2.11. WiFi DICOM enabled;
4.2.12. Height: up to 64 inches maximum, Width: up to 30 inches, Depth:
up to 42 inches; and
4.2.13. Voltage: 100V-240V, Frequency 50/60 Hz.

5. Marking
The System shall have all safety markings in English language or in Arabic.

6. Packing
The System, for the shipment by air to the End-User, shall be packed in
accordance with international standards that are applicable for the shipment by
air of this kind of equipment.

7. Quality Requirements
7.1. The System shall be manufactured, shipped and installed in accordance with
the Contractor’s ISO quality assurance system or an equivalent quality
assurance system.
7.2. The Contractor shall document the compliance with this quality assurance
system.

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 Digital Colour Doppler IAEA Specification
Shared Service Ultrasound
System with Elastography Dated 2021-11-10

7.3. A quality certificate might be requested at any given time of the technical
evaluation.

8. Testing and Acceptance

8.1. The System, prior to shipment, may be tested at the request of the IAEA by
designated agents for conformance of the System with manufacturer’s
performance specifications and the minimum requirements specified herein.
8.2. The System, after installation, shall be tested by the Contractor together with
the End-User to demonstrate that the performance meets the manufacturer’s
performance specifications and the minimum requirements specified herein as
determined by the IAEA and the End-User.
8.3. The results of the testing of the System shall be documented by the Contractor
in an acceptance protocol that shall be signed by the End-User.

9. Support Plan

The Contractor shall provide a clear support plan most appropriate for the End-
User with full contact details for customer and technical support (after-sales
services). In-country support is very important; in the absence of in-country
support, the plan must include relevant information for regional support. The
plan must identify timely access to relevant spare parts (and associated
consumables), availability and promptness of telephone and/or electronic
communication, and proximity of service.

10. Installation and Training

The Contractor shall install the System at the End-User’s location.
The Contractor shall provide onsite applications training for up to five staff of the
End-User in the operation and maintenance of the System as well as in the safe
operation procedures at the End-User’s location immediately after the
installation of the System. At the end of the training, the Contractor shall issue
a personal training certificate with the description of the topics covered to each
training trained staff.
A pre-recorded video training course shall also be included in the package.

11. Deliverable Data Items

The Contractor shall provide four complete sets of operation and servicing
manuals, safe operating guidelines and technical drawings in the English
language or in Arabic.
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