Professional Documents
Culture Documents
Supporting
Proposed Inspection Date: 24-Oct-2023 Inspection time: 10am
Documents
Horizon W Bone
DST0051 Densitometer, Bone, Whole Body Hologic 307543M 1
Densitometer
SUB-CONTRACTOR CONTRACTOR
Engineer Engineer / CM QA/QC Representative Project Director
Requested by: Requested/Verified by: Verified by: Approved by:
Signature:
Company: Ali Bin Ali Medical Signature: Signature: Signature:
Name: Mr. Paulino Flores Name: Mr. Ibrahim Name: Mr. Rakesh NK Name: Mr. Alaaddin Aktan
Date: 23-Oct-2023 Date: 23-Oct-2023 Date: 23-Oct-2023 Date: 23-Oct-2023
EMPLOYER
Comments / Recommendation:
Employer Action Code: A (Approved) B (Approved with Comments) C (Revise & Resubmit) D (Rejected)
Note: To attach the Employer's comment response sheet after the inspection.
The approval and comments shall not in any ways relieve or absolve the Contractor from compliance of any obligations or liability under or in connection with the Contract, Project
Requirements and Specification.
MMC-HBK-QA-F024 Rev.0, Dated 12.09.2023 Page 1 of 1
MEDICAL EQUIPMENT
COMMISSIONING REPORT
MEQ INSTALLATION AND TEST REPORT DETAILS (to attached approval copy)
Installation and Test Report No. (ITR): MMC-HBK-AP-IR-MD-00098 Rev. No.: 0 Date: 23-Oct-23
COMMISSIONING
STATUS
SN ACTIVITIES
PASSED FAILED N/A
1 Software Integration
Consumables Check
2
(to be applied to the Consumables NOT inspected during the Testing phase)
Legend: Passed (Successfully Performed) Failed (Not Successfully Performed) N/A (Not Applicable)
DOCUMENTATION
Remarks:
Enclosures
1.a LIS
1.b RIS
1.c PIS
1.d PACS
1.e HIS / CIS
1.f Data Network connectivity
1.g Wireless Network connectivity
1.h Terminal Server integration
1.i Other #1:
1.j Other #2:
2 Software updated
3 Positioning
3.a Equipment positioned in the final location
3.b Equipment location is functional and operational
4 Accessories and consumables
4.a Expiry date of consumables subsequent commissioning date
4.b Accessories and consumables stored properly
5 Documents
5.a FDA/CE certification
5.b CoO (Country of origin) Certificate
5.c As-built Software configuration
5.d Operational and Service manuals uploaded on Aconex
6 Functional and Operational Verification
6.a Verification
6.b Image QA
6.c Functional and operational test as per the manufacture standards
6.d Test #1 not done in the RFIT:
6.e Test #2 not done in the RFIT:
Integration with other Medical equipment
7
Tag No. Item No. Item Description
7.a
7.b
7.c
7.d
7.e
8 Tags
8.a Electrical Safety Test Tag
8.b Inventory tag
8.c Battery check tag
9 ECRI/FDA recalls / clearance certificate to be attached
Legend: Passed (Successfully Performed) Failed (Not Successfully Performed) N/A (Not Applicable)
Notes
Supporting
Proposed Inspection Date: 22-Oct-2023 Inspection time: 10:00am
Documents
Location: Building: Zone: Level: Approved Drawing
B01 Z01 L0
Material Approval
MST / ITP
Room No.: Z1-L0-IMD-002 Room Name: BONE DENSITY Others
Horizon W Bone
DST0051 Densitometer, Bone, Whole Body Hologic 307543M 1
Densitometer
SUB-CONTRACTOR CONTRACTOR
Engineer Engineer / CM QA/QC Representative Project Director
Requested by: Requested/Verified by: Verified by: Approved by:
Signature:
Company: Ali Bin Ali Medical Signature: Signature: Signature:
Name: Mr. Paulino Flores Name: Mr. Ibrahim Name: Mr. Rakesh NK Name: Mr. Alaaddin Aktan
Date: 21-Oct-2023 Date: 21-Oct-2023 Date: 21-Oct-2023 Date: 21-Oct-2023
EMPLOYER
Comments / Recommendation:
Employer Action Code: A (Approved) B (Approved with Comments) C (Revise & Resubmit) D (Rejected)
Note: To attach the Employer's comment response sheet after the inspection.
The approval and comments shall not in any ways relieve or absolve the Contractor from compliance of any obligations or liability under or in connection with the Contract, Project
Requirements and Specification.
MMC-HBK-QA-F007 Rev.7, Dated 08.10.2022 Page 1 of 1
MATERIAL INSPECTION REQUEST (MIR)
Proposed Inspection Date: 3-Aug-2023 Inspection Time: 10:00 AM Location: HBK Site Store (On-site)
Supporting Documents: Material Approval Delivery Note Country of Origin Test Reports Others
Country of
Cad ID MEQ Item Description Manufacturer Model Quantity
Origin
Horizon W Bone
DST0051 Densitometer, Bone, Whole Body Hologic USA 1
Densitometer
SUB-CONTRACTOR CONTRACTOR
Engineer Store QA/QC Representative Project Director
Requested by: Requested/Verified by: Verified by: Approved by:
EMPLOYER
Comments / Recommendation:
1.) Refer attached HBK/SECO Comments
2.) Provide clarification regarding the COO.
3.) Packing list to be provided
4.) Final approval is subject to succesfull T&C and MOPH approval
Employer Action Code: A (Approved) B (Approved with Comments) C (Revise & Resubmit) D (Rejected)
Note: To attach the Employer's comment response sheet after the inspection.
This document shall not relieve Contractor of his liabilities under the Contract or constitute authorization of any change to Contract documents.
E
N
B07 B08
S
N
LA
.63
W
QIB
252
B14
B09 B05
B02 B03
B01
B06
B12 B13
B11
B10
B04
3713
1715 1998
GENERAL NOTES
PROJECT REFERENCE ELEVATION ±0.00 IS AT +27.50 QATAR NATIONAL DATUM. ELEVATIONS SHOWN
ARE WITH RESPECT TO THE PROJECT REFERENCE ELEVATION OF ±0.00 AT GROUND FLOOR.
ALL DIMENSIONS ARE IN MM UNLESS NOTED OTHERWISE.
DO NOT OBTAIN DIMENSIONS BY SCALING FROM DRAWINGS.
REFER TO TOPOGRAPHICAL SURVEY MMC-HBK-AP-AD-GI-L0-AZ-1001_1015 BY GSL FOR ORIGIN OF
LEVELS.
THIS DRAWING SHALL BE READ IN CONJUNCTION WITH ALL DRAWINGS, ENGINEERING
1. SPECIFICATIONS, ALL OTHER CONSULTANT DOCUMENTATION, AND ALL OTHER WRITTEN
INSTRUCTIONS WHICH MAY BE ISSUED DURING THE COURSE OF THE CONTRACT.
2. CONTRACTOR TO COORDINATE AS PER SITE CONDITIONS.
3. IN THE EVENT OF CONFLICT BETWEEN DRAWINGS DATA & SPECIFICATION DATA. THE
DST0051b 4.
5.
SPECIFICATION SHALL GOVERN. DETAIL DRAWINGS TAKE PRECEDENCE OVER DRAWINGS OF
SMALLER SCALE. SHOULD THE CONTRACTOR AT ANYTIME DISCOVER AN ERROR IN A DRAWING OR
SPECIFICATIONS, OR A DISCREPANCY OR VARIATION BETWEEN DIMENSIONS ON DRAWINGS &
MEASUREMENT AT SITE, OR LACK OF DIMENSIONS OR OTHER INFORMATION CONTRACTOR SHALL
SCL0549 STL0112 6.
REPORT AT ONCE TO THE ARCHITECT FOR CLARIFICATION AND SHALL NOT PROCEED WITH THE
WORK AFFECTED UNTIL CLARIFICATION HAS BEEN MADE.
306
750
KEY PLAN 1
10 10.1 17 17.1
26
788
A
P01 P02 P03 P04 P05 A
P2.1 P3.1
P16
P06 P07 P08
P18
F
P19 P3.A
HAM0009 P2.F
P2.1
P17
P09 P10 P11
P20
P3.1
P3.F
1410 6 13 13.1 21
REFERENCE DOCUMENTS
2857
2020
2404 DST0051 MILITARY MEDICAL CITY HOSPITAL - AL SAILIYAH
Approved as
Commented
C Re-Submit
A Approved
D Rejected
Revise &
3402 Authority Signature Date
5075
B
MMC-PMO
A The approval and comments shall not in any ways relieve or absolve the
Contractor from compliance of any obligations or liability under or in connection
with the contract, project requirements and specifications.
3402
2326 2 DEXA HOLOGIC SAMPLE IMAGE 1 ISSUED FOR CONSTRUCTION 03/05/2023 ABAM ABAM PR SG
LEAD CONSULTANT:
HOLOGIC MEINHARDT
DST00521b 'HORIZON W' 34kg 610mm 670mm 1190mm 14TH FLOOR AMWAL TOWER WESTBAY
P.O. BOX 1362 DOHA, QATAR
OPERATOR CONSOLE TEL: (974) 44117840 FAX: (974) 4411 7845
HOLOGIC
DST00521 'HORIZON W' 3400 311kg 2020mm 1287mm 1420mm
TABLE MEDICAL PLANNER: MEDICAL EQUIPMENT : SUBCONTRACTOR :
MEQ-3401 SCALE: 1:15 MINIMUM RECOMMENDED CORRIDOR WIDTH 1300mm HAVE BEEN VERIFIED.
STATUS:
ABAM PRABHU
ABAM
DESIGNED SCALE A1
MMC-HBK-P1-WD-B01-MEQ-L0-P06-3401 1
E
N
B07 B08
S
N
3712
LA
.63
W
QIB
252
B14
3712 B05
2400 B09
2400 B02
B01
B03
B06
B12 B13
B11
B10
B04
ITEM DESCRIPTION
105
DEDICATED WALL SOCKET 230V, 13 AMP, 1PH H@500MM
150x100mm TRUNKING BY HBK
HOSPITAL GRADE 2X DUPLEX OUTLET FROM PDB
EMERGENCY 25mm GI CONDUIT FOR WITH ISOLATED GROUND.
1000
160 25mm GI CONDUIT FOR GENERAL NOTES
STOP SWITCH BY HBK PDB - Power Distribution WALL SOCKET FROM PDB PROJECT REFERENCE ELEVATION ±0.00 IS AT +27.50 QATAR NATIONAL DATUM. ELEVATIONS SHOWN
845
ARE WITH RESPECT TO THE PROJECT REFERENCE ELEVATION OF ±0.00 AT GROUND FLOOR.
+1500mm aFFL box by HBK EMERGENCY STOP FROM PDB DEDICATED FLOOR SOCKET 230V, 13 AMP, 1PH H@500MM ALL DIMENSIONS ARE IN MM UNLESS NOTED OTHERWISE.
DO NOT OBTAIN DIMENSIONS BY SCALING FROM DRAWINGS.
REFER TO TOPOGRAPHICAL SURVEY MMC-HBK-AP-AD-GI-L0-AZ-1001_1015 BY GSL FOR ORIGIN OF
1941 HOSPITAL GRADE 2X DUPLEX LEVELS.
THIS DRAWING SHALL BE READ IN CONJUNCTION WITH ALL DRAWINGS, ENGINEERING
1. SPECIFICATIONS, ALL OTHER CONSULTANT DOCUMENTATION, AND ALL OTHER WRITTEN
INSTRUCTIONS WHICH MAY BE ISSUED DURING THE COURSE OF THE CONTRACT.
2. CONTRACTOR TO COORDINATE AS PER SITE CONDITIONS.
3. IN THE EVENT OF CONFLICT BETWEEN DRAWINGS DATA & SPECIFICATION DATA. THE
FLOOR DATA POINT. 4. SPECIFICATION SHALL GOVERN. DETAIL DRAWINGS TAKE PRECEDENCE OVER DRAWINGS OF
SMALLER SCALE. SHOULD THE CONTRACTOR AT ANYTIME DISCOVER AN ERROR IN A DRAWING OR
150
150
5.
1715
2 SPECIFICATIONS, OR A DISCREPANCY OR VARIATION BETWEEN DIMENSIONS ON DRAWINGS &
MEASUREMENT AT SITE, OR LACK OF DIMENSIONS OR OTHER INFORMATION CONTRACTOR SHALL
REPORT AT ONCE TO THE ARCHITECT FOR CLARIFICATION AND SHALL NOT PROCEED WITH THE
POWER DISTRIBUTION BOARD 6. WORK AFFECTED UNTIL CLARIFICATION HAS BEEN MADE.
A
P01 P02 P03 P04 P05 A
P2.1 P3.1
B
V V
3402 6 13 13.1 21
3975
WARNING LIGHT CONNECT TO THE
MACHINE LEFT SIDE BOTTOM
CORNER OF MACHINE by HBK
ELECTRICAL USE REQUIREMENTS
Approved as
Commented
C Re-Submit
A Approved
D Rejected
Revise &
PHYSICAL AND ENVIRONMENTAL REQUIREMENTS Authority Signature Date
B
OPERATING TEMPERATURE RANGE 15° C TO 32° C (59° F to 90° F) MMC-PMO
OPERATING HUMIDITY RANGE 20% TO 80% NON-CONDENSING The approval and comments shall not in any ways relieve or absolve the
Contractor from compliance of any obligations or liability under or in connection
with the contract, project requirements and specifications.
MAXIMUM APPARENT LINE RESISTANCE (OHMS) 1.28 0 ISSUED FOR CONSTRUCTION 03/02/2023 ABAM ABAM PR SG
REV REVISION DETAILS DATE DWN DES CHD APD
EMPLOYER
DESCRIPTION:
WARNING LIGHT = STANDARD BOX WITH "X-RAY ON" QATAR ARMED FORCES
MILITARY MEDICAL CITY HOSPITAL PROJECT
MANAGEMENT OFFICE P.O. BOX 2075 DOHA,
RADIATION WARNING (CONDUITS SUPPLIED & INSTALLED BY HOSPITAL'S ELECTRICAL CONTRACTOR.)
QATAR
LIGHT BY HBK
RADIATION WARNING MAIN CONTRACTOR:
LEAD CONSULTANT:
SHOP DRAWING NOTES
1
MEINHARDT
14TH FLOOR AMWAL TOWER WESTBAY
P.O. BOX 1362 DOHA, QATAR
· REVISION ON FLOOR TRUNKING AND POWER AND DATA SOCKET TEL: (974) 44117840 FAX: (974) 4411 7845
25mmØ CONDUIT
to PDB by HBK
CEILING LINE
PROJECT TITLE:
100
WALL SOCKET FROM PDB HAVE BEEN VERIFIED.
2010 04/05/2023
500
WORKING DRAWING
Through this letter, we confirm that Hologic BV, located at The Corporate Village, Building Caprese,
8th Floor, Da Vincilaan 5, 1930 Zaventem, Belgium, is the Authorized European Representative of
Hologic, Inc., located at 36 Apple Ridge Road, Danbury, Connecticut 06810, United States of
America.
Further, that Flextronics Manufacturing, located at Boulevard a Zacatecas Km. 9.5, Jesus Maria,
Aguascalientes 20900, Mexico, physically manufactures Horizon DXA devices on behalf of Hologic
Inc., Danbury, who is the legal manufacturer of these devices.
As such, we Hologic BV are authorized to register Horizon DXA in Hologic Inc., Danbury’s name
through all Europe, Middle East, and Africa.
Sincerely,
Hologic BV, The Corporate Village, Building Caprese, 8th floor, Da Vincilaan 5, 1930 Zaventem, Belgium
T: +32 2 711 46 80 | F: +32 2 725 20 87 | Hologic.com
BNP PARIBAS FORTIS, IBAN BE75 2100 8769 7651, BIC BEBABEBB, BTW: BE 0445 434 787, RPR Brussel: 0445 434 787
1 Consignor - Expéditeur - Afzender - Absender
ORIGINAL
DSV Solutions, Eddastraat 21, 9042 St-Kruis-Winkel, België ORIGINEEL
= = = = = = = = = = = = On behalf of: = = = = = = = = = = = = 93 2023 016556
Hologic BV, Building Caprese, 3rd Floor Da Vincilaan 5, 1930
Zaventem, Belgium EUROPEAN UNION
UNION EUROPEENNE
2 Consignee - Destinataire - Geadresseerde - Empfänger EUROPESE UNIE
EUROPÄISCHE UNION
6 Item number; marks, numbers, number and kind of packages; description of goods 7 Quantity
No d'ordre; marques, numéros, nombre et nature des colis; désignation des marchandises Quantité
Volgnummer, merken, nummers, aantal en aard van colli; omschrijving van de goederen Hoeveelheid
Laufende Nummer; Zeichen, Nummern, Anzahl und Art der Packstücke; Warenbezeichnung Menge
8 THE UNDERSIGNED AUTHORITY CERTIFIES THAT THE GOODS DESCRIBED ABOVE ORIGINATE IN THE COUNTRY SHOWN IN BOX 3.
L'AUTORITE SOUSSIGNEE CERTIFIE QUE LES MARCHANDISES DESIGNEES CI-DESSUS SONT ORIGINAIRES DU PAYS FIGURANT DANS LA CASE NO 3.
ONDERGETEKENDE AUTORITEIT VERKLAART DAT DE HIERBOVEN VERMELDE GOEDEREN VAN OORSPRONG ZIJN UIT HET IN VAK 3 GENOEMDE LAND.
DIE UNTERZEICHNENDE STELLE BESCHEINIGT, DASS DIE OBEN BEZEICHNETEN WAREN IHREN URSPRUNG IN DEM IN FELD 3 GENANNTEN LAND HABEN.
Oost-Vlaanderen
8/08/2023
93 2023 016556
Pascal Buysse
09B3-C6AE-593A
Place and date of issue; name; signature and stamp of competent authority.
Lieu et date de délivrance; désignation, signature et cachet de l'autorité compétente.
Plaats en datum van afgifte; aanduiding, handtekening en stempel van de bevoegde autoriteit.
Ort und Datum der Ausstellung; Bezeichnung, Unterschrift und Stempel der zuständigen Stelle.
E4-0061
Packages as Per MOD Packages as Per Packages as Per
Department Dept Ref ID Room Name Room # CAD ID Description ItemQty Arch Code Supplier Manufacturer Model Serial No.
Contract MAT RBR
Imaging & Dental Radiology Imaging Diagnostic Ground Densitometer, Bone, HORIZON W BONE
BONE DENSITY Z1-L0-IMD-002 DST0051 1 1-Fixed ABAM Hologic 307543M
Package Package Packages Imaging Floor Whole Body DENSITOMETER
Powerful images.
Clear answers.
Horizon® DXA System: An Innovative Solution
for Accurate Diagnosis
Hologic, the pioneer in X-ray based bone densitometry, takes advanced health
assessment to a new level with the Horizon DXA system. This multi-faceted system
can help clinicians assess bone health, body composition and cardiovascular risk —
critical elements that will help patients keep life in motion.1
The Horizon DXA system features the latest innovations in bone densitometry
technology; including a new digital high resolution ceramic detector array, as well as a
new high frequency X-ray Generator.2 When paired with our exclusive OnePass™ true
fan-beam acquisition geometry, Horizon DXA system delivers rapid, dual-energy bone
density measurements in a single-sweep, eliminating beam overlap errors and image
distortion found in rectilinear acquisition techniques. We’ve also improved our Dynamic
Calibration™ System, which delivers pixel-by-pixel calibration2 through bone and tissue
equivalents — for greater long-term precision.3
Lumbar Spine Lumbar Spine Lumbar Spine Lumbar Spine Lumbar Spine
Supine Lateral BMD Decubitus Lateral BMD Decubitus Lateral BMD Decubitus Lateral BMD Decubitus Lateral BMD
Dual Hip Dual Hip Dual Hip Dual Hip Dual Hip
Proximal Femur Proximal Femur Proximal Femur Proximal Femur Proximal Femur
Hip Structure Analysis Hip Structure Analysis Hip Structure Analysis Hip Structure Analysis Hip Structure Analysis
Custom Region Custom Region Custom Region Custom Region Custom Region
of Interest of Interest of Interest of Interest of Interest
The Horizon DXA system packs a lot of performance into a small footprint. Operating from existing dedicated
power sources, the system fits comfortably in an 8’ X 8’ exam room (8’ X 10’ for whole body models) and
requires no protective shielding or special room preparations.*
*Installation requirements for X-ray equipment vary. Check with local regulatory authorities.
References
1. K023398, K041226, K042480, K130277 (AFF), K113356(VAT), K103265(Whole Body), K072847 (AAC), K060111 (AAC) 2. K023398 3. Hangartner, TN. A study
of long-term precision of dual energy X-ray absorptiometry bone densitometers and implications for the validity of the least-significant-change calculation.
Osteoporosis Int. 2007
DS-00382 Rev. 006 © 2019 Hologic Inc. All rights reserved. Printed in USA. Specifications are subject to change without prior notice. Hologic, Advanced Body Composition, APEX, Dual Hip, Dynamic Calibration,
Express Exam, Hip Structure Analysis, Horizon, InnerCore, IRIS, IVA, MXApro, OnePage, OnePass, OneTime, Physicians Report Writer DX, Physicians Viewer, QDR, The Science of Sure and associated logos are
trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks and registered trademarks are the property of their respective
owners. This information is intended for medical professionals in the U.S. and other markets and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic
materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For
specific information on what products are available for sale in a particular country, please contact your local Hologic representative or
write to womenshealth@hologic.com.