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COMPLIANCE MATRIX FOR TECHNICAL PROPOSAL

RFQ NO. AND TITLE


Ref. Specification - Jamaica Compliant Bidder’s Comments
Yes/No
4 Functional and Performance
Requirements

4.1.1 Ultra-fast cardiac acquisition with


hardware and software to reduce patient
dose and exam time to up to 4 minutes
(the Contractor shall describe their
technique);
4.1.2 Be capable of combining a variable
angle and variable geometry dual-head
SPECT gamma camera with diagnostic
CT scanner;
4.1.3 Be capable to obtain independently
SPECT and CT images or both in
combination (SPECT/CT);
4.1.4 Be capable to perform non-uniform
attenuation correction using CT
attenuation maps acquired in the same
system, for cardiac and general SPECT
imaging;
4.1.5 At least two (2) processing/viewing
stations shall be included;
4.1.6 Be fully compatible with the End-
User’s currently available
PACS/DICOM system;
4.1.7 Have high resolution, parallel hole,
pinhole, low, medium and high energy
collimators. Collimator cart/trays must
be included;
4.1.8 Have ECG trigger capabilities and
be able to acquire all general SPECT,
planar, static, dynamic acquisitions and
CT;
4.1.9 Include a full software package of
diagnostic software;
4.1.10 Include all software packages to
allow for fastest acquisition for cardiac
SPECT and SPECT/CT both gated and
non-Gated;
4.1.11 Software shall have
programmability and support to allow
user defined programs to be developed,
example: MPE capability and utilize pt.
data;
4.1.12 The acquisition protocols shall
support all identified processing
programs;
4.1.13 Have adequate connection and
compatibility to colour and film printer;
4.1.14 Allow fusion with PET, MR
and/or CT data from external PACS
access

4.2 4.2.1. Detectors:


4.2.1.1 Two rectangular detectors with
NaI(Tl) scintillation crystals;
4.2.1.2 Detector crystal thickness of 5/8
in (15.9 mm);
4.2.1.3 UFOV of (38 to 39)cm x (51 to
53) cm;
4.2.1.4 At least 55 high quantum
efficiency PMT per each head,
characterized by energy resolution,
magnetic shielding and long-term
stability, with 1 ADC/PMT;
4.2.1.5 Be able to image at energies
between 60 - 511 keV, including the
possibility to acquire the data in multiple
energy windows, both centred on photo
peak and offset;
4.2.1.6 Detectors shall be adequately
shielded;
4.2.1.7 At least one of the two detectors
shall allow for caudal/cephalic tilt.

4.2.2. Collimators:
4.2.1.1 One set of Low Energy (Tc-99m)
High Resolution collimators;
4.2.1.2 One set of Medium Energy (In-
111, Ga-67, Lu-177) General Purpose
collimators;
4.2.1.3 One set of High Energy (I-131)
General Purpose collimators;
4.2.1.4 One Pinhole collimator with 4mm
and 6mm apertures;
4.2.1.5 Cart (or carts) for all collimators.

4.2.3. Gantry:
4.2.3.1 The gantry shall support variable
angle configurability of the detectors
including 90° and 180°;
4.2.3.2 Patient part diameter/aperture of
at least 70 cm;
4.2.3.3 Gantry-mounted persistence
display screen to assist in patient
positioning;
4.2.3.4 The System must incorporate the
ability to acquire contoured and un-
contoured WB imaging, and circular and
elliptical (contoured) SPECT acquisition;
4.2.3.5 Remote hand control for heads
and table movement.

4.2.4. Patient table:


4.2.4.1 The patient table shall be
composed of a low attenuation pallet and
a soft mattress;
4.2.4.2 The patient table shall have
motorized vertical motion activated from
the hand control;
4.2.4.3 Maximum patient load shall be at
least 180 kg;
4.2.4.4 Whole body scan length shall be
at least 200 cm;
4.2.4.5 Patient table shall allow
examination of seated and standing
patients and patients on wheelchairs;
4.2.4.6 Minimum patient table height
shall be ≤ 55cm for easy loading/
unloading of patients;
4.2.4.7 Rear bed patient pallet support
for minimizing of deflection;
4.2.4.8 Pediatric pallet and
immobilization kit for paediatric patients;
4.2.4.9 Touch screen flat panel monitor
for patient positioning display, and
display of different acquisition
parameters (time, count rate and also
information about detector and patient
table position;
4.2.4.10 Integrated ECG in patient table.

4.2.5. Safety features:


4.2.5.1 Emergency stop buttons on
gantry and patient table;
4.2.5.2 Patient contact sensors (touch
plates) mounted on each collimator;
4.2.5.3 Gantry linked to the patient table
and with necessary sensors to recognize
the patient table position at all times to
prevent accidental collisions.

4.2.6. Acquisition workstation:


4.2.6.1 Independent acquisition
workstation to be placed in the control
room, with hardware and software for
SPECT and CT acquisition, quality
controls and display;
4.2.6.2 LCD monitor of at least 19 inch;
4.2.6.3 Acquisition of a wide spectrum of
studies shall be possible, including:
4.2.6.3.1 Planar static
4.2.6.3.2 Planar dynamic
4.2.6.3.3 WB
4.2.6.3.4 SPECT
4.2.6.3.5 ECG gated planar and SPECT
4.2.6.3.6 SPECT/CT
4.2.7. CT scanner:
4.2.7.1 The CT must be integrated,
spiral, fully diagnostic, multi-slice, with
minimum four (4) slices;
4.2.7.2 The System must provide CT
data collection in support of both
SPECT/CT fusion for multi-modality
imaging and validated CT-AC SPECT;
4.2.7.3 3D CT dose modulation;
4.2.7.4 The possibility of sub 1 mm slice
thicknesses in Axial Mode;
4.2.7.5 The minimum CT slice thickness
during spiral acquisition mode shall be <
1 mm;
4.2.7.6 Patient part diameter/aperture of
at least 70 cm;
4.2.7.7 FOV of at least 50 cm;
4.2.7.8 Maximum voltage of at least
130kV;
4.2.7.9 Tube current in range 20-300
mA;
4.2.7.10 Maximum SPR length of at least
160 cm;
4.2.7.11 SPR scanning projections:
anterior-posterior (AP), posterior-
anterior (PA), lateral (LAT);
4.2.7.12 Time of one rotation during
spiral scanning, maximum 1 s;
4.2.7.13 Be capable of automatically
matching the CT slice thickness to the
SPECT slice thickness for accurate
image fusion and attenuation correction.

4.2.8. Processing workstation:


4.2.8.1 The processing workstation for
NM and CT images must be of the latest
technology, with adequate storage
capacity and be separated from the
acquisition workstation;
4.2.8.2 Full DICOM 3.0 compatibility
(send/receive, print, archiving,
query/retrieve, work list) with RIS/HIS
and PACS connectivity to the system
currently available at the End-User
location;
4.2.8.3 CD-DVD RW drive with ability
to archive data to CD and DVD in
DICOM Part10 format;
4.2.8.4 LCD color monitor, min. 24” and
1920x1200 resolution;
4.2.8.5 Adequate connection and
compatibility to color and film printer
(such as CODONICS);
4.2.8.6 Shall allow fusion with PET, MR
and/or CT data from external PACS
access

4.2.9. Software:
4.2.9.1. Clinical processing software and
comprehensive protocols for a wide
spectrum of static, dynamic, WB, SPECT
and ECG gated SPECT studies,
including:
4.2.9.1.1 Static renal imaging
4.2.9.1.2 Dynamic renal imaging
(renogram)
4.2.9.1.3 Myocardial perfusion imaging
4.2.9.1.4 Gated cardiac blood pool
imaging (MUGA)
4.2.9.1.5 Cardiac first pass imaging
4.2.9.1.6 Cerebral perfusion imaging
4.2.9.1.7 Lung ventilation and perfusion
imaging
4.2.9.1.8 Parathyroid imaging
4.2.9.1.9 Gastric emptying
4.2.9.1.10 Esophageal imaging
4.2.9.1.11 Emory tollbox or 4DM
SPECT.
4.2.9.1.12 Condensed dynamic images.

4.2.9.2. Ability to register CT images to


correct for motion between SPECT and
CT imaging (particularly for cardiac
applications); and to facilitate the use of
CT images taken in different scanning
sessions;
4.2.9.3. FBP and Iterative reconstruction
incorporating validated algorithms for
measured and calculated attenuation
correction, scatter correction, and
compensation for detector system
response;
4.2.9.4. Ability to correct for the
presence of metal prosthesis in CT
attenuation correction;
4.2.9.5. Ability to correct for the
presence of i.v. contrast in CT
attenuation correction;
4.2.9.6. Software needed for QC and
calibrations of the system, including:
4.2.9.6.1 Energy calibration (peaking)
4.2.9.6.2 PMT tuning
4.2.9.6.3 Uniformity
4.2.9.6.4 COR
4.2.9.6.5 Accuracy of co-registration of
SPECT and CT images
4.2.9.6.6 Daily QC/calibration of CT.

4.2.10. Ancillary equipment:


4.2.10.1. ECG trigger;
4.2.10.2. A means of support for the
patient’s shoulders and arms such as is
used for myocardial SPECT;
4.2.10.3. Low-attenuation removable
head support for brain SPECT permitting
immobilization of the head;
4.2.10.4. Equipment and phantoms
needed to perform manufacturer's
defined quality control tests and
calibrations, such as:

4.2.10.4.1 Energy calibration (peaking)


4.2.10.4.2 PMT tuning
4.2.10.4.3 Uniformity
4.2.10.4.4 COR
4.2.10.4.5 Accuracy of co-registration of
SPECT and CT images
4.2.10.4.6 Daily QC/calibration Phantom
for CT
4.2.10.5. Color laser printer (at least
2400 dpi resolution) with network
connection;
4.2.10.6. UPS shall be included to protect
the System from voltage surges and rapid
voltage changes. It shall also provide
support for adequate time to allow for
proper shut-down of the System (at least
5 minutes in standby mode).

4.2.11. NEMA performance


parameters:
4.2.11.1. Intrinsic flood field uniformity
with 20% energy window and 20kcps for
Tc-99m

4.2.11.1.1 UFOV Integral ≤ 3.8%


4.2.11.1.2 UFOV Differential ≤ 2.8%
4.2.11.2. Intrinsic energy resolution
(FWHM) at 140 keV:<10%;
4.2.11.3. Intrinsic spatial resolution
(FWHM) with 20% energy window and
20kcps for Tc-99m;

4.2.11.3.1 UFOV<4.1 mm;


4.2.11.3.2 CFOV<3.8 mm.
4.2.11.4. Count rate at 20% count loss: ≥
300 kcps;
4.2.11.5. For CT:

4.2.11.5.1 High contrast spatial


resolution better than14 lp/cm;
4.2.11.5.2 Image Uniformity: ±10 HU
for head and body;
4.2.11.5.3 HU/CT number accuracy
better: 0 ± 5 HU for water and 0 ± 10 HU
for other materials.
The System shall be of the current
newest version, state of the art and not be
obsolete within five (5) years of its
installation. The Contractor shall be
responsible for upgrading the System
otherwise.

4.3 4.3 Optional Requirements


At the option of the IAEA, the
Contractor shall also supply and deliver
the following:
4.3.1. Jaszczak SPECT Phantom;
4.3.2. Four quadrant bar phantom;
4.3.3. Rectangular Co-57 flood source
with activity of at least 555 MBq on the
day of delivery to the hospital. The active
dimensions of the flood source shall be
adequate for the detectors size;
4.3.4. Fully- or semi-automatic
collimator exchange system;
4.3.5. Ability to perform CT iterative
reconstruction.

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

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

8 Testing and Acceptance


8.1 Factory Acceptance Test (FAT): The
System, prior to shipment, shall be tested
for conformance of the System with
manufacturer’s performance
specifications and the minimum
requirements specified herein.
8.2 On-site Acceptance Test (SAT): The
results of the testing of the System shall
be documented by the Contractor in an
Acceptance Document that shall be
signed by the End-User

9 Installation and Training


The Contractor shall install the System at
the End-User location.
9.1 The Contractor shall be responsible
for installation and commissioning of the
requested System, including floor
protection, in case of damage, at the
installation site. The End-User will
provide the enabling works and services
specified in the Contractor’s planning
documentation to points of connection
within one (1) meter of the location
specified in the Contractor’s Final Site
Specific Drawings.

9.2 The Contractor shall provide one (1)


week on-site training to up to five (5)
staff of the End-User in the use of the
System.
The Contractor shall also provide factory
training for one (1) in-house biomedical
engineer, employed by the End-User, for
the purpose of maintaining and quality
control of the System to service level 2.
Such training shall be equal to the
training provided to the Contractor’s
/manufacturing company’s own service
staff.
The Contractor shall provide, as its
reference, site visit for up to two (2) End-
User staff to an institution with identical
System that has been in clinical
operations for at least six (6) months
(and preferably more than one (1) year).

10 Deliverable Data Items


The Contractor shall provide two (2)
complete sets of Operation and Servicing
Manuals and Technical Drawings in hard
copies and one (1) in electronic version
in the English language.
The Contractor shall provide Final Site
Specific Drawings no later than four (4)
calendar weeks after the signature of the
Contract.
11 Maintenance and Spare Parts
11.1. Maintenance
The Contractor shall also provide on-site
full maintenance services for one (1) year
during the warranty period, for the
proper functioning of the System.
Full maintenance services shall include:
- preventative maintenance
- on-call interventions
- any software update/upgrade for the
System that will become available
- all necessary replacement and spare
parts, if not covered under warranty

At the End-User request, the Contractor


shall provide up to five (5) additional
years of maintenance services following
the initial one (1) year full warranty
referred to above. The End-User shall be
responsible for the costs associated with
such additional years of maintenance
services.
As part of the On-Site acceptance, the
Contractor shall provide to the local
engineer and to the hospital medical
physicist a plan for preventative
maintenance and the name and contacts
of a service representative/office for on-
call maintenance intervention.
The Contractor shall ensure that a
suitable qualified person shall be On-Site
within forty-eight (48) hours following
an unexpected breakdown and shall solve
the problem within the next twenty-four
(24) hours during the warranty period.

11.2. Spare parts


Upon installation, an initial set of
essential spare parts for one (1) year
during the warranty period shall be
provided by the Contractor to be stored
at the Site. A list of available spare parts
and prices shall subsequently be
provided and updated as necessary.

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